Cleanroom Validation

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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)

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.

Validation of Clean Rooms

Kalibra is a forerunner in clean room validation. For example, Kalibra is the first organisation to have ISO 17025 (RvA) accreditation in the field of clean room validation in accordance with ISO 14644-3. We also have an ISO 17025 accreditation for classifying operating rooms and covering areas in accordance with RL-7 of the VCCN. This makes Kalibra a unique player in the field of classification and validation of rooms. Before validation is performed, a protocol will be drawn up in consultation, by means of which the purpose, method, and acceptance criteria are described. Attention will be paid to the regulations in force for the application of your classified spaces.

For each location, the most important factors that influence the quality of the business process will be examined. This way you can be sure that the validation process is always tailored to the interests of your organisation.
Common clean room measurements include:

  • Particle concentration measurements in accordance with ISO 14644 and GMP Annex 1
  • Static pressure differences
  • Circulation rate, air speed, and uniformity
  • HEPA filter leak test and pressure difference over HEPA filters
  • RL-7 classification for operating rooms and overhead areas
    • Particle concentration measurements
    • Recovery time measurements
    • Measurement protection level
    • Microbiological contamination of air and surfaces
    • Air patterns
    • Temperature
    • Relative air humidity
    • Recovery time
    • Light (lux)Noise (dB(A))

Need a consultation for a validation? Kalibra is happy to provide expert advice on validating your equipment, spaces, and processes.

Frank Kolen