Following the terror attacks of Sept. 11, 2001, the U.S. Department of Homeland Security issued Presidential Directive 7: Critical Infrastructure Identification, Prioritization, and Protectionto establish a…
Category: Pharmaceutical
Frequently, customers have used fume hood exhaust to ventilate hood base cabinets. The author finds both the need for this practice and the designs for…
The environmental control of classified areas within clean rooms is ensured by systems of humidity control, air temperature, renewal and filtration of the air, by…
In the current context of media attack on antimicrobial preservatives, the cosmetics industry must innovate to continue to develop products devoid of “all” microbiological risks,…
ABSTRACT Cleanroom contamination can arise from a number of sources. Most contamination within the pharmaceutical facility can be traced to humans working in cleanrooms. The…
What is cleanroom documentation? Cleanroom post-it notes are a nessecary but sometimes overlooked cleanroom item. The sensitive nature of cleanrooms means that such day to day…
Making hand hygiene and glove compliance for infection control practitioners is a major concern at Blue Thunder Technologies. Better compliance with aseptic protocol helps to prevent infections acquired…
What if one speck of dust was the difference between success and failure? In some cases, a single speck can even destroy expensive manufacturing equipment. One speck.…
Principles of Cleanroom Testing Quantity: –Turbulently: dilute–air volume (supply and extract) –Unidirectional: remove –air velocity Direction (flow direction): –from clean area à less-clean areas to…
Principle This Annex describes the principles of qualification and validation which are applicable to the facilities, equipment, utilities and processes used for the manufacture of…