Secure Environment

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
  • Versatility
  • Reconfiguration
  • Airflow Control
  • Inexpensive Modifications

Cleanroom validation

Executing cleanroom validation provides you with ISO compliance and a secure environment. This is vital to ensure your process and/or product meets the standards required and therefore vital to the core of your business. A completed validation should be to International Standard ISO 14644 and be performed by a CTCB-I qualified engineer. At Total Clean Air we carry out all our validations to BS 14644 and all our engineers hold the CTCB-1 qualification to give you piece of mind that it is being done correctly.

During the validation we will carry out various performance tests. These tests look at how the cleanroom functions and how it is being managed, also whether it meets the required ISO standard and prove it complies with ISO 14644-1:2015 – Classification of air cleanliness by particle concentration. The tests will cover the areas detailed below but are not limited to these. We can work with you to discuss any other tests you may wish to have carried out.

  • Air pressure difference—Can the cleanroom system maintain the specified pressure differential between the installation and its surroundings?
  • Airflow —This determines what supply airflow volume flow rate is in a non-unidirectional cleanroom and what the air velocity distribution is in a unidirectional cleanroom
  • Airflow direction and visualisation —Confirms the airflow direction, airflow pattern, or both in regard to specifications.
  • Recovery—Can the installation ensure return to a specified cleanliness level within a finite time, after being exposed briefly to a source of airborne particulate challenge?
  • Temperature and humidity—Can the cleanroom air-handling system maintain specified air temperature and moisture levels?
  • Installed filter system leakage—Is the final high-efficiency air filter system properly installed and do the filters required replacement?
  • Containment leak—This detects intrusion of unfiltered air into the cleanroom from outside the cleanroom. Are the filters functioning correctly?
  • Electrostatic and ion generator—To evaluate electrostatic voltage levels on objects, static-dissipative properties of materials, and performance of ion generators.
  • Particle deposition—This measures the surface concentration, quantity, or effects of particles deposited upon surfaces at any orientation.
  • Segregation—To assess the separation effectiveness achieved by a specific airflow.

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
  • Validation

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.

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.

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.

Phillip Godden

Phillip Godden is the Founder & Chief/Executive Officer at Total Clean Air.

Working Hours

  • Monday 08:00 - 19:30
  • Tuesday 08:00 - 19:30
  • Wednesday 08:00 - 19:30
  • Thursday 08:00 - 19:30
  • Friday 08:00 - 19:30