ISO cleanroom validation and GMP qualification/
requalification
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 EU 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.
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 regulatory requirements
- Validation frequency considering guidance and regulatory requirements
- Your monitoring plan, for GMP facilities this should include risk management and the requirements of your Contamination Control Strategy (CCS)
For GMP initial qualification, the validation team will have oversight from our Regulatory Governance department. Testing will include:
- Installation Qualification (IQ) – meeting user and design requirements
- Operational Qualification (OQ) – operating within the defined conditions
- Performance Qualification (PQ) – in the operational state
GMP requalification also has Regulatory Governance oversight.
Angstrom Technology’s in-house team of experienced technicians are CTCB-i professionally qualified to perform cleanroom qualification testing services. Our technicians have extensive cleanroom validation experience 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.
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 ATL’s facilities to cover:
- Annual and interim cleanroom validation
- 24/7 telephone support from our CTCB-I professionally 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 and meet any regulatory requirements.
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. ISO 14644-3:2019 describes the test methods used in validation/qualification.
GMP cleanroom qualification
Angstrom’s in-house team of expert cleanroom engineers provides specialist energy efficiency consultancy for both existing cleanroom facilities and new builds during design stage. We conduct detailed assessments of current systems and utilise advanced modelling to accurately predict energy consumption and running costs for proposed cleanroom environments.
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.
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. MHRA.
You can choose from one of our testing packages, or we can build a custom schedule based on your requirements.
