Quality Assurance, Quality Control, Traceability
RENOLIT SOLMED 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 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 MEDICAL is ISO 13485 certiﬁed to meet the pharmaceutical and medical device industry requirements. The secondary production sites of RENOLIT MEDICAL have at least an ISO 9001 certified quality assurance system.
The RENOLIT SOLMED compounds have been developed in accordance with various international Pharmacopoeias in order to meet the strictest requirements for medical applications amd medical grade raw materials are used. The RENOLIT SOLMED 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 10 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 for different chemical parameters and cytotoxicity according to ISO 10993-5. The test results are registered on a Certificate of Compliance supplied with every batch of RENOLIT SOLMED material.