Cleanrooms command adherence to exacting performance requirements. Our certification process ensures that the facility conforms to the appropriate international standards and to our client’s design specifications.
- Installed filter integrity test
- Containment leak test
- Airflow velocity
- Airborne particle counts
- Temperature & humidity, noise & light levels
- Pressure cascade monitoring
The above tests would also be undertaken if re-certification is required following facility or tooling changes.
Microbial Air Sampling and Analysis
Microbial sampling is carried out to demonstrate a controlled process and facility.
In turbulent flow rooms there should be no stagnant airflow in any part of the rooms. Regular testing using settle and contact plates ensures that the airflow remains unobstructed and controls microbial contamination in the rooms.
Monitoring ensures surfaces are cleaned correctly and that the tooling is not harbouring and depositing colony forming units (cfu`s) on the product. This demonstrates that the cleanrooms under test are in control and that product is not exposed to uncontrolled levels of bacteria and moulds.
Filter replacement and performance verification, including Safe Changes
During the certification visits all HEPA filters are checked with an aerosol photometer for seal and filter face integrity using Shell Ondina El oil smoke as the challenge in accordance with BS/EN/ISO 14644-3:2005 Annex B6.
Where failures are identified or when filters need to be routinely replaced, CPT Services can specify and source replacement filters.
The fitting of filters is critical to the controlled environment and filter changes are carried out by fully trained operatives.
After installation, filters are checked in accordance with BS/EN/ISO 14644-3 Annex B6.
Third party certification of newly built facilities, providing impartial validation reports to both the client and the cleanroom constructor.
Periodic Monitoring Visits
Interim visits are carried out in accordance with clients’ individual requirements, when some or all of the annual certification testing will be undertaken.
Hospital HTM 03-01 Verification
Services include the verification of conventional operating theatres and verification of Ultra Clean Zone (UCV) surgical canopies together with other hospital facilities.
Airflow Visualisation Testing
Airflow in cleanrooms can either help or hinder the process. CPT Services Ltd will carry out airflow visualisation around tooling and fixtures, identify turbulence and reduce cross contamination.
Visualisation is carried out using the same oil based smoke used for testing filter integrity or a Liquid Nitrogen / DI water “Fogger” can be used. This equipment leaves no contamination traces and can be used with the cleanroom in full operation.
Recovery Performance Testing
Shell Ondina El oil smoke is added to the supply air to increase the particle count levels. Readings are taken at 1 minute intervals until the “At Rest” particle level specification is met for the Class of room under test.
The time is calculated between the start time and the time when the room meets the recovery criteria detailed in BS/EN/ISO 14644-3:2005.
Clean Process Design
The following services with regard to clean process design are offered:
Project management of clean process design incorporating the following elements:
- Advice on product storage, transportation and process tooling, including automation.
- Materials cleanroom compatibility, including ESD systems performance and selection
- Choice of garmenting and consumables.
- Control and maintenance procedures to ensure ongoing compliance.
Calibration of magnehelic gauges
Magnehelic gauges will be calibrated against our calibrated micromanometers to ensure an accurate display of the facility pressure regime.
Facility airflow balancing
Setup the amount of airflow that is distributed to each air diffuser or HEPA filter to balance room pressure cascade.
We commission and certify the following:
- Fume Cupboards
- Laminar Flow Benches & Safety Cabinets
- Local Exhaust Ventilation (LEV)
Education and Training covering all aspects of Cleanroom Practices
Controlled environment education and training is an essential part of behavioural conformance, positively influencing product yields, customer expectations and regulatory compliance. It is a key element in ensuring cleanroom and support staff understand what must be done to ensure the above goals are met.
We have several courses on offer, ranging from operator training to managers and supervisor’s courses. Each course can be specifically tailored to the client’s needs.
Short courses on specific contamination control topics are also offered. Examples include remedial activity resulting from adverse audit findings or defect root cause investigations.
Facility cleaning : The build-up of particulate contamination is inevitable in any class of cleanroom. We will clean your facility using alcohol based cleaning agents and approved tools. Operatives are fully conversant with cleanroom protocols and disciplines and the service can be carried out in a shutdown period to suit your manufacturing needs.
Tooling Surveys: As a critical part of your manufacturing process, the tooling must be capable of meeting the contamination classification of the room. We will carry out a survey of the tooling, identifying particle generators and recommend methods of controlling particle levels in the product areas. Static generators can also be identified.
Ductwork Installation and Modifications: All types of ductwork (PVCu, galvanised spiral and square, and stainless steel) can be pre- fabricated and installed. Repairs and modifications to existing ductwork are carried out by our skilled engineers.
Disaster Recovery: In the event of fire or flood damage to a cleanroom and equipment, CPT offers a service to evaluate the damage caused, and the effect on the controlled environment. Solutions will be proposed to isolate and contain the damaged areas and enable the manufacturing processes to restart within the controlled environment parameters.