Some precautions observed during manufacture, storage & use of products to prevent entry of contaminants

1 Once opened, ampul cannot be resealed, unused portion not retained & used (content loss sterility) 2 Prime requisite of parenteral soln: clarity - sparkling clear & free of particulate matter 3 During mfture, parenteral soln is filtered before it goes into the container 4 Containers are selected: - Chemically resistant to the soln - Highest quality to minimize chances of container components leaching into the solns 5 During container filling – use laminar flow hoods 6 Personnel mfg parenterals - provided with monofilament fabrics (does not lint), face hoods, caps, gloves & disposable shoe covers to prevent contamination 7 After filling & sealing: visual/automatic inspection for particulate matter - clarity : test requirement done to avoid distribution & use of parenterals that contain particulate matter