RENOLIT Healthcare: your partner in innovative healthcare solutions
WHAT CAN YOU EXPECT
For more than 50 years RENOLIT Healthcare has cooperated in teams with customers – leading medical device manufacturers and pharmaceutical companies – to make vital contributions to human health. In a changing global environment, we embrace our responsibility for today’s and future generations. We are deeply committed to transforming creative ideas into advanced, responsible market-ready solutions.
HOW WE COOPERATE
We work together with you during all life-cycle phases of solution. In our RENOLIT Healthcare Innovation Centers, we undertake intensive research and development to remain in the forefront of future- viable, high- performance polymers. We customise our solutions according to your requirements and produce them in a clean room environment, placing the utmost importance on quality assurance and control. We also provide international registration support to minimise your administrative involvement.
HOW WE INNOVATE
Our three global Innovation Centers in Europe, the United States of America and China are the incubators for picking up the most current developments in order to transform them into new materials, applications and devices. Together with you, we form mixed R&D teams which lay the foundation for our goal: Together towards Health. With our latest achievemens in the field of technology we can drive our industry towards greener and more sustainable solutions.
Our sales organization is dedicated to the RENOLIT Healthcare products with sales managers for all global areas and agents for specific countries (Egypt, Bangladesh, Pakistan, Indonesia, Thailand, Colombia).
Our customers operate in the medical and healthcare field, like pharmaceutical companies, medical device and system manufacturers and medical bag makers.
RENOLIT Healthcare products are being manufactured in 5 production sites.
At these sites we not only develop and produce semi-finished products like medical grade films, tubes and granules but also offer and sell customized solutions and services.
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Production technology of our RENOLIT Healthcare products
RENOLIT Healthcare products have to have the highest quality in terms of hygiene and cleanliness and have to meet the stringent requirements of the various Pharmacopoeias.The quality assurance system of the main production sites has been certified according to ISO 13485. Where possible Good Manufacturing Practices are used and many precautions are taken to ensure a clean and compliant production environment:
- HEPA filtered air
- positive pressure
- specially validated clean room sections for critical products
- clean room clothing, hair and beard covers, dedicated cleanroom shoes
- insulated machine area
- restricted entry with airlock
- regular audits
The operators are trained regarding Good Manufacturing Practices. The production equipment is custom made and specially designed to operate in a controlled environment.
All products are packed in double polyethylene bags before leaving the production clean room. In a special packaging area, the products are packaged according to customer specifications and transported to the warehouse. The packaging is developed to minimize the risk of transport damage. Multi-roll carton boxes reduce the amount of packaging materials without compromising the packaging’s integrity. For long distance intercontinental shipments a specially developed packing system is used to protect the product and to optimize container loads.
Quality Assurance, Quality Control, Traceability
RENOLIT Healthcare products are used in the ﬁrst steps in the production chain of life-saving medical devices and pharmaceutical systems. This implies that the maximum obtainable quality level of the ﬁnal product is signiﬁcantly influenced by the RENOLIT Healthcare production phase.
Our commitment therefore is to manufacture the best possible quality according to the speciﬁcations and requirements of our customers. The quality assurance system of the main production sites of RENOLIT Healthcare is ISO 13485 certiﬁed to meet the pharmaceutical and medical device industry requirements.
The RENOLIT Healthcare compounds have been developed in accordance with various international Pharmacopoeias in order to meet the strictest requirements for medical applications and medical grade raw materials are used.
The RENOLIT Healthcare products are based on a unique and sensitive balance between choice of raw material, composition and processing conditions. Our documentation system guarantees full lot traceability down to a single roll of a single batch. All quality related documents, production records and test reports are stored for 6 years. To complete this unique single roll detailed traceability system samples of each individual roll are stored for 5 years.
Raw materials and final products are thoroughly tested in our laboratory. The test results are registered on a Certificate of Compliance supplied with every batch of RENOLIT Healthcare material.
Customer specific development support
RENOLIT Healthcare has already introduced for several market applications specialized films based on own development. These products have become successful on global scale enabling our customers to develop new generations of superior products for optimal healthcare support.
In addition RENOLIT Healthcare has been the partner for outsourced film or compound production based on propriety developments of our partners. Based on the RENOLIT processing expertise and available technology RENOLIT offered its partner a cost efficient outsourcing option. This is allowing our partners to move from own investment in machine capacity (Capex) to high quality supply against optimal costs having only OPEX.
Finally RENOLIT Healthcare is open for joined development projects. As such we have a dedicated group of specialized polymer and process engineers capable to start early stage development with the aim to a timely and successful market launch of your end product. Please consider RENOLIT Healthcare as your partner for future development projects.
The regulatory function in healthcare related industries is vital in making safe and effective products available worldwide. The RENOLIT Healthcare Regulatory Affairs department actively monitors developments and changes in (international) legislation, regulations and ISO standardisation. This is considered mandatory to ensures regulatory compliance.
In order to enable our customers to register their end-users’ products, the packaging material Master File (DMF) for most of our products has been registered with the relevant National Health Authorities in many countries all over the world, including the USA. The open part of the DMF is available for applicant registration purposes. The closed authority part, which is strictly confidential, can be used as a reference after authorization is given.
Most formulations have been extensively tested according to the European Pharmacopoeial, US Pharmacopoeial standards and the relevant ISO 10993 series tests. Copies of these test reports can be made available to our customers and to the final producer of the medical device or pharmaceutical product, to support their registration file.
For assistance worldwide our RENOLIT Healthcare Regulatory Affairs department is at your disposal.
As a producer of medical grade high value polymers, we are deeply involved in newest ideas for advanced healthcare solutions