Pharmaceutical Water Systems Training

About this course

Why water deserves its own course

EMA's guideline on water for pharmaceutical use describes water as one of the major utilities of the industry. It goes into products as an excipient, it is used to reconstitute them and during synthesis, and it is the last thing to touch equipment, containers and closures at the final rinse. The guideline calls the control of water quality, especially microbial quality, a major concern. Recent FDA warning letters show why. One site isolated objectionable organisms from its water system on more than sixty occasions. Another kept finding Burkholderia cepacia shortly after each sanitisation, which FDA said indicated a stubborn biofilm. A third sampled only a few of the outlets production used.

What this course does differently

The course covers the whole life of a water system in one place: grades of water and where each is needed, pretreatment and purification, water for injections by distillation or by reverse osmosis, storage and distribution, biofilm, sanitisation and maintenance, qualification, routine monitoring, and excursion investigations. It draws on the current EMA guideline and EMA's questions and answers on non-distillation methods, Annex 1's points on water and pure steam, and FDA's inspection guide and regulations. It explains the change of April 2017, when Europe allowed water for injections to be made by processes equivalent to distillation, and the duty to notify the supervisory authority before using one. Pharmacopoeia monographs are named, never quoted. FDA's inspection guide adds the practical detail inspectors still look for: the system drawing checked against the plant every year, dead legs, vent filters, heat exchangers, action limits for purified water and water for injections, and three phases of qualification that end only with a full year of data. Biofilm gets particular attention: why it hides from grab samples, why a hot water flush alone does not remove its mass, and why a cold system needs stronger controls than a hot one held above 70 °C.

Built around real systems

Two built systems run through every module: a purified water loop at an oral solids site in Mumbai, and a water for injections loop with a pure steam generator at a sterile site in Singapore. The learner follows them from the feed water to the last outlet, through sanitisation schedules, sampling plans, alert levels and a full investigation. Each module ends with a common mistake set against good practice, and a quick check the learner can run at their own site the next day. Two short examples from other sites, from an eye-drop filler to an API plant, show how the same rules apply elsewhere.

Who should take it, and what comes next

The course is for engineers and maintenance staff who run water systems, QC microbiologists and chemists who test water, QA and validation staff, and production supervisors whose way of drawing water at the outlet decides what really goes into the product. Afterwards, learners can walk a loop with its drawing and spot where water could stand still, check that a sampling plan covers every outlet in use, read a trend for both counts and organism names, and judge whether an investigation has reached the products made with the water. A scenario-based exam leads to a Certificate of Completion.