Why is an effective environmental monitoring program so important?
In the end, whether you are manufacturing a medical device or a drug API, the safety of end users is at stake. Having a thorough environmental monitoring program in place will allow you to know the status of your environment, giving you the power to control it and make changes to it.
The overall keys to implementing an environmental monitoring program
1. Determine what the monitoring strategy will be, including:
- Limits and acceptance levels (often based on the product being manufactured and knowledge of your facility)
- Decide what specifically should be monitored
- Determine the frequency of monitoring
- Identify where problem areas might be; note where limits are most likely to be challenged
2. Decide on the type of sampling necessary:
- Air – good for general environment, but be aware that air contamination is affected by levels of activity
- Surfaces – products may come into contact with surfaces so surface collection strips may be necessary
3. Implement a thorough documentation procedure – data must match procedures
4. Must validate the monitoring procedure and ensure that collection media and techniques are sufficient
5. If any change in the manufacturing process or area occurs then you must decide whether monitoring changes need to be implemented. Also, if results have been steady for a long period of time, the frequency of testing may possibly be reduced
6. Use the results of the data to determine whether changes can be implemented to minimize the possibility of contamination
These are just some of the basic keys to implementing a successful program. For a more thorough background, we recommend "Environmental Monitoring: Making the Invisible Environment Visible" in Contract Pharma magazine.
Pacific BioLabs provides many types of microbiological testing services, including environmental monitoring.