We understand the importance of comprehensive validation processes to ensure the quality and safety of our packaging solutions for medical technology and pharmaceuticals. We fulfill the mandatory requirements for Swissmedic’s GPA guidelines. Our offer includes various types of validations that are specifically tailored to the needs of our customers.
Hygiene validation
Thanks to our many years of expertise in packaging pharmaceutical and medical products under controlled cleanroom conditions in accordance with ISO 7 and ISO 8 and the continuous improvement of our environmental monitoring system, we ensure the highest safety standards for the products to be packaged. Our aim is to provide our customers’ products with the best possible protection against particulate and microbiological contamination from the outside.
Process validation
The effectiveness of a process always depends on the quality of its individual components. For this reason, we devote the utmost attention to the qualification of all key processes, such as the sealing process and the qualification of our clean rooms and packaging machines. This careful preparatory work forms the basis for the actual validation of the product packaging process.
Product validation
Our focus is on confirming all product requirements and, in particular, the individual customer requirements for the products to be packaged. In addition to the qualification of process components, this validation also includes stability and performance tests such as packaging integrity tests. Our aim is to ensure maximum product and process safety for the packaged customer products.
Sterilization validation
Products that undergo final sterilization, such as gamma or X‑ray irradiation, undergo sterilization validation in collaboration with our customers in accordance with the standard specifications of the EN ISO 11137 series. This validation ensures that the normative requirements for reducing microbial contamination are met in order to be able to label a medical device as ‘STERILE’.