There is far more guidance for sterile manufacturers than those involved with non-steriles in relation to microbial contamination risks and control measures. To address this gap, Pharmig has produced this guide for microbiologists working in this field.
The guide covers:
- Best facility design requirements.
- Microbial risks in non-sterile manufacturing.
- Best practice tips for achieving microbial control.
- How to clean and disinfect effectively.
- Advice on undertaking risk assessments.
- Microbiological testing.
- Environmental monitoring.
The guide helps steer the microbiologists through the regulatory expectations, offering many practical examples.