Classified environments for the aseptic manufacturing of sterile drug substances and drug products require strict control to minimize the potential for microbiological and particulate contamination of the product.
A well-designed environmental monitoring (EM) program is central to evaluating environmental controls in classified environments. Despite the importance of EM, best practice had not been described in sufficient detail in current guidance documents. A BioPhorum collaboration has addressed this need and developed a harmonized easy-to-use, standardized tool based on objective criteria that facilitates an EM program design.
Using the guide, the user will be able to answer the following questions:
1. What are the risk factors to consider?
2. How should we systematically assess a room with these risk factors?
3. How should we define risk levels?
4. What are the minimum standards for monitoring different risk levels?
This guidance document and template are downloadable free from these pages. The work capture best practices in a useable ‘toolkit’ format, incorporating good practices from 17 biopharmaceutical manufacturers and adheres to current regulatory guidelines.
The document is open for consultation until 31 May. Comments can be submitted using the contact page. Further updates will be posted to these pages. A final version will be available before end 2019.