In many API manufacturing companies the relevancy of Hygiene Management is under-estimated. This is not only the case in sterile API manufacturing or where drug substances are required to have a limited bioburden. Where water is used as final solvent or simply due to product hygroscopicity, APIs may carry a very high microbial load. At the same time, regulatory requirements for APIs are oftentimes blurry.
We can help You to develop a custom-tailored hygiene concept, so that Your API products will be manufactured according state-of-the-art conditions.
Our services in this area comprise:
- Development of hygiene concepts for cleanrooms (including zoning concepts and lock concepts)
- Preparation of hygiene and monitoring plans
- Compilation of checklists and work instructions
- Effective interactive training of production staff and cleaning personnel