Training
 
FREE TECHNICAL TRAINING FOR PHARMA PERSONNEL ON :
Cleanroom Monitoring Liquid Particle Counting For SVP/LVP
Total Organic Carbon Measurement Of Pharma Waters Particle Size Measurement Of Powders
 
As a service to the pharmaceutical industry, we are prepared to organise 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 2,000 personnel have benefited from similar training. No fees will be charged and the lectures will be technical not sales or product oriented.
 
TYPICAL AGENDA
 
9.30 to 10.15 hours 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 Continuous Particle Monitoring Systems for cleanrooms
(Hardware & software for continuous monitoring of airborne particles, relative humidity, air velocity, temp, differential pressure, sequential manifold systems vs. continuous remote sensors)
   
11.00 to 11.15 hrs Tea Break
   
11.15 to 12.00 hrs New International Cleanroom Standards -- their impact on pharma industry
(Demise of FS 209E, Comparison of ISO 14644 & FS 209E, U.S. FDA c GMP, EU GMP Annex 1 revision)
   
12.00 to 13.00 hrs On-Line Total Organic Carbon Measurement of Pharmaceutical Waters (Purified Water and water for Injection)
(On-Line vs Laboratory TOC methods, USP <643> TOC and <645> Conductivity, calibration & system suitability testing of TOC analysers)
   
13.00 to 13.45 hrs Lunch Break
   
13.45 to 14.30 hrs Small and Large volume parenteral tests
(Theory of liquid particle counting, sources of error in particle counting, USP 29-788, EP standards, PharmSpec sotware, USP/EP/JP harmonisation )
   
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 Particle Size Analysis of powders
(Theory of laser diffraction, various methods of particle sizing, etc)