The control and monitoring systems are considered the core of the environmental control system. The final performance of the environmental control system can be evaluated only after these have been validated. PQ protocols covering this system, in general, include the performance challenges…

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There are different sizes and types of Air Handling Units. Some will fit in a closet or within a ceiling space, while others will require a mechanical room or will need to be placed on the roof of a building. Within all…

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An essential element in ensuring aseptic conditions is the maintenance of HEPA filter integrity. Integrity testing should be performed at installation to detect leaks around the sealing gaskets, through the frames or through various points on the filter media. Thereafter, integrity tests…

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 I. PURPOSE OF VALIDATION High-quality water and air are essential for the manufacture of pharmaceuticals. Water is the most commonly used raw material in pharmaceutical manufacturing; it is indirectly used in the manufacture of all dosage forms for cleaning manufacturing equipment, and…

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Introduction:  Heating, ventilation and air-conditioning (HVAC) play an important role the manufacture of quality pharmaceutical products. A well designed HVAC system will also provide comfortable conditions for operators. HVAC system design influences architectural layouts with regard to items such as airlock positions,…

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About HEPA (High efficiency particulate air)   High-Efficiency Particulate Air or HEPA  is a type of air filter. It is a type of filter which has high efficiency to filter out about 99.997% that is why they are termed as High efficiency…

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