Cleanroom Tips in Keeping Compound Pharmacies Regulation Ready

Compounding has been a part of healthcare since the beginning of medicine and is being used in the healthcare industry today. Compound pharmacies are governed under two major set of regulations. 503A pharmacies are subjected to more lenient standards. 503B facilities are required to comply with a very strict regime. This is due to the fact that these facilities produce drugs in mass quantities and distribute them over a vast geographical area. Any source of contamination that goes unidentified can endanger public health. It is for this reason they are held to a much higher standard.

What is a Cleanroom?

Used for scientific research or manufacturing pharmaceutical products, a cleanroom is a controlled environment within a compound facility that uses special air-filtering systems that protect from pollutants such as aerosol particles, dust, airborne microbes, and chemical vapors. A filtered work space is required in which these pollutants and contaminants are kept within strict limits. Otherwise, these pollutants can negatively affect the manufacturing process. Filtering systems that are used most often are Ultra Low Particulate Air (ULPA) or High Efficiency Particulate Air (HEPA) filters.

In addition, a sterile, sanitized environment is required. Adhering to strict guidelines is essential. This lowers the … Read More

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