Medical Plastics Data Service July - August 2018

CToabnletoef nts Vol. 26 No. 4 July - August 2018 18 COVER STORY Clean Room Environment For Medical Devices – ISO 14644 - Sanjay Shah, CEO, Unikal Consultants The Need for Clean Rooms; The Attributes to Create and use a Clean-Room; What keeps Cleanroom “Clean”?; Designing Air Handling Units; Clean Room Certification; ISO 14644. Injectionnique Moulding Machines For Clean Room Applications - Ankur Agarwal, Marketing Communications, Milacron India All-Electric Injection Moulding Machine is developed to comply with clean room standards. Ma chine eliminates hydraulic components and circuits thereby enhancing the degree of transmission efficiency and reduced losses. Removal of hydraulic oil also results in No Contamination of product. Simplifying Setting-up Of Plastic Processing Clean Room By : Medline Department, The Conair Group, USA Depending on the products being manufactured, medical plastic processors have adopted several different configurations for clean environments. Each requires a different level of cleanliness. 27 MATERIALS Polymer Compounds For Medical Devices R C Gupta, Sr. General Manager, KLJ Polymers & Chemicals Ltd. The use of PVC compounds in medical device manufacture for more than 50 years has demonstrated its great ability to satisfy the demanding requirements of the medical health care industry. 37 MANUFACTURING Design Control : Importance and Regulatory Aspects. Anil Chaudhary, CEO, Operon Strategist The Design and Development of the product play vital role in total life cycle of product and to ensure the effective and safe product in market. The well-planned and documented approach is expected while conducting the design and development (D and D) activity. The design control initiates at..... 41 Global Market Insights : Snapshots Medical Polymers, Medical Injection Molding , Medical Device Contract Manufacturing. PVC Hospital Waste Recycling 43 AiMeD & REGULATORY UPDATES • Rs.100 Crore Central Aid Package To Help Medical Device Parks To Set Up Common Facilities • Indian Pharmacopoeia Commission ( PC ) issues first 'Standards for Medical Devices • Govt amends Medical Devices Rules : all NABL-accredited labs can issue performance report on IVDs • Use Auto-Disable Syringes to Prevent Infection : Medical devices industry official 45 INDUSTRY NEWS • Mitsubishi expanding Indian footprint with PVC business acquisition • Covestro Strengthens its Global Film Production • AMTZ sets up Centre for Bio-Materials Testing • India, US move a step closer : Trade Issues including Medical Devices. 46 PRODUCT GALLERY • New Closed Male Luer Lock Valves / New Line of Tyvek® Sterilization Supplies July-August 2018 16 DID YOU KNOW? • Why Clean Room Is Important For Medical Plastics Manufacturing 39 EVENTS CALENDER • Medicall : 21-23 September, 2018 / Medica / Compamed : 12 - 15 Nov. 2018 • IMDI 2018 / 15th National Conference And Technology Exhibition On Indian Medical Devices & Plastics Disposables / Implants Industry 2018 : 26-27 October, 2018 • Medical Fair India 2019 : 21-23 February, 2019 / K 2019 : 16 – 23 Oct., 2019 15

Flashback ?YoDKuindow ? Select Article Index Why Clean Room Is Important For Medical Plastics Manufacturing Jan. 2009 to June. 2009 Unlike other industrial sectors, Medical Device components manufacturing is • Marketing : A Marketing Approach To Over- highly specialized , carrying specific requirements for sterility and regulatory come Recession accountability .This makes it essential for the Medical Device Manufacturers (January – February 2009) to have clean room manufacturing for their molded plastic parts/components. • Market Research : Medical Plastics – Future Clean rooms are classified by International Organization for Standardization Needs From The Perspective Of The Medical (ISO). Clean rooms are enclosed and environmentally-controlled spaces in Device Manufacturing which temperature, humidity, pressure and contaminant levels are kept within (January – February 2009) strict limits. It helps to ensure that products remain under controlled contami- Dr.VinnySastri, President, WINOVIA (R) LLC, nation levels throughout the production process, thereby reducing potential USA risks to patients. Therefore, appropriate clean room designs, and the imple- mentation of personnel policies and procedures that control work within the • Manufacturing : Needle Bonding with Epoxy clean room environment, are critical for the production of safe devices. Adhesives (January – February 2009) Particles found in the clean room include those created by the manufacturing Timothy E. Zack, Engineered Materials equipment, as well as particles already in the room. In regards to plastics Systems, Inc., USA manufacturing for medical devices, injection moulds are a source of contami- nants, especially if the moulds are not properly maintained. Other clean room • Global Trends : CBI Export Guidelines contamination sources specific to plastics are dust that is released during (January – February 2009) production and contaminated raw materials. • Did You Know ? : About Paediatric Medical Basic clean room practices include : Device Institute • Developing a thorough clean room gowning requirements and procedures. (January – February 2009) • Ensuring the correct clean room supplies are present and they are used • Cover Story : Changing Scenario For properly. Medical Device Industry Regulations In India • Instituting clean room housekeeping procedures and schedules. Preventa- (March – April 2009) Mr. Rajiv Nath, Forum Coordinator - Associa- tive maintenance is very useful, especially for plastic mould injection equip- tion of Indian Medical Device Industry (AIMED) ment to reduce contaminants that are produced during the process. and Managing Director, Hindustan Syringes & • Training personnel on behavioral standards within the clean room environ- Medical Devices Ltd. ment. • Continuously auditing and assessing clean room procedures and making • Quality : Quality Assurance Concept in improvements as needed. Medical Devices (March – April 2009) Micro-organisms, dust/smoke, unapproved equipment, inadequate environ- Dr. G. L. Jain, Centre for Active Learning, Guid- mental controls and human error are among leading causes of contamination ance & Solutions in clean rooms. Research has shown that clean room personnel contribute to approximately 80% of all contamination that is found within the clean room. • Quality : Safety Assessment of Medical Devices and GLP Complaint Studies In a (March – April 2009) Nutshell.... Mr.NarendraDeshmukh, Director, Intox Pvt. Ltd. “If facts are the seeds that later produce knowledge and wisdom, • Global Trends : Medical Device Regulations: then the emotions and the impressions Quality System Requirements (March – April 2009) of the senses are the fertile soil in which the seeds must grow.” • Did You Know ? : About Shared responsibil- ity for medical device safety and performance - Rachel Carson (March – April 2009) July-August 2018 • Cover Story : A General Overview Of Silicones Used In Medical Devices (May – June 2009) Mr. Bill Riegler, General Manager - Asia, Nusil Technology LLC, USA • Cover Story : Non-Woven Medical Disposable Products And Its Disposable Techniques (May – June 2009) 16

EDITOR FromDtheeEsdkitor’s D.L.PANDYA, B.E.(Chem), M.I.E. Growing Importance Of Clean Room Manufacturing In Medical Device Industry EDITORIAL ADVISORY BOARD The focus of this issue along with other important Medical Dr. TARANG PATEL Device Manufacturing aspects is on “Clean Room Manufactur- M.B.B.S., M.Ch. (ONCO) ing” - be it end products, raw materials or components. There Cancer & Reconstructive Surgeon are many factors responsible for growing importance of clean including stringent healthcare / medical device industry regulations and demand for Mr. C. BALAGOPAL quality products. Director - Enter Technologies Pvt. Ltd. Chairman - Mobilexion Technologies Pvt. Ltd. The issue is very elaborately explained by experts covering different stages of manufacturing. To start with, Mr Sanjay Shah of Unikal Consultants has given a very Trivandrum thorough overview on the Purpose / need for clean rooms, the sources responsible for generation of particles and other impurities, how clean rooms work, effective Dr. DILIP H. RAIKER ways of maintaining air quality, international standards and clean room Ph.D., M.Sc., PGDBM, AMIE (Chem.Engg.) certifications. Former Chief Manager(P), CIPET - Chennai Injection moulding is an integral part of Medical Device manufacturing. In a very ING LOUIS C. SUHUURMAN detailed article , Mr Ankur Agarwal of Milakron India, has given explanation of clean Formerly Sales Director room systems with focus on various technologies with respect to Injection Moulding. COLPITT B.V., Holland In another informative article by Medline Department of Conair Group, USA, a very Dr. A.V. RAMANI analytical detailing of process of specifying, buying, installing, qualifying and Group Sr. Vice President (R&D), The TTK Group operating Plastics Auxiliary Equipment in a clean room. Dr. Vinny Sastri Extending to the materials aspect, Mr R C Gupta of KLJ Polymers & Chemicals Ltd, President, Winovia LLC, U.S.A. introduces the unique position the versatile material, PVC in compounded form has achieved for the benefit of Medical Device Industry. Further, Mr Anil Chaudhary of Dr. C.S.B. NAIR Operon Strategist has contributed a very well researched article on Importance and Director (R&D), Peninsula Polymers Ltd Regulatory aspects related to Design Control in order to ensure effective and safe product in the market. Dr. BHARAT GADHAVI CEO, HCG Medisurge Hospitals This issue also highlights regular features including ,”AiMED & Regulatory Updates”, Industry News, Global Trends, Events and more. Mr. A.S. ATHALYE Arvind Athalye Technology Transfer Pvt.Ltd, Mumbai We Invites all stake holders of the Industry to participate in IMDI 2018 (www.imdiconferences.com) - The 15th National Conference and Technology Dr. SUJOY K. GUHA Exhibition on “Indian Medical Devices & Plastics Disposables / Implants Industry B.Tech.(Hon), M.Tech., M.S., Ph.D., M.B.B.S. 2018” to be held on October 26-27, 2018 at Ahmedabad. IIT, Kharagpur This annual event, being organized since 2001, is widely supported by leading Industry Associations in Medical Devices, Pharma and Plastics sectors has been Dr. G. S. BHUVANESHWAR organized with a mission to create a platform for the Indian Medical Device Industry Consultant, Medical Devices – Design, development, for sharing knowledge , Brain Storm and Network. I has also proved to be an effective media for the Industry to interact with Technology / Products / Service testing and quality management. Providers. Adjunct Professor, Dept. of Engineering Design, Indian The participation of students of life science courses in this event is an effort to Institute of Technology, Madras. create Industry – Institute Interaction. The “SUSHRUTA INNOVATION AWARD” (SIA) competition being organized as part of this event is an attempt to recognize PUBLISHED BY : and appreciate students with innovative ideas and concepts having wider applicabil- ity to the Society for development of Medical Technology Products. Classic Computer Services B-4, Mandir Apts., Opp. P&T Colony,Jodhpur Char Rasta Ahmedabad-15, India Ph:+91 79-26740611 Fax: +91 79-26754867 E-mail: [email protected] Website : www.medicalplasticsindia.com Reg. No. GUJ-ENG-00446/23/ALL/TC/94 dt. 3/8/94 DESIGNED AND PRINTED BY : Image Virtual Creation, Ahmedabad-54 •Ph:098795 55948 Notice: Every precaution is taken to ensure accuracy of content. However, the publishers cannot accept responsibility for the correctness of the information supplied or advertised or for any opinion expressed herein. July-August 2018 17

Cover Story Clean Room Environment For Medical Devices - ISO 14644 Sanjay Shah, Managing Director Unikal Consultants, Ahmedabad Introduction Like anything technical, how a cleanroom works is essentially basic, but wrapped up in a whole lot of jargon, standards, rules What is the purpose of a clean room? and regulations. The basic principles are actually perfectly understandable. The purpose of every clean room is to control an environment by limiting the presence of sub-micron particles and modifying Cleanrooms do not eliminate contamination altogether. They inadequate environmental conditions. The level to whichthe control it to an acceptable level. How do they do this? environment is controlled is what separates one clean room from There are three things that keep a cleanroom “clean”: another. 1. The internal surfaces of the cleanroom and the equipment For instance, a Class 10 clean room has 10 particles of size 0.5 within; microns per cubic foot of air, where as a Class 100,000 clean room has 100,000 particles of size 0.5 micron per cubic foot of 2. The control of air through the cleanroom; air. 3. The way the cleanroom is operated. The need for clean rooms : Each of the three things above is as important as the other. The electronic, high-tech, semiconductor, pharmaceutical, Let’s look at them in more detail. aerospace, medical and many other industries depend on clean room technology. As products such as cell phone circuit Everything in a cleanroom should be “smooth and impervious”. boards become smaller, the chance of contamination in The whole idea is to have surfaces that: manufacturing becomes higher. • Don’t generate their own contamination ie, don’t create dust, For pharmaceutical and medical device manufacturing compa- or peel, flake, corrode or provide a nice place for bugs to grow nies, clean, safe and contaminant-free products are imperative to manufacturing and distributing a viable product. • Are easy to clean i.e., all surfaces are easily accessible and are easily decontaminated What are the attributes to create and use a clean-room : The largest threat to contaminate devices is personnel working • Are rigid and robust and won’t crease, crack, shatter or dent on processing them! easily. Why? The following statistics have been taken from \"The Austin Index\" to illustrate personnel contamination. This means that a painted wall is better than a bare brick wall; a stainless steel bench is better than a wooden one. Personnel sampled were fully clothed in clean room garments and engaged in one of the following: Cleanrooms need a lot of air. As a general rule of thumb, the cleaner the cleanroom needs to be, the more air it will need to 1. Standing or sitting with no movement resulted in 100,000 use. particles/minute 0.3 microns or larger Air handling systems are designed to circulate air through the 2. Sitting or standing, light head, hand and forearm movement room, removing contamination as air is generated and keeping resulted in 500,000 particles/minute, 0.3 microns and larger the temperature and humidity stable. 3. Sitting or standing, average body and arm movement, toe Particles (contamination) in the air tend to either float around or tapping, resulted in 1,000,000 particles / minute, 0.3 microns slowly settle to the ground, depending on how big they are. The and larger air handling system delivers air into the room in such a way that it captures any particles and sweeps them out of the room. The 4. Changing positions, sitting to standing, resulted in 2,500,000 air taken out of the room and is usually re-circulated through the particles/minute, 0.3 microns or larger. air handling system where filters remove the contamination. Typically, the air is then recycled back into the room. 5a. Slow walking (2 mph), 5,000,000 particles/minute, 0.3 microns and larger. The amount of air we put into the room is important as well. As noted earlier, generally the cleaner the cleanroom the more clean 5b. Average walking (3.57 mph), 7,500,000 particles/minute, air you will need to put in. The more air that goes in, the faster 0.3 micron and larger. the room cleans itself. This can be important for rooms that occasionally experience high amounts of contamination, or some- 5c. Fast walking (5 mph) 10,000,000 particles/minute, thing like a sampling room or dispensary where the room needs 0.3 microns and larger to be cleaned quickly between operations. So, as the amount of air introduced into a cleanroom is tightly controlled, so is the 6. Climbing stairs, 10,000,000 particles/minute, 0.3 microns and amount of air that is taken out. Generally cleanrooms are pres- larger surized, which is achieved by taking out slightly less air than is Let’s see how clean room works to maintain defined July-August 2018 standards: 18

Cover Story from Federal Standard 209 E, at the same time there are some significant differences that affects medical device and put in. The extra air then leaks out under the door or through the pharmaceutical manufacturers. tiny cracks or gaps that are inevitably in any cleanroom. As a rule, within a facility the area you need to be the cleanest oper- ISO 14644-1 primarily addresses the cleanroom classification ates at the highest pressure. The flow of air out of the cleanroom system and the ISO 14644-2 contains specifics on \"how\" to test helps to stop any external contamination from getting in. and monitor clean-rooms or clean zones for compliance. A good air handling system makes sure that air is kept moving ISO 14644 International clean-room standard:- throughout the cleanroom. The properly locating where the air is Part 1 was first published in 1999. It is a 12 part standard. brought in and taken out is the key to good cleanroom design. It is applicable to Electronics, healthcare, biotechnology, phar- The location of the supply and return air should take the highest maceuticals. It replaced FS 209E in 2001 and this was Accepted priority when laying out the room. by EU GMP in 2003 for classification but not monitoring of clean room and FDA aseptic filling guide in 2004. The most effective way of maintaining the air quality in a cleanroom is to operate it properly. This involves : What is the content of these standards series? • minimizing the amount of contamination that escapes from your ISO 14644-1 - Classification of air cleanliness ISO 14644-2 - Specifications for testing and monitoring to prove manufacturing operations continued compliance by ACP. Both parts deal with particles only • strictly controlling access to the cleanroom to trained Details are given below with reference to each of these parts. They are divided in two # 1 & 2 personnel – people are the largest source of cleanroom contamination ISO 14644-1:2015 - Part 1: Classification of air cleanliness • regularly cleaning your cleanroom to strictly controlled Explanation: Classification is the process of qualifying cleanroom procedures environment by number of particles using a standard method. • regular maintenance of equipment This was we can determine classification of clean-room accord- • regular monitoring of the filters and air flows and frequent ing to standards e.g. Room x is ISO class y. This is distinct from recertification of the cleanroom. routine environmental monitoring and also distinct from process monitoring e.g. ongoing assessment of aseptic filling. This requires defining the number of times the air is changed within a cleanroom. It is simply calculated by taking the total ISO 14644-2:2015 - Part 2: Specifications for testing and volume of air introduced into the cleanroom over an hour and monitoring to prove continued compliance with ISO 14644 dividing it by the volume of the room. ISO 14644-3:2005 - Part 3: Test methods ISO 14644-4:2001 - Part 4: Design, construction and start-up HEPA is one of the most important elements of a cleanroom. ISO 14644-5:2004 - Part 5: Operations They are large, box shaped filters that remove contamination very ISO 14644 – parts #2 : ISO 14644-6: 2004 - Vocabulary efficiently, but they take quite a bit of energy to push the air through ISO 14644-7:2004 - Part 7: Separative devices (clean air hoods, them. They must also be monitored and tested regularly to make glove-boxes, isolators and mini-environments) sure they are still integral. ISO 14644-8:2013 - Part 8: Classification of air cleanliness by chemical concentration (ACC) DOP testing or integrity testing is a testing procedure to ensure ISO 14644-9:2012 - Part 9: Classification of surface cleanliness that a HEPA filter has no holes and is properly sealed in its frame. by particle concentration ISO 14644-10:2013 - Part 10: Classification of surface cleanli- A micron is a millionth of a metre. A human hair is around 100 ness by chemical concentration microns thick. Bacteria are 1 or 2 microns wide. Particles less No part 11 in draft than 50 microns cannot be seen by a naked eye. ISO 14644-12:draft - Part 12: Classification of air cleanliness by nanoscale particle concentration An airlock is a room where personnel, materials or equipment ISO 14644-13:draft - Part 13: Cleaning of surfaces to achieve are transferred to a cleaner environment. It can be the size of a defined levels of cleanliness in terms of particle and chemical small box, through to a large room where personnel change into classifications and out of cleanroom garments. ISO 14644-14:draft - Part 14: Assessment of suitability for use of equipment by airborne particle concentration Grades A through to D refer to cleanroom cleanliness for the Pharmaceutical Industry for European, Australian and some Asian ISO 14644 Became live in December 2015. Thus it forms the countries. Grade A is the cleanest, for sterile operations, through latest guideline standard/s for clean rooms. to Grade D for packing or support operations. These Grades can be related to the ISO Classes. The clean room environment is defined further with its Occupancy states Thus there is a need to use clean room technology to reduce the contamination which will ultimately affect cleanliness of the prod- If it is as built: condition where the installation is complete with uct and in our case medical device being manufactured in the all services connected and functioning but with no production environment. equipment, materials, or personnel present Cleanliness level is classified under specific conditions. Before the use but at rest: condition where the installation is The cleanliness of a clean room is measured by the size and complete with equipment installed and operation in a manner number of dust particles in a given volume of air. The rating or agree upon by the customer and supplier, but with no personnel classification by the number of particles in a given volume of air present. and under specific conditions is called cleanliness level class. We will discuss more in future article/s on aspects of maintain- CLEANROOM AND CLEAN ZONE CERTIFICATION ing and monitoring clean rooms. Regulations vary from country to country, but in most places, the 19 national rule is established by referring to US Federal standard 209E and now ISO 14644. New series of standards ISO 14644-1 have derived its structure July-August 2018

Cover Story Selected airborne particulate cleanliness classes for cleanrooms and clean zones ISO CLASS LIMITS (particles/m3) classification Maximum concentration limits (particles/m3 of air) for particles equal to and number larger than the considered sizes shown below (N) 0.1 um 0.2 um 0.3 um 0.5 um 1 um 5 um ISO Class 1 10 2 ISO Class 2 100 24 10 4 ISO Class 3 1000 237 102 35 8 ISO Class 4 10000 2370 1020 352 83 ISO Class 5 100000 23700 10200 3520 832 29 ISO Class 6 1000000 237000 102000 35200 8320 293 ISO Class 7 352000 83200 2930 ISO Class 8 3520000 832000 29300 ISO Class 9 35200000 8320000 293000 Note: Uncertainties related to the measurement process require that concentration data with no more than three significant figures be used in determining the classification level. Following applicable rules for the manufacture of notified Medical Devices in India, from January 01, 2018 are described briefly. ENVIRONMENTAL REQUIREMENTS FOR NOTIFIED DEVICES Name of Device Type of Operation Grade ISO Class (At rest) Cardiac Primary Packing and Crimping A 5 stent/Drug Washing, Ultrasonic cleaning & Drug coating C 7 Eluting Stent Assembly, Wrapping & Packaging D 8 Laser cutting, Descaling, Annealing & Electro polishing Well ventilated area 9 Heart Valve Valve Packing A5 Ultrasonic Cleaning & Visual Inspection C7 Frame & Disc Assembly C7 Intra Ocular Lenses Primary Packing & Sealing A5 Final Inspection C7 Power Checking & Final Cleaning D8 Tumble Polishing & Lathe Cutting Well Ventilated Area 9 Bone Cements Final Product Filling A5 Sieving & Calcinations C7 Powder Preparation, Granulation & Drying D8 Internal Prosthetic Primary Packing A5 Replacement Product Preparation C7 Component Preparation D8 Orthopedic Implants Cleaning & packaging (to be sterilized in factory premises) C 7 Cleaning & packaging (Non Sterile- to be sterilized in Hospital) D 8 Cutting, lathing and Polishing Well Ventilated Area 9 Catheters/ Ablation Devices/ Assembly, Coating, Wrapping & Packing C 7 I V Cannulae/Scalp Vein Set Component Preparation & Cleaning D 8 Hypodermic Syringes/Hypo- Molding Ventilated Area 9 dermic Needles/Perfusion Set Also included are IUD, Tubal Rings, Blood Bags, Suture, Staplers, Ligatures, Surgical Dressings & IVD Medical devices (kit/reagents) Specific details are given in Medical Device Rules GSR78E on pages 200-201 of English version. 20 July-August 2018

Cover Story All Electric Injection Moulding Machines for Clean Room Applications Mr Ankur Agarwal, Marketing Communications Milacron India The world of medical manufacturing is considered one with the are fewer than 10 locations), do not exceed the particle concen- most stringent requirements. To avoid contamination, the tration limits of the specified ISO class at the considered particle concept of clean room is devised. A clean room for a medical size. process is a controlled environment with low / negligible level of pollutants such as dust, airborne microbes, aerosol particles, and Clean room varies in size and complexity, and are used in indus- chemical vapors. tries such as • Biotech, medical device, Cleanrooms can be classified to a number of standards, the most • Pharmaceuticals, common being ISO 14644, which is an international metric • Food & Packaging and standard with classification based on the maximum allowable • Life sciences, concentration of particles greater than 0.1 µm per cubic meter of air. Compliance to a specific class can be made at particle sizes As well as critical process manufacturing common in between 0.1 and 5.0 µm depending on cleanroom class, design, • Aerospace and process requirements. • Optics • Military and Department of Energy Particulate cleanliness classification is normally determined • The key component is the High Efficiency Particulate Air using a discrete particle counter (DPC) and a specified sampling protocol, with sampling sites located on an evenly distributed grid (HEPA) filter that is used to trap particles that are 0.3 micron at a height determined by the work activity. A cleanroom is and larger in size. considered compliant if the average concentration at each • Some cases where stringent cleanliness performance is location, and the 95% upper confidence limit (required if there necessary, Ultra Low Particulate Air (ULPA) filters are used. Clean room air flow principles 21 • Cleanrooms maintain particulate-free air through the use of either HEPA or ULPA filters employing laminar or turbulent air flow principles. • Laminar air flow systems are typically employed across 100% of the ceiling to maintain constant, unidirectional flow. • Laminar flow criteria is generally stated in portable work stations (LF hoods), and is mandated in ISO-1 through ISO-6 classified cleanrooms. • Personnel selected to work in clean rooms, they enter and exit the cleanroom through airlocks, air showers, and they must wear special clothing designed to trap contaminants that are naturally generated by skin and the body. July-August 2018

Cover Story Injection Moulding Machine To comply with the clean room standards, MILACRON has developed Elektron – an all-Electric Injection Moulding Machine. This machine eliminates the hydraulic components and circuits thereby enhancing the degree of transmission efficiency and reduced losses. Removal of hydraulic oil also results in No Contamination of the product. The Elektron machine is built with enclosed covers to minimize any accumulation of dust particles in the clean room. The Elektron provides extreme reproducibility, prolonged accuracy and instant repeatability. The low energy consumption results in 40 – 80% energy savings for the manufacturing unit. It has a narrow processing window for thin walled components in engineering polymers. High uptime, smaller shot size utilization, low emissions, water savings, noiseless environment need are the features of Elektra for a clean room necessity. 22 July-August 2018

Cover Story Clean Air Module – CAM is also available to achieve clean environment in moulding area. The basic working principle of Cycle time reduction respect to hydraulic machine the CAM module is described below: T1: Clamp tonnage & pre-injection T2: Tonnage Breakaway T3: Clamp Open & Refilling (NSOV / Mould gate) T4: Clamp Open & Ejector Forward T5: Clamp Close & Ejector Retract Reading Schematic Points Drawing of Clean Air Module Environment at Moulding area Environment at Part drop area The various parts of CAM are as follows: Operating Unit Preliminary Filter Ventilator Main Filter Illumination Ionisation Unit Classification • Clean room classification 3 at air outlet possible About Milacron • Clean room classification 7 in the mould area in production Milacron is a global leader in the manu- (according to ISO 14 644) facture, distribution and service of highly engineered and customized sys- Filtering • Preliminary filter, type F 5 tems within the plastic technology and • High performance filter for suspended matter, type H 14 processing industry. Milacron is the • Main filter monitoring via differential pressure transmitter only global company with a full – line • Signal lamp for filter exchange and display on machine screen product portfolio that includes hot run- ner systems, injection molding, blow Ionisation • DC high voltage molding and extrusion equipment plus • Simultaneous positive and negative electric charge a wide market range of advanced fluid • Plastic frame system with electrode strips technologies. Overpressure • Against environment Visit Milacron at www.milacronindia.com Ventilators • Radial ventilator with backward curved blades For more information, contact: Air Flow • Variable pre-adjustable ventilator rotation speed Ankur Agarwal, Marketing Communications, • Control of function Milacron India Ventilator monitoring • Limit switch [email protected] • Indication of function and display on machine screen Illumination • Energy saving lamps Mold change • Moveable along the machine axis above mould mounting area July-August 2018 23

Cover Story Simplifying Set-Up of Plastics Clean-Rooms By : Medline Department, The Conair Group, USA Navigating the highly regulated Figure 1 and other controlled environments. world of medical manufacturing (Similar to US Fed Std 209E.) and clean room operations can To simplify the process of specifying, buying, • ISO 13485 – a quality management be a daunting, time-consuming installing, qualifying and operating plastics system where an organization needs to task. Regulations and standards, auxiliary equipment in a clean environment, demonstrate its ability to provide medi- developed by such organizations Conair has introduced a line of products – 170 cal devices and related services that as the U.S. Food & Drug Admin- units in all – for molding and extrusion of medi- consistently meet customer require- istration, the International Orga- cal products (Figure 2). The new MedLine® ments and regulatory requirements nization for Standardization (ISO) product line includes equipment for convey- applicable to medical devices and and others, are many and com- ing and storage, resin drying, blending, heat related services. plex. For those who want to be- transfer and downstream extrusion. All are • ISO 17025 – the single most important gin manufacturing medical plas- based on proven Conair designs, but they standard for calibration and testing tic products and components, have been specially sized, configured, docu- • FDA 21CFR – current good manufactur- understanding the regulatory re- mented and supported for use in cleanrooms ing practices (CGMP) for medical quirements is only the first and other controlled environments. Here is devices and pharmaceutical packaging. hurdle to be overcome. Then why that’s important: specialized facilities, including These standards and regulations provide the cleanrooms (Figure 1), white REGULATORY SITUATION checks and balances that lead to rooms and hybrid rooms, need The regulations that govern today’s consistent and predictable outcomes in to be designed and built, and cleanrooms were first developed in the US reduced product variation. Following their processing equipment needs to Federal Standard 209E Airborne Particulate guidelines, and using good cleanroom be sourced with special attention Cleanliness Classes in Cleanrooms and Clean management techniques, will help ensure not only to performance, effi- Zones. As cleanrooms became more sophis- quality and reduce costly mistakes in the ciency and quality, but also to ticated, the industry recognized a need for production of medical plastics components. cleanliness, calibration, mainte- more wide-ranging standards for cleanroom nance and record-keeping. classification and testing. This led to the for- In developing the MedLine family of equip- Mistakes can result in delayed mation of ISO Technical Committee 209, which ment, Conair carefully considered each of start-up, lost production, quaran- was tasked with the \"standardization of equip- these standards. Then they identified equip- tined parts, rework and lack of ment, facilities, and operational methods for ment features, calibration standards and process validation. cleanrooms and associated controlled documentation that can help processors get environments.\" Today, the most common to a state of compliance faster and more 24 standards governing “the methods, facilities, easily, whether they need a single piece of and controls” used in manufacturing, process- equipment or a complete system ing, and packing of plastics medical devices are : DIFFERENT LEVELS OF CLEAN Depending on the products being manufac- • ISO 9001 – based on a number of qual- tured, medical plastic processors have ity management process approach and adopted several different configurations for continual improvement and aimed at clean environments. Each requires a differ- enhancing customer satisfaction through ent level of clean. See Tables I and II. continual improvement of systems and processes, and conformity to customer and A White Room is a typical entry-level clean regulatory require ments. environment meeting ISO 9 standards. Although a white room is typically air-condi- • ISO 14644 - a tiered structure that tioned, there is no attempt made to allows a specific maximum number of control particulate or air change-over. particles per cubic foot of air cleanliness Otherwise, it is treated like a cleanroom, with in various classifications of cleanrooms gowning, hairnets and shoe covers. Typical applications would include lip-balm tubes, pill holders, medical cases, thermometer housings and the like. Although standard equipment has been used in white room en- vironments for many years, there is increas- ing focus on the cleanliness and compliance. Calibration, preventive- maintenance, and installation qualification procedures are becoming more commonplace. ISO 8 or Class 100,000 cleanroom applica- tions – for instance, pumps, auto-injectors, blood-bag components, diagnostic and test- ing devices – require an approach that limits particulate generation by equipment and per July-August 2018

Cover Story sonnel working in the room. These rooms generally have air ISO 7 (Class 10,000) cleanrooms have more stringent require- turnover rates of 5 to 48 times per hour in order to keep particu- ments. These rooms generally have air turnover rates of greater late levels in compliance with the standards. The equipment used than 60 to 90 times per hour. Humidity control is an important in ISO 8 environments must be designed and manufactured to factor in controlling static electricity and bacteria growth. Because minimize generation of particulate, chemical vapors and airborne of this, many of these rooms also require bio-burden testing (to microbes. ISO 13485, which governs the manufacture of medi- measure the number of micro-organisms on surfaces), antimi- cal devices, generally requires this or more stringent levels of crobial-coated materials on room wall panels, equipment cover- cleanliness. Equipment used in an ISO 8 environment usually is ings and other surfaces. Room air ionization also becomes more made with anodized aluminum, certain acceptable powder important. This much-cleaner environment is much more coatings, chemical resistant HMIs (to allow antiseptic wipe down suitable for pharmaceutical and sterile device packaging, syringes, of surfaces), and even urethane casters that allow machines to vials and implantable devices. Equipment, then, needs to be be moved for cleaning without generating rubber or vinyl designed and manufactured with consideration for these more particulate. stringent requirements. That means stainless-steel housings, Table I: ISO 14644-1 cleanroom standards Class Maximum Particles/ft3 Fed Std 209E equivalent ISO 1 =0.1 µm =0.2 µm =0.3 µm =0.5 µm =1 µm =5 µm ISO 2 10 2.37 1.02 0.35 0.083 0.0029 Class 1 ISO 3 100 23.7 10.2 3.5 0.83 0.029 Class 10 ISO 4 1,000 237 102 35 8.3 0.29 Class 100 ISO 5 10,000 2,370 1,020 352 83 2.9 Class 1,000 ISO 6 100,000 23,700 10,200 3,520 832 29 Class 10,000 ISO 7 1.0×106 237,000 102,000 35,200 8,320 293 Class 100,000 ISO 8 1.0×107 2.37×106 1,020,000 352,000 83,200 2,930 Room air ISO 9 1.0×108 2.37×107 1.02×107 3,520,000 832,000 29,300 Table II 1.0×109 2.37×108 1.02×108 35,200,000 8,320,000 293,000 Fed. Std. Class ISO Equivalent Air Change Rate per Hr. Class 1 ISO 3 360 – 540 Class 10 ISO 4 300 - 540 Class 100 ISO 5 240 - 480 Class 1,000 ISO 6 150 - 240 Class 10,000 ISO 7 60 - 90 Class 100,000 ISO 8 5 - 48 July-August 2018 Examples of equipment being offered as part of the expanded MedLine® family of products include (from L-R) a Carousel® Plus desiccant-wheel dryer, a ResinWorks central drying system, MedLine MicroReceiver and a redesigned MedLine puller/cutter with integral conveyor. 25

Cover Story In all, Conair offers over 40 models across the five equipment families with 170 fully configurable variations to match the castings, and covers instead of anodized aluminum, as well as complexity of the environment and/or regulatory standards. FDA-complaint gasket materials and plenum-rated cabling. Machines are factory calibrated to meet regulatory requirements, Particulate control is much more important and so equipment labeled and certified. Installation qualification forms are supplied, typically will be cooling-fan-free, using water cooling or remote ready to be filled out and filed. Preventive maintenance proce- exhaust valves. These are just a few things that need to be dures required for regulatory compliance are also detailed and considered for an ISO 7 environment. reporting forms are provided. This documentation significantly reduces the paperwork processors typically need to generate in Hybrid Cleanrooms are typically installed to minimize costs or to order to validate compliance of their cleanroom facilities and adapt to building design constraints. The cost to build, run and processes. maintain true cleanroom conditions can be high and so the smaller Besides the mechanical and finishing features like non-ferrous they are, the less they cost and the easier it is to maintain the fittings, powder coating of cabinets, stainless-steel components, necessary cleanliness. Hybrid rooms are designed so that most HEPA filters and chemical-resistant HMI screens, many MedLine of the particulate-generating equipment is kept outside the clean products also have control and data-gathering capabilities that environment. Polymer dryers, blenders, and vacuum conveyers, are indispensable to clean-room operation and documentation. for instance, would be installed outside and plumbed or connected For instance, a Material Vision Proofing or MVP system provides to processing equipment inside the cleanroom. Thus, standard critical verification in central resin distribution systems. The Dry- equipment can be spec’d without cleanliness concerns. In some ing Monitor 3 delivers early alert notification should drying condi- cases, even the processing machines operate outside of the room tions drift beyond critical set-points. Blenders can be equipped and only molded or extruded components enter the room under with SQL data-gathering packages and the FLX conveying controlled conditions for final processing. This arrangement can control has an alarm history log. pose a design and installation challenge but considerable money What the MedLine label signifies to the medical plastics industry can be saved by not having to buy or maintain special is peace-of-mind. When a processor selects a piece equipment equipment. with a MedLine label on it, whether it is designed from the ground up for cleanroom applications or it is a part of a standard product PEACE OF MIND line, they can be sure it has been pre-evaluated, pre-configured, Conair has used the MedLine trade name previously to cover pre-calibrated and is suitable to meet the requirements downstream extrusion equipment designed especially for pro- necessary for compliance with applicable standards. ducing precision tubing including multi-lumen heart and brain catheters. Now the registered trademark has been extended to AVAILABLE encompass the full range of medical auxiliaries, including not only downstream extrusion, but also material-handling, drying, PRE USED SYRINGE blending/feeding and heat-transfer equipment. MANUFACTURING AN ISO 13485-2012 CE certified Company EQUIPMENT Manufacturer & Exporter of Medical Moulds : 2, 3, 5, 10ml Disposable Devices & Surgical Syringe Printing Machine : Products 2/3, 5, 10ml Syringe 4 Parts Assembly Machine : Range of Products : 2/3, 5, 10ml • Infusion Set • Blood Administration Set Contact : 7895648113 • Measure Volume Set • Urine Collecting Bag [email protected] • Urine Collecting Bag - Uro Meatry • Respiratory Exerciser July-August 2018 • Twin Bore Nasal Oxygen Set • Oxygen Face Mask • Nebulizer Kit • Vaccum Suck Suction Set • Latex Surgical Gloves • Umblical Cord Clamp Contact Yogesh Patel M. : +91 98241 21383 MEDICARE DEVICES 8, Maruti Industrial Estate, Nr. Sindhvai Mata Temple, C.T.M.-Ramol Road, C.T.M. Cross Road, Amraiwadi, Ahmedabad-380 026.Gujarat (India) Phone 079-2585 5711 E-mail : [email protected] Website : www.medicaredevices.com 26

Materials Polymer Compounds For Medical Devices R C GUPTA, Sr. General Manager KLJ Polymers & Chemicals Ltd. SILVASSA The use of PVC compounds in medical device manufacture for more than 50 years has demon- strated its great ability to satisfy the demanding requirements of the medical health care indus- try. Before PVC can be made into products, it has to be modified by adding a range of additives like plasticizers, stabilizers, lubricants, processing aid, impact modifiers, antioxidants, UV stabilizer and pigments. Various grades of PVC compounds meet national & international standards like USP, ISO, heavy metal free, kink resistant, ESD protection etc. India is among the fastest growing economy of the world. With KLJ is manufacturing medical grade compound in dust free clean the Government of India’s thrust on health care, sector grew at a room area on automatic plant, where human touch is minimal. rate of 17% from 2010 to 2016 and is expected to grow by more than 15% during 2016 to 2020. That means, requirement of PVC compounds are manufactured with premium grade of plas- medical devices increases by same percentage. ticizers, phthalate & non phthalate Kanatol-800FG, Kanatol-8080 One of the most versatile & popular polymer used for medical and DINCH. These plasticizers are also manufactured by KLJ at devices is Polyvinyl chloride. It has widest range of applications their KLJ plasticizer plant. In addition to phthalate, KLJ also from rigid to flexible, opaque to transparent, colored and insulat- supply adipates, malleate, epoxy and other plasticizers. Follow- ing or conducting. ing the medical sector requirements our company developed a range of DEHP free products. The use of PVC compounds in medical device manufacture for more than 50 years has demonstrated its great ability to satisfy Various grades of PVC compounds meet national & international the demanding require- standards like USP, ISO, heavy metal free, kink resistant, ESD ments of the medical health care industry. protection etc. PVC was originally devel- oped to replace natural Our compounds are for- rubber and glass. Medical mulated using raw mate- devices made from these rials, which complies to traditional materials need REACH, ROHS and USP cleaning and re-steriliza- requirements. tion before reuse. High performance of PVC ma- KLJ Quality Assurance is terial at a reasonable cost able to perform chemical advantage made it pos- and toxicological analysis, sible to manufacture appearance, ox disable single use devices, replac- substance, acidity, alkanity ing glass and rubber & UV spectrum), to mea- products. sure hardness of com- pound, thermal stability, Before PVC can be made into products, it has to be modified by and to carry out an adding a range of additives like plasticizers, stabilizers, lubricants, extrudability test on each product batch. processing aid, impact modifiers, antioxidants, UV stabilizer and pigments. Additives will influence or determine the mechanical Complete analysis is carried out periodically by approved exter- properties, light and thermal stability, color, clarity and electrical nal laboratory according to USP class VI and ISO 10993-1. properties of the product. Main applications of KLJ compounds are blood bags, soft medi- KLJ is into medical compounding business for the last 50 years. cal tubing, heart/lung bypass kits, blood tubing, IV sets tubing, KLJ compounds can be sterilized by ETO , gamma rays and drip chambers, stiff medical tubing,, catheters, disposable steam. We are known for offering a wide range of PVC com- syringes, Soft molding components face masks, enema nozzles, pounds for medical applications that are rigid and extra soft both transfusion & dialysis components, urine bottles, etc. for molding and extrusion applications. Another versatile polymer used in medical devices is TPE, Thermo Plastic Elastomers, pure & safe material. TPE for medical July-August 2018 devices offer many advantages: • Minimum of potential extractable and leach-able 27

Materials National Healthcare • FDA compliance and sterlizability. • Silicon, latex & PVC free An ISO 9001 : 2008 Company • Offer excellent ceiling and adhesion performance. • Soft-touch appeal Manufacturing & Exports of • 40 Shore A to 40 Shore D Medical Disposables : • Transparent & crystal clear • Anti kinking I.V. Set, B.T. Set, Urine Bag, • Sterlizable with gamma, ETO and steam Measured volume set, Cord Clamp, Surgical KLJ is one of the renowned manufacturers of Thermoplastic Gloves etc. Elastomer for injection molding and extrusion products. Injection Moulded Medical Components KLJ has separate R&D departments attached to each plant, which and Extended Tubes : are well equipped with modern equipments like Brabender Plasicorder, FTIR, UTM, MFI, Spectrophotometer, mini twin screw I.V. Set components, Urine bag Components, extruders etc. Connectors for Catheters, I.V. Set / B. T. Set / Our experienced R&D group is able to custom formulate unique Urine Bag Tubes etc. TPE Alloys & PVC compounds and incorporate functional addi- Contact : tives in support of any most demanding product developments. Naresh Patel 5/4, Anand Estate, Opp. Ravabhai Estate, C.T.M., KLJ offers customized solutions manufactured at their High capacity automated plants. Research & Development is at the Ahmedabad (India) Ph. : 079-25857530, centre of developing innovative solutions & is recognized by DSIR. Fax : 079-25862206 To ensure consistent quality and high performance, all products undergo extensive R&D and Application Testing before entering E-mail : [email protected] the market. Website: nationalhealthcare.in KLJ Group manufactures the widest range of Plasticizers of consistent quality and reliable performance for standard and special applications, along with dedicated lines for non-phthalate Reach compliant plasticizers. 28 July-August 2018

















Manufacturing Design Control: Importance And Regulatory Aspects Anil Chaudhari, CEO The Design and Development of the product play vital role in Operon Strategist total life cycle of product and to ensure the effective and safe product in market. The adequate design documentation helps to The Design and Development of the product improvise the product performance while product remains in play vital role in total life cycle of product and to market. As per FDA data, significant portion at about 44 % ensure the effective and safe product in market. percent of the recalls of medical devices are due to lack of the The well-planned and documented approach is adequate Design Controls. The minimum expectations are clearly expected while conducting the design and laid down in 21 CFR part 820.30 and Clause 7.3, ISO 13485:2016. development (D and D) activity. As per expectations design and development activity has to be performed and evidenced through DHF at the contract manufac- turing site, Legal manufacturers site, design and development firm as per the business module and it shall be continually maintained and upgraded. The design control initiates at the stage, where the manufacturer decides to make a product and start finding the marketed products already available in the market, we can call them as a “Predicated devices”. The manufacturer is expected to create the “ Design Team” which shall have the Product designers, Regulatory expert, QA experts, representative of the user, manufacturing expert, marketing representative, the internal reviewer and the peer reviewer. The representation and hierarchies of the activities are given in Figure 1: Design Control Overview DEFINATION DEVELOPMENT AND VERIFICATION Clinical Study COMMERCIALIZATION CONCEPT / FESIBILITY VALIDATION Design Input Design Output Design Change Transfer Velidation Verification Research Design Design Design 5W Product Risk Prototype Pilot Pre-Production Production Life Cycle Mgmt Design Input Review Design Input Review Design Review Design Review Design Validation System Sub-System Design Freeze Design Review Pre-Submission Review Phase Review Phase Review Pre-Clinical Definition Development & Verification Phase Review Phase Review Design Validation Commercialization July-August 2018 37

Manufacturing the “Summary report” The report shall be reviewed to check if the design output is giving the expected design input expecta- The well-planned and documented approach is expected while tions. In case, design output attributes fails to achieve the conducting the design and development (D and D) activity. The desired expectations laid down in design inputs, then it may call adequate “design plans” are shall be available during all stages up for the changes in the design. All the changes shall be docu- of the Design and development, defining the roles and responsi- mented through the “design change requests” which shall be bility in timed manner for of all team members. The design plans approved by all the team members. Once the change request is are continually updated as the activity progresses. approved, then design outputs and/or design is changed with the aim to achieve the expectations given in the design inputs. The The study of the marketed products and data collected about the characteristics of the products can be used as design inputs. The repeat verification is design inputs are performed to recheck if also collected from the expected design the Initial risk analy- inputs are being sis as per ISO achieved. 14971, “Medical de- vices — Application It is necessary to verify of risk management if the device achieves to medical devices”. the user needs before By Performing the launch of the device in usability Engineer- market for commercial ing studies as per use. The activity is standards, like ISO called as “Design Vali- 62366 “Application dation”. The typical ex- of ample of the validation usability Engineer- studies may be simu- ing to medical de- lated product study, vices”. The recalls clinical trials, bench happened before on testing, Animal studies, the similar devices is reliability studies, us- also a important ability studies, market study to get away surveys etc. The stud- from the similar de- ies are carried out on the production equivalent. The validation sign flaws. All the data collected from the available studies and plan shall be approved and studies conducted. The studies car- resources are used as “Design Inputs”. The manufacturer shall ried out are adequately documented and reports are prepared. always try to establish as much as possible the available data to The data collected during the validation activities are used for create the design inputs. The design inputs shall not be ambigu- 510 (k) submission, Technical File, Device Master File etc. The ous and shall be clearly defined, which helps to create the risk analysis and usability studies on final product shall be per- adequate design outputs. It follows the philosophy of “Garbage formed to know, the exact status of the designed product going in..Garbage out” poor design inputs create the poor design and suitability of the same for commercial purpose. The output of outputs. the risk analysis and usability studies can contribute to make the “Instruction for use” (IFU). The relation ship between design The product characteristics required to achieve the design input verification and validation can be determined in Figure 2 : expectations are called as “Design outputs”. The design outputs are normally in form the raw material specifications, finished good The design verification determines “If we design the product right” specifications, drawings, in-process controls, machineries and and design validation determines “If we design the right product”. equipment required, process flow charts, vendor details etc. The “traceability matrix” shall be created to demonstrate the linkage The compilation of all documentation done during the design and between design input and the design outputs. development activity is called as “Design History File” (DHF). The DHF is the dynamic document and shall be amended as the During all the stages of the development, the “Design reviews” of changes in the design happen based on the market performance the activities shall be performed by the team members and the of product. The Corrective and preventive actions arising from peer reviewers to check if the project is being moved to achieve the various sources related to product performance may lead to the user needs. The comment from the reviews will determine design changes and the activity performed is amended in the the changes in the plan or the design and shall be circulated to DHF. all the team members. The design transfer shall be performed to the commercial manu- The adequacy of the design output against each of the design facturing site, the activity is called as “ Design Transfer”. It is the input shall be demonstrated. It can be achieved through the set effort to transfer the “know-how” and experience gained during of experimentation and the activity is called as “ Design Verifica- the design and development activity. The design transfer involves tion”. The design verification activity shall be done by creating the transfer of the Raw material specification, Finished goods the test cases for each of the design output and corresponding specifications and test methods, Test equipment, Process flow input. The typical example of the verification studies may be tech- charts, manufacturing machines and utilities specifications, nical, physical, chemical characterization or other engineering In-process test parameters, release parameters, vendor details, analysis, bench testing etc. The test protocols are approved labeling details, Instruction for use, Primary and secondary before execution and are executed and data collected. The packaging material details etc. The document in which this is compilation of the data shall be done to interpret the results in July-August 2018 38

Manufacturing Events Calender mentioned is called as “Device Master record” (DMR). The Medicall relationship between DHF, DMR and DHR is shown on figure 3: India’s Larges B2B Medical Equipment Exhibition Figure 3: The relationship of the DHF, DMR and DHR can be 21-23 September, 2018 shown in below schematics: Venue : Pragati Maidan, New Delhi, India The DMR becomes the basis to formalize the “ Device History 15th National Conference And Technology Exhibition record” (DHR). The DHR provides the adequate traceability for On Indian Medical Devices & Plastics Disposables / the commercial batches manufactured. In case of the customer Implants Industry 2018 complaint or any adverse events, the complete batch history can Date : 26-27 October, 2018 be traced through DHR. Venue : Ahmedabad Management Association, The continual and deliberate efforts shall be made to collect data Ahmedabad, Gujarat from users about the performance of the product and to evaluate the impact of the residual risks posed to the customer the activity Medical Fair India 2019 is called as “Post market surveillance” (PMS). The adequate post 25th International Exhibition and Conference market surveillance will help to “Fine tune” the design of the Pragati Maidan, New Delhi, India product and put added features to the device to improvise the 21-23 February, 2019 device. The design and development activity plays a vital role in the total K 2019 lifecycle of the device. This necessitates the regulators and The World’s No. 1 Trade Fair for Plastics and Rubber certifying bodies to have the detailed review of the design and Date : October 16 - 23, 2019 development documentation to ensure compliance. Venue : Dusseldofr, Germany SANIDHYA ENTERPRISE Manufacturers of : Medical Plastic Injection Molded Articles & Job Works Our Product Range Includes Medical Components like : • Urine Container • Adaptors (PP) • All types of Urine Bag parts like H.D. - ABS & PVC Connectors / Covers, PVC Closures • And many other Surgical Medical Components Contact : 39 Contact Person : Kamlesh Shah Mobile : 9825474789 SANIDHYA ENTERPRISE Office : 29, Yogeshwar Estate, Near Laliteshwar Mahadev. B/h. New Cotton Mills, A. E. C. Road, Amraiwadi, Ahmedabad-380026. Ph. : (M) 9825474789 E-mail : [email protected] July-August 2018

® Alpha Medicare and Devices Ltd. (taking care…Since1984) Manufacturers & Exporters of Disposable Medical Devices GMP, ISO 13485 : 2003 & CE CERTIFIED COMPANY Product Range : • Infusion Set • Blood Transfusion Set • Measured Volume Burette Set • Scalp Vein Sets • Urine Bags • Uromeasure Urine Bags • Mucus Extractors • Cord Clamp • Guedel Airway • Three Way Stop Cocks • Extension Tubes with 3 way Stop Cock • High pressure Monitoring Tubes • Feeding Tubes • All kinds of Catheters • Closed Wound Suction Unit • Yankaur Suction Set • A.D. Kit Sets • Water Sealed Drainage Bags • Other Diagnostic Products like • Urine Culture Bottles Screw Type [30ml. 45ml. & 60ml.] • Petri Dish (55mm & 90mm) • Class 10000 Assembly NEW PRODUCTS • In house Imported Injection Molding Machines • Easy Morning Walker • Adult Diapers • Latest ET.O. Sterilization Facilities • Blood Pressure Monitors • Dial Flow Controllers with I.V. Set • Own certified laboratory to perform Physico • Personal Weigh Scales • Nebulizers Chemical, Sterility & Micro Biological Tests. • Exporting our products to almost more than 23 countries. ISO 13485 : 2003 Contact : 0434 Mr. Dinesh Shah (Manager) (M) 9638979798 97, Alpha Estate, Near Abad Estate, Opp. Kashiram Textile, Narol, Ahmedabad-382 405. (Guj.) INDIA Phone : +91-79-25390601/25390832 • Fax : +91-79-25353680 Website : www.alphamedicare.com • E-mail : [email protected] : Attention : MEDICAL PRODUCTS MANUFACTURERS FOR Surgical Peelable & Tearable Pouches, Lids & Reels For Sterilized Medical Disposables & Devices Contact : Surgi Pack India Pvt. Ltd. PLANT : J/49, MIDC Tarapur Indi. Area, Boisar, Taluka : Palghar, Thane - 401 506 India. • Tel. No. : 93245 51325 OFFICE : 102, Pran Kutir, Ram Lane, Off. S. V. Road, Kandivali (West), Mumbai - 400 067 India. Contact Person : BIRJU TANNA (CEO) Cell : +91 98199 70333 E-mail : [email protected] • [email protected] 40 July-August 2018

Global Trends Global Market Insights : Snapshots • Medical Polymers • Medical Injection Molding • Medical Plastics : Market Scenario : • Medical Device Contract Manufacturing The polypropylene raw material is anticipated to dominate the market, which is followed by the ABS segment. The growing • PVC Hospital Waste Recycling application of ABS in consumer appliances, medical devices, electronic housing and others is attributed to the growth of this segment. On the basis of the application, the packaging is expected to register over • The global Medical Nonwovens 30% of total market share during the forecasted years. market is valued at million US$ in 2017 and (http://www.digitaljournal.com/pr/3893275#ixzz5O17NNYnL) will reach million US$ by the end of 2025, growing at a CAGR of during 2018-2025. • Global plastic injection molding (https://thefreenewsman.com) market expected to reach $233 billion by 2023 In 2017, the global market for plastic injection molding was • The global medical device contract valued at $117 billion; it is expected to reach $233 billion in 2023, manufacturing market was valued at $70 reflecting a 10.9% compound annual growth rate, according to a new bn in 2017. Visiongain forecasts this report from BCC Research , Injection Molding: Global Markets and market to increase to $115 bn in 2022. The Technologies through 2023. market will grow at a CAGR of 9.5% Rising demand across several vertical industries such as packaging and throughout the forecast period. food and beverages is expected to drive growth. One robust segment is the (https://markets.businessi nsider.com) medical device space, which accounts for 18.7% of the plastic injection molding market and is expected to see strong growth over the forecast period as healthcare becomes an increasingly integral • 150 hospitals in Australia part of household expenditures, especially in more and New Zealand to recycle PVC developed countries with aging populations, medical waste by end of 2018 said the report. The PVC Recycling in Hospitals An ISO & CE certified Company programme has diverted over 200 tonnes of high-grade PVC waste from landfill to recycling AMIGO SURGI CARE PVT. LTD. sites since its launch in 2009. Manufacturer of Disposable Surgical Products The programme helps redirect material to reprocessors in Australia and New Zealand, enabling manufacturers I.V.CANNULAS / B.T.SETS / I.V.SETS / to use the recycled polymer in goods such as garden SURGICAL LATEX GLOVES / CORD hoses or outdoor playground matting. CLAMPS / MEASURE VOLUME SETS / URINE BAG / CATHETERS / By collecting IV bags, face masks and oxygen tubing for OXYGEN MASK / NEBULIZER MASK / SCALP VEIN recycling, hospitals can help contribute to carbon and energy savings; especially considering that PVC is 100% recyclable. SET / CANNULA FIXATOR ETC. Now the programme, which is managed by the Vinyl Council of Australia and its member partners, is aiming to reach 150 Only Manufacturer of IV CANNULA in GUJARAT Contact : hospitals by the end of 2018. Mr. Chandrakant Sayal, B.E. (Mech. & Elec.) (Director) “Thanks to great support and enthusiasm from healthcare Mobile : 0091-9825057180 professionals, the PVC Recycling in Hospitals program is Tel.: 0091-2764-268249 now operating in every state in Australia except the E-mail : [email protected] Northern Territory. Website : www.ivcannulaindia.com Plant Address “It’s a great example of how the healthcare sector can demonstrate leadership in PVC sustainability and recover Plot No. 780, Near Canara Bank, Rakanpur (Santej)-382721. Gujarat,India. high quality material that can be genuinely recycled locally for use in new products. We are currently looking at further end product applications for the recyclate,” MacMillan added. In the UK a similar project is currently in its pilot phase and is being financed by the European’s PVC industry’s sustainable development programme. https://www.medicalplasticsnews.com/news/150-hospitals- in-australia-and-new-zealand-to-recycle-pvc-me/ July-August 2018 41

42 July-August 2018

Central Aid Package To Help Medical Device Parks To Set Up Common Facilities; Rs.100 Crore Budgeted For 2018-20 New medical device parks coming up in various states can avail approval. a one-time financial assistance of up to Rs.25 crore to set up common facilities such as component testing units, electro-mag- A tripartite agreement should be entered into among the Central netic interference laboratories and radiation and sterilisation government, the state government concerned and the SIA for checking centres under a new scheme proposed by the Central CFC projects. The SIA should be a legal entity set up by the state government. government for implementing the park project and responsible for its day-to-day management. According to official sources, the scheme will be implemented through a one-time grant-in-aid to be released to a state imple- Of late, the government has been adopting strategies to promote menting agency (SIA) set up for the purpose. The initiative is localisation in the medical devices industry and the aid plan is expected to help reduce the cost of production significantly at the latest step in that direction. The new Medical Devices Rules, medical device parks and would be beneficial to new zones which came into effect in January, were introduced to remove planned in Andhra Pradesh, Telangana, Tamil Nadu, Maharashtra regulatory bottlenecks in the government’s Make in India and Gujarat. initiative and facilitate ease of doing business. The rules classify medical devices into Class A, B, C and D based on associated The Department of Pharmaceuticals (DoP), which proposed the risks. scheme, allocated Rs.100 crore for the initiative for the next two years. The maximum limit for the grant would be Rs.25 crore per According to official data, the sector is valued at $5.2 billion and medical device park common facility centre (CFC) or 70 per cent contributes 4-5 per cent to the health care industry. Currently, of its project cost, whichever is less. there are about 750–800 medical device manufacturers in the country, with an average investment of Rs.170–200 million and The grant will be cleared by a Scheme Steering Committee (SSC) an average turnover of Rs.450–500 million. headed by the DoP secretary after screening the proposal. The CFC should go on stream within two years from the date of final (http://www.pharmabiz.com/ NewsDetails.aspx?aid=109834&sid=1 - July 5, 2018 ) Indian Pharmacopoeia Commission ( PC ) issues first 'Standards for Medical Devices - To provide information on quality Parameters Nearly eight months after the implementation of the Medical till September 1, 2018. The document, reviewed by Pharmabiz, Device Rules 2017, the Indian Pharmacopoeia Commission (IPC) has elaborate sections on classification, registration process, has brought out the first reference document for medical devices grouping and labelling. More than 20 pages are dedicated for manufactured and sold in the country. Framed mainly on the classification of devices and quality parameters. basis of MD Rules, the 241-page draft rule book is expected to provide manufacturers, licence holders, regulators and healthcare The reference manual is the latest step from the Union health professionals with requisite information on regulatory and ministry to ensure the reliability of medical devices available in technical requirements under one umbrella. the domestic market. Plans are afoot to bring all implantable medical devices and other critical medical equipment under the In addition to the new MD Rules, the document is based on the purview of the Drugs and Cosmetics (D&C) Act 1940 and the standards adopted in Indian Pharmacopoeia 2018, British Central Drugs Standard Control Organisation has notified the list Pharmacopoeia, Japanese Pharmacopoeia, European Pharma- of devices to be regulated under the Act. Apart from all medical copoeia and the Bureau of Indian Standards. implantables, the list includes defibrillators, bone marrow cell separator, dialysis and X-ray machines as well as PET, CT scan Currently, India’s medical device sector is dominated by multina- and MRI equipment. tional companies, which is evident from the fact that about 80 per cent of the sales are generated by imported devices. Though While welcoming these positive moves, the domestic industry many multinationals have set up operations in India over the years, representatives continue to make a pitch for creating a separate a majority of them focus on distribution of imported devices and act to regulate medical devices. A draft medical devices regula- support functions. The MD Rules 2017 were framed around the tory bill has been lying with the health ministry since 2016. guidelines of the Global Harmonisation Task Force to ensure that the Indian norms are on par with those in vogue globally. Medical “The law to regulate medical devices needs to be passed and devices, both indigenously produced and imported, now have to stakeholder consultation for the draft created by the health conform to the best international practices of manufacturing. ministry needs to be expedited as clearly medical electronics are Against this backdrop, the new reference document will come in not drugs and a misfit in current legislation of D&C Act,” says handy since the industry is growing at a rapid pace and there is Rajiv Nath, forum coordinator of Association of Indian Medical need for an easy-to-access guidebook on regulations and Device Industry. export-import guidelines. (http://www.pharmabiz.com/ The draft document is likely to be modified as the IPC has re- NewsDetails.aspx?aid=110485&sid=1&utm_source=Mailer&utm_ quested industry experts and other stakeholders to submit their comments and suggestions on it. Comments can be submitted medium=ET_batch&utm_campaign=ethealth_news_2018-08- 10 - , August 10, 2018 ) July-August 2018 43

Govt amends Medical Devices Rules to remove regulatory hurdle, all NABL-accredited labs can issue performance report on IVDs The approval process for in-vitro diagnostic (IVD) devices will facility approved by National Accreditation Board for Hospitals soon enter the fast track as the Central government has done and Health care Providers and obtain a PER. away with a regulatory bottleneck and allows all NABL-accred- ited laboratories and institutes specified by respective state Industry representatives have cheered the move as a step in the licensing authorities to issue performance evaluation report (PER) right direction. “This will help manufacturers get products tested on such products. nearer to their facility and is a welcome move for ease of doing business. Earlier they had to get products tested at NIB and if According to top officials at the Central Drugs Standard Control there was any dispute it was difficult to resolve as the tests were Organisation (CDSCO), the health ministry has amended relevant done by the highest decision maker in hierarchy of regulations provisions in the Fourth Schedule of the Medical Devices (MD) for IVD testing. Now these accredited labs will be the safe middle Rules to this effect after weighing up suggestions from various ground and disputes can be referred to the higher hierarchy of industry stakeholders. The proposal was backed by the Drugs NIB for retest of batch and settlement. Industry is hopeful that Technical Advisory Board (DTAB), the country’s highest drug this initiative will greatly reduce the time taken for issuing the advisory body on technical matters, in May. manufacturing licenses as currently it’s taking 6-9 months against 3-4 months earlier, and we were hopeful that, with an online IVDs include all blood testing techniques and test kits that can application system, the process will hasten the process than detect major diseases or infections including Human Immunode- earlier and not make it lengthier,\" Forum Coordinator of ficiency Virus (HIV) and viral hepatitis. Association of Indian Medical Device Industry Rajiv Nath said. “The amendment will facilitate ease of doing business as a manu- Of late, the government has been adopting various measures to facturer can now obtain the PER from any accredited laboratory ensure the quality of medical devices sold in the country. in the country,” Dr Ravi Kanth Sharma, Assistant Drug Controller, Recently, an extensive set of safety and performance guidelines CDSCO, told Pharmabiz. was formulated by the ministry. These norms are applicable to all medical devices including IVDs. As per the MD Rules 2017, it is mandatory for an applicant to submit a PER to obtain approval for a product. In June, almost In the coming days, the government may also remove the clinical six months after notifying the rules, the government named five trial clause for IVDs which have been marketed for a minimum of laboratories in the public sector to evaluate medical devices and two years in countries such as the UK, the US and Canada to the Noida-based National Institute of Biologicals (NIB) was des- increase their availability in the domestic market. The DTAB has ignated as the apex institution to test IVD devices for HIV, Hepa- already agreed to this proposal, the minutes of its meeting show. titis B surface antigen, Hepatitis C virus, blood grouping sera, glucose test strip and analyser-based glucose reagent. However, Currently, India imports around 80 per cent of its medical there was no designated laboratory for many other IVDs, includ- devices’ requirement and a fourth of that comes from the US. ing those for malaria, dengue, chikungunya, syphilis, typhoid, The overall medical devices market in the country is estimated to tuberculosis or cancer markers. With the new amendment, a be Rs. 640 billion. manufacturer can approach any NABL-approved lab or healthcare ( Pharmabiz - August 3, 2018, ) Use Auto-Disable Syringes to Prevent Infection: Medical devices industry official The official said Punjab has the highest incidence of managing director of Hindustan Syringe and Medical Devices hepatitis B and C spreading from drug addicts to other Limited. patients in the already-challenged healthcare He said Punjab has the highest incidence of hepatitis B and C spreading from drug addicts to other patients in the already- infrastructure. challenged healthcare infrastructure. Rather than banning the sale of syringes without a doctor’s pre- According to Nath, the ban on sale of syringes without prescrip- scription to prevent drug abuse, it will be better if the government tion will amplify the problem of reuse by drug addicts and accel- hastens the switch over to auto-disable syringes, said a senior erate the spread of hepatitis C in Punjab. “It would be more pru- medical devices industry official. dent to accelerate a switch to auto-disable syringes in private sector in Punjab and have a state policy as was done by govern- He was referring to the recent ban on sale of syringes without ment of Andhra Pradesh to prevent reuse with the help of state doctor’s prescription in some districts in Punjab as a measure to drug controller to address this magnifying problem in Punjab,” fight drugs. Nath said. “While the law exists in the US of syringe sale limited to prescrip- https://www.hindustantimes.com/punjab/use-auto-disable- tion, this is not the case in India, and the intent of solving a syringes-to-prevent-infection-medical-devices-industry-official/ problem may be noble but the management tool being used is questionable,” Rajiv Nath, forum coordinator at Association of story-jfn01LngFoFYRFNo6q7YNM.html - July 7, 2018. Indian Medical Device Industry (AIMED) said. He is also the joint 44 July-August 2018

Industry News Mitsubishi expanding Indian footprint with PVC business acquisition Japan’s Mitsubishi Chemical Corp. (MCC) is acquiring the The company has indicated that it is also expanding its TPE PVC compound business of WelsetPlast Extrusions Pvt. Ltd, business for automotive applications in India, focussing mainly a Mumbai, India-based plastics specialist. on airbag covers. Welset currently has two masterbatch and PVC compounds busi- With the acquisition, MCC expects to find a foothold in the nesses and MCC expects the acquisition of the PVC business to medical PVC compound business, while improving its be completed by the fourth quarter of this year. existing PVC and thermoplastic elastomers businesses in India and ASEAN markets. According to Tokyo-based MCC, Welset’s PVC compound business has a “leading” market share in India’s medical The acquired business has a production plant in Silvassa, west segment, and a solid presence in the ASEAN markets in general. India, and manufactures medical devices, electrical wires and cables. As of 1 June, the plant has 100 employees. The Japanese supplier is already active in the Indian market, manufacturing and supplying thermoplastic elastomers in India. (http://www.plasticsnewseurope.com, 26 June 2018) Covestro Strengthens its Global Film Production Covestro intends to expand its global production capacities for \"We want to expand our global film production as quickly as pos- special films, to meet the growing demand in all regions. sible to meet the growing demand in the regions,\" explains Michael Friede, global head of the Coatings, Adhesives and Specialties The company plans capacity expansions at its site at Map Ta segment. \"With modern and efficient production facilities, we want Phut, Thailand, Guangzhou, China, South Deerfield, USA, and to offer our customers growth opportunities and strengthen them Dormagen, Germany. in their competitive environment. \" More so, Covestro will invest more than •100 million to expand At the Guangzhou site in China, Covestro’s focus will initially be any associated infrastructure and logistics. Current plans are on converting the existing coextrusion line. New capacities are anticipated to create over 100 jobs across the world for the expected to be available by the middle of 2019 with a second operation of the new plants. phase already planning to be scheduled. Speaking about the plans, Dr Markus Steilemann, CEO of Dr Thorsten Dreier, global head of the Specialty Films business, Covestro, said: “With this capacity expansion, we are investing in said: “With these expansions we create the conditions to meet promising technologies and applications. The innovative high- customer requirements more flexibly and quickly. Our tailor-made tech materials offer solutions for future challenges and deliver products enable versatile applications in various industries.” their contribution to making the world a brighter place.\" (https://www.medicalplasticsnews.com, 20 July 2018 ) AMTZ sets up Centre for Bio-Materials Testing A scientific facility - Centre for Biomaterial Testing - has been medical device industry for physio-chemical evaluation as well developed in country’s first medical technology manufacturing as biological evaluation of samples can also serve industries like park- Andhra Pradesh Med Tech Zone (AMTZ) to help manufac- chemical, polymer and pharmaceuticals to evaluate the turers test their products and assist them to overcome deficien- characteristics of materials using spectroscopic and imaging cies in their products, thereby enhancing product value in the modalities like scanning electron microscopy (SEM) and transmission electron microscopy (TEM). market. The facility will help serve the purpose of sterility evaluation, his- AMTZ has also inked formal agreements to set up scientific topathology evaluation, physio-chemical evaluation, accelerated facilities like Centre for Electro-Magnetic Interference/ Electro- aging and package validation in accordance with international Magnetic Compatibility (EMI/EMC) and Electrical Safety Testing standards like ISO and ASTM to to address unmet clinical needs. (EST), Centre for X-ray and CT Scan Tube Manufacturing, Centre for 3D Designing, Printing, Rapid Prototyping & Centre Accelerated aging is an artificial procedure for establishing the for Gamma Irradiation. lifespan or shelf life of a product in an expedited manner. Data obtained from the study is based on conditions that simulate the AMTZ with in-house high investment scientific facilities would help effects of aging on the materials. manufacturers reduce the cost of manufacturing by more than 40 per cent to 50 per cent. The state-of-the-art laboratory which is primarily intended for (http://pharmabiz.com , July 30, 2018 ) India, US move a step closer : Trade Issues including Medical Devices. India and the United States have moved a step closer in resolv- September. ing trade disputes, with India agreeing to accept some of the US' demands on medical devices and electronics (IT), Hindustan Commerce minister Suresh Prabhu spoke to US Trade Timesreports. Representative Robert Lighthizer last week, the report said. The two countries have discussed concessions on medical Moneycontrol could not independently verify the news. For devices, dairy and IT products, sources told the paper. medical devices, India will probably cap the prices for some US products, instead of imposing direct price controls, the report It is still unclear if there has been breakthrough on US tariffs on added. steel and aluminium, and India's retaliatory tariffs, the report said. India is likely to postpone the retaliatory tariffs, which are due to The update on the trade issue is likely to be announced before start on August 4. the 2+2 talks between India and the US, which will be held in https://www.moneycontrol.com July-August 2018 45

Product Gallery Qosina Adds New Closed Male Luer Lock Valves to Its Line Ronkonkoma, NY, USA, July 9, 2018— ponents. The company’s vast catalog Qosina has added four new closed male features more than 5,000 products luer lock valve connectors to its existing line shown in full-scale illustrations on a of luer-activated valves. one-centimeter grid. Qosina offers free samples of most items, low minimum These normally closed male valves connect order requirements, just-in-time deliv- directly to a female luer lock or luer-acti- ery, modification of existing molds, and vated valve, and disconnect simply by twist- new product design and development. ing counterclockwise. These valves are Qosina is ISO 9001, ISO 13485 and DEHP-free and completely close upon ISO 14001 registered, and operates disconnection, eliminating the need for in a 95,000 square-foot facility with an clamping or capping. They are ideal for ISO Class 8 Clean Room. To learn flushing and drainage applications; prevent about Qosina’s full component dripping and leakage; restrict the free flow offering, which includes the newest products. of fluids; and are suitable for gamma and EtO sterilization. visit www.qosina.com or call +1 (631) 242-3000. Founded in 1980, Qosina is a leading global supplier of OEM Contact : Qosina Corporation, Rachelle Morrow, single-use components to the medical and pharmaceutical in- dustries. Qosina’s philosophy is to address its customers’ need +1 (631) 242-3000 [email protected] to reduce time-to-market by providing thousands of stock com- Qosina Unveils a New Line of Tyvek® Sterilization Supplies Ronkonkoma, NY, USA, August 1, 2018— dustries. Qosina’s philosophy is to Qosina has rolled out a new line of Tyvek® address its customers’ need to re- sterilization supplies for biopharmaceutical duce time-to-market by providing equipment and medical device components. thousands of stock components. The With 54 options from which to choose, the company’s vast catalog features company’s off-the-shelf Tyvek® sterilization more than 5,000 products shown in supplies include a large assortment of full-scale illustrations on a one-cen- pouches, sheets and tubes, and are avail- timeter grid. Qosina offers free able in many sizes and styles. Qosina’s new samples of most items, low minimum Tyvek® line provides optimum contact clar- order requirements, just-in-time de- ity for visibility; is offered with and without ster- livery, modification of existing molds, ilization indicators; and is compatible with autoclave, steam and and new product design and devel- EtO sterilization methods. opment. Qosina is ISO 9001, ISO 13485 and ISO 14001 regis tered, and operates in a 95,000 square-foot facility with an ISO Lightweight and durable, Tyvek® is the trusted material of choice Class 8 Clean Room. To learn about Qosina’s full component as it provides a superior microbial barrier to ensure devices stay offering, which includes the newest products, sterile; excellent tear strength and puncture resistance; heat seal- ing and self-sealing options; peelable and non-peelable fusion visit www.qosina.com or call +1 (631) 242-3000. seal options; and maximum breathability during sterilization. Contact : Qosina Corporation, Rachelle Morrow, Founded in 1980, Qosina is a leading global supplier of OEM +1 (631) 242-3000 [email protected] single-use components to the medical and pharmaceutical in- 46 July-August 2018

ISO : 13485 : 2012 We are a leading Consulting organization JIMIT MEDICO providing an integrated services with SURGICALS PVT. LTD. focus on project technology : AN ISO 13485 : 2012 & CERTIFIED COMPANY Quality Management System as per ISO 9001, ISO 13485, Medical Devices Manufacturers & Exporters of CE marking as per MDD/93/42, FDA Disposable Medical Devices 510k, Audit, Documentation, training and c-GMP. Infusion Set, Blood Administration Set, IV Cannula, Urine Bag, Catheters, Gloves, Sanjay Y .Shah – Owner Promoter HIV KITs, Ophthalmic KITs, Ophthalmic Knives (Blades), Cap, Mask, Gown, Drapes, Bandages, M : +91 98240 17850 Dressings etc. Obelis European Specialized in Handling Large Quantity Authorized Representative Center (O.E.A.R.C) based in Brussels, Belgium since 1988 is one of the largest & OEM / Contract Manufacturing Regulatory Centers in Europe, assisting non-European manufacturers’ successful endeavors into Europe. Factory : 16, Ranchodnagar, Near Vinzol Railway, Crossing, Vatva, Ahmedabad-382445, INDIA F/6, Goyal Plaza, Vastrapur, Ahmedabad-380 015. INDIA. Tel. : +91 79 66090225 E-mail : [email protected], [email protected] Tele : +91-79-25835567, +91-79-25834850 Website : www.unikalindia.com E-mail: [email protected] • Web: www.jimitsurgicals.com July-August 2018 47

Manufacturer And Exporter Of a ISO 9001-2000 Quality Medical Devices wide range Of Medical Devices ISO 9001 : 2000 & ISO 13485 : 2003 Products available with CE marking Facilities : Controlled Molding Area, Clean Room of Class 10000, ETO Gas Sterilization Pla nt along with all other amenities and equipments required for manufacturing and testing of Medical Devices. The Company also have certified Laboratory to perform Physico-Chemical, Sterility, Micro-Biological Tests. Products : Infusion Sets, IV Cannula, Burette Set, Scalp Vein Set, Extension Lines, Three Way Stopcock, Peritoneal Dialysis Set, Blood Administration Sets, Blood Lines, REGISTERED Feeding Tube, Ryle’s Tube, Levin’s Tube, Stomach Tube, Colostomy Bag, Urine Bag, FIRM Urine Meter, Nelaton Catheter, Male External Catheter, Oxygen Mask, Nebulizer Mask, Wide Range Of Products : Suction Catheter, Endotracheal Tube, Tracheostomy Tube, Guedel Airways Wound The company Suction Set, Yankaur Suction Set, Thoracic Catheter, Mucucs Extractor, Umbilical manufactures a wide range Cord Clamp etc... of Medical devices, which The company markets products its own brand name ANGELTOUCH. fall under the Certification : ISO 9001 : 2000, ISO 13485 : 2003, CE marking & GMP. main domains of : Expertise & Experience : Infusion Therapy, – OEM/Contract Manufacturing. Transfusion Therapy, – Supply of Components for Medical Devices. Dialysis, Gastroenterology, Urology, Anesthesia, ANGIPLAST and Surgery. Private Limited Plot No. 4803, Phase IV, G.I.D.C. Vatva, Ahmedabad-382 445. India. Phone : +91 79 25840661 / 25841967 (O) 9662004148 / 49, Fax : 2584 1009 E-mail: [email protected]/[email protected] Website : www.angiplast.com GMP I. V. SETS AND MEDICAL ISO - 9001-2008 DISPOSABLES MANUFACTUR- Certified Company ING UNIT FOR SALE S. Nath & Co. Unit in Good Running Excellence in Quality Condition Manufacturer & Exporter of • Holding Gujarat State FDA Mfg. Licence Surgical Disposable Products since 1980 • Located in Industrial Area in Ahmedabad • Built up Area More Than 390 Square Meter IDEAL® • Machinery / Equipments in Good Working Condition • Includes : Assembly Furniture, Clean Room Systems, • Infusion Set • Blood Administration Set E.T.O. Sterilizer, Laboratory Equipments, Urine Bag • Urine Collection Bag Mfg. Machines, Packaging Equipments, Utilities Etc. • Urine Specimen Container • Promoters Interested to sell because of other • Umblical Cord Clamp business commitments. • No Short Term / Long Term Liability Address Contact : E-mail [email protected], S. Nath & Co. [email protected] B. N. Estate, Near Uttam Dairy, Sukhramnagar, July-August 2018 Ahmedabad-380021, Gujarat, India. Contact No. : +91-79-22743246, 9825360531 Website : www.snathco.com • [email protected] 48

Airways Surgical Pvt. Ltd. Manufacturer of Oxygen Therapy & Critical Care And Anaesthesia Therapy Critical Care & Anaesthesia Therapy Products • T-Oxygenator • Endotracheal Tube(Plain & Cuff) • Catheter Mount(Standard Double • Endotracheal Tube Reinforced Swivel Mount & Expandable Double Swivel Mount) • Endotracheal Tube Holder With Bit • Ventilator Circuit • Ventilator Circuit with Single Water Block Oxygen Therapy Products Trap(Adult, Pediatric, Neonatal) • Inflatable Anaesthesia Mask • Nasal Cannula • Ventilator Circuit with Double Wa- • Anaesthesia Mask Silicon ter Trap(Adult, Pediatric, Neonatal) • Breathing Filters(HME & BVF) • Trachostomy Tube With Cuff • Oxygen Mask Breathing Filters • Resuscitator(Ambu Bag) Airovent T-Humidifier • Anaesthesia Circuits (Mapleson D, • Endotracheal Tube Holders • Multi flow Venturi Mask Mapleson F, Bain Circuit with APL Valve) • Yankaures Suctions Systems • Single Dial Venturi Mask • Stylet • Guedel Airway • Airovent T-Humidifier • High Concentration Mask • Nasopharyngeal Airway • Dialflow Regulator • Nebulizer Set • Laryngeal Mask Airway • Airopap Full Face Mask • Nebulizer Chamber • Mallaeble gum Bougie • Close Ventilation Suction System • Incentive Spirometer • 3 Ball Spirometer • Three-way Stopcock • Extension Tubing for Infusion Systems • Pressure Monitoring Line Contact : Dr. Inder Jain +91 9820321901 Anaesthesia Circuits Incentive Spirometer Head Office : 106, Vijay Industrial Estate, I. B. Patel Road, High Concentration ET Holder with Bite Expandable Catheter Goregoaon (E), Mumbai - 400 063, INDIA. Mask Block Mount Tel.-Fax : 91-22-2685 2973 / 2686 9090 Works : Airway House, Plot No. 2209 & 2210 Phase IV, GIDC Vatva, Ahmedabad - 382 446. INDIA. Tel. : 91-79-2584 2525 / 2584 0905 Email : [email protected] [email protected] • Web : www.airwayssurgical.com ISO 9001:2008 CERTIFIED COMPANY MANUFACTURER & EXPORTER OF MEDICAL DISPOSABLE PRODUCTS Address : • I.V. Infusion Sets Apex Medical Devices • Blood Administration Sets • Scalp Vein Set Plot No. 10/B, • Urine Collection Bags Shyam Ujjawal Indurstrial Estate, • Ryles / Feeding Tubes Opp. SBI Bank, Phase 1, G.I.D.C, Vatva, • Catheters and Tubes Ahmedabad-382445. Gujarat, India. • Surgical Gloves. Phone No. : +91-79 - 29701333 Contact : E-mail : [email protected] Mr. Bhavin Shah Website : www.apexmedicaldevice.com MANUFACTURER & EXPORTER OF MEDICAL DISPOSABLE PRODUCTS July-August 2018 4-5, Khodiyar Ware House Estate, B/h. Mahalaxmi Mill, Narol - Isanpur Highway, Narol, Ahmedbad-382405. (India) Phone : (O) 079- 25733318 (R) 079-25430211 (M) +91-9825018952 Email : [email protected], [email protected] Website : www.mescosurgical.com 49

ISO 9001-2015 ISO 13485-2012 CE WHO GMP Range of Products • ECG Paper & ECG • Mount Catheter Accessories • “T” Recovery Kit • Breathing Circuit • ECG Paper Roll & Z • Ambu Bag Folding • Bain Circuit • 3 Ball Spirometer • Nasal Canula • Patient ID Belt • Oxygen Mask • Yankur Suction Set • Nebulizer Mask & • Nebulizer Chamber • Guidal Airways Nebulizer Compressor • B. P. Meter • Multiflow Mask • Ventury Mask • High Concentration Mask • Breathing Filter Life-O-Line Technologist Mfg. & Importer of : Medical Surgical Devices & Healthcare Products Nr. Shiv Chamber, C.T.M., Ahmedabad - 380 026. M. : 9898162576 • E-mail : [email protected] Customer Care No. +91 9898162576 & 7600020901 50 July-August 2018