[ EQUIPMENT & PROCESS LIBRARY ]

How GxP equipment works, and how it is assured

20 equipment families explained end to end: what each one does, its components, the instruments that watch it, the parameters that matter and in what context, its controls and failure modes, the evidence that assures it, and the sources every statement rests on.

How to use this library

Narrow by area or search for the equipment you work with; each page runs from what it does to the evidence that assures it and the sources every statement rests on.

An equipment family page teaches how a kind of equipment works and how it is assured. It is not a qualification of any site’s equipment, sets no universal limits, and was checked by SPEQ against the sources it lists, not by an independent engineer.

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20 equipment families

Site order

E01Cleanroom HVAC and pressure cascadeThe air system that keeps each cleanroom grade clean: filtered supply, pressure differences between grades, airflow patterns, and the qualification and requalification that show it works.Cleanrooms and air

E01HEPA filtration and integrity testingThe final air filters that make cleanroom air clean, and the installed leak test that shows each one, and its seal, is still intact.Cleanrooms and air

E03Clean (pure) steam systemThe generator and distribution that supply steam clean enough to sterilise product-contact surfaces, and the tests that show its quality at the point of use.Water, steam and gases

E04Compressed air and process gasesThe air and gases that touch the product, its containers or its equipment: their specification, the sterilising filter at the point of use, and the checks that they stay clean.Water, steam and gases

E02Purified water and WFI systemThe plant that makes pharmaceutical water and the loop that keeps it fit for use at every outlet: generation, storage, circulation, sanitisation and monitoring.Water, steam and gases

E08Autoclave (moist heat steriliser)The chamber that sterilises loads with saturated steam or superheated water, and the validation, daily and weekly tests and cycle records that show each run did what it was validated to do.Sterilization and depyrogenation

E08Depyrogenation tunnel and dry heat ovenThe continuous tunnel or batch oven that sterilises and depyrogenates glass with hot, HEPA-filtered air, validated by endotoxin reduction as well as heat.Sterilization and depyrogenation

E08Sterilising filter assembly and integrity testerThe 0.22 µm filter train that sterilises a liquid that cannot be terminally sterilised, and the integrity tests before and after use that show the filter stayed intact.Sterilization and depyrogenation

E09Aseptic isolator and RABSThe enclosures that keep people out of the grade A zone where sterile product is exposed: how isolators and RABS differ, what they are built from, how they are controlled and what proves they work.Aseptic processing