Manufacturing pharmaceutical excipients, the topic of Hygiene Management is oftentimes underestimated. This is not only the case for excipients that need to be sterile or that are required to carry only a limited bioburden. Where water is used as final solvent or simply due to product hygroscopicity, excipients may carry a very high microbial load. To make matters worse, the regulatory requirements for excipients are rather inexplicit in this area.
We can help You to develop a custom-tailored hygiene concept, so that Your excipient products will be manufactured according state-of-the-art conditions.
Our services in this area comprise:
- Development of hygiene concepts for cleanrooms (zoning and lock concepts)
- Preparation of hygiene and monitoring plans
- Compilation of checklists and work instructions
- Effective interactive training of production staff and cleaning personnel