Getting to the nitty-gritty, so to speak, of the guidelines of USP 797 clean room requirements isn’t very easy. So, at TCA we just wanted to take a few minutes to help break through the mumbo-jumbo of government language and get to what you really need to know; as we did in previous blogs in regards to cleaning requirements within the clean room itself.
Air quality takes precedence in sterility regulations as USP guidelines point out that contamination through airborne impurities is more likely than through floor or surface matter. Environmental sampling of air quality is therefore needed to check for particulates, this should be a part of a routine action plan. Refer to USP797 Table 1 for matter limits. The guidelines call for measurements to be performed within 1 foot of worksite, within airflow and during filling and closing operations. Areas that see less activity and where laminar flow stations are located need to meet ISO 8 air quality standards. The areas immediately adjacent to the processing line need to meet ISO 7 standards.
Sample both air and surfaces for contaminants using contact plates or swabs to sample surfaces of all ISO-classified areas; documenting time of day and procedures taken. Personnel clothing, gear and gloves must be sampled regularly for contamination. Other regulations regarding annual risk assessments and media fill tests are further explained in the guidelines of USP 797. As this blog is simply an interpretation of the actual regulations set forth within, all questions and further explanation should be referred to USP 797.
TCA Modular Clean Rooms is the authority in designing and building of modular clean rooms that meet that standards and guidelines of USP 797. Our experience building more than 1,200 clean rooms in the US and elsewhere, allows us the knowledge it takes to build only the best clean rooms available.