Dear Member,

IS YOUR CLEANROOM 2017 READY?

New versions of ISO 14644-1 & ISO 14644-2 went “live” in December 2015. Cleanroom owners and validators had a “Grace Period” until 31st December 2016 to implement the changes. This period is now almost over. Are you PREPARED?
Changes have also been proposed to ISO 14644-3, are you aware of them?
 
U.S. FDA has issued several Inspectional Observations /Warning Letters Form 483a regarding cleanroom pressure differentials. Pharma manufacturers – do you want to KEEP receiving 483s on Differential Pressure violations in your cleanroom?
 
Filter manufacturers and cleanroom users - the new test standard ISO 16890 for filter testing and assessment will replace EN 779 by the end of 2016, with a transition period of 18 months. This new method for the evaluation of air filter elements represents a paradigm shift. In future, filter efficiencies will be determined with regard to the particulate classes PM1, PM2,5 and PM10. Are you aware of the intricacies of this new standard?
 
ISO 29463 High-efficiency filters and filter media for removing particles in air, is derived from EN 1822 with extensive changes to meet the requests from non-EU members. It contains requirements, fundamental principles of testing and the marking for high-efficiency particulate air filters with efficiencies from 95 % to 99,999 995 % that can be used for classifying filters in general or for specific use. Are you conversant with all 5 parts of this Filtration standard?
Are you fully cognisant of the latest Recommended Practices Related to Air Filtration in Cleanrooms and Other Controlled Environments, including: IEST-RP-CC001.6: HEPA and ULPA Filters; IEST-RP-CC002.4: Unidirectional-Flow, Clean-Air Devices;  IEST-RP-CC007.3: Testing ULPA Filters; IEST-RP-CC021.4: Testing HEPA and ULPA Filter Media; IEST-RP-CC034.4: HEPA and ULPA Filter Leak Tests ?         
 
There are several lakh kilometres of air conditioning ducts in Indian buildings. Industry experts estimate that more than two-thirds of them are leaky enough to need sealing or repair. Leaky ducts can greatly increase air conditioning bills, do you know how to pinpoint where these leaks are?
 
If your answer is NO to any of the above questions, then you MUST attend the full day technical seminar being organised by CCSI, supported by ISHRAE and ASHRAE, in Mumbai on 21st.January. Full details attached.

Please refer below link for Brouchure, Agenda and Speaker details :

https://drive.google.com/open?id=0B21krPoXwzGqcGs4emZEWHdQdG8

Please Feel Free to Call for any queries to Ms. Jyoti Gangwani on Cell: 9022686802and email: jyoticcsi@gmail.com

Thanks & Regards

Nasir Khan
Advocacy Chair
ISHRAE MUMBAI CHAPTER