Cleanroom Validation

Are you looking for an expert for clean room validation? Kalibra can check whether your low-dust (sterile) rooms and operating rooms comply with national and international standards and guidelines. We check whether your rooms meet all criteria and make recommendations to meet the applicable quality standards.

Why clean room validation?

The facility you currently use has been designed and realised with the utmost care. Obviously, before you start using the clean room, you want to have demonstrated that it meets the requirements. By having the ‘right’ measurements conducted, you will receive written proof that the clean room is suitable for its intended purpose.
Depending on the industry, the applicable guidelines, and the type of room, the clean room will have to be periodically validated. You can also contact Kalibra for additional advice related to your situation.

Guidelines for Clean Room Validation

Clean rooms are used in many different fields for research, production, or operations. Each field has to deal with different supervising bodies and applicable regulations, which is why it is important to carefully coordinate the exact clean room validation to be performed.
Standards and guidelines that apply to clean room validations we perform include:

• ISO 14644
• ISO 14698GMP Annex 1
• WIP guideline – Air treatment in ORs and overhead areas for operating department class 1
• VCCN guideline 7 – Testing and classification of ORs and overhead areas
• VCCN guideline 8 – Monitoring of ORs in use
• VCCN guideline 11 – Central Sterilisation Department (CSA)
• HACCP

Based on the guidelines that apply to your facility, we will draw up a validation protocol. This customer-specific protocol is submitted for approval before any measurements are taken.