In the highly regulated industries of pharmaceuticals, biotechnology, cosmetics, and medical devices today, cleanliness of the production environment is paramount. Environmental monitoring (EM) is an important tool to ensure that your cleaning and disinfection procedures, as well as your operational processes, are effective. At Chromak Research, we specialize in microbiological environmental monitoring to ensure your controlled environments and cleanrooms are compliant with regulations, specifically as outlined in USP<1116>.

What is Environmental Monitoring?

Environmental monitoring is a systematic scientific technique for determining air, surface, water, and personnel quality in the manufacturing environment for microbiology. The purpose is to detect and control potential sources of contamination prior to compromising product integrity. EM is essential in any plant involved in aseptically manufacturing or processing products whose microorganism control is essential.

Why Environmental Monitoring is Important

Good environmental monitoring assures:

Compliance with industry standards, e.g., USP<1116>, FDA guidelines, and GMP standards.

Less risk for contamination with direct impact on the safety, quality, and shelf life of the product.

Better quality control, building confidence and trust in your company.

Data-driven decision-making to facilitate ongoing improvement in cleanroom operations.

Here at Chromak Research, we assist you in identifying key control points and establish a successful environmental monitoring program specific to your facility’s distinctive operations and risk model

Environmental Monitoring Services with Chromak Research

Our environmental monitoring microbiological analysis services include:

Air Quality Analysis

Air sampling using active (impactors or impingers) and passive (settle plates) approaches to airborne microbial contamination testing. Our USP<1116> compatible testing procedures ensure that our results will be valid and reproducible.

Surface Monitoring

Through contact plate and swab sampling methodology, we collect your high-touch locations, equipment, and significant surfaces in your plant. This verifies cleaning and disinfection operations operate at peak efficiency and microbial charges are within acceptable limits.

Water Quality Testing

Production and cleaning water must be of high microbiological quality. We analyze purified water (PW), water for injection (WFI), and potable water for the absence of microorganisms.

Personnel Monitoring

Our specialists examine microbial shedding of personnel through glove, gown, and exposed skin sampling post-surgery. In this, it is of utmost importance to verify gowning protocols and personal hygiene processes.

Tailored Environmental Monitoring Plans

After a thorough risk assessment and data review, our specialists will create and execute a tailored environmental monitoring program, including:

  • Frequency and area monitoring
  • Alert levels and action
  • Trend analysis and reporting
  • Remediation deviation protocols
  • Training programs for aseptic procedures and contamination control

USP<1116> and Reg Compliance

Our environmental monitoring programs rigorously adhere to USP<1116> – Microbiological Control and Monitoring of Aseptic Processing Environments, making your operations compliant with the regulatory expectations of today. Our scientists are highly adept at data interpretation of EM and observations that help keep your facility under control.

Choose Chromak Research

We know the complexities of a sterile manufacturing space, staying free from contamination at Chromak Research. From opening a new facility or optimizing an existing one, our environmental monitoring program is set to safeguard your product, your process, and your reputation. Utilizing the newest testing procedures, regulatory knowledge, and customer-driven model, we give you actionable outcomes that complement your quality assurance program.

Call us today to learn how Chromak Research can serve your environmental monitoring and microbiological testing requirements.