INSIGHTS ON CRITICAL ENVIRONMENTS

CRITICAL ENVIRONMENT SOLUTIONS

  • What Is Annex 1 and Why Is It Important? Annex 1 is a GMP document published by the European Commission and dedicated to the manufacturing of sterile products. All pharmaceutical companies that produce sterile products must comply with these regulations. The document is a joint initiative between the EMA and PIC/S.

  • Microbial impactors for continuous viable monitoring, minimize false positives, and are Annex 1 compliant.

  • Streamline large equipment transfers with integrated bio-decontamination. This airtight system ensures a log 6 microbial reduction while maintaining strict ISO Class 5 cleanroom integrity.

  • Compact microplate washer with maximum flexibility in a minimum footprint

    The MultiWash+™ Microplate Washer is an automated, compact, quiet, efficient washer with 20 different wash protocol options. The variations include adjustable speed and volume, adjustable aspiration speed and time, adjustable soak times, and three modes of shaking. Four wash/rinse bottles are included and configurable for both 96- and 384-well plates.

  • The AES Profile cleanroom system is another AES hallmark system, a 2” [50mm] thick modular wall system with a uPVC finish, with all seams cold welded together to create a monolithic finish. The reduced wall cross section with all flush finishes at doors and windows provides a superior performing system.

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Learn how to employ science-, risk-, and statistics-based approaches to cleaning and cleaning validation at your facility with this free, 100-page e-book, written by a global team of cleaning validation experts, pharmaceutical toxicologists, statisticians, and Six Sigma professionals.