ISO cleanroom validation and GMP cleanroom requalification 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, ISO 14644-1:2015 or GMP Annex 1.
With a tailored cleanroom qualification testing schedule, Angstrom Technology will certify the class or grade of your cleanroom facilities and localised clean air devices, then produce an immediate interim report followed readily by a full report as evidence for auditors.
Cleanroom qualification and testing
Our team will assess your needs to build a custom testing schedule. To determine the most appropriate cleanroom validation tests, we’ll consider factors such as:
- ISO standard or GMP guideline requirements
- Validation frequency requirements, including annual and interim testing
- Your URS, risk assessment, and monitoring plan
For GMP or pharma cleanroom commissioning, validations will have oversight from our regulatory governance team and tests will also depend on which cleanroom lifecycle phase needs qualification, including:
- Installation Qualification (IQ) – meeting user and design requirements
- Operational Qualification (OQ) – operating within the defined conditions
- Performance Qualification (PQ) – in the operational state
Angstrom Technology’s in-house team of experienced technicians is CTCB-i qualified to perform cleanroom qualification testing services. Our technicians have extensive cleanroom validation training and a wide range of qualifications to ensure they are technically competent to test and validate your cleanroom.
From running particle counts and air change testing on a small cleanroom to coordinating a full scope of testing on 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 downtime for your process.
Validation agreements and service contracts
We can build a validation agreement to cover your validation requirements for a single year or multiple years. This can include servicing of HVAC to HTM03-01, as well as servicing of cleanrooms and bespoke clean air equipment such as laminar flow devices and air handling units.
The benefit of a validation 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 also available on Angstrom Technology 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 warranty options
We will work with you to provide the most appropriate level of support, to keep your critical process protected.
ISO cleanroom validation
ISO 14644 is the international suite of standards for cleanrooms and associated controlled environments. Part 1 (ISO 14644-1:2015) details the classification of air cleanliness by particle concentration. ISO 14644-2:2015 recommends that organisations complete risk assessments and monitoring plans to determine the frequency of testing and validation appropriate for their processes. The maximum time interval between validations is six months for ISO class 5 cleanrooms and below, and 12 months for ISO class 6 cleanrooms and above.
GMP cleanroom qualification
Good manufacturing practice (EU GMP) describes the minimum standard a medicines manufacturer must meet in their production processes. EU GMP Annex 1 details the maximum permitted particle concentrations for classification for ‘at rest’ and ‘in operation’ states for sterile manufacturers.
The maximum time interval for requalification of grade A & B areas is 6 months and 12 months for grade C & D areas.
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Our cleanroom validation documentation is detailed and auditable. You will receive an interim report on the day of testing, followed by the full report within 10 working days. Reporting is aligned with ISO standards and GMP guidelines to meet your requirements and those of any nominated regulatory body, (e.g. the MHRA).
You can choose from one of our testing packages, or we can build a custom schedule based on your requirements.
REQUEST A VALIDATION APPOINTMENT