Controlling fiber and particle contamination in cleanrooms used for producing and assembling single-use bio production systems is crucial for ensuring the quality and safety of the final product. Particulate matter, such as mobile substances and extraneous materials, can significantly impact the final drug product. This is why it is essential to monitor and control particulate matter in cleanrooms, especially in producing single-use systems.
Identifying the source of particles found on the product is a considerable problem for manufacturers of single-use bioprocess systems.
Several single-use system manufacturers have implemented the PolyCHECK particle identification system to detect the source of foreign particle contamination. Surprisingly, it was found that the most significant source of contamination was the cleanroom wipers used in the cleanrooms. The average particle size released by the wipers was over 100 microns, making it a considerable concern for cleanroom managers.
The USP has outlined guidelines for evaluating particulates in final drug products, and the test methodology is described in USP 788, 789 and 790. Particulate matter is classified based on its origin, including inherent, intrinsic, and extrinsic particulates. Inherent particulates come from the product itself, intrinsic particulates come from the production process and primary packaging, and extrinsic particulates come from outside the process.
Particulate matter testing is crucial to ensure that unintended and non-therapeutic particulates in solution dosage forms do not exceed established limits. The size of the particulate matter is a critical factor, with subvisible particulates (1-100 microns) presenting the highest risk to patients as they are respirable. Particulate matter less than 10 microns can be used as a quantitative impurity test, while particles larger than 10 and 25 microns are monitored for product quality rather than safety risk.
In conclusion, controlling fiber and particle contamination in cleanrooms used for producing single-use bio production systems is essential for ensuring the quality and safety of the final product. By implementing the PolyCHECK particle identification system and adhering to USP guidelines, cleanroom managers can ensure that their cleanrooms are free from particulate matter and foreign particle contamination. This is crucial in ensuring that the final drug product meets regulatory requirements and is safe for patients.
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