Microbial Control in Manufacturing
Evaluate and trouble-shoot microbial contamination and microbial control issues and practices related to the microbiology program and aseptic technique. Services may include:
- Evaluate microbial control strategies and practices for non-sterile and sterile dosage forms
- Review of environmental monitoring and gowning practices
- Review of cleaning and disinfecting practices
- Evaluate and trouble-shoot down-stream process contamination issues and recommend control strategies
- Review microbiological and environmental monitoring results and make recommendations to mitigate potential contamination of the process and product
- Determine environmental monitoring limits and microbial specifications for API, excipients, in-process materials and finished products
- Establish microbial stability requirements
- Trouble-shoot microbiology contamination problems in storage areas, e.g., cold rooms and stability chambers
