Supporting Associations plastics exhibitions PLEXPO in the year 1979, 1995,2004, 2007 Plastindia Foundation established in 1987 with an objective of & 2010. These events are considered to be the landmark in the jointly promote interests of Indian Plastics Industry globally, and history of GSPMA PLEXPO’79 was the fist-ever plastics & Nodal Agent for Arabplast Exhibition held in Dubai. AIPMA was packaging exhibition show held in India. Indian partner for PlastPack Africa Exhibition in Kenya/South Af- rica. AIPMA has representations in various Bodies / Commit- Indian Plastics Institute (IPI) tees of Government of India for promotion of Plastics and Petro- chemical industries. Business delegations to Chinaplas, K, Indian Plastics Institute (IPI) is the national Association of Koplas, Taipei Plas, NPE, etc. are organised regularly. The 10th Plastics professionals from industry, academics and students Plastivision India -2017 from 19-23 January, 2017 at Mumbai and established to pursue following objectives: 3rd Plastivision Arabia 2016 from 10-13 January, 2016 at Sharjah, • Advance & develop the art, science, technology & engineering UAE are announced. of plastics for the benefit of its members & the public … Indian Drug Manufacturers’ • Form & organize a strong professional body of those connected Association (IDMA) or concerned with plastics… Indian Drug Manufacturers’ Association “Gujarat State Board” is • Institute, supervise, advise upon & advance the standard & a state level Association, represents 200 units from the State of Gujarat. It was established in the year 1979, under the Chair- methods of education & training at all the levels in the fields of manship of Shri I. A. Modi, Cadila Pharmaceutical Ltd. plastics… Ahmedabad. • Project plastics… as ‘eco friendly material’ As a State level Association, it has been active in resolving gen- • Project the vital contribution of plastics in various fields of eral issues pertaining to Pharma industries. Association is hav- economy… ing a closed rapport with the Central & State Government, simi- • Disseminate for public awareness all relevant information about larly, Association maintains closed cordial relations with various plastics … to remove myths & misconceptions…educate financial institutions of the state. Association is actively studying public … the beneficial role plastics play in improving overall the problems like Finance, Power, Pollution, Sales Tax and un- quality of life. healthy interference in laws and Rules. Association hold semi- Indian Plastics Institute was registered as Society (under Society nars, workshops and interactive Sessions to educate members, Act 1860- Regn. No.333 dated 17.4.1985)in Mumbai and as a Due to the implementation of Schedule-M, lot of works have been Public Trust in May 1985, as a successor to Plastics & Rubber done to educate the members of the units. Institute, London (Indian Section) which had started its educa- Over & above, Association carries out following activities. Spot tional activities in India in 1963. Guides, Development Programmes, Central Excise Problems, IPI has 11 Chapters and 5 Sub-Chapters spread all over India Workshop and Seminar on Sale Tax & Income Tax. Association with more than 3,500 members in different categories. always believes in representing right cases of the Pharma Main activities of IPI fall in following categories: Industries. Its motto is service to the Pharma Units. • Education, Training and Manpower Development for the Plastics Industry Engineering ExportPromotion • Spreading awareness on responsible use of Plastics amongst Council (EEPC India) society under program- Plastics and Ecology, conducted individually or associating with other institutes. EEPC India is the premier trade and investment promotion • Spreading awareness of use of Plastics in agriculture for effic organization in India, sponsored by the Ministry of Commerce & ient use of water and protecting the crop and subsequent Industry, Government of India and caters to the Indian engineer- agricultural produce, associating with other institutes- ing sector. As an advisory body it actively contributes to the Plasticulture program of Plastindia Foundation policies of Government of India and acts as an interface between • Encouraging and recognizing innovations in Industry and the engineering industry and the Government. Academia, associating with other associations. - Plasticon Set up in 1955, EEPC India now has a membership base of over Awards of Plastindia Foundation. 13,000 out of whom 60% are SMEs. • Providing expert guidance on matters of technology to Industry Keeping ‘Engineering the Future’ as the motto, EEPC India serves and individuals under AAP (Anything About Plastics) program as the reference point for the Indian engineering industry and the of IPI. international business community in its efforts towards establish- ing India as a major engineering hub in the future. EEPC India is All India Plastics Manufacturers’ also working aggressively on the promotion of the Indian Medical Association (AIPMA) Device & Pharma Machinery sector. Year 2015 holds a special significance for EEPC India as it marks Products / Services: The All India Plastics Manufacturers’ Asso- the 60 years of its establishment. Hon’ble President of India, Mr. ciation (AIPMA) established in 1945 is the oldest and largest apex Pranab Mukherji graced the Diamond Jubilee celebrations of body to promote development and growth of Indian Plastics In- EEPC India as “Chief Guest”. Department of Posts has released dustry. Spectrum of membership include all categories of plas- a Commemorative Stamp to mark the 60 years of EEPC tics industry spread over 175 cities and towns nationwide. Over establishment. 44 National and Regional Plastic Associations all over India are affiliated to AIPMA. AIPMA is one of the founder promoters of 51 Jan.-Feb. 2017
Supporting Associations The Society Of Plastics Engineers (SPE) business environment. The Society Of Plastics Engineers (SPE) founded in 1942, the pre- The objective of the SPE is to promote the scientific and engineer- mier source of peer-reviewed technical information for plastics pro- ing knowledge relating to plastics. SPE helps people and compa- fessionals. SPE India has been in existence for over 25 years, and nies in the plastics industry succeed, by spreading knowledge, has effectively functioned as an extension of the parent body to strengthening skills & promoting plastics. SPE is the only place fulfill its objective of serving the Indian Plastics Industry. where people from all parts of the industry can come to- gether around important issues & technologies. The organization is divided into five parts: Local and Geographical Sections, Technical Divisions, Staff, Vol- It has never been more important to be a member of your profes- unteer Leadership, Student Organizations. There are also groups sional society than now, in the current climate of change and vola- which are under formation, such as Sections in Formation (SPE tility in the plastics industry. Now, more than ever, the information Sections) or Special Interest Groups (SPE Divisions.) It has been you access and the personal networks you create can holding numerous technical seminars and international conference and will directly impact your future and your career. to facilitate the transfer of knowledge across various industry segments. Active membership in SPE – keeps you current, keeps you informed, and keeps you connected. SPE India constituted of some of the top individuals from the plas- For more details visit www.speindia.org tics industry who volunteer their time, resources and efforts towards furthering the cause of the India Plastics Industry. SPE is the only Orthopedic Implant place where people from all parts of the industry can Manufacturers Association come together around important issues & technologies. (OIMA) SPE’s contribution to the plastics industry has made a significant • An Association of FDCA Approved Manufacturers of Orhopedic difference to the technologies & innovations the industry enjoys Implants And Instruments. today. Today, the industry is more interdependent than ever, and professional networks have taken on global dimensions. Such net- • To Develop The Orthopedic Fraternity For The Well-Being Of works are almost impossible to develop and maintain in our Mankind. fast-paced industry. • To Promote Good Practices In Manufacturing And Services Participation in SPE is a key success factor to thrive in today’s Of Orthopedic Implants. AN ISO 13485-2012 • Standardization Of Product Processing Service Approved CE certified Company Indian FDA. Manufacturer & Exporter of Medical • Following All The Necessary Regulatory Norms. Disposable Devices & Surgical • Encouraging Research And Development Through Clinical Products Analysis. Range of Products : • Increase Awareness of FDCA To All. • Infusion Set • Blood Administration Set GMP. & ISO 9001 – 2000 Certified Company • Measure Volume Set • Urine Collecting Bag AMIGO SURGI CARE PVT. LTD. • Urine Collecting Bag - Uro Meatry • Respiratory Exerciser Manufacturer of • Twin Bore Nasal Oxygen Set Disposable Surgical Products: • Oxygen Face Mask • Nebulizer Kit I.V.CANNULAS / B.T.SETS / I.V.SETS / • Vaccum Suck Suction Set SURGICAL LATEX GLOVES / CORD • Latex Surgical Gloves CLAMPS / URINE BAGS / MEASURE • Umblical Cord Clamp VOLUME SETS ETC. Contact Yogesh Patel M. : +91 98241 21383 Manufacturers / Exporters / Hospital Suppliers Dealer are requested to MEDICARE DEVICES 8, Maruti Industrial Estate, Nr. Sindhvai Mata Temple, Contact : C.T.M.-Ramol Road, C.T.M. Cross Road, Amraiwadi, Mr.Chandrakant Sayal , B.E. (Mech. & Elec.) Ahmedabad-380 026.Gujarat (India) Phone 079-2585 5711 E-mail : [email protected] (DIRECTOR) Mobile:0091-9825057180 Website : www.medicaredevices.com Tel.:0091-2764-268249 52 E-mail : • [email protected] • [email protected] Website:www.amigo-india.com Plant Address Plot No.780, Opp.: Kemron Lab Sola Santej Road, Rakanpur (Santej) – 382721 Gujarat, India Jan.-Feb. 2017
Product Gallery Medical OEM Tubing Solutions From Qosina Ronkonkoma, NY – February 14, 2017 – sure to sign up for our monthly e-newsletter Qosinaoffersa wide selection of in-stock and to stay current with our newest product custom medical tubing for your prototyping additions.Our product development team can and large-scale production requirements. work with you to customize a part to your Whether your project requires PVC, Silicone, specifications. Call our customer service FEP, HDPE or DEHP-Free PVC tubing, specialists to discuss your project in detail via Qosina supplies various sizes and durometers phone +1(631) 242-3000 or off- the-shelf to meet yourever-changing email [email protected]. needs. Founded in 1980, Qosina is a worldwide For over 35 years, our Sales and Product supplier of thousands of stock OEM Development Teams have been providing our components including bioprocessing customers with custom tubing solutions. accessories,compression fittings, ENFit™ Qosina has the capability to provide cut-to- connectors, luers, clamps, clips, check valves, length tubes and multi-lumen configurations, stopcocks, hemostasis valves, tuohy borst along with custom durometers, sizes, colors adapters, swabs, spikes, syringes and tubing and materials. With popular brands such as to the medical and pharmaceutical industries. Tygon®,C-Flex® and PharmaFluor® available Qosina is based in Ronkonkoma, NY in a for immediate shipment, our tubing is 95,000 square-foot facility with an ISO Class competitively priced and is easily customized 8 Clean Room and is ISO 9001, 13485 and to your specification. Let Qosina be your 14001 registered. trusted supplier for medical OEM tubing. Contact a member of our Sales Team for Contact : complimentary samples today. Deanna Whelan Qosina, 2002-Q Orville Drive North, Qosina offers low minimums and short lead Ronkonkoma, NY 11779. times. Log on to qosina.com to see pricing, Phone: +1 (631) 242-3000, obtain our latest catalog, request Fax: +1 (631) 242-3230. complimentary samples and place orders. Be Email: [email protected] Jan.-Feb. 2017 53
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, Goregoaon (E), Mumbai - 400 063, INDIA. Tel.-Fax : 91-22-2685 2973 / 2686 9090 Works : Airway House, Plot No. 2209 & 2210 Phase IV, High Concentration ET Holder with Bite Expandable Catheter GIDC Vatva, Ahmedabad - 382 446. INDIA. Mask Block Mount Tel. : 91-79-2584 2525 / 2584 0905 Email : [email protected] [email protected] • Web : www.airwayssurgical.com 54 Jan.-Feb. 2017
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, and Surgery. ANGIPLAST 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 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 : 55 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] Jan.-Feb. 2017
: 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] 56 Jan.-Feb. 2017
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List & Profile Of Advertisers Company Name Products / Services Website P. No. www.accuprec.com 8 Accuprec Research Labs Pvt. Ltd., A’bad. Bio Compatibility Services for Medical Devices www.airwayssurgical.com 54 www.alphamedicare.com 60 Airways Surgical Pvt. Ltd., Ahmedabad Surgical Products www.atplworld.com 10 www.ambicamedicareengg.com 75 Alpha Medicare and Devices Ltd., A;bad. Surgical Disposable Products www.americanplasticstechnologies.com 67 Alpha Therapatics Pvt. Ltd., Ahmedabad Surgical Disposable Products www.amipolymer.com 72 Ambica Medicare Engineering, A’bad. Sterilization Equipment www.amigo-india.com 52 www.amtz.in 19 American Plastic Technologies, INC, Turnkey Manufacturing Plants For I.V. Solutions, I.V. Sets, www.angipalst.com 55 USA. Pharmaceuticals etc., www.apexmedicaldevices.com 61 56 Ami Polymer Pvt. Ltd., Thane Specialized In Medical Grade Silicone Tubes, Radiopaque www.medicaredevices.com Tubes & Customized Medical & Surgical Products 52 www.bhavyapolymers.com Amigo Surgi Care Pvt. Ltd., Gandhinagar Surgical Disposable Products 54 www.bryairsystems.com AMTZ, Andhra Pradesh India’s 1st Integrated Medical Devices Manufacturing Park www.caliberassurance.com 70 www.covestro.com 80 Angiplast Pvt. Ltd., Ahmedabad Medical Disposable Products & Components 1 www.eewaengineering.com Apex Medical Devices, Ahmedabad Medical Disposable Devices & Surgical Products www.excelformulations.com 84 www.milacronindia.com 11 Beacon Plastics, Ahmedabad Disposable Needle, Disposable Needle IV Set, Regulator 81 IV Set, IV Set Chamber www.glowtronics.com ; www.wifiltronics.com 14 Bhagwati Medicare Devices, Manufacturer & Exporter of Medical Disposable Devices www.glrlabs.com Ahmedabad & Surgical Products 85 www.btm.gujarat.gov.in Bhavya Polymers, Mehsana Silicon rubber products manufactures: tubes, extruded section, 68 sleevings, cords, strips, molded parts www.i-kare.in 76 BRY-AIR (ASIA) PVT. LTD., Haryana Plastic Auxiliary Equipments www.ignisol.net www.styrolution.com 72 Caliber Assurance Services, Bangalore ISO 13485 Certified R&D, QA and RA Consultancy Firm 6 www.jainrubbers.com COVESTRO, Thane(W) High Performance Material Manufacturers, Component for 80 Coating Adhesive & Elastomer for Healthcare Industry www.jimitsurgicals.com www.kljindia.com 61 Eewa Engineering Co P. Ltd, Ahmedabad Packing Machine, Sealing Machine, Welding Machine etc. 69 www.elastomer.kuraray.com Excel Formulations, Ahmedaad ETO gas / ETO gas mixtures 7 www.Ldmoulds.com/medical Ferromatik Milacron India Pvt. Ltd., Cleaner and Precise Injection Moulding Solution for Medical 12 Ahmedabad Equipment, All Electric Machine www.lubrizol.com 41 18 Glowtronics / Wifiltronics Pvt. Ltd., OEM, Designers and Manufacturers of Medical Devices, www.maiderchina.com Mysore Electro-Surgical & Precision Stamped Parts 2 www.medicall.in GLR Laboratories Pvt. Ltd., Chennai Nonclinical safety testing of pharmaceuticals, chemicals, 74 medical devices and other products Gujarat State Biotechnology Mission, Biotechnology Policy For Gujarat Gandhinagar. I Kare Polyalloys, Nani Daman Soft Transparent PVC Compounds, General Compounds, various Rigid PVC Compounds, CPVC compound Etc. Ignisol Mediplas Corporation, Mumbai Medical Surgical and Healthcare Products INEOS Styrolution India Limited, Global styrenics supplier with focus on styrene monomer, New Delhi polystyrene, ABS and styrenic specialties. Jain Rubbers Pvt. Ltd., Tamilnadu Rubber Products For Disposables And Rubber Stoppers For Pharmaceutical Packaging Jimit Medico Surgicals, Ahmedabad Medical Disposables products KLJ Polymers and Chemicals Ltd., Polymer compounds like PVC, XLPE, PP, TPR, TPE, EVA, New Delhi EPR, ZHFR, Master Batches etc Kuraray India Private Limited, Manufacturer Of Innovative Polymers for applications like New Delhi medical tubes and pouches, orthopedic gels, patch adhesives and elastic nonwovens. Lakshmi Designers, Bangalore Medical disposable products and Infrastructure Life-O-Life Technologist, Ahmedabad Respiratory Disposale and Medical Surgical Devices Lubrizol LifeSciences, Mumbai. Medical Disposables, Catheters and Medical Thermoplastic Polyurethane Resins. Maider Medical Industry Equipment Co., Sterile Medical Automation Equipment Ltd., China MEDICALL, Chennai Medical company conference 58 Jan.-Feb. 2017
List & Profile Of Advertisers Company Name Products / Services Website P. No. Medical Disposable Products 64 Mesco Surgical, Ahmedabad Medical Technology & Conf. www.mescosurgical.com 79 Messe Düsseldorf India Pvt. Ltd., www.md-india.com; New Delhi Surgical Disposable & Medical Devices www.medicalfair-india.com 41 Morrisons Lifecare Pvt. Ltd., Chennai www.morrisonslifecare.com National Healthcare, Ahmedabad Medical Disposables products www.nationalhealthcare.in 64 13 NU-VU Conair Pvt. Ltd., Ahmedabad Plastics auxiliary equipment such as Dehumidifying Dryers, www.conairgroup.com/india Chillers, Conveying System, Blending System, Mould Tempe- 53 rature Controllers etc., 61 17 Operon, Pune Turnkey Projects, Regulatory, Quality Assurance, Validation and www.operonstrategist.com Certification for Medical Devices, Pharmaceuticals, etc. 57 16 Pack-Equip, Ahmedabad Packaging Machinery 77 86 PLASTINDIA FOUNDATION, Mumbai Apex body of major associations, organizations and www.plastindia.org institutions connected with plastics, promoting development 71 of plastic industry. Next event : PLASTINDIA 2018 73 61 Pradeep Surgipack, Bangalore Medical Grade Paper-Poly Pouches www.pradeepsurgipack.com 9 55 Pragati Plastics Pvt. Ltd., New Delhi PTFE, FEP Tubing; Gaskets for Disposble syringes in Butyl and www.pragatiplastics.com 5 silicone rubbers; S.S. Needles / Cannula 78 82 PVC Coloring Compounding & Medical Grade PVC Compound, Extruded Medical Grade www.pvclplastics.com Processing, Ahmedabad Tubings 83 Qosina, U.S.A Stock components such as lipid resistant stopcocks, luers, www.qosina.com 56 43 ports, caps, tuohy borst adapters, USP Class VI tubing, spikes 60 64 instrument and many more 4 R R Patel Gases (P) Ltd., Ahmedabad Ethylene Oxide Mixture Gas For Sterilization 67 15 RAUMEDIC, Pune Medical Grade PVC Tubing, Silicon Tubing, noDOP Tubing www.RAUMEDIC.com 3 Connectors S.Nath & Company, Ahmedabad Surgical Disposable Products www.snathco.com San Printech Pvt. Ltd., Mumbai Manufacturer of Industrial adhesives & innovative UV - and www.panacol.com; www.hoenle.de UV-LED curing systems Sanidhya Enterprice, Ahmedabad Injection Moulded Medical Components www.medisourceasia.com/ productgallery/sanidhya.htm Shin Yan Sheno Precision Industrial Molds of Medical Parts and components www.medical-part.com.tw Co., Ltd., Taiwan Sitech Software, Baroda New Product Development, Design to Manufacture, Medical www.sitechplm.com Device & Equip. Development, Drug delivery, Diagnostic products. SMC Medical Manufacturing Pvt. Ltd., can design, develop prototypes, build tools, manufacture comp- www.smcltd.com Karnataka onents, assemble and package your finished device while managing entire supplychain along the way Sterimed Surgicals India Pvt. Ltd., Steripore Non Woven Microporous tape, Cuff & Plain www.sterimedgroup.com New Delhi Endotracheal Tube, Customized Gynecological & Other Kits, Medical Disposables Surgi Pack India Pvt. Ltd., Mumbai Manufacturers for Surgical Peelable & Tearable Puches, www.surgipackindia.com Lids & Reels for Medical Disposables & Devices. Symbiorph Clinical Trialogy, Ahmedabad Medical Device Regulatory Compliance Consulting Company www.symbiorphclinicaltrialogy.com Proven Trade Contacts, New Delhi An International monthly magazine for hospital, medical, www.webptc.com healthcare and related trades Unikal Consultant, Ahmedabad Integrated services with focus on project technology: www.unikalindia.com Quality Management System, Medical Devices CE marking, FDA 510k, Audit Documentation, Training and c-GMP VERIPACK, Mumbai A world leader in Thermoforming Machines www.veripackindia.com Vinit Performance Polymers, Mumbai Engineering Plastic Stock Shapes and custom www.polymatindia.net components for Medical Devices Welset Plast Extrusions Pvt. Ltd., Mumbai Medical Grade PVC Compounds www.welset.com Yuhuan Shengjiu Mould Co., Ltd., China Molds for Medical Instrument www.yhsjmould.com Jan.-Feb. 2017 59
® 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] 60 Jan.-Feb. 2017
PACK-EQUIP (Mfg. Packaging Machinery) Office / Communication : 91, Avnish Society, Opp. Pavitrakunj Society, CTM Cross Road, Amraiwadi, Ahmedabad-380 026. Phone : 25855027 (M) 9825380739 Works : 16, Arbuda Estate, Near Nidhi Bank, CTM Cross Road, Amraiwadi, Ahmedabad-380 026. GMP ISO : 13485 : 2012 ISO - 9001-2008 Certified Company JIMIT MEDICO SURGICALS PVT. LTD. S. Nath & Co. AN ISO 13485 : 2012 & CERTIFIED COMPANY Excellence in Quality Manufacturers & Exporters of Manufacturer & Exporter of Disposable Medical Devices Surgical Disposable Products since 1980 Infusion Set, Blood Administration Set, IDEAL® IV Cannula, Urine Bag, Catheters, Gloves, HIV KITs, Ophthalmic KITs, Ophthalmic Knives • Infusion Set (Blades), Cap, Mask, Gown, Drapes, Bandages, • Blood Administration Set • Urine Collection Bag Dressings etc. • Urine Specimen Container Specialized in Handling Large Quantity • Umblical Cord Clamp & OEM / Contract Manufacturing Address Factory : 16, Ranchodnagar, Near Vinzol Railway, S. Nath & Co. Crossing, Vatva, Ahmedabad-382445, INDIA B. N. Estate, Near Uttam Dairy, Sukhramnagar, Tele : +91-79-25835567, +91-79-25834850 Ahmedabad-380021, Gujarat, India. E-mail: [email protected] • Web: www.jimitsurgicals.com Contact No. : +91-79-22743246, 9825360531 Website : www.snathco.com • [email protected] 61 Jan.-Feb. 2017
Contents Disconnections 2.11 Particulate Matter In Blood Bags Foreword 2.12 Complications Related To The Use Of Bone Cement Preface to First Edition 2.13 Failure Of The Tracheostomy Tube Preface to Second Edition 2.14 Potential Cross-Contamination Linked To Haemodialysis Acknowledgments Treatment Chapter 1 : Introduction to Medical Device 2.15 Complications Related To The Use Of Vascular 1.1 Medical Devices: Managing The Mismatch 1.2 “Catheters”.... Haemostasis Devices 1.3 Self-Expanding Plastic Stents Used In The Treatment Of 2.16 Occluded Endotracheal Tubes Benign Esophageal Conditions 2.17 Allergic Reactions To Medical Devices Containing Latex 1.4 A Combination Product 2.18 IV Catheter-Associated Infections 1.5 Defining A Medical Device 2.19 That Long Needles ‘Cut Injection Pain’ For Babies 2.20 Old Dialysis Filters Are Responsible For Kidney Patient Chapter 2 : Adverse Events . 2.1 Trends In Medical Device Adverse Events Injuries 2.2 How Easily Bacteria Clog The Medical Devices…!! 2.3 Risk Management For Medical Devices Chapter 3 : Applications 2.4 Complications Associated With Urological Devices 3.1 PU Dressings Help Wounds To Heal 2.5 Catheter Introducers – A Potentially Life Threatening 3.2 The Economics Of Prefilled Syringes Episode 3.3 Coronary Drug-Eluting Stents 2.6 Human Factors Leading To Medical Device Adverse 3.4 Intravenous Infusion Sets ( IV Set ) In Anaesthesia Practice Events 2.7 Luer Taper Fitting As Connectors In The Medical Industry Chapter 4 : Regulations & Quality Issues 2.8 Problems With Transvaginal Surgical Mesh 4.1 Challenges Of Using Combination Products 2.9 Heparin In Medical Devices Linked To 11 U.S. Deaths 4.2 FDA Regulations Regarding Medical Devices 2.10 Preventing Dangerous Hemodialysis Catheter Chapter 5 : Markets & Emerging Trends 5.1 What Global Medtech Manufacturers Need To Copy From India And China 62 Jan.-Feb. 2017
5.2 India’s Success In Developing Its Own Health Related 10.2 Prevention Of Catheter-Related Infections Technologies 10.3 Dialysis Procedure 10.4 Five Steps To Safer Healthcare 5.3 The WHO Report On Medical Devices And Equipment 10.5 Healthcare Supply Chain 5.4 Humanitarian Use Medical Devices (Huds) 10.6 The “Distribution Channel” For Hospitals 5.5 The Ageing Population In Europe 10.7 The Reuse Of Single-Use Devices Chapter 6 : Innovation & Product Developments Chapter 11 : Environment, Waste management & Safety 6.1 High Impact Frugal Innovations In India Concerns 6.2 Medical Device Innovation 6.3 Replacement Cornea Makes Clear Difference 11.1 PVC : The Environmental Perspective For Health 6.4 First Medical Device Derived From New Class Of Products Biopolymers: Absorbable Suture Product 6.5 Remote Monitors For Medical Devices 11.2 Establishing A Healthcare Plastics Recycling Program 6.6 Silicon Sensors For Use In Catheters 11.3 Healthcare Plastics Recycling 6.7 Phatik Intraocular Lenses 11.4 Shared Responsibility For Medical Device Safety And 6.8 Temporary Artificial Heart 6.9 Coatings For Blood-Contacting Devices Performance 6.10 Knowledge Management 11.5 Safeguarding Cardiac Guide Wires To Avoid Breakage 6.11 Why The Great Scientist APJ Abdul Kalam Developed 11.6 Infectious Hospital Waste Orthosis Callipers Weighing Just 300 Gms ! 11.7 Safety Of Healthcare Professionals 6.12 Why I.V. Administration Sets Require In-Line Filters? 11.8 Vinyl And The Environment? Chapter 7 : Materials : Medical Polymers, Biopolymers & Chapter 12 : Industry, Government Research & Academic Other Materials Institutiona 7.1 Polymers To Restore The Sound Of Music? 12.1 Sterilization Packaging Manufacturers Council 7.2 Conductive Plastic Which May Preserve Eyesight...!! 12.2 Pediatric Medical Device Institute 7.3 UHMWPE Fibers 12.3 The Center For Devices And Radiological Health (CDRH) 7.4 Engineered Medical Coatings Advancing The 12.4 The US Healthcare Industry Performance Of Medical Devices About the Author 7.5 Intelligent Materials To Revolutionise Surgical Implants 7.6 Medical Device Coatings Product and Subject Index 7.7 Why You Should Not Use PVC Tubing In The O2/ References Aircircuit If You Are Using Forane ADDENDUM Chapter 8 : Manufacturing : Technologies & Trends 8.1 Welding Of Thin Polymeric Films For Medical 1. About Regulatory Science Priorities For Assuring Safety, Applications Effectiveness, Performance and Quality of Medical 8.2 When To Consider Outsourcing Medical Device Devices Manufacturing To A Contract Manufacturer? 8.3 Health Technology Assessment (HTA) 2. About Implants As The Fastest Growing Application For 8.4 Ultrasonic Welding For Assembling Of Medical Medical Plastics Components 8.5 Filters In Intravenous Filter Sets 3. About Best Practices to Ensure Good Supplier 8.6 Hypotension And Bedside Leukocyte Reduction Filters Management Chapter 9 : Packaging & Sterilization 4. About Effect of Medical Device Quality Performance on 9.1 Determining Breathable Area Of Sterilization Package? Business Performance 9.2 Packaging Failures: The Largest Source Of Sterility Recalls 5. About Failure of Endotracheal Tubes 9.3 Sterilization Of Plastics 9.4 Using Steam For Sterilization 6. About Hospital Errors on Medical Tubing Killing Patients 9.5 Packaging Combination Products (Medical Devices) 9.6 How Different Sterilisation Methods Were Developed? 7. Balancing Product Development Effectiveness with 9.7 The Importance Of Keeping Premixed IV Bags Covered Regulatory Compliance In Their Plastic Overwraps 8. About Welding of Thin Polymeric Films For Medical Chapter 10 : Healthcare Practices, Procedures & Techniques Applications 10.1 Safe Injection And Safety Practices 9. About Challenges Of Using Combination Products Jan.-Feb. 2017 10. About Trends In Medical Device Adverse Events 63
Events We are a leading Consulting organization providing an integrated services with Events Calender focus on project technology : • Medical Fair India 2017 : Quality Management System as per ISO 9001, ISO 13485, Medical Devices 23rd International Exhibition and Conference CE marking as per MDD/93/42, FDA Date: 06-08 April, 2017 510k, Audit, Documentation, training Venue: Pragati Maidan, New Delhi. and c-GMP. • Medicall 2017 : Sanjay Y .Shah – Owner Promoter 17th Edition M : +91 98240 17850 Date: 28-30 July, 2017 Obelis European Venue: Chennai. Authorized Representative Center (O.E.A.R.C) based in Brussels, Belgium since 1988 is one of the largest • Medicall 2017 : Regulatory Centers in Europe, assisting non-European manufacturers’ successful endeavors into Europe. 18th Edition Date: 06-08 Oct., 2017 F/6, Goyal Plaza, Vastrapur, Ahmedabad-380 015. INDIA. Venue: Mumbai. Tel. : +91 79 66090225 E-mail : [email protected], [email protected] Website : www.unikalindia.com • PLASTINDIA 2018 : MANUFACTURER & EXPORTER OF MEDICAL DISPOSABLE PRODUCTS 10th International Plastics Exhibition, Conference & Convention • I.V. Infusion Sets Date: 07-12 Feb., 2018 • Blood Administration Sets Venue: Gandhinagar - Ahmedabad. Gujarat. • Scalp Vein Set • Urine Collection Bags National • Ryles / Feeding Tubes Healthcare • Catheters and Tubes • Surgical Gloves. An ISO 9001 : 2008 Company Manufacturing & Exports of Contact : Mr. Bhavin Shah Medical Disposables : I.V. Set, B.T. Set, Urine Bag, MANUFACTURER & EXPORTER OF MEDICAL DISPOSABLE PRODUCTS Measured volume set, Cord Clamp, Surgical 4-5, Khodiyar Ware House Estate, B/h. Mahalaxmi Gloves etc. Mill, Narol - Isanpur Highway, Narol, Injection Moulded Medical Components Ahmedbad-382405. (India) Phone : (O) 079- and Extended Tubes : 25733318 (R) 079-25430211 (M) +91-9825018952 I.V. Set components, Urine bag Components, Email : [email protected], Connectors for Catheters, I.V. Set / B. T. Set / [email protected] Urine Bag Tubes etc. Website : www.mescosurgical.com Contact : Jan.-Feb. 2017 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 64
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