Discipline
Pharmaceutical
The plant where the product has to be clean as well as correct. Cleanroom grades and the air that holds them, purified water and WFI, clean steam and sterilisation, hygienic piping and surface finish, cleaning validation, and the qualification record that proves all of it.
- Topics
- 6
- Standards covered
- 21
Beginner
No prior knowledge assumed
Cleanrooms — grades, particle counts and the air that holds them
What an ISO 14644 class actually counts, how EU GMP grades A to D map onto it, why a cleanroom is defined at rest and in operation, and why the pressure cascade matters more than the filters.
Pharmaceutical water — purified water, WFI and why the loop never stops
What separates purified water from water for injection, why conductivity and TOC are the two numbers that matter, why the distribution loop runs hot and never stands still, and what a dead leg does to a water system.
Intermediate
Builds on the basics
Clean steam and sterilisation — saturation, F0 and the load you cannot see
Why pure steam is a different utility from plant steam, why air in an autoclave is the thing that ruins a cycle, what F0 actually accumulates, and why depyrogenation and sterilisation are not the same process.
Hygienic piping — tube, surface finish and the weld you cannot see
Why hygienic systems use tube rather than pipe, what a surface finish designation actually controls, why orbital welding and weld logs exist, and how slope, drainability and fitting choice decide whether a system can be cleaned at all.
Cleaning validation — CIP, SIP and proving the residue is gone
What CIP actually does and why its four parameters are what get recorded, how a cleaning limit is set now that health-based exposure limits have replaced the old dose and ppm rules, and why swab recovery decides whether a clean result means anything.
Qualification and validation — DQ, IQ, OQ, PQ and the record that proves it
What each qualification stage actually tests, why the user requirement specification governs everything that follows, where the three-batch convention comes from, and why a deviation handled properly is better evidence than a protocol with no deviations at all.