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.

  • Explore a broad range of ready-to-use culture media designed to detect a wide range of microorganisms and meet the highest requirements of microbial monitoring in sterile production environments.

  • When transparency is paramount, the AES infinity system provides the viewer with a close-up and very clear viewing experience, enabling interested personnel to see the process without entering the cleanroom environment. The AES infinity glass wall system is easily integrated with other wall systems.

  • Sensitivity range: 0.3 - 25.0 µm; 1.0 CFM (28.3 LPM) - Built-in vacuum, PoE, VHP resistant

  • Your one-stop shop for repair requests, contracts, maintenance, and service history.

FREE CLEANING VALIDATION E-BOOK

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.