CLEANROOM TESTING

Our specialists and team are knowledgeable in regulatory compliance requirements. We provide guidance, technical support, and services in accordance with up-to-date standards and industry guidelines such as ISO-14644, FED-STD-209E, NEBB, IEST, ASHRAE, GMP, WHO, PIC/S, FDA to ensure you that the controlled environment, system and process meets all of your validation and compliance needs.

Standard Reference

Testing Reference
1. ISO 14644 Series standards, International Organization of Standardization
2. IEST-RP-CC006: Testing Cleanroom, Institute of Environmental Sciences and Technology (IEST)
3. IEST-RP-CC034:HEPA and ULPA filter leak tests, Institute of Environmental Sciences and Technology (IEST)

Design and Manufacturing Reference
1. Pharmaceutical Inspection Convention/Pharmaceutical Inspection Co-operation Scheme (PIC/S), Guide to Good Manufacturing Practice for Medical Product, www.picsheme.org 
2. WHO Technical Report Series # 937/Fortieth Report, WHO Expert Committee on Specifications for Pharmaceutical Preparation, Annex 4: Supplementary Guidelines on Good Manufacturing Practices; Validation
3. ASHRAE Standard 170-2013, Ventilation of Health Care Facilities