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As a service to the pharmaceutical industry, we are prepared to organize a one-day training program for your QA / Production / Regulatory Affairs staff at your premises on the above topics. In the last 5 years, over 5,000 personnel in India and abroad have benefited from the similar training. No fees will be charged. If a site is outside Mumbai, airfare and hotel expenses to be borne by you.

Keynote Speaker: Sheesh Gulati who has over 4 decades of experience in this field.


9.30 to 10.15 hrs

Monitoring non-viable particles in a Cleanroom — the basics (Sources of contamination, how a particle counter works, particle counting terminology)

10.15 to 11.00 hrs

Validation & Certification of Pharma Cleanrooms (URS/IQ/OQ/PQ, Certification Tests)

11.00 to 11.15 hrs

Tea Break

11.15 to 12 hrs

Continuous Particle Monitoring Systems for cleanrooms (Hardware & software for continuous monitoring of airborne particles, sequential manifold systems vs. continuous re1ote sensors)

12.00 to 13.00 hrs

Understanding the new Revised ISO 14644-1 & 2:2015
New classification table, number of locations, representative location, M descriptor, Matters to consider when developing a monitoring plan

13.00 to 14 hrs

Lunch Break

14 to 14.30 hrs

Airflow Visualisation Studies
Why perform smoke studies, filming the smoke study, smoke generators

14.30 to 15.15 hrs

HEPA filter leak testing
HEPA filter standards and design, filter testing with aerosol photometers & generators, cold and thermal aerosol generators, efficiency vs. leak testing etc.)

15.15 to 15.30 hrs

Tea Break

15.30 to 16.00 hrs

Video on Cleanroom Gowning

16.00 to 16.30 hrs

FAQs on Particle Counting & HEPA Filter Testing