During and after assembly, the single-use assemblies undergo multiple quality checks.
Our single-use assemblies undergo:
Each single-use assembly is linked to a unique batch code and is fully traceable down to component level. Even after months, we can reproduce the same configuration, including the validation file.
A change to the single-use product you purchase from us may affect your end product. Naturally, you need to be aware of the impact that changes may have on, for example, quality, specifications, packaging, labels or the certificate, the production process and the supply chain. If a component needs to be replaced, you will always receive a notification and we will assess whether additional validation is required.
Upon delivery of the single-use assemblies, you will receive all necessary documentation to comply with audit and quality control requirements. This documentation assists in complying with guidelines and regulations from, for example, the FDA and EMA. With each delivery, you will receive:
Are you curious about the most suitable single-use assembly for your process? View our range of standard assemblies or contact us using the form below to find the perfect customised assembly.
We are happy to help you. Please submit your question using the form below. We will contact you as soon as possible. Would you prefer direct contact? Please call us on 0297-514714.