Environmental Monitoring Programs in Pharmaceutical Facilities

In an article written by Dr. Ross Caputo, titled Environmental Monitoring Analyses: Early Warning Opportunities for Sterile Compounders, Dr. Caputo discusses the importance of environmental monitoring and how a successful program could provide early signs of present contaminants.

Microbial contamination decreases the effectiveness of a drug. In addition, it can also put patients’ health at risk. Drug contamination can cause serious illness, adverse effects or death. For this reason, pharmaceutical compounding facilities have sterility tests in place to check their products for contamination. Nonetheless, sterility tests cannot be relied upon to detect every potential contaminant. Sometimes other measures are needed.

The United States Pharmacopeia (USP) outlines the environmental monitoring requirements each pharmaceutical compounding facility must abide by. Currently, in high-risk compounded sterile preparations (CSPs), a facility must facilitate air and surface samples semiannually. Ultimately, an environmental monitoring program tests the sterility of the manufacturing process and environment rather than the actual products. According to Dr. Caputo, this is where environmental monitoring programs could further be improved and is, in fact, needed.

What makes a successful environmental monitoring program? Dr. Caputo claims that the program should evaluate data over time and be frequently reviewed in order to detect early signs of environmental deterioration that could harm pharmaceutical compounds. Then, a facility can make changes accordingly without having to instate damage control. This can help create stability instead of a reactionary approach.

According to Dr. Ross Caputo's research, a successful environmental monitoring program should:

1. Detect indications of potential contaminations on product quality. However, it is important that this happens before the product is compounded;
2. Collect and monitor data to indicate the state of control of an environment.

Dr. Caputo suggests monthly reviews and using a more sensitive metric in order to create one of these environmental monitoring programs,. He claims measuring the frequency in which contamination is detected rather than the amount detected is a more accurate measurement of control and safety.

With more than 50 publications, Dr. Caputo focuses his research on sterilization process control and efficiency. Dr. Ross Caputo has his Ph.D. in Microbiological Physiology and Immunology from Miami University and has more than 30 years of experience working in the FDA-regulated pharmaceutical industry. He is the founder of Pharmaceutical Systems, Inc. (PSI), a company focused on helping clients solve issues of product development, optimization, sterilization validation and quality control. Currently, he is President of Eagle Analytical Services, a company that provides preparation testing for compounding pharmacists and other services.