INSIGHTS ON CRITICAL ENVIRONMENTS

CRITICAL ENVIRONMENT SOLUTIONS

  • In the spectrum of pharmaceutical manufacturing facilities, injectable product manufacturing facilities represent the most sophisticated and challenging to design, build, qualify and operate, particularly when products manufactured in these facilities are rendered sterile when complete, ready to inject directly into a human. For this reason, very careful consideration must be made when developing such a facility.

  • Extract Technology aseptic isolators are designed to allow operators to perform aseptic processes in a sterile environment providing assurance of process integrity.

  • Presaturated cleaning wipes can offer many benefits over bottled solvents and dry wipes for cleanroom use. Contec’s presaturated wipes help reduce solvent use, increase convenience in hand wiping, reduce airborne VOCs, and increase process control and reliability.

  • TSI AeroTrak+ Remote Particle Counters offer cleanroom professionals top-notch reliability and no-hassle operation in measuring a wide range of particle sizes, including a 6-channel model with upper size threshold of 25 µm. 

  • Used Kiefel Technologies Bag Making Machine, Model KIF 52, Serial #416-030, for forming, filling, and sealing medical-grade bags and IV bags.

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.