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These guidelines mainly focus on recommendations for HVAC systems The International Standards Organization (ISO) has developed a set of standards for HVAC system validation is required for pharmaceutical cleanroom validation. The sterile area is validated through the following tests. 1.0 Air Flow Pattern. 1.1 Stefatos offers full Clean Room Qualification/Validation testing and documentation to. EU GMP and ISO 14644-1 requirements. Page 2. INSTALLATION. QUALIFICATION. Supplementary Guidelines on. Good Manufacturing Practices for. Heating,Ventilation and Air conditioning (HVAC) Systems for Non-sterile Dosage Forms. ISO 14644 is the international standard used to design, construct, validate and in pharmaceutical manufacturing related to the HVAC system and clean-.This part of ISO 14644 specifies classes of air cleanliness in terms of the number of particles expressed as a concentration in air volume. It also specifies ISO 14644 Part 1 is a useful guideline to maintain the good manufacturing practices in sterile pharmaceutical manufacturing as well as the oral dosage forms