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…

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…

Managing complaints and controlling adverse events are critical for a pharmaceutical company. While varying international regulations for adverse event reporting and product complaint handling make…