How to get listed in E-Catalogue 1. Visit the website http://www.ingineering-brands.com be part of the E-Catalogue along with product certification information. Please note, certification is mandatory, if you 2. Along with many useful information about the E-Catalogues, do not have product certificate, then you will not be able to you will get the names of the industry, for which currently list your products in the E-Catalogue. the E-Catalogue registration is open, c. You will also be able to upload maximum five product a. Pumps & Valves, images in a predefined format and size mentioned in the b. Medical Devices, E-Catalogue interface. c. Electrical Machineries, Equipment & Components d. The third step is the optional questionnaire. After d. Textile Machinery & Accessories responding to the questions, companies are requested to accept the Terms & Conditions and submit their entry. 3. Click on the link for the desired E-Catalogue. 8. Once all the data entry validations are successfully passed, 4. The corresponding E-Catalogue home page is displayed. It your registration will be submitted. describes about the industry and some important statistics. 9. After submission, the E-Catalogue Admin will verify your entry 5. On the top banner, there is a button named “Get Listed”. for accuracy or any missing information and your application will be either accepted or rejected. If your entry is approved, 6. Click on that button, which will take you to the Manufacturer your company and products gets listed in the E-Catalogue. Registration page for the corresponding catalogue. Reference : http://www.eepcindia.org/eepc-download/ 7. Manufacturer Registration is a 3 step process. 96-Users-Guide.pdf a. In the first step, you need to mention details about your company. b. In the second step, enlist all the products that you want, to 20 Mar.-Apr. 2017
CToabnletoef nts Vol. 25 No. 2 Mar. - Apr. 2017 24 Cover Story • ASEAN Medical Devices & Plastics Sectors : Immense Market Potential Medical manufacturing is one of the key growth areas in countries belonging to the Association of Southeast Asian Nations (ASEAN). A rapidly expanding middle class is largely responsible for a projected near doubling of the medical device market in these countries. 26 Manufacturing • Developing Drug / Device Combination Products: Concept to Commissioning Dr. Atul Sardana, Chairman, Alfa Corpuscles Pvt. Ltd., New Delhi A Drug Device combination products are emerging as innovative medical products due to their contribution in advancing medical care and are thus expected to have an impact in coming years. Development of Drug / Device combination entails the following steps….. • Packaging Testing for Medical Devices Mr. Bunty Kundnani, Business Manager, Life And Health Science, UL India Pvt. Ltd., Mumbai. Historically devices have been tested for degradation by accelerated aging and other various material characteristics. Testing a new packaging design before full scale manufacturing can save time and money. 34 Product Gallery • Dilators and Introducer Sheaths Mar.-Apr. 2017 30 Global Trends • Global Medical Disposables Market to Reach US$193.9 Bn by 2018 • Medical Polymers Market to exceed $24bn by 2024 • Asia-Pacific Reprocessed Medical Devices Market Will Hit at a CAGR of 15.7% by 2017 to 2027 32 Industry News • Med Devices Import up 16.8%, Export By 25.7% During 2012-16 • DCGI begins registration of notified bodies to carry out audit of mfg sites of Class A & Class B medical devices • 10% price hike cap on most medical devices • CDSCO to go online for all services in six months 22 Did You Know? • About Drug / Device Combination Products & ASEAN Markets 42 Events Calendar • T-Plas, 2017: Sept. 20 – 23, 2017, Thailand, with “MEDICAL & HEALTHCARE PLASTIC PAVILION” • Medicall 2017, 17th Edition: July 28 - 30, 2017, Chennai • Medicall 2017, 18th Edition: Oct. 6 – 8, 2017, Mumbai • MEDICAL FAIR INDIA 2017 Event Report 21
Flashback ?YoDKuindow ? About Drug / Device Combination Products & ASEAN Markets Sept.-Oct. 2004 Many of today’s most innovative medical devices are actually drug/device combination From Editor’s Desk products that generally include a medical device part and a drug part. Dear Reader’s, The growth of global drug device combination products market is attributed to the growing incidence of chronic diseases such as prostate cancer, cardiovascular diseases, colorectal Importance of “Plastics” in medical grows more and more cancer, diabetic neuropathy; increasing concerns related to obesity and diabetes; and with growth of medical technology. This is because of growing geriatric population. excellent forming qualities, low weight and favourable economics. As per a recent BCC Research Study , the overall global market for Drug-Device Combinations is growing at a compound annual growth rate (CAGR) of 7.1% from 2014 to ......As per Prof. Jurgen Fleischer, the chair of the Institute 2019, and thus sales are projected to reach $31 billion in 2019. For Production Technology at the University of Karlsruhe, “Increasing miniaturization combined with simultaneous Western- type diseases have become increasingly prevalent in Asia. Increased lifespans integration of functions is a key theme of global product and growing incomes have led many to adopt Western habits—such as overeating, development in the most diverse application fields”. In consuming fast food, smoking, and engaging in little exercise—putting Asians at an particular, this applies to medical technology, which increasingly higher risk for lifestyle diseases. In particular, the growth rates of diabetes, receives major inspiration from ComPaMED. On one orthopedic problems, cardiovascular disease, and cancer are rising quickly. Western device hand, the focus is on materials that are prerequisites for manufacturers already make products to diagnose and treat these diseases. Hence, the permanent system reduction and, on the other hand, ASEAN nations are attractive markets for Western device firms. these innovative materials require that their manufacturing and forming processes are Although ASEAN countries have traditionally been known for low-end medical device co-developed. product manufacturing, such as simple catheters and drainage bags, this is no longer the case. Some manufacturers in ASEAN countries are now able to produce more sophisticated As per Mr. Horst Giesen, Project Director for MEDICA Class II and, in some cases, Class III medical devices. and ComPaMED, “there can be no doubt: small and tiny components, functional surfaces and innovative materials Besides selling their device products in ASEAN countries, an increasing number of Western will play an important role at ComPaMED 2004”. medical device companies are also manufacturing or sourcing their products there. ........CBI, The Centre For The Promotion Of Imports From They are doing so for a variety of reasons, including Asia’s low overhead costs, low labor Developing Countries, Under their export development costs, and improving technical capabilities. While labor costs have increased significantly programme for medical devices which covered high-tech in China, they remain low in some of the ASEAN countries, including Vietnam. products as well as less sophisticated ones, supported 26 companies including about 10 companies from India. In a In the report by CBI Consultant Leendart Santema, “The Nutshell.... second and third time participants saw an overwhelming increase of turnover”....... “ The illiterate of the future will not be the person CONTENTS who cannot read, • Cover Story : Plastics Gain New Importance In it be the person who does not Medicine. know how to learn” • Materials : Present Trends and Future Prospects of -Alvin Toffler Plastics in Medical Applications. • Global Trends : CBI’s Export Development Mar.-Apr. 2017 Programme For Medical Devices • Industry News : - Indian Healthcare Federation (IHFC) To Launch Country’s First Accreditation System For Healthcare Institutions - Asia’s Largest Healthcare City Soon In West Bengal (India) - Medical Insurance Set To Grow By 30 % - Medical Tourism in India: Attracting 15 million 22
EDITOR FromDtheeEsdkitor’s D.L.PANDYA, B.E.(Chem), M.I.E. Focused “Medical & Healthcare Plastics Pavilion “ @ T-Plas 2017, Thailand – A Unique Opportunity For Medical Plastics ASSOCIATE EDITOR Industry Suppliers to reach Asean Markets . Mr. Rutul Bhavsar For the first time ever in the Industry, “Medical Plastics Data Service” conceptualized B.Tech (Biomedical & Instrumentation Eng.) and successfully created a focused Pavilion during the Plastivision India 2017 EDITORIAL ADVISORY BOARD event in Mumbai in Jan.2017 as a mission with multiple objectives : Dr. TARANG PATEL - A knowledge Platform complete with Posters, Audio-Visuals, Models and M.B.B.S., M.Ch. (ONCO) Samples. Cancer & Reconstructive Surgeon - To help Medical Plastic Industry Suppliers To Reach Out To Medical Devices, Mr. C. BALAGOPAL Pharmaceuticals & Diagnostic Industry. Director - Enter Technologies Pvt. Ltd. Chairman - Mobilexion Technologies Pvt. Ltd. - To help Non-Medical Plastics Industry To branch Out Into Medical Products. - Enhance the value of “Brand Plastic”. Trivandrum The experiment was extremely successful and very well received not only by the Dr. DILIP H. RAIKER existing Industry but also new entrepreneurs as well as those looking for expansions Ph.D., M.Sc., PGDBM, AMIE (Chem.Engg.) and diversifications. Former Chief Manager(P), CIPET - Chennai Extending same objective , “MPDS” has conceptualized similar Pavilion in ING LOUIS C. SUHUURMAN association with “T-Plas 2017” at Bangkok during Sept. 20 – 23, 2017, providing Formerly Sales Director global platform with an ASEAN perspective. Medical manufacturing is one of the COLPITT B.V., Holland key growth areas in the ten member Asean countries led by Malaysia, Indonesia, Thailand and Singapore. Unlike the past, these rapidly expanding countries are Dr. A.V. RAMANI not only projected to double the medical device industry markets, they are fast Group Sr. Vice President (R&D), The TTK Group moving from low-end medical device products to more critical and sophisticated products manufacturing. Dedicated Pavilion in “T-Plas” show is a very good Dr. Vinny Sastri opportunity for Medical Plastics Industry Suppliers to reach Asean Markets. President, Winovia LLC, U.S.A. This issue covers two excellent and well researched articles by Dr Atul Sardana Dr. C.S.B. NAIR and Mr Bunty Kundanani covering very important Medical Device manufacturing Director (R&D), Peninsula Polymers Ltd issues. We are extremely grateful to them, particularly Dr Atul Sardana , for being generous enough to share his valuable experience in developing Drug / Device Dr. BHARAT GADHAVI Combination products from concept to commissioning for the benefit of Indian CEO, Medisurge Hospitals Industry. Mr. A.S. ATHALYE Under Brand India Engineering campaign by Govt. of India, EEPC India has Arvind Athalye Technology Transfer Pvt.Ltd, Mumbai developed Brand India Engineering E-Catalogue with an objective to bring out 360 degree change in perception of Indian products from a supplier of low value Dr. SUJOY K. GUHA added products to high value, technologically advanced and price competitive B.Tech.(Hon), M.Tech., M.S., Ph.D., M.B.B.S. supplier. “Medical Devices “ is one of the focus sectors as part of e-catalogue. We appeal the Indian Medical Device Industry manufacturers to take benefit of this IIT, Kharagpur golden opportunity by getting listed in this world class catalogue at the link : http://ingineering-brands.com Dr. G. S. BHUVANESHWAR Consultant, Medical Devices – Design, development, testing and quality management. Adjunct Professor, Dept. of Engineering Design, Indian Institute of Technology, Madras. PUBLISHED BY : 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. Mar.-Apr. 2017 23
Cover Story ASEAN Medical Devices & Plastics Sectors : Immense Market Potential ASEAN (Association of Southeast Asian Nation). Economy ASEAN Medical Devices Industry : Immense Market Potential The ten member states making up ASEAN include Indonesia, Malaysia, Philippines, Singapore, Thailand, Brunei, Vietnam, Medical manufacturing is one of the key growth areas in countries Laos, Myanmar and Cambodia. ASEAN’s fertile consumer base belonging to the Association of Southeast Asian Nations with a combined population of over 600 million and a combined (ASEAN). A rapidly expanding middle class is largely responsible GDP of US$ 2.6 trillion, as well as presence in the global market, for a projected near doubling of the medical device market in enables the region to tap the right opportunities, hinging on the these countries, from $4.6 billion in 2013 to $9 billion by 2019. region’s rising middle class sector and substantial consumer base. One of ASEAN’s top export sectors by value is plastics Three ASEAN countries—Malaysia, Indonesia, and Thailand— and plastic products earning US$ 39.3 billion in export revenues account for approximately 65% of the current medical device in 2013, the International Trade Statistics reported. market among the 10 member countries, according to Matthew Zito, Benedict Lynn, and Emily Liu of business intelligence firm The sector’s production rates have witnessed a steady average Dezan Shira & Associates. The other seven are Singapore, the growth over the recent years, especially in the ASEAN-6: Phillipines, Brunei, Vietnam, Laos, Myanmar, and Cambodia. Indonesia, Malaysia, the Philippines, Singapore, Thailand, and Vietnam, which account for more than 95 % of regional GDP, Medical device markets within the region have been charting according to McKinsey & Company. Countries like Cambodia double digit growth rates in recent years, and will likely continue and Myanmar are growing strongly, with increased economic to do so. “With the increased demand for better healthcare, liberalisation and development, but will still contribute only a encouraged by governmental focus on healthcare as a priority sector for trade and service liberalization . . . the upside market potential for medical devices in the region is immense,”. small percentage of manufacturing foreign direct investment The individual medical device markets across ASEAN’s 10 (FDI) in the coming years. member countries are in various stages of development. Those with the greatest presence in the medtech market can be broken ASEAN’s Plastics Industry down as follows: ASEAN’s plastics industry is anticipated to expand in the coming • Malaysia and Indonesia, which are rich in rubber, lead global years . production in latex products such as surgical gloves and syringes. Malaysian exports in diagnostic imaging have In the ASEAN Business Outlook Survey , by the American expanded in recent years, according to research by Espicom, Chamber of Commerce Singapore and US Chamber of which estimates the country is likely to see compound annual Commerce, it was revealed that 19 % of ASEAN businesses growth of 16.1% to 2018, with growth for consumables as themselves plan to shift investment or business from China into high as 24.8%. their own region. Respondents also identified Indonesia as the most attractive country for new business expansion, followed • Singapore, the region’s medical and technological hub, has a by Vietnam, Thailand, and Myanmar. The availability of low-cost thriving biomedical research and development industry, and labour in countries such as Cambodia, Indonesia, Laos, a competitive advantage in advanced manufacturing. It is Myanmar, and Vietnam could be a competitive advantage. home to the manufacturing operations of more than 30 medical technology firms. With the growth of ASEAN countries’ consumer bases, broadening of plastic import and export markets, and expanding • Thailand also has a relatively robust medical device market, foreign trading powers, ASEAN’s plastics industry offers worth approximately $1 billion and growing 15% annually, significant opportunities. Mar.-Apr. 2017 24
Cover Story conceptualized by “T-PLAS 2017 “ in association with “MEDICAL PLASTICS DATA SERVICE” which will be participated by according to Ames Gross, President of Pacific Bridge Medical Exporters and Manufacturers of Materials , Machinery and (Bethesda, MD). Products to the Medical Plastics, Medical Devices and On the regulatory front, ASEAN member countries have made Pharmaceuticals Industries. significant strides toward developing a mature regulatory framework for medical devices, both individually and regionally. The Pavilion will showcase latest ASEAN countries currently remain reliant on imports to satisfy developments by regional and international demand for medical devices: for example, as much as 97% of exporters And manufacturers Of Medical devices consumed in Indonesia in 2013 were imported, mainly Plastics Processing Machinery, from the United States, Japan, and Europe. Nevertheless, Pharmaceuticals / Medical Products momentum is building for local manufacturing to transition toward Packaging Machinery, Medical more advanced products, as foreign companies move into the Polymers, Components / Tubings / region to take advantage of lower costs and rising demand. Adhessives, Packaging Films / Pouches etc. South East Asian Pharma Industry The South East Asian pharma industry has been growing at an Driven by the nation’s various burgeoning sectors such as average of 6-10 percent in the past 10 years. The governments Medical, Pharmaceuticals, Packaging as well as Lifestyle, across the ASEAN region are introducing universal healthcare Thailand is well positioned to become Southeast Asia’s very own programmes, with the consequential rising demand for all hub for its plastics and rubber industries. These areas of interests categories of medicines, especially generic drugs. have seen significant growth in recent years, and are projected Comprising almost 40 per cent of the SEA economic output, to expand to new heights in years to come. Indonesia is now the largest pharma market in the Southeast Asia/Asia Pacific region (SEA/AP), experiencing an impressive Special Visitor Campaign for Medical 85 per cent growth in between 2007-2013. The country has the Device and Pharmaceutical Industries biggest and fastest growing economy in the SEA region and a pharma economy consisting of approximately 200 Calling all Exhibitors pharmaceutical companies. specialising in : There are already 25-30 generic domestic companies with access to the international market and equally, there are Clean Room Products approximately 35 multinational companies, such as Sanofi, ACG Medical Plastic - Components, Sub-assemblies and Novo Nordisk, established in the area. Most significantly Medical Plastic Tubings and Extruded Products however, are the remaining domestic manufacturers, who are Medical Plastic Resins, Chemicals & Additives increasingly targeting international sales in neighbouring countries. Medical Plastic Processing Machinery Medical Plastic Devices Sept. 20 – 23 , 2017 Medical Packaging Films and Pouches T-PLAS 2017 - A Global Platform with an ASEAN Medical & Pharmaceutical Packaging Supplies Perspective on the Buoyant Opportunities in the region. Bringing together industry leaders from the best local and & Machinery international brand names from the plastic and rubber sectors, T-PLAS 2017 to be held in Bangkok offers a full spectrum Concept & Contents By : of specialised equipment, high-precision machinery, semi- finished products, raw materials, applications and solutions 25 serving the plastic and rubber value chain. Gain special insights on growing markets such as manufacturing of plastics for the medical, packaging, and automotive sectors. A synergistic platform with Focused Medical & Healthcare Plastic Pavilion - Global Innovations , Strategic Presence A dedicated “Medical & Healthcare Plastic Pavilion” is Mar.-Apr. 2017
Manufacturing Developing Drug / Device Combination Products : Concept to Commissioning Dr. Atul Sardana, Chairman, Alfa Corpuscles Pvt. Ltd., New Delhi. Definition of Drug/ Device Combination Classification of Drug/ Device Combination • A Drug Device combination is a product comprising of active • “Single Entity” or “Integral” product comprises of two pharmaceutical ingredient(s) and a medical device that are or more different regulated components (drug/device) that physically or chemically combined to produce a single product. are physically, chemically, or otherwise combined or mixed. • Such combination products are emerging as innovative medical • “Co-packaged” or “Kitted” unit in a single package products due to their contribution in advancing medical care and comprising of drug(s) and device(s). are thus expected have an impact in the coming years. • “Cross-Labelled” comprise of drug(s) or device(s) • These offer several advantages including reduced adverse/side packaged separately that according to its investigational effects, improved patient compliance, controlled release of drugs plan or proposed labelling is intended for use only with and targeted drug delivery, overall reduction in healthcare another individually and where both are required to expenses and augmented performance. achieve the intended use, indication, or effect. Examples of Drug/ Device Combinations “Single Entity” or “Integral” • Medicated Devices Examples of Drug/ Device • Other - Drug-coated stents Combination - Collagen sponge with bone • Prefilled Drug Delivery Systems - Drug-coated catheters “Co-packaged” or “Kitted” morphogenic protein - Prefilled syringes - Drug-coated pacemaker leads • Convenience kits - Prefilled autoinjectors - Antimicrobial surgical scrubs “Cross-Labelled” - Prefilled pen injectors - Antimicrobial wound dressings - Surgical trays with anaesthetic • Companion diagnostics - Prefilled on-body delivery systems - Antimicrobial Sutures and/or surgical scrub • Photodynamic therapy (laser - Dry-powder inhalers - Drug impregnated surgical mesh - Metered dose inhalers - Antibiotic bone cements - Vial and syringe packs activated drug) - Prefilled nasal sprayers - Spermicidal condoms - Injector pen with user-loaded • Contrast agent and diagnostic - Transdermal patches - Oral Vaccine Delivery Devices prefilled cartridge imaging - Liquid medication with dose- • Iontophoretic delivery systems dispenser The Development of Drug/ Device Combination entails the • To provide targeted drug delivery following steps : 2.Design Development 1.Unmet Need Identification Design development of a drug device combination needs in depth • A Device may require a drug to understanding and critical analysis of the following : • Improve its Safety especially over long term implantation or • Understanding the drug device Interphase with the body • Understanding the interactions between the drug and the when being placed in pathological conditions or challenging environments within the body. device throughout the product life cycle • To augment the function of the device by providing synergy Raw Material Selection for the device is based on the following • To enhance the efficacy of the device by suitably modifying criterion that need to be evaluated in all phases of the product the local or systemic conditions development and use. To reduce device associated co-morbidities and complications. • Leachable interaction with the body and the drug • A Drug may need a Device in order to : • Extractable interaction with the body and the drug • Ensure or regulate proper dosing • Additives and Coatings to be used on the device and their • To provide a constant rate of drug elution and sustained release • To monitor drug release and concentration levels as in a loop interactions with the drug. feedback • Barrier Properties of the Material and effects of oxygen, • Improve patient compliance • To ease administration and make self administration possible. moisture and other gases on the drug. • To enhance the shelf life of the drug • Stability Testing of Drugs in the drug device combination • To reduce filling and administration losses and drug • The effect on drug(s) on Polymer(s) properties and function contamination • DMPK (Drug Metabolism and Phamacokinetics) Study • To improve drug safety • Shelf life study and accelerated ageing of the drug device 26 combination • Method of sterilization to be used for the combination with Mar.-Apr. 2017
Manufacturing • Integration of Automation • From Production to Filling/ Coating respect to drug stability. • Validation Protocols to be used • Prototyping challenges for drug device combination usually • Clinical Trials requirements for Novel Devices • P a c k a g i n g R e q u i r e m e n ts (Intermediate and Final) preclude 3D printing as the combination needs to be tested with actual polymer proposed. Though it may be used for • Filling Lines mechanical and dimensional validation. • Sterility of Ready to Fill Systems • A thorough understanding by the devices manufacturer is in Aseptic Lines required with regards to the drug • Labeling for Regulators and filling lines and due consideration should be given to the Users environmental challenges of the • Choice of Sterilization Methods aseptic conditions to be • Standardization of Exchange of maintained. Data amongst Device and Drug The Current Challenges faced Manufacturers During the Development and Marketing of Drug / Device 2. Affixing Responsibility Combination can be summarized • Post Market Clinical Feedback as below : • Post Market Surveillance • Vigilance and Incident Reporting 1.During Manufacturing of the • Complaints Drug Device combination the • Corrective and Preventive following challenges may be encountered Actions • Large Scale Manufacturing 3. Classification of Drug/Device • Device Filling in Aseptic Lines combinations in the currently with Drugs prevailing law in India. • Replication of the Drug 4. Regulatory Approvals Impregnation / Coating process on commercial scale 5. Legal and Intellectual Property • Combipack Development Right Issues amongst the parties involved in collaborative development (drug manufacturer and device manufacturer) Mar.-Apr. 2017 27
Manufacturing Packaging Testing for Medical Devices Mr. Bunty Kundnani, Business Manager Life and Health Science, UL India Pvt. Ltd. Mumbai. Introduction manufacturer conducts the testing at different phases of product Medical Device Packaging is highly regulated and must meet the life cycle like product design stage, product launch, and new pack- standard requirement. Historically devices have been tested for age design, resolve package damage issue and sometimes based degradation by accelerated aging and other various material char- on client requirement. acteristics. Packaging testing is measuring the characteristics and property of packing material. Most precarious factor is the Regulations and Standards for Packaging Testing sterility which should be maintained through the distribution and storage. Packaging must comply with ISO 11607 and EN 868-1, Packaging testing guidelines are listed in ISO 11607 describing in order to satisfy European regulations and obtain a CE Mark. the available ASTM packaging tests. The key aspects of packag- Testing a new packaging design before full scale manufacturing ing validation are material qualification, seal validation process can save time and money. Many manufacture conduct packag- and whole package seal integrity. Physical tests like burst, peal, ing testing in-house or through third party lab (ISO/IEC 17025 creep and leak tests are performed as per ASTM standards. ISO accredited) which is accredited and certified (ISTA certified, ISO 11607 require both accelerated and real time aging to be per- 17025). The testing is vital to ensure integrity of the package's formed simultaneously. The key areas to be focused in the pack- seal. The general factors that influence the product stability are aging are stability, performance, package integrity and strength physical, chemical, microbiological and toxicological.Most of the testing(Figure 1). Figure 1 : Package validation testing with Standard Reference Regulations and Standards Package Validation Testing Package Integrity Testing Distribution Simulation Testing Stability Testing Test Procedures : Test Procedures : Test Procedures : • Seal Intefrity • Atmosphere Conditioning (ASTM D4332) • Accelerated Aging (ASTM F 1980) • Drop Test (ASTM D5276) - Visual inspection (ASTM F1929) • Vibration Test (ASTM D4728) • Seal Strength • Compression Test (ASTM D642) • Low Pressure (ASTM D6653) - Peel Test (ASTM F18) - Burst Test (ASTM F 1140) - Bubble Test (ASTM F 2066) • Microblel Challenge - ASTM F1603 Package Integrity Test Seal strength test is conducted through a simple burst and / or Depending on package design, a variety of packageintegrity test- creep test where packages are pressurized and evaluated for ing methods may be employed. Thisis to ensure the integrity of the rupture pressure points and time of failure. It is conducted to package seal and system.Visual inspection, peel strength, burst measure the ability of package seal to resist separation. Burst strength, creeps and bubble emission test are some of the pack- and creep testing entails pressurizing theinside of the package age integrity test. During the study conduct deformities break or and measuring the pressurerequired to either cause seals to sepa- crack, blister can be observed(Figure 2). rate or packaging materials to rupture. Some packages use po- rous materials,allowing the contents to be gas sterilized throughthe Figure 2 : Deformities from visual porous package walls after the package has beensealed; burst inspection testing of these packages can require higher inflow capability in order to achieve sufficientpressure to challenge the package. Figure 3 : Burst test (ASTM F1140) Dye penetration test is conductedto detect the presence of any leakage in the seal, (Figure 4). This test method is limited to porus material which can retain the dye penetrant solution and prevent 28 Mar.-Apr. 2017
Manufacturing Drop test study is used to determine the package ruggedness nature and interior cushioning effectiveness when the products/ it from discoloring the seal for 5 seconds. The study can be con- packages systems are exposed to bumpy situation during ducted through different methods like injection, edge dip and eye material handling operations. dropper. Vibration study as per ASTM D999 & ASTM D4728is used to Figure 4 : Dye penetration determine the package withstand to the stresses, shock and vi- bration that will be encountered during the transit and package's ability to function and protect in real world conditions. Compression study as per ASTM D642 is to determine the maxi- mum resistance of compression and lock term stacking strength of the packages (Figure 7). For example, foam is compressed to determine how well it maintains its cushioning properties. Figure 7 : Study results Bubble test as per ASTM F2096 standard is conducted by visu- Drop Test Shock Test Compact Test ally inspecting for bubble streams caused due to affect in the packaging while it is submerged in water.This destructive testing Stability Testing/ Shelf Life Testing provides a practical way to examine packages for gross leaks, Accelerated Aging is a testing method used to estimate the prod- which may render the product non-sterile. This test may apply to uct lifespan when actual data is unavailable or have not gone very large or long packages, which do not fit into any other through the entire product lifespan cycle. A product can be re- package integrity test method apparatus. leased to market based upon successful Accelerated Aging of the package/product that simulates the period claimed for prod- Figure 5 : Bubble Test uct expiration (1 year, 2 years, etc). Accelerated Aging data is recognized by regulatory bodies as an acceptable means to gen- Peel Testing is performed in accordance with erate data quickly, but is only accepted until those tests can be ASTM F88 and EN 868-5Standard Method repeated on \"real time\" samples. for Seal Strength of Flexible Barrier Materials.The test results are not only related Accelerated Aging test is carried out by subjecting the product to to package integrity, but also to measuring unusually high levels of stress (rapid, but controlled, changes in the packaging processes' ability to produce temperature, humidity, pressure, strain, etc.) designed to mimic consistent seals. Given that seal strength is the effects of normal use. a necessary requirement for packaging, Peel Tests are ubiquitous for all types of Real-Time Aging provides the actual data to determine shelf life packaging. and the effects of aging on materials. Transport Simulation Conclusion The medical packages encounter many variables during the transit In packaging medical products that impact lives andhealth, the from the manufacturing site to the sterilization facility, distribution costs of poor quality control can be enormous.In today’s fast- center, health care facility, etc. moving global markets, thestakes are higher than ever. As com- petition and timepressures have grown, the industry and its Distribution Simulation is large and quintessential component that regulatorshave come to recognize that traditional testing complies with the standard and are of three types (Figure 4);Drop methodscan be slow and potentially risky. Package integritytesting test, Vibration test and Compression test. It is necessary to ex- has been acknowledged to be an importanttool for ensuring the pose the packages and products to atmospheric conditioning in safety of package systems and the products they protect. UL test- order to simulate particular field conditions that a packaged prod- ing and validation services are based on ISO 11607-1:2006 and uct or component may encounter during its expected life cycle. ASTM standards are designed to assure compliance with FDA, ISO, EN and CE Mark requirements. UL can support the non Figure 6 : Transport Simulation active medical device manufacturers with Biocompatibility test- ing as per ISO 10993, Materials Characterization, Microbiologi- Compression Vibration Drop cal testing, Virological testing, Physico-Chemical analysis, Shelf Mar.-Apr. 2017 Life of devices and packages, Transport safety and Testing of Ophthalmic devices. References 1. ISO 11607-1:2006, Packaging for Terminally Sterilized Medi- cal Devices; Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems 2. ASTM D999 – 08, Standard Test Methods for Vibration Testing of Shipping Containers 29
Global Trends Global Medical Disposables Market to Reach US$193.9 Bn by 2018 As per a recent study by Transparency Market Research, admissions, surgical procedures, and emergency visits. the global medical disposables market was worth US$144.6 Bn and is anticipated to be worth US$193.9 Bn by the end It has been further segmented on the basis of geography into of 2018, growing significantly at a 4.30% CAGR between North America, Asia Pacific, Europe, and Rest of the World. 2012 and 2018. Among all these regions, North America exhibited strong demand for all product segments of the market in the recent years. The Rising demand for healthcare due to the rising global aging U.S. medical disposables market held around 70% of the North population, rising prevalence of chronic conditions that need America medical disposables market. In 2011, and was long-time therapies, and expanding volume of inpatient days accounted for the largest share of 35% in the global medical and hospital admissions are some of the major factors boosting disposables market. On the other hand, Asia Pacific is the demand for medical disposables in the coming years. On expected to witness rapid growth owing to rising awareness the other hand, rigid FDA and GMP approval norms and reduction for healthcare. Some of the other factors that are expected in the prevalence of healthcare-associated infections are the to boost the demand for medical disposables in the Asia factors that are expected to curb the growth of this market in the Pacific market are the huge aging population, increasing forecast period. disposable income, and rising expenditure by governments on healthcare. The substantial rise of developing nations The market has been classified on the basis of end use into such as China and India is anticipated to propel the Asia home healthcare facilities, outpatient facilities, emergency care, Pacific medical disposables market. hospitals, and physician offices. Among these, the hospitals segment is at the forefront of the U.S. medical disposables (Ref.: http://www.transparencymarketresearch.com/ market. The demand for medical disposables is anticipated to pressrelease/medical-disposables-market.htm) rise in hospitals, thanks to the rising number of patient Medical Polymers Market to exceed $24bn by 2024 Medical Polymers Market size is slated to cross USD 24 healthcare industry generated more than USD 200 billion and it billion by 2024; as per a new research report by Global Market will grow by CAGR over 8% up to 2024. Insights, Inc. rapidly enhancing pharmaceutical devices demand owing to the prevalence of heart diseases, infections, or general Medical fibers & Resins will be a noteworthy product segment illness and technological advancements in the treatment process which generated more than USD 8 billion in 2015. Polypropylene will steer the global medical polymers market growth in upcoming based fibers & resins will likely grow at a significant rate owing years. Increasing health awareness among developed nations to its chemical inertness, light weight, and favorable mechanical will also support the industry throughout the forecast spell. properties. Overall medical fibers & resins will flourish at more than 8% CAGR up to 2024. Pharmaceutical device industry generated over USD 300 billion in 2015, of which U.S. had a major share of around 45%. U.S. Developments and preferences of bio-based polymers for recorded over 6,500 pharmaceutical device manufacturers by environmental sustainability will characterize the growth of 2015 and the growing demand in the country as well as export biodegradable medical plastics and are likely to register a CAGR demand in the emerging economies will escalate the market over 15% in the overall medical polymers market. Medical growth in coming years. Growing application of polymers packaging applications will be a fast-growing segment owing to including polysulfone, polyphenylsulfone, polyether-ether- mandatory sterilization and medical disposable regulations. ketone or PEEK, and polyetherimide in pharmaceutical devices will propel the overall medical polymers industry Regional medical polymers market growth will be focused growth. around the emerging economies in Asia Pacific, Latin America, and Middle East & Africa, owing to rapidly Increasing global geriatric population will also be a significant increasing medical awareness and government initiatives. medical polymers market driver. Population over the age of 65 Asia Pacific will register more than 10% CAGR in the years increased from 7.6% of global population in 2010 to around forecast time span. 8.3% in 2015 and will increase owing to pharmaceutical developments and increasing geriatric care units. The American Raw material price volatility will hinder the medical polymers Geriatrics Society has predicted the U.S. geriatric population to market growth. As, Petrochemical based raw materials prices reach 20% of total population by 2030. Ubiquity of chronic are dependent on the global crude oil prices, which is highly disorders such as cardiac diseases, calcium deficiencies, fluctuating in nature. Strict norms about volatile organic arthritis, etc. will likely have a positive influence on global. compound (VOC) content in the polymers may also restrain the medical polymers market. End products are based on superior Medical polymers market will also be driven by the growing biocompatibility with various product blends, and the expensive home-based private healthcare demand due to its ease and manufacturing technologies will restrain the entry of new market affordability along with factors including commotions in public participants. facilities, chronic or contagious diseases, and elderly patients will enhance the home-based healthcare industry in the (Ref.: https://www.gminsights.com/pressrelease/medical- upcoming years. In 2015, the global home-based private polymers-market) 30 Mar.-Apr. 2017
Global Trends Asia-Pacific Reprocessed Medical Devices Market Will Hit at a CAGR of 15.7% by 2017 to 2027 Availability of reprocessed medical devices at low prices, coupled 2027-end. Meanwhile, orthopedic or arthroscopic devices, with assurance of qualitative production, has also prompted the gastroenterology devices, ENT devices and other such medical market’s growth to a considerable extent. According to recent devices will be showcasing a comparatively steady growth in report by ‘Future Market Insights’ on the reprocessed medical terms of revenues. devices market in Asia-Pacific region projects that in 2017 and beyond, Japan, China and Southeast Asia will By the end of 2027, one of every two reprocessed medical collectively account for more than 60% share of overall devices sold in Asia-Pacific will be classified under semi- market revenues. It estimates that reprocessed medical critical medical devices. This indicates that demand for devices market in Asia-Pacific is presently valued at US$ reprocessing is higher for semi-critical medical devices, as 236.9 Mn. In a ten-year forecast period, the market is being opposed to critical or non-critical medical devices. The most projected to expand at 15.7% CAGR and bring in a little prominent method of reprocessing medical devices, over US$ 1 Bn by the end of 2027. observed across Asia-Pacific, is likely to be third-party reprocessing. Third parties assisting drug makers in Rising focus of government authorities towards dumping of reprocessing businesses is serving as a consolidator for medical waste or biowaste is slated to promote the reprocessing Asia-Pacific’s reprocessed medical devices market. of medical devices. Manufacturers of medical devices are continuously striving to control their product costs for recording The hospitals are identified as the largest end-user of greater sales. Reprocessed medical devices, thus, become the reprocessed medical devices in Asia-Pacific. Similarly, diagnostic most feasible option for both, manufacturers and end-users. centers and ASC’s will also contribute significantly, by exhibiting Availability of reprocessed medical devices at low prices, coupled revenues growth at more than 11% CAGR. Furthermore, the with assurance of qualitative production, has also prompted the leading reprocessed medical device manufacturers partaking market’s growth to a considerable extent. in the Asia-Pacific region are companies such as Stryker Sustainability, Medline ReNewal, Hygia Health Services, Inc., The report reveals that in 2016, more than US$ 100 Mn worth CLEANPART HEALTHCARE, ReNu Medical, Inc., SureTek of reprocessed medical devices turned out to be used in Medical, and NEScientific. the field of cardiology. Demand for reprocessed cardiology devices is expected to continue surging in the years to come, (Ref.: http://www.crossroadstoday.com/story/35077832/ registering the highest revenue CAGR of 18.4%. Reprocessing asiapacific-reprocessed-medical-devices-market-will-hit-at-a- will also gain traction among laparoscopic tools & devices, revenues from which are predicted to reach US$ 111 Mn by cagr-of-157-by-2017-to-2027) AVAILABLE PRE USED SYRINGE MANUFACTURING EQUIPMENT Mar.-Apr. 2017 Moulds : 2, 3, 5, 10ml Syringe Printing Machine : 2/3, 5, 10ml Syringe 4 Parts Assembly Machine : 2/3, 5, 10ml Contact : 7895648113 [email protected] 31
Industry News Med Devices Import up 16.8%, Export By 25.7% During 2012-16 Between FY12 to FY16, the import of medi- other medical devices form 86 per cent of lion ( Rs.2,093 crore) in FY 16. Other Medi- cal devices into India has increased by 16.8 total export trade in India in FY1613. cal Device (e.g. ECG, opthal equipment, per cent, whereas export increased by 25.7 Amongst the exporters’ portfolio, USA was heart lung machine, etc.) has grown by per cent, as per the key findings of a gov- the chief destination for export and contrib- 9.6% from USD 878 million ( Rs.5,707 ernment led study in collaboration with utes close to 15 per cent of the export trade. crore) in FY12 to USD 964 million Andhra Pradesh MedTech Zone (AMTZ) Singapore, Germany and China were the (Rs.6,266 crore) in FY 16. and World Health Organisation (WHO). other leading export destinations with shares of 7.0 per cent, 6.7 per cent and 6.4 Diagnostic imaging medical device export India is one of the top 20 global medical per cent respectively. trade has grown by 27.2 per cent from USD device markets and the 4th largest 210 million ( Rs.1,365 crore) in FY12 to medical device market in Asia. The European Union (including Germany) USD 267 million ( Rs.1,736 crore) in FY16. cumulatively constitutes of 21.7 per cent of Medical Consumables export trade has The import of medical devices has grown the total export trade13. USA, Germany, grown by 26.1 per cent from USD 228 mil- from USD 2.46 billion ( Rs.15,990 crore) in China, Japan, and Singapore constitute the lion ( Rs.1,482 crore) in FY12 to USD 288 FY12 to USD 2.87 billion ( Rs.18,655 crore) five largest exporters of high technology million ( Rs.1,872 crore) in FY16. IV Diag- in FY16. The export of medical devices has medical equipment to India. nostic devices export trade has grown by grown from USD 0.78 billion ( Rs.5,070 58.7 per cent from USD 24 million ( Rs.156 crore) in FY12 to USD 0.98 billion In FY 2015 imports alone from these five crore) in FY12 to USD 39 million ( Rs.254 (Rs.6,370 crore) in FY16. countries accounted for approximately 65 crore) in FY16. per cent of total import of high technology Diagnostic imaging (e.g. CT scan, X-Ray, medical equipment while USA, remained While technological advancement and ex- MRI, USG, X ray-tubes etc.), IV Diagnostic the largest exporter accounting for 28.1 per pertise that the global market leaders of- (lab equipment and reagents, etc.) and cent. fered has proved to be an advantage, Other Medical Device (ECG, opthal equip- India’s medical device sector is dominated ment, heart lung machine, etc.) form 70% Diagnostic imaging medical device import by multi-national companies, which is evi- of total import in India in FY16. trade has grown by 19% from USD 636 dent from the fact that about 78% of the million ( Rs.4,134 crore) in FY12 to USD sales are generated by imported medical However it is estimated that import trade 757 million ( Rs.4,921 crore) in FY 16. IV devices. will fall with increasing number of interna- Diagnostic medical device import trade has tional and Indian manufacturers setting up grown by 43.2% from USD 225 million ( http://www.pharmabiz.com/ medical device manufacturing in India. Rs.1,463 crore) in FY12 to USD 322 mil- ArticleDetails.aspx?aid=100896&sid=1 Diagnostic imaging, consumables and DCGI begins registration of notified bodies to carry out audit of mfg sites of Class A & Class B medical devices The Drugs Controller General of India metic Act, 1940 to regulate the clinical in- through online portal to carry out the audit (DCGI) has started the process of registra- vestigation, manufacture, import, sale and of manufacturing sites of Class A & Class tion of notified bodies to carry out audit of distribution of the medical devices. The B medical devices to verify conformity with manufacturing sites of Class A & Class B Chapter III (Rule 13) of Medical Device Rule the Quality Management System and other medical devices as laid down in the Medi- 2017 provides for the registration of noti- applicable standards. In this regard, cal Device Rules 2017 which will come into fied bodies with the DCGI office (CDSCO). CDSCO has put in place an online portal effect in the country from January 1, 2018. for the registration of notified bodies. Subsequently, with effect from July 1, 2017, The Medical Device Rules 2017 have al- the notified bodies have to file their appli- http://www.pharmabiz.com/ ready been published vide G.S.R. 78 (E) cation to the Central Licensing Authority ArticleDetails.aspx?aid=101382&sid=1 dated 31.01.2017 under Drugs and Cos- (DCGI) for registration in Form MD-1 10% price hike cap on most medical devices The prices of all medical devices except While the government has notified 22 medi- ing consumers, the regulator said it was for stents, condoms and intrauterine de- cal devices as drugs under the Act, the closely monitoring prices of not only sched- vices can only be raised by up to 10% in a prices of stents, condoms and intrauterine uled but also non-scheduled products, and year, the National Pharmaceutical Pricing devices are capped by the NPPA directly, any violation wo*uld attract severe action Authority (NPPA) said in a new office order and companies manufacturing or selling and penalty under the Essential Commodi- on Friday. these products have to take permission ties Act. from the regulator before implementing any The drug price regulator also clarified that hike. However, for other 'non-scheduled' Several leading hospitals have already all medical devices notified as drugs under products, the regulator has allowed an an- come under the NPPA's scanner for the Drugs and Cosmetics Act, including nual increase of 10% in prices. For any hike allegedly overcharging stents, orthopaedic implants, catheters and beyond the limit, companies will have to intra-ocular lenses, will have to mandato- seek permission from the regulator. rily carry their maximum retail price (MRP) Cautioning companies against overcharg- on their packs. 32 Mar.-Apr. 2017
Industry News CDSCO to go online for all services in six months The Central Drugs Standard Control Organisation (CDSCO) is set to become paperless within six months with completely shifting its services to online portal Sugam. The agency digitized 60-70 per cent of its services through Sugam portal so far. In another six months we are planning to go completely elec- tronic for all our services by doing away with requirement of any physical documents, said a senior CDSCO official. With the launch of Sugam on November 14, 2015, firms can apply online for grant of registration certificates for import of drugs or import license of drugs in Form 10, under D&C Rules. They can also file online applications with respect to import registra- tion and license of medical devices. Online submission has also been started for grant of approval to conduct bioequivalence studies for export purposes. The main aim of this e-governance drive is to bring in transpar- ency, accountability and competency in CDSCO which allows creating a real time platform and improve the safety and security programmes taken up by it. http://www.pharmabiz.com/ PrintArticle.aspx?aid=100721&sid=1 Mar.-Apr. 2017 33
Product Gallery Dilators and Introducer Sheaths Ronkonkoma, NY, March 15, 2017— Qosina offers low minimums and short lead Qosinacarries a large selection of times. Log on to qosina.com to see pricing, obtain dilatorsavailable with and without tear-away our latest catalog, request complimentary introducer sheaths in various lengths, sizes, samples and place orders. Be sure to sign up materials and colors. for our monthly e-newsletter to stay current with our newest product additions. Our product Tear-away introducer sheaths with dilatorshave development team can work to customize a part a zero clearance dilator-to-sheath transition and to your specifications. Call our customer service are equipped with a unique locking mechanismon the hub. The specialists to discuss your project in detail via phone +1(631) sheaths areconstructed of Teflon® for a smoother tear-away, or 242-3000 or email [email protected]. pre-scored polyethylene, which ensures consistent peel-away performance. Founded in 1980, Qosina is a worldwide supplier of thousands of stock OEM components including bioprocessing accessories, Tear-away introducer sheaths and dilators with griplock hubsalso compression fittings, ENFit™ connectors, luers, clamps, clips, have a zero clearance, a locking mechanism on the hub and an check valves, stopcocks, hemostasis valves, tuohy borst ergonomically designed handle for easy removal. adapters, swabs, spikes, syringes and tubing to the medical and pharmaceutical industries. Qosina is based in Ronkonkoma, NY Valved tear-away introducer sheaths with dilatorsincludetabs for in a 95,000 square-foot facility with an ISO Class 8 Clean Room more comfortable handling after device insertion, and the valve and is ISO 9001, ISO 13485 and ISO 14001registered. maintains a tight seal to help prevent air or fluid leakage.The Teflon® sheath allows for a smoother peel. For Immediate Release Contact : Qosina, Rachelle Morrow, 2002-Q Orville Drive Qosina also carries introducer needlesin a wide range of gauge sizes, hub configurations, needle lengths and tips to complete North, Ronkonkoma, NY 11779 your project needs. Phone: +1 (631) 242-3000, Fax: +1 (631) 242-3230 Email: [email protected] SANIDHYA ENTERPRISE Manufacturers of : Medical Plastic Injection Molded Articles & Job Works Our Product Range Includes Medical Components like : • Urine Container • Adaptors (PP) • Regulators / Cord Clamp • All types of Urine Bag parts like H.D. - ABS & PVC Connectors / Covers, PVC Closures • PP Mucas Container • And many other Surgical Medical Components Contact : Contact Person : Kamlesh Shah Mobile : 9825474789 / Chitan Shah Mobile : 9722612646 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] 34 Mar.-Apr. 2017
Events MEDICAL FAIR INDIA 2017 closes with a huge boom in International Tradefair visitors for the Plastic and Rubber Industries New programme highlights were well received Opportunity For Exporters And Manufacturers Of Medical With a huge boom in visitors, the MEDICAL FAIR INDIA has Plastics Processing Machinery, Pharmaceuticals /Medical definitely marked out its position as the leading medical trade Products Packaging Machinery, Medical Polymers, fair for the Indian market and built on the growth of the previous Components / Tubings / Adhessives, Packaging Films / years. 13,480 decision makers from all sectors of the healthcare Pouches etc. industry came to MEDICAL FAIR INDIA 2017 at the Pragati Exhibition Center in New Delhi from 6 to 8 April. They visited EXHIBIT IN THE ”Medical & Healthcare Plastics 519 exhibitors to learn about the latest trends and innovations Pavilion” @ T – PLAS BITEC, Bangkok, Thailand. for medical healthcare. September 20 – 23, 2017 Organized By : Messe Dusseldorf Asia “Visitor numbers increased by 15% in comparison with the 2016 event in Mumbai. The floor space booked by the exhibitors also A dedicated “Medical & Healthcare Plastic Pavilion” is expanded by 16%. As expected with great results like these, the conceptualized by “T-PLAS 2017 “ in association with “MEDICAL atmosphere in the trade halls was buzzing”, summed up Thomas PLASTICS DATA SERVICE” which will be participated by Schlitt, Managing Director of Messe Düsseldorf India. The Exporters and Manufacturers of: Clean Room Products, Medical MEDICAL FAIR INDIA takes place in New Delhi and Mumbai, Plastics-Components, Sub-assemblies, Medical Plastic Tubing’s alternating between these locations each year. and Extruded Products, Medical Resins, Chemical & Additives, Medical Plastics Processing Machinery, Medical Plastics “The MEDICAL FAIR INDIA is the top event for the healthcare Devices, Medical Packaging Films and Pouches, Medical & industry. We saw that it was even better than our expectations” Pharmaceutical Packaging Supplies & Machinery. said Raghvendra Bansal, Managing Director of RR Instruments, recapping the successful trade fair on behalf of many very T – PLAS 2017 (www.tplas.com), organized by “Messe satisfied exhibitors. The synopsis of Prashant Narula, Marketing Dusseldorf Asia, provides a global platform with an ASEAN Director of Narula Udyog was also positive: “Not only the perspective on the buoyant opportunities in the region by numbers but also the quality of the visitors was well above our bringing together local and international industry leaders from expectations. We are very happy with the outcome.” these dynamic growth sectors. New highlights also contributed to the success of MEDICAL FAIR The top 6 country visitors for this show are from Indonesia, INDIA. They enriched the supporting programme for the event Malaysia, Singapore, Thailand and Vietnam on and above and aroused much interest from visitors on all three of the trade India. fair days. A novel digital health platform was created in the FTR4H Lab & Lounge (Future for Healthcare powered by MEDICA). A SPECIAL VISITOR COMPAIGN FOR MEDICAL PLASTICS, The Lab & Lounge centred around information, start-ups MEDICAL DEVICE AND PHARMACEUTICALS INDUSTRIES presenting their product ideas, expert dialogues and networking IS BEING CARRIED OUT on all the fascinating topics concerning the digital transformation of the healthcare industry (i.e. mobile health, the internet of things Capitalize on the leading trade show and connect with the world and targeted and secure data handling). today! The Indian market for health IT offers particularly good Driven by the nation’s various burgeoning sectors such as opportunities, with an estimated volume of 2.5 billion USD Medical, Pharmaceuticals, Packaging as well as Lifestyle, (Deloitte). High-tech infrastructures for state-of-the-art clinics in Thailand is well positioned to become Southeast Asia’s very own big cities as well as remote medical applications that ensure hub for its plastics and rubber industries. These areas of interests medical care in remote countryside regions are included in this, have seen significant growth in recent years, and are projected among others. to expand to new heights in years to come. The CLIN LAB INDIA also celebrated its premier as an integral For more details, please write to: Medical Plastics Data part of the programme of MEDICAL FAIR INDIA this year. The Service, [email protected] conference and its accompanying exhibition were designed by Scherago International and organized in cooperation with the In terms of content, the MEDICAL FAIR INDIA 2017 included Messe Düsseldorf Group. The focal point of the talks was on the following areas and many more: Medical products and trend topics that are particularly relevant to the practice of medical technology, laboratory technology and diagnostics, laboratory medicine, such as point-of-care testing, molecular equipment and furniture for clinics and health centres, products diagnostics and clinical chemistry. The CLIN LAB INDIA for physiotherapy and rehabilitation as well as health IT and exhibition area (in Hall 9) had booked out 330 square metres, mobile health solutions. with companies such as Mindray, Randox and SMC Pneumatics along with others, taking up this space. All the details on MEDICAL FAIR INDIA are available online at: http://www.medicalfair-india.com. Mar.-Apr. 2017 The next MEDICAL FAIR INDIA will take place from 16 - 18 March in Mumbai. 35
® 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] 36 Mar.-Apr. 2017
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 Mar.-Apr. 2017 37
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 Obelis European Dressings etc. Authorized Representative Center (O.E.A.R.C) based in Brussels, Belgium since 1988 is one of the largest Specialized in Handling Large Quantity Regulatory Centers in Europe, assisting non-European manufacturers’ successful endeavors into Europe. & OEM / Contract Manufacturing F/6, Goyal Plaza, Vastrapur, Ahmedabad-380 015. INDIA. Factory : 16, Ranchodnagar, Near Vinzol Railway, Tel. : +91 79 66090225 E-mail : [email protected], [email protected] Crossing, Vatva, Ahmedabad-382445, INDIA Website : www.unikalindia.com Tele : +91-79-25835567, +91-79-25834850 38 E-mail: [email protected] • Web: www.jimitsurgicals.com Mar.-Apr. 2017
Mar.-Apr. 2017 39
Manufacturer And Exporter Of a ISO 9001-2000 wide range Of Medical Devices Quality Medical Devices ISO 9001 : 2000 & ISO 13485 : 2003 Facilities : Controlled Molding Area, Clean Room of Class 10000, ETO Gas Products available with CE marking 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 PACK-EQUIP ISO - 9001-2008 Certified Company (Mfg. Packaging Machinery) S. Nath & Co. Office / Communication : 91, Avnish Society, Opp. Pavitrakunj Society, Excellence in Quality CTM Cross Road, Amraiwadi, Ahmedabad-380 026. Manufacturer & Exporter of Phone : 25855027 (M) 9825380739 Surgical Disposable Products since 1980 Works : IDEAL® 16, Arbuda Estate, Near Nidhi Bank, CTM Cross Road, Amraiwadi, Ahmedabad-380 026. • Infusion Set • Blood Administration Set Mar.-Apr. 2017 • Urine Collection Bag • Urine Specimen Container • Umblical Cord Clamp Address S. Nath & Co. B. N. Estate, Near Uttam Dairy, Sukhramnagar, Ahmedabad-380021, Gujarat, India. Contact No. : +91-79-22743246, 9825360531 Website : www.snathco.com • [email protected] 40
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 Mar.-Apr. 2017 MANUFACTURER & EXPORTER OF MEDICAL DISPOSABLE PRODUCTS • I.V. Infusion Sets • Blood Administration Sets • Scalp Vein Set • Urine Collection Bags • Ryles / Feeding Tubes • Catheters and Tubes • Surgical Gloves. Contact : Mr. Bhavin Shah MANUFACTURER & EXPORTER OF MEDICAL DISPOSABLE PRODUCTS 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 41
Events National Healthcare Events Calender An ISO 9001 : 2008 Company • Medicall 2017 : India’s Largest Hospital Equipment Manufacturing & Exports of Expo, 17th Edition Medical Disposables : Date: July 28 - 30, 2017. I.V. Set, B.T. Set, Urine Bag, Venue: Chennai. Measured volume set, Cord Clamp, Surgical • T-Plas 2017 : A Synergistic Platform With Focused Gloves etc. Medical & Healthcare Plastics Pavilion Injection Moulded Medical Components Date: Sept. 20 – 23, 2017. and Extended Tubes : Venue: Bangkok, Thailand. I.V. Set components, Urine bag Components, • Medicall 2017 : India’s Largest Hospital Equipment Connectors for Catheters, I.V. Set / B. T. Set / Expo, 18th Edition Urine Bag Tubes etc. Date: Oct. 6 – 8, 2017. Venue: Mumbai. Contact : Naresh Patel • 4th PLASTIVISION Arabia 2017 : International 5/4, Anand Estate, Opp. Ravabhai Estate, C.T.M., Plastics, Printing & Packaging Exhibition Ahmedabad (India) Ph. : 079-25857530, Date: Dec. 11-14, 2017. Fax : 079-25862206 Venue: Sharjah, UAE. E-mail : [email protected] • PLASTINDIA 2018 : 10th International Plastics Website: nationalhealthcare.in Exhibition, Conference & Convention GMP. & ISO 9001 – 2000 Certified Company Date: Feb. 7-12, 2018. Venue: Gandhinagar – Ahmedabad, Gujarat, India. AMIGO SURGI CARE PVT. LTD. • Medical Fair India : 24th International Exhibition Manufacturer of Disposable Surgical Products: And Conference Date: March 16-18, 2018. I.V.CANNULAS / B.T.SETS / I.V.SETS / Venue: Goregaon (East), Mumbai. SURGICAL LATEX GLOVES / CORD CLAMPS / URINE BAGS / MEASURE AN ISO 13485-2012 CE certified Company VOLUME SETS ETC. Manufacturer & Exporter of Medical Manufacturers / Exporters / Hospital Suppliers Disposable Devices & Surgical Dealer are requested to Products Contact : Range of Products : Mr.Chandrakant Sayal , B.E. (Mech. & Elec.) • Infusion Set • Blood Administration Set (DIRECTOR) Mobile:0091-9825057180 • Measure Volume Set Tel.:0091-2764-268249 • Urine Collecting Bag • Urine Collecting Bag - Uro Meatry E-mail : • [email protected] • Respiratory Exerciser • [email protected] • Twin Bore Nasal Oxygen Set Website:www.amigo-india.com • Oxygen Face Mask • Nebulizer Kit Plant Address • Vaccum Suck Suction Set Plot No.780, Opp.: Kemron Lab • Latex Surgical Gloves • Umblical Cord Clamp Sola Santej Road, Rakanpur (Santej) – 382721 Contact Yogesh Patel M. : +91 98241 21383 Gujarat, India MEDICARE DEVICES Mar.-Apr. 2017 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 42
Search
