CToabnletoef nts Vol. 25 No. 3 May. - June. 2017 22 Cover Story • Medical Polymers Processing – Selecting Right Materials & Manufacturing Systems Materials selected for use in new medical devices can have major ramifications throughout the product lifecycle, from design through testing… 23 Materials • Compatibility of Thermoplastic Polyurethanes with Drugs for IV Sets - Ms. Elena Draganoiu, Global Technology Manager, Lubrizol LifeSciences, USA. The purpose of this study was to evaluate in vitro compatibility of IV sets of thermoplastic polyurethanes with an array of drugs with different properties. 26 Manufacturing • Designing and Manufacturing of Molds for Medical Components - Mr. Ketan Panchal, Production Manager, IndoGerman Tool Room, Ahmedabad. The better output need more attention in the area of product applications, standards, plastic material selection, product design considerations, injection molding machine to be use etc. 30 Technology • Syringe Plungers Can Contribute to Patient Safety Silicone contains only a small number of additives, reducing the likelihood that harmful substances will be released. The material can, therefore…. 35 Global Trends • Healthcare Plastics Recycling Project: A Success • Trends Pushing Solid Growth in Global Market for Medical Plastics 36 Industry News • Tekni-Plex Announces $15 Million Investment in New China Manufacturing Facility (Page 22) • AMTZ Partners With GMDN Agency For Identification Of Medical Devices • Gujarat FDCA To Tie Up With NIPER Ahmedabad To Train Inspectors For Detecting SAE Of Medical Devices • HLL Takes Over Tech For Production Of 3 Medical Devices • NIPER To Team Up With Cos Furthering Make In India 38 Product Gallery • ‘Male And Female Connectors And Caps, Low Dose Syringes, Spikes, Adapters And Y Connectors’ • New Tuohyborst Adapters 20 Did You Know? • Why “PEEK” Offers Success For The Manufacture Of Medical Parts 46 Events • Motivation Behind “Medicall”, Now With 16 Successful Edition • Medicall 2017, 17th Edition: July 28 - 30, 2017, Chennai • T-Plas, 2017: Sept. 20 – 23, 2017, Thailand. • Medicall 2017, 18th Edition: Oct. 6 – 8, 2017, Mumbai • Plastivision Arabia 2017: Dec. 11-14, 2017, UAE • PLASTINDIA 2018: Feb. 7-12, 2018, Ahmedabad • Medical Fair India 2018: March. 16-18, 2018, Mumbai May-June 2017 19
Flashback YoDKuindow ? Nov.-Dec. 2004 Why “PEEK” offers success for the manufacture of medical parts From Editor’s Desk Medical devices that are intended for long-term contact with body tissues must meet particularly high quality requirements for registration in Europe or in the US. The Dear Reader’s manufacturers have to demonstrate on the one hand, that the raw materials are suitable for the respective area of application, and on the other hand demonstrate how they ensure The total healthcare market in India is expected to grow consistent quality. significantly and its contribution to the country’s GDP Today more and more manufacturers of medical products are using PEEK will increase from 5.2% at present to 8.5% over the (polyetheretherketone) for bone surgery, but also in areas of traumatology and orthopaedics. next ten years. The expenditure on healthcare will Why PEEK? Because this material is biocompatible, inert to body fluids and can be more than double by the year 2012 and the healthcare processed relatively easy with high precision micro moulding for individual implants or spending is expected to increase from Rs 86,000 crore surgical instruments. at present to Rs 2,00,000 crore in the next decade, PEEK provides a great benefit: It saves weight, allows more design freedom and a greater reveals a CII-McKinsey study on healthcare. functional integration, it also scores with X-ray transparency and elasticity which corresponds approximately to bone. At the same time it is a lower cost alternative to Titan According to the study, private healthcare will continue the classic implant material, especially when using medical instruments or endoscopes, to be the largest component of healthcare spending where the good electrical insulation properties of PEEK come into play. and is expected to double from 60,000 crore to Rs The complete detachment of ligaments, tendons or other soft tissues from their associated 156,000 crore by 2012. Moreover, if health insurance bones within the body is relatively commonplace injuries, particularly among athletes. cover becomes operative, the private spending will Such injuries are generally the result of excessive stresses being placed on these tissues. further go by an additional Rs 39,000 crore. For example, tissue detachment may occur as the result of an accident such as a fall, over-exertion during a work-related activity, during the course of an athletic event, or Some other important features of Indian Healthcare activities. For a complete detachment, however, surgery may be needed to re-attach the Industry are : soft tissue to its associated bone or bones. Numerous devices made out of PEEK material are currently available to re-attach soft tissue to bone. Examples of such currently-available • Growing Exponentially: An Innovation - led growth devices include screws, staples, suture anchors and tacks. • The economy is passing through a vibrant phase, with ( Ref : http://www.medicalplasticsnews.com/news/close-to-the-bone-why- manufacturers-are-using-peek-products/ ) an exceptionally high rate (17.9%) of entrepreneurial activity, second only to Thailand (18.9%), among 37 In a Entrepreneurship Monitor (GEM) Report. Nutshell.... • Suitability For contract research as well as clinical trials “Just because you are CEO, don’t think • The IT skill of Indian manpower offer services in you have landed. You must continuously bioinformatics and data mining. increase your learning, the way you think and the way you approach the organization” These and many such enlightening facts, figures and data have been highlighted in this issue of “MEDICAL - Indra Nooyi, Chairperson & CEO of PepsiCo PLASTICS DATA SERVICE” as well the two web sites, www.medisourceasia.com and www.medicalplasticsindia.com from time to time. For the benefit of readers, some of the important developments covered in last 2-3 years in the magazine are reproduced in this issue which gives an overview of this important “Growing And Innovating High-Tech Area : Indian Healthcare Industry”. Contents : • Coverstory : Indian Healthcare Industry : Growing and Innovating High-Tech Area. • Materials : Present Trends and Future Prospects of Plastics in Medical Applications. • Global Trends : European Disposable Surgical Drapes and Gowns Markets. • Events: CompaMED 2004 - A report, HOSPIMedica INDIA 2005 20 May-June 2017
EDITOR FromDtheeEsdkitor’s D.L.PANDYA, B.E.(Chem), M.I.E. For selecting the right material for a Medical Device, it is important to have understanding of polymers, additives and their properties ASSOCIATE EDITOR including basic understanding of polymer morphology. Thoroughly Mr. Rutul Bhavsar defined application requirements are needed to select appropriate material. One such application is Intravenous Infusion. An excellent analysis showing B.Tech (Biomedical & Instrumentation Eng.) “Compatibility of Thermoplastic Polyurethanes with Drugs for IV Sets” is covered EDITORIAL ADVISORY BOARD in the article by Ms Elena Draganoiu, Global Technology Manager, Lubrizol Lifesciences, USA . Dr. TARANG PATEL M.B.B.S., M.Ch. (ONCO) Process for manufacturing injection moulds for medical components has become Cancer & Reconstructive Surgeon more complex as the Medical Device Industry places higher demands on Polymeric products.Industry expects moulders to provide parts that meet all their requirements Mr. C. BALAGOPAL of dimensional stability, low cost, fast turn around and particulate free (clean). An Director - Enter Technologies Pvt. Ltd. article by Mr. Ketan Panchal, Production Manager, Indo German Tool Room, very Chairman - Mobilexion Technologies Pvt. Ltd. effectively explains how to take care of all the requirements in “Designing and Manufacturing of Molds for Medical Components”. Trivandrum One more interesting case for using right material is regarding Syringe Plungers Dr. DILIP H. RAIKER made of silicone to facilitate precise dosing of the drug being administered as Ph.D., M.Sc., PGDBM, AMIE (Chem.Engg.) detailed in the “Technology” column in this issue. The “Did You Know “column Former Chief Manager(P), CIPET - Chennai explained “ Why “PEEK” offers success for the manufacture of Medical Parts, particularly in the areas of Traumatology and Orthopaedics . ING LOUIS C. SUHUURMAN Formerly Sales Director We hope, the coming GST regime creates beneficial impact on all the stakeholders COLPITT B.V., Holland of the Indian Medical Devices Sector, and not increase the healthcare cost. As Per “AiMED”, there will be little or no impact. However, it is important for the Government Dr. A.V. RAMANI to see that Patients benefit by lowering of MRP and “GST” boost s “Make in India” Group Sr. Vice President (R&D), The TTK Group in Medical Device Sector. Dr. Vinny Sastri This issue also highlights very important positive trends favoring the Growth of President, Winovia LLC, U.S.A. Indian Medical Device Industry. Shining examples of building up of right eco- system are “AMTZ”, “NIPER, Ahmedabad”, FDCA, Gujarat and many more. Dr. C.S.B. NAIR Director (R&D), Peninsula Polymers Ltd While already covered in one of our issues earlier, an interesting highlight is the report on a collaborative multi-hospital recycling project between Healthcare Plastics Dr. BHARAT GADHAVI Recycling Council ( HPRC ) and the Plastics Industry Association aimed to introduce CEO, Medisurge Hospitals a viable recycling model for healthcare plastics. The focus being on non-infectious plastic packaging and products from clinical areas of the hospitals. It is high time, Mr. A.S. ATHALYE Indian Industry understands the importance and takes such initiative. Arvind Athalye Technology Transfer Pvt.Ltd, Mumbai Dr. SUJOY K. GUHA B.Tech.(Hon), M.Tech., M.S., Ph.D., M.B.B.S. IIT, Kharagpur 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. May-June 2017 21
MEDICAL POLYMERS PROCESSING – SELECTING RIGHT MATERIALS & MANUFACTURING SYSTEMS Applications in the healthcare industry and medical devices in particular, have some demanding requirements for polymeric materials. While polymers have been used in the healthcare industry for decades, it has only been in the recent past the designers have started to explore the benefits of using special materials in the medical applications. Materials selected for use in new medical devices can have major ramifications throughout the product lifecycle, from design through testing, during regulatory approvals and production, and in the build up to market adoption and even disposal. There are many considerations to keep in mind while choosing a polymer for Medical Device viz Environment during transportation and product use, Chemical Resistance, Durability, Biocompatibility, Appearance, Feel, Sterilization, Molding, Price, Weight, Recyclability etc. Discussions analyzing two important aspects follows. The first is related to selecting a polymer in direct contact with the flow of drugs through a device. It is required to look at the effect the material has on drugs. Chemical resistance is also important, as the drugs should not promote the materials degradation. Also the potency of the drug should not be affected by the polymeric material it is in contact with either via extraction of additives and monomers, or via the chemical reactivity between the drug and the polymer. One more important aspect is regarding molding. It is possible to make extremely precise design tolerances. Complex, intricate features can be effortlessly included with the help of rightly designed moulds. Tekni-Plex Announces $15 Million Investment in New China Manufacturing Facility New facility supports Tekni-Plex’s continued The facility also will produce Natvar’s recently-announced silicone commitment to global supply network extrusion tubing for catheters, feeding tubes, drug delivery and peristaltic pump applications, as well as micro extrusion tubing that Wayne, Pa. (June 8, 2017) —Tekni-Plex, Inc. is announcing a $15 targets a wide variety of demanding neurovascular interventional million investment in a new state-of-the-art manufacturing facility in therapies and surgical applications. The facility will also manufacture Suzhou, China, near Shanghai. It represents the single largest recent Colorite custom compounds for medical device applications, and investment by Tekni-Plex and reflects the growing needs of the Asia- Action Technology’s dip tubes used in a wide variety of food/beverage, Pacific pharmaceutical and medical device market. Production for pharmaceutical, personal care, industrial and household pump some product lines has already begun. applications. “Tekni-Plex’s investment in our new China facility is another step in our continuing commitment to support our customers with robust global supply. Pharmaceutical, medical device and other manufacturers want access to exactly the same components and materials regardless of where in the world their manufacturing facility is located. It is our goal to meet those objectives,” said Paul Young, chief executive officer. Tekni-Plex is in the process of phasing out production at its existing facility in Suzhou that it has operated since 2005. Initially, the more than 140,000-square-foot (13,000-square-meter) About Tekni-Plex, Inc. facility will manufacture products for Tekni-Plex’s Natvar, Colorite and Celebrating its 50th anniversary in 2017, Tekni-Plex is a globally- Action Technology business units. The facility will feature three Class integrated company focused on developing and manufacturing 100K cleanrooms to accommodate medical-grade tubing and innovative packaging materials, medical compounds and precision- components production plusone Class 10K cleanroom that will crafted medical tubing solutions for some of the most well-known produce Natvar’s pharma-grade tubing. names in the medical, pharmaceutical, personal care, household and industrial, and food and beverage industries. Tekni-Plex is headquartered in Wayne, Pennsylvania, and operates 30 manufacturing sites across eight countries worldwide to meet the needs of its global customers. For more information visit www.tekni- plex.com. 22 May-June 2017
Compatibility of Thermoplastic Polyurethanes with Drugs for IV Sets Ms. Elena Draganoiu, Global Technology Manager, Lubrizol LifeSiences, USA. Yolanda Zhu1, Clark Yan1, Wei-bo Qiu1, Hong Zhang2, Elena • Plasticizer free Draganoiu3 • Good compression strength, excellent kink resistance, 1Lubrizol LifeSciences, Lubrizol Specialty Chemicals Co., Ltd., Shanghai, China, 2Institute of Chemistry Research, China flexibility and softness National Science Academy, Beijing, China, 3Lubrizol • Superior clarity LifeSciences, Lubrizol Advanced Materials, Inc., Cleveland, OH, • Greater strength with good flexibility compared to PVC, USA Introduction allowing thinner wall tubes ab fluid storage bags with enhanced Thermoplastic polyurethanes(TPU) are formed by step-growth burst resistance polymerization between di-isocyanates and diols. Polymeric diol • Easily incinerated, no corrosive or dangerous chemical and isocyanate groups aggregate to form a two phase domain emissions structure consisting of : • Manufactured on world class ISO 9001:2008 facilities - Soft segments (low Tg) - contribute to the elasticity / flexibility - Hard segments (urethane) form crystalline domains and The use of thermoplastic polyurethanes for intravascular (IV) sets has seen a recent increase, however comprehensive testing physical crosslinks due to hydrogen bonding; they confers to evaluate their compatibility with drugs has not been conducted mechanical strength prior to this study. TPU schematic structure Compatibility between medications and intravascular TPUs have a long history of proven biocompatibility and in vivo administration sets (containers, tubing, and delivery) is important stability in biomedical applications, including cardiovascular for administration of prescribed medications to assure predictable (central venous catheters, heart pacemaker connectors, cardiac delivery of the drug dose, safety and efficacy. Potential assist pump bladders, tubing, housing, coatings, lead insulators, interactions between drugs and IV sets include: vascular grafts, patches, percutaneous shunts), urology (catheters, hemodialysis tubing, membranes), orthopedics Sorption (orthopedic splints, bone adhesives), wound care, etc. • Adsorption of the active pharmaceutical ingredient (API) to Pellethane® TPUs produced by Lubrizol LifeSciencesare aromatic polyether and polyester TPUs available in natural color the inner surface (without further penetration) results in initial and in a wide range ofdurometers. Specially developed extrusion reduction in drug concentration delivered to the patient and and molding grades allow ease of use with existing equipment as the surface become saturated, concentration restores and minimal modifications. Pellethane® TPUs are widely used • Absorption of the API into the material. The drug for a variety of medical applications including tubing, catheters concentration in the infusate is initially low and slowly recovers and implants due to theirattributes: as the material becomes saturated • Excellent biostability and biocompatibility • Permeation - drug migrates through the material and out onto • Outstanding hydrolysis resistance and non-hemolytic the outer surface of the IV set. Substantial drug loss that continues throughout the duration of administration properties • Leaching - components of IV sets (plastics) migrate to drug • Polymer modification – drug modifies properties of the IV May-June 2017 set (polymer) The purpose of this study was to evaluate in vitro compatibility of IV sets of thermoplastic polyurethanes with an array of drugs with different properties. Methodology Three types of infusions sets (manufactured by Jiangsu Suyun Medical Materials Co., Ltd., China)were tested : • Thermoplastic polyurethane set made from Pellethane® TPU • Styrene butadiene thermoplastic elastomer set (TPE) • Polyvinyl chloride(PVC) set (standard PVC with diethylhexyl phthalate) All sets had similar tube design: OD 4 mm,ID 2.4mm, length 1.6 m (Fig. 1-3). 23
designed to simulate clinical administration (Table 1). Fig. 1. TPU IV set Fig. 2. TPE IV set Fig. 3. PVC IV set The concentration of drug in the solution circulated through the IV sets was quantified atdifferent time intervals by high- The study included seven common IV drugs, to cover different performance liquid chromatography with UV detection, using properties (aqueoussolubility and log P) and therapeutic classes reference standards. The impurity level, pH of the solution and as shown in also tested. The study parameters (drug dose, particulates were measuredbefore and after circulation in the IV volume, concentration, flow rate, administrationtime) were sets. IV sets based on TPE and PVC were alsoevaluated for comparison. Table 1.Drug properties and study parameters Drug Levofloxacin Moxifloxacin Metronidazole Docetaxel Furosemide Ranitidine Pantoprazole hydrochloride hydrochloride hydrochloride sodium Class Antibacterial Antibacterial Antibactrial Antibacterial Loop diuretic H2 antagonist Proton pump inhibitor Fluoroquinolone Fluoroquinolone Nitroimidazole Antimicrotubular log P 2.10 2.90 -0.02 2.40 2.03 0.27 0.50 Solubility in Sparingly Sparingly Sparingly Practically Practically Very soluble Freely soluble soluble soluble insoluble insoluble water (USP/NF) soluble Daily dose (mg) 400 400 1000 120 400 100 160 404 220 Volume (ml) 80 250 500 134 140 0.25 0.73 Concentration 5 1.6 2 0.9 2.86 (mg/ml) Administration 1.0 1.5 1.0 1.0 1.67 2.0 0.25 time (h) Administration 80 167 500 134 84 200 880 rate (ml/h) Recirculation 24 24 24 6 24 24 4 time (h) Results Lubrizol’s Pellethane® TPU IV sets did not affect the pH, impurity and particulates of the drug products tested. For all drugs tested, independent of their aqueous solubility and logP, Pellethane®TPU sets showed verylow drug sorption during infusion ofthe recommended administration time, delivering more than90% of the dose. Further recirculation of the solution in the sets beyond the recommended administration time did not result in an increased drug absorption (for up to 4 – 24 hours) - Fig. 4. Pellethane® TPU based IV sets performed similar or better than TPE or PVC – Fig 5, 6. In the case of pantoprazole sodium,Pellethane® TPU IV sets performed slightly better, having lower initialsorption compared to TPE and PVC – Fig. 7. Fig. 4. Drug recovery following circulation through TPU IV sets Fig. 5. Drug recovery following circulation through TPE IV sets 24 May-June 2017
Fig. 6. Drug recovery following circulation through PVC IV sets Fig. 7. Pantoprazole recovery following circulation through TPU, TPE and PVC IV sets Conclusion Lubrizol’s Pellethane® TPU based IV sets performed similar or In the case of pantoprazole,Pellethane® TPU IV sets better than TPE or PVC, showing very low sorption for drug of performed slightly better, having lower sorption compared to different properties: TPE (initial stage) and PVC (entire duration). • Levofloxacin hydrochloride • Moxifloxacin hydrochloride Lubrizol’s Pellethane® TPU properties and their • Metronidazole compatibility with drugs, make them suitable for use in • Docetaxel intravascular administration sets. • Furosemide • Ranitidine hydrochloride Reference: *The United States Pharmacopeia and The • Pantoprazole sodium National Formulary (USP–NF) USP 39–NF 34, United States Pharmacopeial Convention, Rockville, Maryland, 2016. May-June 2017 25
Designing and Manufacturing of Molds for Medical Components Mr. Ketan Panchal, Production Manager, Indo German Tool Room, Ahmedabad. The best output is based on optimum inputs. Normally we believe 2) Parts with uniform and non uniform wall thickness that the mold makers has main role to produce the best components. The mold maker’s selection is based on low cost The uniform wall thickness will give warpage free component and minimum delivery time. Sometime we also choose mold due to even cooling of wall thickness. Some time non uniform maker based on only quality of product. In fact in all the case wall thickness is the requirement of product need better our output is samples to produce molds. Some time we also cooling to avoid warpage. More cooling is required in thick demand merging of different features of different samples and wall area and less cooling is requiring in thin wall area. This make one product design. Sometime we provide samples of can be judge with mold flow analysis. existing mold and ask for modification. Now all the mold makers are used to with this situation and do the work. Part with non uniform wall Part with uniform wall The better output need more attention in the area of product 3) Sharp corners and corners with radius. applications, standards, plastic material selection, product design considerations, injection molding machine to be use etc,. There The sharp corners are not advisable in plastic products. Some are stated requirement, non stated requirement and hidden radius must be providing in the product design which make requirement. deformation free product. Stated requirements are dimensions, tolerances, weight, surface Part with sharp corners Part with rounded corners finish, fitments, applications and mold life. These are the most important requirement which is always stated in the drawing. 4) Parts with draft angles. We should study all the points and try to make very informative product design. The draft angles are must in plastics products. The draft angle to be provided in the direction of ejection. The draft angles Non stated requirements are flash free, sink mark free, warpage can be half degree to one and half degree according to product free etc. These are not stated but it should be taken care as design requirement and plastic material to be use. stated requirement by the mold maker. Hidden requirements are assembly of parts in automatic machine, automatic packaging, adhesive use in assembly, use of temperature in post process, sterilization, ultrasonic welding etc. These requirements should be clear in the beginning in product design. This will clear product design requirements in the beginning. The above requirements are input which give better output in mold making. Product design features 1) Parts with thick wall thickness and thin wall thickness The plastics material is having range of minimum and maximum wall thickness. During product design the range of plastic material thickness should be taken care to produce defect free component. Part with thick wall Part with thin wall Part without draft angle Part with draft angle 26 May-June 2017
5) Parts with ribs. SELECTION OF STEEL MATERIAL FOR MEDICAL COMPONENTS The ribs can help to reduce wall thickness and confirm application as it is. The ribs will eliminate warpage, sink mark Selection of steel is very much important in medical plastics etc. The ribs design is also important to control weight of the because the product should be produce in corrosion free with component. highly polished mold surface. The some of the recommendation of steel selection is as under. Part with thick wall Part with ribs to avoid thick wall 1) Plastic materials like PET, Polyimide, PC, ABS, PEEK, PU, PMMA Part with incorrect ribs Part with correct rib direction • 1.2344,SKD61, H13 for better hardness and toughness • 1.2083, AISI420 having 13% chromium for good polishing Ribs design • 718M high nickel alloy for corrosion resistance • D53 (D2 supreme) for PC and PEEK material 6) Part design with boss 2) Plastic materials like PP,PE,PS,PBT Sometime boss is required for clamping of two components • 8407 supreme for excellent toughness, high purity and fine with screw or pin. The boss cannot be eliminating form the product design but the boss design has different design structure possibility. • S136, 1.2083 pre hardened steel for corrosion resistance • 618,P20,1.2738,1.2711 for good wear resistance Part with isolated boss Boss with ribs option no. 1 3) Plastic materials like PVC,PA Boss withgussets Boss in corner • 718M nickel alloy ( 17-21% chromium, 50-55% nickel, 32-40 HRC) • 1.2316 ( 15-17% chromium, 40-46 HRC) SURFACE TREATEMENT OF MOLD SURFACES 1) Hard chrome plating can be used for PP,PE,PS and ABS. We can get 72HRC surface hardness. 2) Electroless nickel plating can be used for PVC,PC,PMMA and Polyamide. We can get 50HRC hardness. 3) Titanium nitride plating can be used for glass filled material and PVC. We can get hardness up to 90 HRC. It has good abrasive resistance, corrosion resistance and excellent wear resistance. METHODS OF PRODUCT DEVELOPMENTS The product development technology improved a lot in last 10 years of period. The product developed in past days with concept design sketch, then detail drawing. With detail drawing model makers were making model from wood, plaster of paris and acrylic sheets. This kind of proto type was time consuming and without perfection. The modification in proto type was also difficult as especially in intricate parts. Then the product development was improved with 3D model in concept design. The proto type was made with hand molds, jigs, fixture or cnc machining. This was again time consuming and difficult in machining of intricate parts. This was costly and disturbing production activity of tool room. Now days it is very easy to develop product proto type without limitations. The 3D model of concept design is required. Then additive manufacturing processes like SLS, SLA, FDM, 3D printing can be use for proto type model. This has only one disadvantage of higher cost but development is possible in minimum time with accuracy. The proto type can also use in application and confirm the function. The plastic material of proto type is nylon, ABS, PC, epoxy resin and other rubber based materials. The proto type machines can be use for various applications and also for marketing of product. Ribbed boss in corner May-June 2017 27
RAPID TOOLING Rapid tooling is one the benefit of rapid proto typing. We can manufacture core and cavity with metal rapid proto typing with H11, SS316 material and reduce mold making time. IGTR has produced plastic injection molds and die casting dies with metal proto typing machine. The core and cavity can be hardened with 50 HRC and any surface treatment is possible on core and cavity surface. The other advantage is conformal cooling. The conformal cooling will reduce 30% cooling time and produce components in less cycle time. This will give more productivity. The example of conformal cooling is in below pictures. Some of the examples of product development with additive manufacturing. Conformal cooling can be provide very close to cavity surface which give uniform cooling. Medical device housing developed with proto type Medical device housing assembly view. Core and cavity of mold made with metal proto typing. 3D SCANNING WITH BLUE LIGHT SCANNER The scanning will reduce manual errors of measurement. This is the fast process of capturing data and make 3D model for the product reverse engineering. Dental teeth development in plastic proto typing as well as Scan data of body inplants. metal proto typing die Inplant made with metal proto typing after scanning the object and made 3D model. 28 May-June 2017
MOLD MAKING WITH USE OF CAD PREVENTIVE MOLD MAINTENANCE The input is product design in 3D model. The product design • Parting surface to be clean with mild clean solvent with soft confirmed with proto type and its application and function. tissue papers The mold design can be done with use of CAD software. The • All water lines should be drained and blown free of all residual steps are….. water • Use database of CAD software for standard parts • Do not use hard tools on any molding surface, parting surface • Use of libraries for frequent use of components or shut or surface • User interface for machine suitability • Mold ability assessment of product design • Use soft or treated water in cooling • Nos. of cavity to be done with layout • Avoid excessive clamp pressure, high injection pressure and • Mold base selection from library • Feed system design over packing • Shrinkage calculation according to use of plastic material • Use rust preventive like WD40 on molding surface before • Parting line design • Cooling design unloading mold from machine • Venting design • Lubricate the appropriate mold components • Detail mold design • Bag the last shot as an example of the typical quality of this After the completion of mold design mold flow analysis will run and store this part with mold. confirm the mold functions and product design defects solving. The mold flow analysis can give clear idea about mold filling, INSPECTION OF MOLD cooling and warpage. The animation of mold function is also possible to give idea to mold manufacturing section as specially • Inspection is to note small problems and scheduled for repairs assembly and processors. • This inspection to be done by experience operator after about 20,000 cycles. • Preventive to be done every day and every time the mold unload from the machine • It is recommended maintenance after 1,00,000 cycles • It is also recommended major maintenance like replacement of wear parts, bearings, ejector pins, springs, resurfacing or re plating etc., after 2,50,000 cycles. The use of above technology will improve product quality and reduce time of correcting mold after first trial. May-June 2017 National Healthcare An ISO 9001 : 2008 Company Manufacturing & Exports of Medical Disposables : I.V. Set, B.T. Set, Urine Bag, Measured volume set, Cord Clamp, Surgical Gloves etc. Injection Moulded Medical Components and Extended Tubes : I.V. Set components, Urine bag Components, Connectors for Catheters, I.V. Set / B. T. Set / Urine Bag Tubes etc. Contact : Naresh Patel 5/4, Anand Estate, Opp. Ravabhai Estate, C.T.M., Ahmedabad (India) Ph. : 079-25857530, Fax : 079-25862206 E-mail : [email protected] Website: nationalhealthcare.in 29
Syringe Plungers Can Contribute to Patient Safety Syringe plungers made of silicone allow for precise dosing of assistance with product approval.” the drug being administered. Other advantages of this material For instance, the special material formulation for Raumedic include its physical/mechanical properties and the high-chemical silicone plungers is officially registered in a “master file” at the purity of its formulation. Finally, silicone allows for customized U.S. Food and Drug Administration (FDA). So, medical product configurations and designs. engineering and pharmaceutical manufacturers that are active on the international market can get their new products approved Enhance safety aspects more quickly and easily not only in the United States but also all Silicone contains only a small number of additives, reducing the around the world. likelihood that harmful substances will be released. The material (Ref: http://www.medicalplasticsnews.com/ can, therefore, contribute to protecting the patient, while also How%20syringe%20plungers%20can%20contribute%20to%20patient%20safety/) increasing product safety for the medical and pharmaceutical manufacturer. AVAILABLE Polymer specialist Raumedic produces custom-tailored silicone PRE USED SYRINGE components, including high-grade syringe plungers produced MANUFACTURING by injection moulding. But that’s not all: Thanks to its staff of scientifically-trained professionals, the company’s Regulatory EQUIPMENT Affairs department can also provide support in preparing product- specific extractables studies. In Raumedic’s own laboratory or Contact : 7895648113 in external labs, potentially critical extractables from the material’s interaction with the pharmaceutical formulation can be quantified May-June 2017 and evaluated for their toxicological properties. A focus on customization Silicone is known for its immense versatility in terms of form and design. At Raumedic, medical engineering and pharmaceutical manufacturers can decide for themselves what their syringe plungers should look like. There are virtually no limits on a manufacturer’s design ideas or size and shape requirements. As a development partner for the medical and pharmaceutical industry, Raumedic’s focus is on custom-tailored product solutions, not mass-produced items. One clear sign that the silicone plunger is truly custom-tailored involves access to tools: Raumedic provides its customers with an individualised tool from which the geometry of the respective component is manufactured exclusively for them. Geometry modifications and optimizations can also be carried out during the development phase. Ensure competitive advantages “We’re able to offer real competitive advantages,” says Jörg Prescher, Head of the Technical Center of Excellence for silicone moulding at the Bavarian company. “Personalised consulting is our top priority. From the initial idea to product development, and right through to industrial manufacturing, we’re there for our customers at every step in the process. We even provide 30
Healthcare Plastics Recycling Project: A Success A collaborative multi-hospital recycling project between the The highest volume of material collected was sterilisation wrap Healthcare Plastics Recycling Council (HPRC) and the and as such, the material was evaluated as a viable substitute Plastics Industry Association (PLASTICS) has been or supplement for virgin resins in product manufacturing. Other completed in the Chicago market. packaging materials such as film plastics, as well as rigid plastic packaging were also collected. The project aimed to address the issues surrounding the use and recycling of plastics used in the healthcare industry. HPRC The team were also successful in testing the potential to and Plastics aimed to introduce a viable recycling model for demonstrate value through energy conversion and chemical healthcare plastics, the focus being on non-infectious plastic recycling, showing that value can still be realised through other packaging and products collected from clinical areas of the recovery processes. hospitals. Plastic materials in hospitals are currently difficult to recycle in Chris Rogers, HPRC project manager said: “This project an economically viable way due to the material failing to provided valuable insights into the realities of implementing represent enough value to attract the attention of recyclers. The plastics recycling programs in clinical healthcare settings. What project brought together multiple hospitals in an attempt to we learned is that collection of plastics must be made simple for overcome this issue. clinical staff in order to be effective. Detailed sorting at the point Plastics primarily from main operating rooms and ambulatory of generation is too complex and a distant priority from clinician’s surgery centers were collected and then transported by waste primary focus of ensuring positive patient outcomes. It’s also haulers to material recovery facilities (MRFs) for processing, or important to remember that behavioural change around recycling transferred to specialised plastics recyclers. can be a slow process, one that takes constant reinforcement The project was a success in many areas, such as defining the over time.” relative quantities of material types and understanding the complexity of sorting the materials once collectively amassed. Kim Holmes senior director of recycling and diversion at PLASTICS said: “In addition to testing the recovery and mechanical recycling of healthcare plastics, we were also able to explore alternative pathways of chemical recycling and conversion to fuel products with our technology partners. Proving the value of these hospital plastics in the conversion process was an exciting dimension of this project and underscores the importance of adding non-mechanical recovery technologies to our resource management tool kit.” Participating hospitals included Advocate Illinois Masonic Medical Centre, and NorthShore University HealthSystem’s Evanston, Skokie and Glenbrook Hospitals. (Ref : http://www.medicalplasticsnews.com/news/healthcare- plastics-recycling-project-is-a-success/) Trends Pushing Solid Growth in Global Market for Medical Plastics New proprietary research by BCC Research reveals that long– and the introduction of new and lifesaving devices. term trends in the global healthcare industry are boosting the medical plastics market. Among its key drivers, aging populations “Commodity thermoplastics dominate the global market with and the increasing use of minimally invasive surgical techniques around 60% of total volume”. requirements, pricing, are pushing the global medical plastics market to reach about environmental and regulatory issues.” 17.2 billion pounds in 2021, up from 12.7 billion pounds in 2016. Emerging Healthcare Trends Shaping the Plastics Market Plastics usage in medical devices has been growing faster than Long–term trends in the global healthcare industry are favorable the gross domestic product (GDP) of the U.S. and other major to the continued growth of the medical plastics market, markets. The aging U.S. population, ongoing cost-reduction particularly aging populations in most major markets, which drive pressures in the healthcare field, advances in polymer increased healthcare spending. performance, and environmental issues surrounding disposable and non-disposable medical devices are key factors in the “One key trend that should benefit the market is healthcare market’s 6.2% CAGR. provision in settings such as the home or outpatient clinics,” Fitzgerald says. “The movement of healthcare activities to less Research Highlights costly locations have increased the need for lighter materials, • The demand for lighter materials is rising as healthcare especially for housings. Thus, home healthcare and other out- of-hospital treatment and service systems require prepackaged activities move to locations outside clinical and hospital diagnostic and therapeutic kits that can be used on site and settings. discarded. Most of these kits are plastic, as are the package • The shift toward using disposable medical products, especially contents.” single–use versions packaged and placed in kits, continues to expand. ( Ref : https://globenewswire.com/news-release/2017/06/13/ • Other market drivers include advances in polymer performance 1018090/0/en/Trends-Pushing-Solid-Growth-in-Global-Market- for-Medical-Plastics.html ) May-June 2017 35
AMTZ Partners With GMDN Agency For Identification Of Medical Devices In order to facilitate regulation of medical device with Shardul Nautiyal, MumbaiSaturday, June 03, 2017, 08:00 classification system as stipulated in medical device rules, 2017 Hrs [IST] among other aspects like sale and distribution, import and labeling of medical devices, Union Health Ministry has permitted Attracting attention of medical device fraternity across the world, AMTZ to host a dedicated help desk for understanding and the Andhra Pradesh MedTech Zone (AMTZ) recently joined the smooth implementation of Medical Device Rules, 2017. Global Medical Device Nomenclature (GMDN) Agency as partners. The help desk would also facilitate information on following changes of medical devices rules to manufacturers like licensing The GMDN Agency is responsible for the Global Medical Device authorities and functions of notified body, manufacture of medical Nomenclature used for identification of medical devices. Formed devices for sale and distribution, import and labeling of medical in 1991, medical device experts from around the world devices, clinical investigation of medical device and clinical (regulators, healthcare providers and manufacturers) have performance evaluation of IVD’s, import or manufacture medical compiled the GMDN to facilitate taxonomy on medical devices. GMDN is a list of generic names used to identify all medical device which does not have predicative device, duties of medical device products including those used in the diagnosis, device officer, medical device testing officer and notified body, prevention, monitoring, treatment or alleviation of disease or registration of laboratory for carrying out test for evaluation. injury in humans. Taking forward its mandate of Make in India, Government of A standardized and unambiguous system for naming and coding Andhra Pradesh last year established country’s first medical medical devices is critical in an environment increasingly technology manufacturing park, AMTZ in Vishakhapatnam. N dependent on electronic data records for sharing and storing Chandrababu Naidu, chief minister of Andhra Pradesh laid the patient information. GMDN is recommended by the International foundation stone of AMTZ. Medical Device Regulators Forum (IMDRF) and is now used by Since then, AMTZ has received good response in terms of over 70 nationalmedical device regulators to support their activity. commencing of booking of plots and its active participation at With AMTZ as a Consulting Organisation to GMDN, it will be a Indian Medical Device Conference – 2017, one of the largest great value-addition to all the manufacturers at AMTZ. GMDN events for the Indian pharmaceutical market. association with AMTZ will come as an enabler of export and (Ref : http://www.pharmabiz.com/ global market expansion potential. NewsDetails.aspx?aid=102330&sid=1) 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] 36 May-June 2017
Gujarat FDCA To Tie Up With NIPER Ahmedabad To Train Inspectors For Detecting SAE Of Medical Devices would be a boon for the Indian manufacturers to help adhere to Gujarat FDCA is planning to collaborate with National Institute compliance towards patient safety as the country today lacks in for Pharmaceutical Education and Research (NIPER) registering and thereby reporting adverse events due to faulty Ahmedabad to equip officers on detection of serious adverse medical devices at the point of care. events (SAE) caused by the use of medical devices to ensure Till date, products are usually sent to foreign countries for testing patient safety. due to lack of a reliable and advanced medical device testing This will be a major boost to the government’s materiovigilance facility in the country. Though the government plans to set up programme of India launched two years ago. Materiovigilance two medical device testing labs in the country at Vadodara in Programme of India was launched by the Union Health Ministry Gujarat and another at Noida subject to getting approvals, on July 6, 2015 at Indian Pharmacopoeia Commission (IPC), medical device testing lab in Gujarat would be the first and the Ghaziabad. only dedicated biomaterials and implants testing lab in the Ministry has already sanctioned an amount of Rs. 15 crore country. The lab at Noida will be set up primarily to test electrical towards setting up a dedicated medical device testing lab at and electronic medical devices in the country. Vadodara some time back. Gujarat FDCA pursued the matter of setting up the medical Recommended and promoted by the Union commerce ministry, device testing lab based on an Engineering Export Promotion the country’s flagship project will be developed in partnership Council (EEPC) Meet at Ahmedabad one and a half years ago with Union health ministry with technical support from Healthcare which raised the demand for setting up a dedicated medical Technology Division of National Health Systems Resource device testing lab to ensure quality assurance of medical devices Centre (NHSRC), a technical support institution under the Union manufactured in the country. health ministry. (Ref : http://www.pharmabiz.com/ Setting up of a dedicated medical device testing lab in the country NewsDetails.aspx?aid=102360&sid=1) HLL Takes Over Tech For Production Of 3 Medical Devices Public sector HLL Lifecare Limited (HLL) will take over industrial babies in thermo neutral condition and come with temperature production of three medical devices, technology for which has controls, displays, alarms and safety features, he said. been developed by Sree Chitra Tirunal Institute for Medical The blood and IV fluid warming system enables quick warming Sciences and Technology (SCTMST) here. of refrigerated material (from 4 degrees Celsius to 37 degrees Union Minister of Health and Family Welfare J P Nadda officially Celsius in just a few minutes) for transfusion. transferred the know-how to HLL CMD R P Khandelwal during It consists of a blood bag warming chamber and IV tube warming the 2nd Technology and Industrial Meet organised by Sree cartridge lined with infra-red LEDs for the heating, and Chithra Institute here recently. adjustments that allow for both slow and rapid transfusion. The three technologies transferred to HLL are Blood/IV Fluid The Instant Warming Bassinet has a retractable top cover fitted Warning System, a Thermo Regulated Infant Warming Bassinet with a warming pad and a bed with a warming pad under it. and Thermo Regulated Infant Warming Wrapper, a company The pads have infra red-emitting LEDs for warming and sensor release said here today. to control temperature levels. “The two infant warmers will mark a first for HLL in paediatric “As with all products and services of HLL, our goal with these medical devices. By warming fluids with accuracy and speed, new devices will be to ensure quality care and affordability to the Blood/IV Fluid Warming System can help providers deliver general public,” Khandelwal said. higher-quality care to more patients,” HLL CMD RP Khandelwal (Ref : http://www.business-standard.com/article/pti-stories/hll- said. takes-over-tech-for-production-of-3-medical-devices- The infant warmer bassinet and wrapper are both transportable, 117051701186_1.html) light weight, battery-operated devices that can be used to keep NIPER To Team Up With Cos Furthering Make In India The National Institute of Pharmaceutical Education and updates on technology advancements in the country. Research (NIPER), Ahmedabad is planning to collaborate with two Ahmedabad-based biotech companies for research and Development of domestic industry has gained further impetus development with an integrated approach to equip students to as government of India is planning to expand NIPERs across take up job roles for the development of medical device industry the country to nurture manpower and hence boost domestic and further the Make in India campaign. manufacturing of medical devices in the country. More than 70 per cent of medical devices are imported as of today which has This is a significant milestone as India’s import dependency on impacted the development of the domestic industry. high-end medical devices is over 80 per cent and 60 per cent to 70 per cent for other devices. As a step towards setting up a National Centre for Medical Devices (NCMD), National Institute of Pharmaceutical Education and Research (NIPER) Ahmedabad has sent a fresh proposal This comes close on the heels of its tie-up recently with Johnson to the Department of Pharmaceutical (DoP) to sanction an & Johnson and Sahajanand Laser Technologies for development amount of around Rs. 150 crore for setting up a Centre of of industry-oriented skilled manpower in the medical device Excellence (CoE) for strengthening academic research and sector. This would also be a value addition to the post-graduate development of skilled manpower for medical device Sector. studies in medical devices run exclusively at the NIPER Ahmedabad campus towards equipping students with the latest (Ref : Chronicle Pharmabiz, June 8, 2017 & June 1, 2017) May-June 2017 37
Qosina Expands Its ENFit™ Product Line Ronkonkoma, NY, May 2, 2017—Qosinahas customize a part to your specifications. Call our addeda number ofcomponents to its customer service specialists to discuss your extensiveENFit™ product line, including male project in detail via phone +1(631) 242-3000 or and female connectors and caps, low dose syringes, spikes, adapters and Y connectors. email [email protected]. ENFit™ is a brand of enteral feeding connectors that meet the ISO 80369-3 standard, which was Founded in 1980, Qosina is a worldwide supplier developed to improve patient safety and reduce the risk of small- of thousands of stock OEM components bore misconnections used in liquid and gas healthcare including bioprocessing accessories, compression fittings, applications. Thesenew partsare available in various sizes and ENFit™ connectors, luers, clamps, clips, check valves, materials and complement Qosina’s already-vast selection of stopcocks, hemostasis valves, tuohy borst adapters, swabs, ENFit™ products. spikes, syringes and tubing to the medical and pharmaceutical industries. Qosina is based in Ronkonkoma, NY in a 95,000 Qosina continues to grow its ENFit™line to meet clients’ enteral square-foot facility with an ISO Class 8 Clean Room and is ISO project needsandcan modify any existing component or build 9001, ISO 13485 and ISO 14001registered.Qosina also is a new tooling to suit exact requirements. Visitqosina.com/enfit to member of the Global Enteral Device Suppliers Association view all ENFit™ products, as well as request samples and place (GEDSA). orders. For Immediate Release Qosina offers low minimums and short lead times. Log on to Contact : Qosina, Rachelle Morrow, 2002-Q Orville Drive qosina.com to see pricing, obtain our latest catalog, request complimentary samples and place orders. Be sure to sign up North, Ronkonkoma, NY 11779 for our monthly e-newsletter to stay current with our newest Phone: +1 (631) 242-3000, Fax: +1 (631) 242-3230 product additions. Our product development team can work to Email: [email protected] Qosina Adds 2 Tuohy Borst Adapters to Their Line Ronkonkoma, NY – June 7, 2017 – Qosina is complimentary samples and place orders. Be pleased to announce 2 new tuohyborst adapters. sure to sign up for our monthly e-newsletter to One adapter features a female luer lock side port stay current with our newest product additions. connector (#80460), while the other has a 6 inch Our product development team can work with DEHP-Free PVC side port tube to a female luer you to customize a part to your specifications. lock connector (#80461). Both tuohyborst Call our customer service specialists to discuss adapters are available to fit 0 – 9 French your project in detail via phone +1(631) 242- guidewires and have a proprietary tri-cut silicone valve 3000 or email [email protected]. technology which provides a leak proof seal. Made of a polycarbonate body and cap, it takes less than 3 rotations to Founded in 1980, Qosina is a worldwide supplier of thousands seal the valve, providing rapid engagement of the seal and of stock OEM components including bioprocessing accessories, prevents hand fatigue. The wide cap design is preferred for its compression fittings, ENFit™ connectors, luers, clamps, clips, ease of use and also has a stop mechanism which prevents it check valves, stopcocks, hemostasis valves, tuohyborst from separating from the body when fully opened. These adapters, swabs, spikes, syringes and tubing to the medical and adapters feature aCOPEswivel male luer lockwhich minimizes pharmaceutical industries. Qosina is based in Ronkonkoma, NY tubing kinks and have a lower profile than a typical valve. Qosina in a 95,000 square-foot facility with an ISO Class 8 Clean Room offers a variety of caps, syringes, tuohyborst adapters, and is ISO 9001, 13485 and 14001 registered. hemostasis valves and guide wire accessories for you to complete your project. Call or log on to Qosina.com to request For Immediate Release samples or place an order. Contact : Qosina Corporation, Maria Stazzone, 2002-Q Qosina offers low minimums and short lead times. Log on to Orville Drive North, Ronkonkoma, NY 11779 qosina.com to see pricing, obtain our latest catalog, request Phone: +1 (631) 242-3000, Fax: +1 (631) 242-3230 38 Email: [email protected] May-June 2017
An ISO & CE certified Company AMIGO SURGI CARE PVT. LTD. Manufacturer of Disposable Surgical Products I.V.CANNULAS / B.T.SETS / I.V.SETS / SURGICAL LATEX GLOVES / CORD CLAMPS / MEASURE VOLUME SETS / URINE BAG / CATHETERS / OXYGEN MASK / NEBULIZER MASK / SCALP VEIN SET / CANNULA FIXATOR ETC. Only Manufacturer of IV CANNULA in GUJARAT Contact : Mr. Chandrakant Sayal, B.E. (Mech. & Elec.) (Director) Mobile : 0091-9825057180 Tel.: 0091-2764-268249 E-mail : [email protected] Website : www.ivcannulaindia.com Plant Address Plot No. 780, Near Canara Bank, Rakanpur (Santej)-382721. Gujarat,India. May-June 2017 39
® 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. ISO 13485 : 2003 • Exporting our products to almost more than 23 countries. 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 May-June 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 41 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 May-June 2017
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 42 May-June 2017
May-June 2017 43
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 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 May-June 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] 44
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 • Endotracheal Tube Holder With Bit Swivel Mount & Expandable Double Block Swivel Mount) • Inflatable Anaesthesia Mask Oxygen Therapy Products • Ventilator Circuit • Anaesthesia Mask Silicon • Nasal Cannula • Ventilator Circuit with Single Water Trap(Adult, Pediatric, Neonatal) • Trachostomy Tube With Cuff • Oxygen Mask Breathing Filters • Ventilator Circuit with Double Wa- • Endotracheal Tube Holders Airovent T-Humidifier ter Trap(Adult, Pediatric, Neonatal) • Yankaures Suctions Systems • Multi flow Venturi Mask • Breathing Filters(HME & BVF) • Resuscitator(Ambu Bag) • Airovent T-Humidifier • Single Dial Venturi Mask • Anaesthesia Circuits (Mapleson D, • Dialflow Regulator Mapleson F, Bain Circuit with APL • Airopap Full Face Mask • High Concentration Mask Valve) • Close Ventilation Suction System • Nebulizer Set • Stylet • Nebulizer Chamber • Guedel Airway • Nasopharyngeal Airway • Incentive Spirometer • Laryngeal Mask Airway • 3 Ball Spirometer • Mallaeble gum Bougie • 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, Goregoaon (E), Mumbai - 400 063, INDIA. High Concentration ET Holder with Bite Expandable Catheter Tel.-Fax : 91-22-2685 2973 / 2686 9090 Mask Block Mount 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 May-June 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 45
Motivation Behind “Medicall”, Now With 16 Successful Editions Medicall, is India’s largest B2B Medical Equipment Exhibition sale force to meet all these hospital owners. Since I have is organized by Medexpert Business Consultants Pvt Ltd, undergone the difficulty for my hospital, I thought Medicall will promoted by Dr. Manivannan S, Joint Managing Director of bring in all equipment manufacturers under one roof.” Kauvery hospital a1000 bedded Hospital group in South India. Medicall serves as a marketing platform wherein the equipment Early in his career, he identified that nursing homes, small companies showcase their products and services to Hospital hospitals and clinics in tier 2 and 3 cities faced a distinct owners and decision makers. disadvantage in the market while procuring hospital equipment Thus Medicall was born. or service. They neither had the choice nor the price advantage Medicall shows are held at Chennai, Mumbai, Delhi, Ahmedabad, enjoyed by the biggies. Kolkata, Hyderabad and Colombo since 2006. Medicall has While talking about the motivation behind starting this expo, Dr completed 16 successful editions. Medicall Chennai 2016 had Manivannan S says, “Small and medium sized hospital owners more than 750 exhibitors, 15000 professional visitors and over from tier II and III cities cannot afford to have qualified purchase 5000 products. managers. Equipment companies also do not have adequate www.medicall.in AN ISO 13485-2012 Events Calender CE certified Company • Medicall 2017 : India’s Largest Hospital Equipment Manufacturer & Exporter of Medical Disposable Devices & Surgical Expo, 17th Edition Products Date: July 28 - 30, 2017. Venue: Chennai. Range of Products : • Infusion Set • T-Plas 2017 : A Synergistic Platform With Focused • Blood Administration Set • Measure Volume Set Medical & Healthcare Plastics Pavilion • Urine Collecting Bag Date: Sept. 20 – 23, 2017. • Urine Collecting Bag - Uro Meatry Venue: Bangkok, Thailand. • Respiratory Exerciser • Twin Bore Nasal Oxygen Set • Medicall 2017 : India’s Largest Hospital Equipment • Oxygen Face Mask • Nebulizer Kit Expo, 18th Edition • Vaccum Suck Suction Set Date: Oct. 6 – 8, 2017. • Latex Surgical Gloves Venue: Mumbai. • Umblical Cord Clamp • 4th PLASTIVISION Arabia 2017 : International Contact Yogesh Patel M. : +91 98241 21383 Plastics, Printing & Packaging Exhibition Date: Dec. 11-14, 2017. MEDICARE DEVICES Venue: Sharjah, UAE. 8, Maruti Industrial Estate, Nr. Sindhvai Mata Temple, C.T.M.-Ramol Road, C.T.M. Cross Road, Amraiwadi, • PLASTINDIA 2018 : 10th International Plastics Ahmedabad-380 026.Gujarat (India) Phone 079-2585 5711 E-mail : [email protected] Exhibition, Conference & Convention Website : www.medicaredevices.com Date: Feb. 7-12, 2018. Venue: Gandhinagar – Ahmedabad, Gujarat, India. 46 • Medical Fair India : 24th International Exhibition And Conference Date: March 16-18, 2018. Venue: Goregaon (East), Mumbai. May-June 2017
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