Manufacturing and Production

Pharmaceutical Water Systems and Utilities Qualification

Water is the largest ingredient in most medicines and the utility most likely to fail an inspection, because a system that produces compliant water on the day of testing can still grow a biofilm that no sampling regime was designed to detect. This course covers designing and running one that does not. Delegates work through water grades and where each is required, from potable through purified water to water for injection. Pretreatment is covered, including filtration, softening and dechlorination. Generation follows across reverse osmosis, electrodeionisation and distillation, with the quality each achieves. Distribution loop design is addressed in detail: velocity, dead legs, slope, drainability and the sanitisation regime that keeps a loop clean. Biofilm formation is treated directly. Monitoring is covered, including conductivity, total organic carbon, endotoxin and microbial testing, with alert and action limits. Clean steam and compressed air are addressed. Qualification and periodic review follow. The course closes on excursion investigation and on the inspection findings these systems attract.