INSIGHTS ON CRITICAL ENVIRONMENTS

CRITICAL ENVIRONMENT SOLUTIONS

  • Formulation and aseptic filling solutions are crucial at every stage of development. Consider a manufacturing partner who can address every challenge on the path from pre-clinical programs to commercialization.

  • Extract Technology's self-contained, ready-to-use design provides functional clean room space wherever and whenever it's needed. Whether the need is to expand manufacturing, R&D or processing capacity at an existing facility, a remote location, or around the globe, the company's MCRs can be transported and fully operational more rapidly than other clean room options.

  • 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.

  • Rapid Decontamination Stations (RDS) facilitate the offline decontamination of materials, such as monitoring equipment.

  • If you are looking to manually clean coveralls, bunny suits, bouffants, and the like, the Alconox detergent you have in house will be great.  In a more ideal circumstance, we would go with what is essentially Alconox powder enhanced with protein enzymes.  This truly gives thorough removal/cleaning of biological, proteinaceous, viral, and microbial residue.  This is Tergazyme® Enzyme-Active Powdered Detergent – see our Tergazyme detergent video.  Both detergents, the Alconox and Tergazyme powder, do not contain traditional “laundry” detergent attributes: florescent whitening agents, softeners and fragrances. They both contain excellent dispersants, emulsifiers and wetting agents that can enhance cleaning significantly.  So they won’t “smell” clean, they just will be clean.  In fact, critically clean.

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.