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.

  • Insertion technology for ASEP-TECH® Blow/Fill/Seal systems was pioneered by Weiler Engineering, Inc. The technology incorporates the use of a barrier isolator, typically located outside the machine room and integrated with the BFS machine. Sterile inserts such as tip and cap assemblies or multi-entry rubber stoppers are loaded into the isolator (which is maintained at Class 100 conditions) through a rapid transfer port.

  • Incorporating 45 years of particle counting experience, the Lasair® Pro Aerosol Particle Counter is designed with the latest technology to meet global requirements for data integrity.

  • The AES modular cleanroom system is engineered with inherent flexibility to seamlessly incorporate essential modular cleanroom accessories while maintaining structural integrity and eliminating the need for costly engineering rework.

  • Protect sterile materials during transfer with mobile ISO Class 5 airflow zones. These customizable trolleys eliminate contamination risks while ensuring operator safety and process integrity.

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.