Requirements on Validation of Sterilisation Procedures according to ISO 17665-1

The qualification of a steriliser and the validation of sterilisation procedures are essential GMP requirements in the manufacture of sterile medicinal products. You can find requirements about these topics in the pharmacopeia and in the Annex 1 of the EU GMP Guide. However, there are no further executive regulations.

EN ISO 17655-1 presents the state of technology regarding moist heat sterilisation procedures for medical devices. This standard succeeds the EN 554 (58946-6) standard and explicitly also applies to other health care products as medical devices. These can be medicinal products too.

The broad document is composed of 51 pages, divided in 12 chapters, 6 appendixes and a reference list. The first pages are filled with detailed definitions, an introduction and the scope and normative references are set. The content gets interesting with the sixth chapter on "Characterisation of procedures and equipment" which defines requirements on specifications of sterilisation procedures and on adequate equipment. After Chapter 7 and 8 on "Product and Procedures definitions", Chapter 9 deals with Validation over 3.5 pages. Here, reference is continually made to Chapter 6 "Characterisation of procedures and equipment". Beside a general part, following sub-chapters are treated: IQ, OQ, PQ a well known terminology in the pharmaceutical environment. The sub-chapter "Review and Acceptance of Validation" finally ends the chapter. In the following chapters, the requirements on "Routine Monitoring" (Chapter 10) and "Batch Release" (Chapter 11) are presented. The "Maintenance of Procedure Effectiveness" (Chapter 12) also covers the topics of Re-calibration, Re-Qualification and Re-Validation Aspects. Examples of "Changes" are to find at the end of this chapter. Six appendixes complete the document (among other thing about Overkill-procedure and operating cycles during moist heat sterilisation) as well as further readings.

Conclusion: the GMP environment provides few concrete guidelines on Validation of Steam Sterilisation. Nevertheless, you can find some help to implement these requirements in the ISO standard. 

You can purchase the standard at Beuth Verlag (

Sven Pommeranz 
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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