USP <1116> Microbiological Control and Monitoring of Aseptic Processing Environments

About USP <1116> Guidelines for Cleanrooms

Maintaining qualified cleanroom is a top priority, whether you produce medical devices, sterile drug products, active pharmaceutical ingredients, pharmaceutical products, or excipients in your facility.

When you own or manage a cleanroom facility, where you control the risk of microbial contamination through aseptic processing, your organization needs to follow the information and recommendations in the United States Pharmacopeia’s USP <1116>, Microbiological Control and Monitoring of Aseptic Processing Environments.

To help companies manage their cleanrooms more effectively and within regulations, BA Sciences is proud to offer on-site services for cleanrooms and labs, following the guidance of USP <1116>.

What Is a Microbiological Evaluation of Aseptic Processing Environments?

Organizations that use aseptic processing systems must evaluate their cleanrooms with environmental monitoring equipment to verify they are producing their biologics and drugs in a manner that is safe and in accordance with applicable regulations. Protocols for on-site testing involve checking the cleanroom layout and verifying how it is classified, with an eye toward potentially installing new environmental monitoring equipment.

One thing to keep in mind is that USP <1116> is premised on the idea that you measure contamination according to CRRs or contamination recovery rates, instead of CFUs (colony forming units).

Your team will report on CRRs as the maximum level of contamination in samples for a specific amount of time, as part of routine trending of environmental monitoring data.

Environmental control:

Developing products for human consumption entails maintaining strict environmental controls. You have to assume that when people are working in your lab or cleanroom, microbial ingress will occur.

Environmental monitoring:

You cannot hope to remain compliant with USP <1116> if you lack a rigorous, modern system to monitor and control the environment, such as a cleanroom with airflow moving in one direction, any restricted access barrier system (RABS), and the fill/seal/blow system you have in place.

Above all, you must always remain vigilant against contamination. Periodic testing, in conjunction with continued training, is essential.

Choose BA Sciences for On-site Monitoring Services

The experts at BA Sciences provide on-site microbial air and surface environmental monitoring services that are suitable for organizations needing professional assistance in maintaining their cleanrooms.

We stay on top of industry best practices and government regulations to help our customers use aseptic processing to curb microbial contamination.

To support your efforts to remain compliant with USP <1116>, our cleanroom services professionals will help you achieve your goals for employee safety and create products with the requisite levels of purity.

To that end, we’ll evaluate the cleanroom layout and work collaboratively with you to implement or revise robust environmental monitoring protocols. What’s more, we will educate your workers on current best practices for gowning, cleanroom behaviors, and environmental sample collection.

BA Sciences uses state-of-the art testing equipment. Our experts are fully versed in validating and testing cleanrooms in the context of adhering to USP <1116> microbiological evaluation of cleanrooms. You can depend on us to bring your lab into compliance with current standards, providing training to your employees for the greater safety of everyone involved, from workers to customers.

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