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GEMÜ GmbH has been a reliable partner in the development and manufacture of customized products for medical and pharmaceutical technology for years. In order to satisfy both the current and future requirements of customers, our capabilities are regularly expanded. We make every effort to satisfy our customers in the long term. In doing so, we follow the primary objective of implementing the regulatory requirements and wishes of our partners in all phases of the product lifecycle.
Under the motto "Free of viable micro-organisms", we are informing you that we have expanded our scope within the certification according to (EN) ISO 13485:2016. Since the beginning of the year, our partners have been able to rely on our support in the sterilization process, too. Our customers benefit with immediate effect from the following services:
Sterilization of healthcare products (acc. to EN ISO 11137)
Packaging for fully sterilized medical products (acc. to EN ISO 11607)
Planning and organization of sterile barrier system ageing tests (acc. to ASTM F1980)
Planning and organization of sterile barrier system transport stability tests (acc. to ISTA standards).
Our experience shows that we can create the most value for our customers when we are involved early in the development of products. So, don't hesitate to contact us if you have questions about the sterilization process according to ISO 11137. We are pleased to support you.