Cleanroom Validation & Service
Proven compliance. Peace of mind.
Cleanroom validation is provided by conducting a series of tests to qualify if a controlled environment is performing in accordance with process requirements and the applicable regulatory guidelines, such as ISO 14644-1 or GMP Annex 1.
Ongoing validations are not only a requirement of this standard, they also give peace of mind that your investment remains protected and continues to add value to your company and critical processes.
With a tailored cleanroom qualification testing schedule, Connect 2 Cleanrooms will certify the class or grade of your cleanroom facilities and localised clean air devices, then produce an on-time report within 24 hours as evidence for auditors.
We have an in-house team of experienced Validation Technicians, who are CTCB-i qualified to perform cleanroom qualification testing services. With extensive training records, our technicians are proven to be professionally competent in providing the testing services we offer giving you peace of mind.
From running particle counts and air change testing on a small cleanroom, to coordinating a full scope of testing on full suites of cleanrooms within a planned maintenance period - we have the experience and expertise to manage your cleanroom validation effectively.
Our planning team will coordinate with you to ensure this critical service is completed efficiently, with minimal down-time for your process.
Validation frequency & scope
To ensure that your cleanroom continues to perform efficiently and enhance your business process, it needs to be validated at process-dependent intervals to prove it complies with ISO 14644-1 - Classification of air cleanliness by particle concentration.
ISO 14644-2 - Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration, recommends customers to complete risk assessments and monitoring plans to determine the frequency of testing and validation to their individual processes.
It states the suggested maximum time interval between airborne particle concentration testing of a cleanroom of ISO class 5 and below is 6 months and ISO class 6 and above is 12 months. However this should be assessed to ensure it is in-line with your monitoring plan and risk assessment, which is required to be reviewed on a regular basis.
We offer options to configure your scope to ISO 14644, including additional parameters of your internal risk assessment and monitoring plan. Tests to consider:
- Filter integrity testing according to ISO 14644-3
- Airborne particle counts
- Airflow readings
- Air changes and volumes
- Smoke visualisation testing according to ISO 14644-3
- Containment leak testing according to ISO 14644-3
- Recovery rate testing according to ISO 14644-3
- Air pressure differentials according to 14644-1
- Comfort tests such as lux, noise levels, temperature and RH readings
The format of the report is in line with the ISO standards, so should meet your requirements and those of any nominated regulatory body.
We can build a cleanroom maintenance and validation agreement to cover your requirements for a designated time period, i.e. 3 or 5 years. The agreement can also include servicing of clean air equipment such as laminar flow units.
The benefit of a service agreement is that we can use year-on-year data to make recommendations and generate a cycle of continuous improvement. It also helps you budget for critical spares and planned maintenance.
Service contracts are available on Connect 2 Cleanrooms’ facilities to cover:
- Annual and interim cleanroom validation
- 24/7 telephone support from our CTCB-I qualified team
- Call out visit with an agreed response time
- Extended all-in warranty
We will work with you to provide the most appropriate level of support, to keep your critical process protected.
Does your room require validation?
Request a quotation based on your specific situation.