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Medical Plastic Systems Medical Plastic Systems 1 Quality for medicine: More safety for people better quality for life Gerresheimer Medical Plastic Systems All benefits at a glance Full service from development
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Medical Plastic Systems Medical Plastic Systems 1 Quality for medicine: More safety for people better quality for life Gerresheimer Medical Plastic Systems All benefits at a glance Full service from development through to logistics Global player worldwide production sites and clean room capacities Concentration of technical expertise in our international Technical Competence Centers in Germany and the USA In-house Product and Process Development In-house Mold Making In-house Automation Engineering Innovative production technologies Competence in validation and certification and highest quality standards Gerresheimer is one of the leading specialists for the production of high-quality glass and plastic products for the international pharmaceutical and healthcare industry. We offer a wide range of products and services, from pharmaceutical vials right through to complex drug delivery systems such as syringe systems, insulin pens and inhalers for reliable and safe drug dosing and application. In cooperation with our partners we develop concepts that set new standards and serve as a model for the entire industry. Our group of companies with a total staff of 9,500 people and 44 production sites in Europe, Americas and Asia posts sales of above EUR 1 bn. The systematic consolidation of our strong market position is based on state-of-the-art technology, technically sound innovations and strategic investments. The Medical Plastic Systems Division focuses on activities in the plastics segment. For more than sixty years, we have been supplying special injection molded and assembled plastic systems to renowned customers from all parts of the world. Gerresheimer s Medical Plastic Systems Division employs more than 1,600 people and is established as an important system supplier to global players in the pharmaceutical, diagnostics and medical technology segments. As a full service provider Gerresheimer Medical Plastic Systems performs all levels of the value-added chain from planning up to the CE-certified point-of-sale product. Product development, engineering, mold making, automation engineering, large-series and smallseries production (in clean room, if required) under FDA / GMP conditions, product finishing, manual, semi-automated and fully-automated assembly as well as packaging and logistics Gerresheimer Medical Plastic Systems is your one-stop service supplier. As a result of our long experience we are very familiar with the world of our custo mers. We speak their language, know their working conditions and can respond to their wishes individually. Furthermore, we constantly deal with current medical issues. The intense dialogue with pharmacists, biologists, institutes as well as academies and colleges enables us to react early to important innovation potentials. If you choose Gerresheimer Medical Plastic Systems you choose the technological leader, you choose a flexible company which is able to decide quickly and puts the wishes of the customer in the center of thinking and acting. For highest quality. From left to right: Novel press-and-inhale multidose DPI produced for Almirall, Analyzer with test cartridge HbA1C. 2 3 Validation and certification Qualification and validation for international markets Quality in plastics is our philosophy. Our customers rely on receiving products of excellent quality right on schedule. After all, the health and possibly even the life of the patient might be at risk. We realize this demand with a quality management on the highest level that is consistently adjusted to the international market and especially to FDA requirements. Quality management is an important part of the 20 Keys program implemented at Gerresheimer Medical Plastic Systems. This comprehensive management and benchmarking system systematically enhances the productivity, the quality and the cost efficiency of the company. All areas from suppliers via development, production and logistics up to customers are scrutinized in 20 fields of activity ( Keys ). The result: Constantly high quality on all levels of the value-added chain of your project. All businesses of Gerresheimer Medical Plastic Systems are certified according to DIN EN ISO 9001:2008. Additionally, all German locations comply with guideline DIN EN ISO Our production sites in Germany, Switzerland, the Czech Republic, USA, Brazil and China are also certified according to DIN EN ISO Those business areas involved in Medical Technology operate in compliance with GMP standards (Good Man u facturing Practice for Medical Devices). Gerresheimer Medical Plastic Systems performs the qualification according to GMP and FDA guidelines, furthermore, we create the documentation and request its approval for medical products and pharmaceutical packaging (for example, DMF type III, EU file). In order to ensure a GMP-compliant production of these primary and secondary packaging, we perform a continuous validation of respective procedures as well as the qualification of equipment, premises and rooms. HandiHaler quality made by Gerresheimer Medical Plastic Systems. Excellent quality out of one hand: plastic parts, test strip and packaging. Short ways ensure highest quality at all stages of the value-added chain. An example: Gerresheimer Medical Plastic Systems produces complete Lateral Flow Tests and the test strip production is located in the own laboratory. Validation and certification Quality management according to DIN EN ISO 9001:2008 DIN EN ISO DIN EN ISO FDA Guidelines 21 CFR Part 11 GMP Certificate of accreditation as overseas manufacturer Manufacturing license for pharmaceutical operations FDA inspection without observation for the production of a medical product with direct blood contact Support for the registration 4 of product files 5 Validation and certification Certified quality Validation according to 21 CFR Part 11 For pharmaceutical products falling under the responsibility of the FDA, an additional validation according to 21 Code of Federal Regulations Part 11 (21 CFR Part 11) might be necessary. In such cases, we document all data and interferences with the system in order to ensure that electronic documents and electronic signatures fulfill the same safety level as a traditional paper documentation does. Certificate of accreditation as overseas manufacturer The Pfreimd production site has been accredited as a manufacturer of medical products for Japan in cooperation with Roche Diagnostics. The certificate of accreditation as overseas manufacturer is valid for five years until January 22, Manufacturing license according to the German Medicines Act Gerresheimer Medical Plastic Systems operate with a long-standing manufacturing license for large-scale production and for the production of clinical test samples in accordance with the German Medicines Act. Example of excellent performance: FDA inspection A successful inspection by the FDA confirmed that Gerresheimer Medical Plastic Systems regarding performance and quality has acquired a first-class position among all companies worldwide manu facturing medicaltechnological products. The audit covered the complete value-added chain of the production of the CentriMag blood pump system. Gerresheimer Medical Plastic Systems was responsible for injection molding, assembly, testing and sterile packaging of the blood pump in an ISO class 8 clean room as well as hygiene monitoring in compliance with GMP class D. The audit included a production observation by an FDA investigator and the customer Levitronix. The pleasant result: No observations zero-variation operation and thus classification as FDA-Inspected Device Manufacturer. Extractables/leachables Gerresheimer Medical Plastic Systems also performs the examination of original materials and products on extractables. This examination is also reasonable regarding primary packaging materials for medical products because plastics may contain undeclared additives which might be toxic or react with other substances when administered. Such substances might discharge after a certain time, mix with the agent of the drug and thus be consumed by the patient. Gerresheimer Medical Plastic Systems is dedicated to execute such analyses within a release check and is competent to do so. We perform this examination with high-resolution analyses and the corresponding expertise knowledge. Successful FDA inspection: production of the CentriMag blood pump system»our aim is that our customers can rely on receiving the products in good quality on the desired date. After all the health and possibly even the life of the patient is at stake.«6 7 PHARMACEUTICAL The company Alexza Pharmaceuticals Almirall AstraZeneca Bayer Schering Pharma AG Becton Dickinson Boehringer Ingelheim Bristol-Myers Squibb IVAX - Teva Meda Pharma Novartis Novo Nordisk DIAGNOSTICS Alfa Wassermann Bayer Crop Science Becton Dickinson biomérieux Bio-Rad British BioCell International Chempaq CSL Behring DiaSorin Evogen Thermo Fisher Genetix Horiba ABX SAS Immucor Merck MRC Nunc Ortho-Clinical Diagnostics Phadia Qiagen Roche Diagnostics Securetec Trinity Verax MEDICAL TECHNOLOGY Aesculap B. Braun Melsungen Beurer Darex Gambro Hamilton Medical Levitronix NDD Ness Business Areas Pharmaceutical Inhalation Pen Systems Injection Transmucosal Oral Diagnostics Laboratory diagnostics Molecular diagnostics Point-of-care testing Diabetes Care Medical Technology Home Care products Surgery Invasive disposables Components for the DosePro needle free delivery system for Zogenix, Inc. Premium quality for our customers products Gerresheimer Medical Plastic Systems manufactures innovative and groundbreaking products in the segments Pharmaceutical, Diagnostics and Medical Technology. Our core area of competence lies in fully automated large-series production as well as in the manual and partly automatic small-series production of complex and technically demanding products made of several plastic components. The combination of plastics and metal for cannulas for implants, needles for lancets or springs for driving elements in systems as well as the production of very small parts with high-cavity molds are part of our know-how. For the pharmaceutical industry we produce complex drug delivery systems that work with several systems to transport the active substance into the body precisely. For leading diagnostic enterprises we produce disposables A quick overview on the Medical Plastic Systems product range. From left to right: component for Dialysis machine, VITEK test card, syringe for contrast agent. for various analysis systems used in laboratories and in medical practices, instant tests for patients used in the doctor s office or hospitals as well as skin-pricking devices and lancets for diabetics. To medical-techno lo gical companies we offer disposables for dialysis, home care products, invasive disposables and surgical devices made of plastics. The best criterion: Satisfied customers Well-known customers from all around the world rely on our absolute demand for quality, our all-inclusive service and on our decadelong experience. Numerous awards we received from well-known companies give proof of highest customer satisfaction. Dialysis & blood therapy 8 9 Pharmaceutical Usage: Turbuhaler. Easy handling and high reliability of drug delivery systems Drug delivery systems by Gerresheimer Medical Plastic Systems comply with all requirements of up-to-date primary pharmaceutical packaging. We cover the entire spectrum of delivery types: Administering the active substance via pulmonary inhalation, through the skin, via the mucous membranes or orally. Jointly with the customer we develop optimum primary and secondary packaging for the most diverse active substances. So we manufacture products that can be dosed more easily, provide very convenient and user-friendly handling to the patient and transport the active substance quickly and efficiently to where it is needed. With Gerresheimer Medical Plastic Systems as your partner you can benefit from more than 15 years of experience in the development of drug delivery systems. We offer our customers reliable large-series production to the very highest standards as well as manual and partly automatic small-series production in ISO Class 8 (100,000) clean rooms. If needed, we can also perform the mass production in an ISO class 7 clean room (10,000). Our knowhow includes the entire inhaler product range: Powder inhalers, capsule inhalers and nebulizers. More than 50 % of the total clean room area of Gerresheimer Medical Plastic Systems are used for producing drug delivery systems we manufacture approximately 100 million inhalers per year. From left to right: Aerolizer, Turbuhaler. As a system supplier Gerresheimer Medical Plastic Systems takes the full responsibility and performs own order developments for drug delivery systems. We develop and produce your primary and secondary packaging according to requirement specification sheets or optimize the existing concepts or designs of the customer for injection molding. Gerresheimer Medical Plastic Systems engineers assure that all individual parts can be assembled easily and solidly and provide an optimum of functionality. Our quality guarantee: Already prior to production highest demands are applied to material selection, assembly technique and functionality of the devices. Own pharmaceutical laboratory We wanted to offer a significant gain of time to our customers so we set up a pharmaceutical laboratory for development-related laboratory analyses. Here, small runs are filled as samples for clinical pilot studies. The evaluation of inhalers and systems is also part of this field of activity. It goes without saying that the creation of the entire documentation later representing the basis for the authorized approval of the product (for example, the device master file) is also part of our full service concept. Pharmaceutical Inhalation Powder inhalers: Turbuhaler, Novolizer, Genuair Capsule inhalers: Aerolizer, HandiHaler Nebulizer: Housing components for the Respimat Soft Inhaler Pen Systems Components for different insulin pens Injection Components for needlefree injection systems Plastic components for X-ray contrast agents Plastic components for injection systems 2-component injection systems Sterile wound plaster set Transmucosal Various applicators Oral Tablet dispenser for round, oval and squared tablet formats 10 11 From development to the point-of-sale product: Schreiner MediPharm has developed Needle-Trap, an active label-integrated system, that helps to prevent needlestick injuries. Gerresheimer Medical Plastic Systems was tasked with developing the actual needleprotection device. The services offered by Gerresheimer Medical Plastic Systems include the development of the plastic part, including all required simulations, mold making and production in controlled area. Top quality for injection systems and tablet dispensers Pharmaceutical Image: Schreiner MediPharm Injection systems As one of the few enterprises in the industry, the Gerresheimer Group has specialized equally in the two major primary material categories for the pharmaceutical and life science industries, i. e. glass and plastics. Two experts in their respective sectors, namely Gerresheimer Medical Plastic Systems as plastics expert and Gerresheimer Bünde as specialist for pharmaceutical glass products, offer you customized solutions for injection systems. Regardless of whether conventional syringes, needle-free syringes, safety syringes, auto-injectors or pen systems are required Gerresheimer Medical Plastic Systems is an experienced partner. In the injection segment, our longstanding experience in the area of skin-pricking devices and lancets represents a special advantage. We are actively involved in dermatological questions, e. g. penetration characteristics and pain development, using this knowledge for the development and production of the most sophisticated injection systems. Two-component injection systems, components for injection systems with tamper-evident closures and components for needle-free syringe systems are all current examples of how innovative products have been successfully launched. Dispenser systems In the field of oral care, Gerresheimer Medical Plastic Systems offers multifaceted concepts for the single dispensing of tablets, caps and effervescent tablets of all forms. The dispenser systems are always developed in close partnership with the customer and are specifically adapted to concrete product requirements.»long-term experience, a continuous will to improve and openness towards new application areas those are the ingredients for the recipe of the success of Gerresheimer Medical Plastic Systems.«Components for an insulin pen for diabetics Micro titer plate Diagnostics Laboratory Diagnostics Cuvettes Pipette tips Sample vessels Micro well plates Filter tubes PFA capillars Test card for microbiological system Reagent racks Sterile nutrient solution carrier Molecular Diagnostics Micro fluidic cartridge for nucleic acid analyses Disposables for diverse analysis systems, for example COPAS AmpliPrep Sample vessels for PCR analysis Point-of-care tests (near patient testing) Rapid tests for Cardiac Monitoring Test cartridges for the quantification of hemoglobin in blood Test cartridges for hematology test systems Immunological rapid tests for whole blood DRUGWIPE (lateral flow test for drugs of abuse) Rapid tests for microbiological purposes (e. g. food) Laboratory disposables from Gerresheimer Medical Plastic Systems innovative customer solutions Whether disposables for sample preparation, reagent vessels and tips for sample processing or cuvettes and micro well plates for sample analyses we develop and produce disposables for the entire sample run in labora tories. Gerresheimer Medical Plastic Systems is your expert for customer-specific laboratory disposables. Diagnostics Our main focus is on product-specific requirements: Optical quality, resistance to chemicals and wetting behavior. Consistently high quality and identical standards of reproduction are mandatory since even slightest deviations have adverse effects on optical and chemical analy tical procedures and could lead to misinterpretation of the results. A reliable selection of materials as well as precise and complex molds are essential for sensitive products that require flawless quality. The enormous quantities in which they are produced also necessitate a high degree of process automation. We develop specific products and turnkey solutions. These efficient high-class production systems consisting of automated handling equipment are directly coupled to our injection molding machines, nest-specific picking systems, test systems and automated assembly and packaging lines. This way Gerresheimer Medical Plastic Systems produces cuvettes in annual quantities reaching into billions.»world market leaders such as Roche Diagnostics, biomeriéux and Ortho-Clinical Diagnostics trust in the reliability and availability of our innovative solutions.«diabetes Care Skin-pricking device ACCU-CHEK Mobile FastClix Skin-pricking device ACCU-CHEK Multiclix Skin-pricking device ACCU-CHEK Softclix Lancet stack for ACCU-CHEK Mobile FastClix Lancet stack for ACCU-CHEK Multiclix Various lancets for skin-pricking devices From left to right: Carrier Well-Cell, micro cuvette Diagnostics Gerresheimer Medical Plastic Systems Diagnostics reliable instant test and award winning skin-pricking devices Gerresheimer Medical Plastic Systems also offers full service in the Point-of-care area. This applies to drug detection, pregnancy tests, detection of emergency parameters or allergy tests: We develop and produce your complete instant test. Here, we focus on user-friendly housing designs and an optimum connection technique such as snap fits, adhesion or heatseals. We select the best material to suit the required flexibility of tests, carry out co
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