Non-Sterile Pharma & Personal Care

In microbiology and pharmaceutical development, environmental monitoring (EM) is a process that determines the quality of a controlled environment via microbial data collection. Data comes from samples of air, surfaces, and personnel in a clean space. Environmental monitoring plays a critical role in developing sterile (ie: injection, infusions, ophthalmic solution) and non-sterile (ie: solutions, capsules, tablets, ointments) drug products.

Cutibacterium acnes (C. acnes) is a Gram positive bacteria that prefers anaerobic (without air) growth conditions1. Cutibacterium acnes can be found on the skin of virtually every human, and it is one of the bacteria that can cause acne. Acne is one of the most common skin diseases, affecting more than 45 million individuals in the United States.

Bacillus subtilis is a gram-positive bacteria found in soil and the gastrointestinal tract of ruminants and humans. It is rod-shaped and can form a tough, protective endospore, allowing it to tolerate extreme environmental conditions¹. Bacillus subtilis is considered the best studied gram-positive bacterium and a model organism to investigate bacterial chromosome replication and cell differentiation.