Last December, international experts unveiled drafts of updated international ISO cleanroom standards that could have consequences for clean room design, implementation, and manufacturer practices in the future. The revised standards have introduced an improved statistic-based plan for room cleanliness that focuses on particle concentrations in various areas of the room to gain a more accurate reading of overall room concentration.
The US FDA has not made any official comment on the revised standards, but the Division of Manufacturing and Product Quality within FDA’s Center for Drug Evaluation and Research has commented that they are supportive of efforts to improve standards and encourage them to be followed internationally.
Since the new standards mark such a noticeable departure from previous standards, more opinions will undoubtedly arise as to the effectiveness of the new standards. The standards feature a procedure of random sampling that may force manufacturers like pharmaceutical producers to update their protocols for sampling and testing a room’s cleanliness.
Some manufacturers may object to these new procedures on various grounds, but the experts behind the updated standards have argued that the statistics have shown that the new approach is more beneficial and have published a paper to prove their point. Time will tell how the overall set of guidelines is received by the various industries to be affected.