Sterilization Processes PDF

Validation Of Sterilization Processes

Sterilization Process Challenge

Sterilization processes require periodic validation to demonstrate that they are working correctly and functioning within established norms. 

Such validation entails detailed measuring of various physical parameters throughout the sterilization process and assessing and comparing these results to relevant international standards

To ensure end-users, which include hospitals, clinics and care institutions, the seal of approval must be issued by a qualified entity with worldwide recognition. 

Bureau Veritas is a leading partner of choice with a 15-year track record of performing global sterilization process validation.

Solution for Sterilization Processes

Bureau Veritas validates the following sterilization processes:

  • Steam sterilizers (EN285, NEN-EN-ISO17665-1, prEN13060)

  • Hot air sterilizers, including infrared sterilisation (NEN-EN-ISO11138, R6111)

  • Ethylene oxide sterilizers (NEN-EN-ISO11135-1)

Under its EN45004 accreditation, Bureau Veritas can also perform validations in accordance with the end-user’s Standard Operating Procedures (SOPs).


WHY CHOOSE BUREAU VERITAS?

Recognition 

Founded in 1828, Bureau Veritas is the worldwide leader in QHSE and Social Responsibility services. Certified to ISO 9001 for all of its worldwide activities, Bureau Veritas actively works with professional authorities, helping to develop international standards and regulations.

Network

With a network of 930 offices and laboratories and over 48,000 employees in more than 140 countries, Bureau Veritas serves 400,000 customers across many different industries worldwide.

Expertise

All measurements and samplings are performed by experienced technicians and in line with the latest standards and procedures.

FAQ

  • Which equipment need to be validated?

    • Central sterile supply unit

    • Autoclaves and sterilizers

    • Medium and small sterilization equipment

    • ICU* equipment

    • Washing machines with required temperature cycle

     

    * ICU - International Components for Unicode

  • How often do I need to perform a validation?

    Yearly is the minimum recommended timeframe. We also advise to perform a validation after major changes on the equipment or sterilization protocol.

  • Who can perform a validation?

    A third party can guarantee total independence from manufacturer to user. This inspection should be performed under the 17020 accreditation.


Contact us

Bureau Veritas

Phone: +33 1 55 24 70 00

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