For a clean room to be considered a secure environment relevant for the process or product carried out within, it must satisfy certain standards. The main standard used for this is the BS ISO 14644 “Cleanrooms and associated controlled environments”, along with internal risk assessments and monitoring plans.
A cleanroom will have a cleanliness level that is quantified by the amount of particles of a particular size measured at every cubic meter. To confirm that your cleanroom is a secure environment, it is essential to carry out a cleanroom validation following installation and at regular intervals determined by the ISO classification of the cleanroom; the requirements of the facility and the process being carried out within the cleanroom. ISO 14644-2:2015 – “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.
Modular Cleanroom Benefits
- Modular Construction
- Quick Assembly Time
- Airflow Control
- Inexpensive Modifications
Cleanroom Design, Build & Validation
- Budgeting and planning
- Engineering, design & layout
- Airflow and filtration design
- Construction and Installation
- Full Certification of our product
- Industry-specific equipment installation
Maintaining the integrity of a secure environment to ensure continued effective performance of a cleanroom will require validations to be performed at process-dependent intervals. ISO 14644-2:2015 – “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 does state however the maximum time interval between airborne particle concentration testing of a cleanroom of ISO class 5 and below is six months and ISO class 6 and above is 12 months.
|Test Parameter||Class||Maximum Time Interval|
|Airborne particle concentrations||= ISO Class 5||6 months|
|Schedule of additional tests||>ISO Class 5||12 months|
|Airflow velocities in unidirectional airflow||All classes>||6 months|
|Airflow volume supply in non-unidirectional airflow||All classes||12 months|
|Pressure differentials||All classes||Continuously monitored|
At Total Clean Air we can discuss the requirements of the cleanroom and advise and work with you on a validation strategy that enables continued compliance to ISO 14644-1:2015 – Classification of air cleanliness by particle concentration.
Modular Cleanroom Services
- Design & Build
- Free Site Survey
- Free Design Service
- Cleanroom Planning
- Construction and Installation
- CNC Engineered
- Training & Support
- Discounted Service Contracts
- Remedial Works
- Panel Repairs
- BMS Management
- Cleanroom Certification
- Differential Pressure Qualification
- Servicing Testing Validation
- Smoke Testing
- DOP Testing
DOP testing to Ensure Secure Environment in a Cleanroom
It is vital that the HEPA or ULPA filters within the cleanroom, be it part of the cleanroom or within the equipment within the cleanroom are functioning correctly. In order to ascertain this filter integrity testing or Dispersed Oil Particulate (DOP) testing is an assessment executed to determine integrity and performance of an installed Ultra Low Penetration Air (ULPA) filter or a High Efficiency Particulate Air (HEPA) filter. As these HEPA or ULPA filters are prone to damage it is paramount that this DOP test is not only carried out at regular intervals, but also when equipment is moved.
Using a cloud of dispersed oil particulate as an aerosol, DOP testing involves releasing a high concentration of the aerosol into the airstream, upstream of the filter. The filter face is then scanned using a photometer to measure the concentration of particles which have made their way through the filter. DOP filter testing provides assurances for all parts of the filter, including the seals and the housing of the filter.
Involving highly specific and technical guidelines to ensure consistent testing, as well as being a part of your regulatory obligations, the DOP testing for your specialist ventilation system should be carried out by professionally qualified engineers to avoid costly mistakes. We at Total Clean Air carry out all our DOP testing to BS ISO 14644-3: Test Methods B.6.2 Procedures for installed filter system leakage scan test with an aerosol photometer, using qualified, experienced engineers.
- ISO 4-9
- ISO 14644
- Low Power Consumption
- Environmentally Friendly
- HEPA Filters
- Air Filtration
- Fan Filter Units
- Cleanroom Ceiling System
- Temperature Control
- Access Control
- Inter Lock Door Systems
- Air Showers
- Unidirectional Airflow
- Desiccator Cabinets
- Horizontal Flow Wall Modules
- Horizontal Laminar Flow Clean Benches
- Laminar flow cabinets
- Laminar Flow Canopy
Planning and designing a Secure Environment
Various advancements in cleanroom technology currently exist and are available to reduce contamination risk and improve process control in an active cleanroom environment. We can provide you with modular cleanrooms that convert existing facilities into classified, smart and secure environments.
By collaborating with us during the design phase, our team of specialists can offer you the most suitable combination of parameters to guarantee best results and optimal security. Technologies such as CFD airflow modelling and point cloud surveys are just some of what we use to plan and ensure performance with definite accuracy.