Question: “Can you speak to the requirements for monitoring Class D clean areas for viable and nonviable particulate? The regulations don’t make it black and white.”
The regulations surrounding viable and nonviable monitoring of Class D clean areas point toward appropriate actions being established on a site-by-site, risk-based assessment. The FDA Guidance on Sterile Manufacture – 2004 states:
“The nature of the activities conducted in a supporting clean area determines its classification.”
We can also establish best practices by triangulating reasonable standards from other global regulatory bodies. For instance, guidance is available regarding what should be done for monitoring the background support areas from the Japan Aseptic Processing Guidance, which states:
“Classes C and D airborne microbial monitoring should be performed twice per week, and airborne particles once per month.”
The frequency recommendation for monthly monitoring of aseptic areas also aligns with the PDA TR13 (2001 – since revised) Fundamentals of an Environmental Monitoring Program, which also suggested that:
“Grade D areas be monitored for total particles on a monthly basis.”
The rationale for monitoring these less critical areas is that there is, albeit low, contamination exposure of components or materials that are handled in these areas. As evidenced by the regulations quoted above, it is generally recommended that periodic monitoring be performed to prevent any significant buildup of contaminants where these activities are performed.
If a space is determined to be a Grade “mentionable” area due to the activities within it, we have a responsibility to demonstrate that the area meets our own, internal quality attributes based on risk to the product or activities performed there. If it is determined that there is a low risk to finished product or materials that area may be given a lower Grade classification, and consequently, a lesser demand on resources will be necessary to demonstrate that quality is being maintained.
We receive many questions from our customers and cleanroom operators regarding suitable or “best” practices in environmental monitoring. Please continue to send your questions to [email protected] If you’re asking the questions, there are no doubt others in the industry who are wondering the same things, and we’d like to share your FAQ’s in upcoming blogs.
Mark Hallworth
Life Sciences Global Manager and Sr. GMP Scientist, Particle Measuring Systems
Mark Hallworth is the Life Sciences Strategic Senior GMP Scientist. Mark has managed the design, installation and validation of over 200 environmental monitoring system projects worldwide. He has designed several products specific for pharmaceutical environmental monitoring, including particle counters for explosive and corrosive areas and 21 CFR part 11 compliant software for batch test and release. He currently lectures for the PDA, ISPE and other international pharmaceutical societies on environmental monitoring and GMP compliance design and validation. Mark has written over 100 technical papers on environmental monitoring and contributed to several books specific to this field, he was awarded the IEST James Mildon award for “significant contributions to the advancement and increase of knowledge in the field of contamination control”.
Additional Resources:
Three Core Events to Establish Environmental Contamination Control – Per EU GMP Annex 1
The Antibacterial MiniCapt® Mobile – For Best-in-Class Microbial Contamination Monitoring
