5Particle Monitoring: Old and NewBrian G. Ward Eli Lilly and Company, Indianapolis, Indiana1.INTRODUCTIONAt this time. it is very costly and time consuming to pcrfortn the level o l conventionnl sampling nnd laboratoryanalysisneeded lor compounds having exposureguidelines i n the ng/m3 concentrations. The pharmaceuticalindustry is at-frequently beyond-the limiting edge of current analytical chemical speciation techniques. Air smnpling times can become extremely long at these levels. and incapable of revealing transient particulate releases in the workplace. For a manufacturing facility to control its destiny. the sampling and data analysis (and its frequency) and sampling strategy have to be enhanced to provide regular feedbe almost instantaneous back on facility performance. Ideally, fecdback should to afford the maximum advantage t o operations. Optical particle-counting instruments hold great promise for use i n identifying and measuring releases of high-potency compounds. Optical particle counting based on discrete particle counts lends itself to observing the ambient versus incident experiences at very low levels of fugitive airborne releases. These instruments are conventionally used a s total particle counters t o measure compliance with International Standards Organization (ISO) standard 14644 (having evolved from I S 0 9000 and 9002) for clean rooms. By contrast. conventional industrial hygiene optical particle counters (OPCs) are designed for use in a relatively COP tatninated background where typical exposure levels of the pg/m3 concentrations and upward are encountered.55
