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Viable Air Sampling Services

Perritt Labs understands that the integrity of your non-sterile pharmaceutical and medical products depends on a controlled manufacturing environment. As an early proponent of viable air sampling for non-sterile pharma manufacturing, our dedication to safeguarding public health, particularly that of children and families, drives our commitment to excellence.

We provide viable bioburden air sampling services that assist with compliance, mitigate microbial risk, and instill confidence in your final product. Effective pharmaceutical air monitoring is far beyond a regulatory checkbox — it is an investment in product quality and safety.

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Services Available From Perritt Labs

Our environmental monitoring services address several facets of microbial control within your facility.

Utilizing state-of-the-art equipment, we quantitatively assess viable airborne microorganisms, providing data on the microbial load in critical environmentally controlled GMP areas. This method is crucial for identifying potential sources of contamination and verifying the effectiveness of your HVAC systems.

This method complements active sampling by capturing microorganisms that settle on surfaces over time. Settling plates give insight into the overall microbial cleanliness of an environment.

Our specialized procedures for compressed air sampling enumerate and identify microorganisms, verifying that your utility systems do not jeopardize product safety.

Following cGMP Regulations

Compliance with current Good Manufacturing Practices (cGMP) is important to maintain your brand reputation. Perritt Labs helps you navigate your organization’s regulatory landscape. Feel confident that your environmental monitoring programs adhere to global standards, such as sections of 21 CFR 211.

  • Ventilation, air filtration, heating, and cooling (211.46): This regulation demands adequate equipment to control microorganisms, dust, humidity, temperature, and differential air pressures.
  • Sanitation (211.56): This section requires written procedures for the use of rodenticides, insecticides, fungicides, fumigating agents, and cleaning and sanitizing agents. These procedures must be designed to prevent the contamination of equipment, components, drug product containers, closures, packaging, and labeling materials.
  • Monitoring (211.42(c)(10)(iv)): A system for monitoring environmental conditions needs to be put into place.

By conducting air sampling services, we provide data that demonstrates your HVAC air filtration system and compressed air system are in a state of control. This evidence is vital for regulatory audits and for maintaining product qualityand assists in remedial efforts. Perritt Labs also provides recommendations for ongoing improvement.

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Reasons to Partner With Perritt Labs

Choosing Perritt Labs means partnering with an industry leader known for its scientific expertise, dependability, and personalized service. Our understanding of microbial control and regulatory requirements, coupled with our commitment to protecting end-users, makes us the trusted choice for your environmental monitoring needs. We deliver precise results and expert guidance so that you can focus on your core mission.

Contact Perritt Labs for Service Details

Ready to enhance your environmental monitoring process? Our experts are prepared to tailor a solution that meets your needs and regulatory obligations.

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