How AST Achieved Seamless GMP Compliance with PMS Contamination Monitoring: A Fully Integrated Solution
In the high-stakes world of sterile pharmaceutical manufacturing, precision and compliance are non-negotiable. That’s why AST—an industry leader in flexible aseptic filling systems—partnered with Particle Measuring Systems to integrate advanced contamination control monitors directly into their isolators and filling lines. This case study explores how AST leveraged PMS’s viable and non-viable monitoring technologies to deliver a turnkey solution that simplifies GMP compliance, streamlines batch reporting, and enhances operational confidence.
Why AST Trusts PMS Monitors for Reliable Isolator Contamination Control
To help its customers meet stringent GMP contamination control standards—including EU Annex 1 and ISO 14644-1/2—AST integrates Particle Measuring Systems’ viable and non-viable monitors directly into its aseptic filling lines. This single-provider approach simplifies sourcing and ensures seamless compatibility with AST’s Electronic Batch Reporting system, delivering a truly integrated contamination control solution.
The BioCapt Single Use impactor stands out for its ease of use and compliance with Annex 1 single-use requirements, making it a practical choice for cleanroom operations.
AST customers have widely embraced these instruments, citing their reliability and the responsive support from PMS.
“We would recommend Particle Measuring Systems to other companies because of their reliable instruments and great service.”
How AST Integrates PMS Monitors for Seamless Contamination Control
Contamination monitors from Particle Measuring Systems (PMS) are offered as an integrated option in AST’s aseptic filling machines—and most customers choose to include them as part of the complete package. This seamless integration reflects AST’s commitment to partnering with suppliers who share its values and dedication to delivering fully unified solutions.
By aligning with PMS, AST ensures that all contamination control instruments—viable and non-viable—connect directly to its Electronic Batch Reporting system. This not only simplifies compliance with GMP regulations like EU Annex 1 and ISO 14644-1/2, but also streamlines data collection and reporting for customers.
Together, AST and PMS deliver cutting-edge technology designed around one central goal: meeting the evolving needs of pharmaceutical manufacturers with reliability, innovation, and ease.
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