Pharmacy compounders, including FDA Section 503A pharmacies and 503B outsourcing facilities, operate in a highly regulated environment where contamination control is paramount. The need for sterile, safe medications is not just a quality concern, it’s a regulatory mandate. Meeting cGMP guidelines, such as USP 797, requires a proactive, reliable contamination control strategy. That’s where Particle Measuring Systems (PMS) steps in.
PMS offers a suite of purpose-built environmental monitoring solutions to help pharmacy compounders comply with regulations and streamline their contamination control workflows. Let’s take a look at how these innovative tools, the Lasair® Pro, MiniCapt® Mobile, and DataAnalyst™ software, can make all the difference.
The Lasair Pro portable aerosol monitor is a cleanroom-ready particle counter that helps compounders monitor and validate controlled environments with confidence. Designed to meet ISO 14644, it allows for precise and real-time non-viable particle counting in critical areas like ISO regulated laminar flow hoods and cleanrooms.
Why it matters for Section 503A & B compliance:
Helps maintain control over ISO Class 5 and ISO Class 7/8 zones
Provides data to support room classification and routine monitoring
Enables compliance with FDA cGMP and USP 797 particle monitoring requirements
With its intuitive touchscreen and remote monitoring capability, the Lasair Pro particle counter is ideal for the fast-paced, highly controlled settings of pharmacy compounding.
When it comes to viable (microbial) contamination, the MiniCapt Mobile Active Air Sampler offers a comprehensive solution. This portable microbial air sampler simplifies environmental monitoring in cleanrooms and hoods. It works seamlessly with a wide range of agar plates and provides precise colony-forming unit (CFU) counts per cubic meter, helping compounders monitor microbial levels in real time.
Key advantages for compounders:
Meets ISO 14698 and GMP Annex 1 requirements for viable monitoring
Lightweight and easy to move between compounding areas
Compatible with PMS’ BioCapt® Impactor for high-efficiency sampling
Microbial monitoring is a critical component of any contamination control plan, and the MiniCapt microbial monitor makes it easier and more accurate than ever.
Environmental monitoring is only as good as the data you can analyze and report. The PMS DataAnalyst software ties everything together by collecting, organizing, and visualizing the data gathered from both particle and microbial monitoring devices.
For compliance-focused operations, DataAnalyst software delivers:
Automated trend analysis and deviation alerts
Simplified reporting for audits and inspections
21 CFR Part 11 compliance for electronic records and signatures
With clean, intuitive dashboards and powerful filtering tools, DataAnalyst turns raw environmental data into actionable insights, helping you stay ahead of potential issues and remain fully audit-ready.
Regulators are raising the bar, and pharmacy compounders, especially 503B’s, need monitoring tools that are accurate, reliable, and compliant. Particle Measuring Systems brings it all together with:
Lasair Pro non-viable particle counter
MiniCapt Mobile viable microbial monitor
DataAnalyst software for seamless data analysis and reporting
Together, these tools form a comprehensive contamination control solution that supports a culture of quality, safety, and compliance.
Our customer support is ready to answer your questions or get a quote ready for you.
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