Analysis shows how a facility can benefit from lower air change rates without risking non-compliance. Regulatory bodies around the world require that cleanrooms meet the allowable particle counts as required per their classification. Most pharmaceutical manufacturers take a conservative approach to ensure compliance with particle count limits and often, this is based on historical data from previous projects where air change rates are set at a very high level, relative to the need. There are many factors that contribute to varying particle counts to fluctuate between facilities, including process functions, air filtration equipment, physical design, human activity and level of gowning, surface deposition, cleaning regiment and frequency and space pressurization. Click Here For Complete Article Text
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