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Environmental Monitoring & Why it Matters: Part 1

by | Feb 5, 2020

Avoid Relying on Sterility Tests Alone

Sterility tests cannot reliably detect contamination in compounded sterile products (CSPs) because of inherent limitations in testing and sampling methodologies. Nor can the sterilization process be relied upon to eliminate all contamination.

In this three-part article, we’ll cover several aspects of a healthy environmental monitoring program that operates in line with USP <797>, and demonstrates that the sterile process at your compounding facility remains in a state of control.

 

Developing A Holistic Approach

Environmental monitoring is an important element of the quality assurance program at sterile compounding facilities. These facilities need to be in a state of control that does not contribute to contamination, especially microbial, to in-process materials that are to be rendered sterile. The goal of an environmental monitoring program is not to test the product, but to test the control of the process by providing important data about the environment where the product is produced.

Products with a greater pre-sterilization bio-burden pose an increased challenge to the sterilization process.

High-Level of Control Over Aseptic Processes

Assurance (a probabilistic assessment) is best achieved by maintaining a high level of control over aseptic processes and the microbiological quality of the environment in which they are conducted. The primary objectives of a successful environmental monitoring program in a compounding facility are twofold:

1 To collect data that shows that the environment is operating in a state of control, and;
2 To detect trends that indicate a potentially negative impact on the quality of the product before it is compounded.

In the next article, we’ll cover “The Importance of Trending and Analyzing Data:” a powerful practice that both protects the quality of the product and makes good business sense.

Need Help With Your Environmental Monitoring Program?

Eagle consultants are helping compounding facilities implement successful quality systems. Our team has over 200 years of combined experience in the FDA-regulated pharmaceutical industry and can provide guidance in establishing the systems and processes that will help your facility meet and exceed regulatory expectations. Follow the link below to learn more about our consulting services.

Ross A. Caputo Ph.D.