Testing Cleanroom Environments

Testing Cleanroom Environments

All Cleanroom process environments must remain unfailingly clean, so merely filtering the factory’s air is inadequate. To minimise particle contamination it is important to build separate environments, called cleanrooms. These areas allow particle limits to be maintained at measurable and controllable levels locally.

Testing Cleanroom Environments

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Clean rooms environments achieve these acute cleanliness levels by maximising laminar airflow and minimising particle traps. Laminar airflow is air moving in one direction, which allows particles to be swept away from an area within the cleanroom. Particle traps within a cleanroom environment are areas where particles gather and escape laminar airflow, such as the corners of the rooms and behind machinery and instrumentation, careful cleanroom design and placement of room furniture can minimise these areas.

In efficient cleanrooms HEPA filters installed in the ceiling allow filtered air to pass down toward the floor. The floor tiles have small holes that allow the air to pass under the floor, where air-returns (air ducts) transport the air back to the ceiling HEPA filters. This filtration process can exchange the clean room’s entire volume of air more than thirty times per hour, resulting in a very clean environment while minimising the movement of air particles.

Clean Room Commissioning 

To further reduce contamination within a cleanroom requires personnel to wear protective gowns, hair and beard covers, hoods, overshoes, and gloves. In the cleanest environments, personnel all the aforementioned clothing as cleanroom apparel is extremely important in controlling micro-contamination to contain the particles emitted by people.

We undertake the Following Cleanroom Validation Services:

  • Airborne Particulate Testing
  • Air Change Rate Calculations (ACR)
  • Air Volume Flow Rates
  • Differential Pressure Measurements
  • HEPA Filter Integrity Leak Testing – DOP Method
  • Temperature, Humidity, Light and Noise Level readings
  • Recovery Performance testing
  • Airflow Visualisation tests, supported by a full written report
  • We also provide temperature mapping of rooms and storage facilities, in order to meet customers regulatory and QA requirements.

APT can carry out your Clean Room Testing Requirements

I hope the above information was informative. If you would like some more information in regards to our Cleanroom Testing Service, please don’t hesitate to contact Darren directly on 07775623464 and/or email us at: info@aptcleanroomtesting.co.uk

 

Fume Cupboard Testing Methods

Fume Cupboard Testing Methods

APT Cleanroom Testing offer a wide range of testing services to meet the needs of our clients across all cleanroom industries from automotive to Nano Production. For every test we will issue a comprehensive test report. This will include the fume cupboard identification number, the date of the test, the type of test that has been carried out, the general room conditions at the time of the test, the results of our inspection and of the performance test, and any remedial actions that were needed or are required to meet the required standards.

Fume Cupboard Testing to Clean Rooms

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The type of Fume Cupboard Testing may include:

 Containment testing using tracer gas

We provide a quantitative measure of fume cupboard containment under normal working conditions. We undertake containment testing using tracer gas analyses the escape routes of sulphur hexafluoride (the gas tracer) from within the fume cupboard. This type of testing is particularly recommended for newly installed equipment and following any major repairs as its highlights any weaknesses in the fume cupboard envelope.

Face velocity measurements

We measuring the average rate at which air is drawn through the opening of the fume cupboard, face velocity measurements are the conventional method for measuring fume cupboard performance. This does not measure the containment ability of the fume cupboard which is undertaken using tracer gas.

 APT Clean Room LEV Testing Service

At APT Cleanroom Testing we believe in delivering a quality service in everything that we do. Whether you choose to work with us via an ongoing contract arrangement, which allows us scheduling the testing/servicing or whether you’d prefer to work with us on a job by job basis we always offer a proactive encompassing end to end service. We also offer an “out of hours” service to minimise disruption for our clients.

APT can carry out your Fume Cupboard and LEV Testing

As part of our Cleanroom Testing Service, we also provide particulate testing and HEPA filter testing as well as many other services.

I hope the above information was informative. If you would like some more information in regards to our Fume Cupboard Testing Service and/or LEV Testing Service, please don’t hesitate to contact Darren directly on 07775623464 and/or email us at: info@aptcleanroomtesting.co.uk

The Test Criteria for Fume Cupboards

The Test Criteria for Fume Cupboards

All fume cupboards should be maintained in line with manufactures recommendations and performance thresholds, including expected face velocity and containment values, recommended and confirmed by them at the time of commissioning.

Testing Fume Cupboards

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Sometimes it may be difficult to find the manufacturer’s performance specifications as the units may be old, in which case the best practice velocity guidelines for ducted fume cupboards carrying out standard work with hazardous substances, are that the face velocity should be 0.5m/s ±10% with the sash set to 500mm height, and if face velocities fall below 0.45m/s the unit should be removed from use until remedial work has been completed. If you are using radioactive materials that could result in a gaseous or aerosol release, these may require a higher airflow velocity, usually 0.7 m/s or an average SF6 containment of 0.01ppm, it is essential that these minimum requirements are met.

Fume Cupboard Testing Requirements

When it comes to fume cupboard and LEV testing, the HSE have updated their guidance in the second edition of their publication HSG 258 – ‘controlling airborne contaminants at work: A guide to local exhaust ventilation (LEV)’.

Clean Room Testing and Commissioning 

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While a variety of qualitative and quantitative methods may be employed for LEV testing, HSE guidance for fume cupboard testing states the need to measure face velocity and that any further testing should be carried out in accordance with BS EN 14175.

When it comes to testing recirculating fume cupboards, the fume cupboards must also include particular filter and seal integrity testing and gaseous phase filter capacity testing as outlined in BS 7989:2001.

Prior to the commencement of testing all equipment to be used must be appropriately calibrated and maintained and the performance specifications for the fume cupboard to be tested must be checked to ensure the correct ones are being used. Any visual inspections of the fume cupboard should be carried out in strict accordance with HSG 258 and BS EN 14175-4:2004.

 APT can carry out your Fume Cupboard and LEV Testing

I hope the above information was informative. If you would like some more information in regards to our cleanroom testing service please don’t hesitate to contact Darren directly on 07775623464.

APT Cleanroom Testing provides clients with a reliable and proactive clean room testing service. If you would like to know more about our particulate testing service and/or HEPA filter testing service to cleanrooms, please don’t hesitate to contact us at:  info@aptcleanroomtesting.co.uk

Clean Room Testing

Clean Room Testing

Clean rooms play critical roles in maintaining contamination free production environments for critical processes. To ensure your clean room is working as designed it is essential that a well planned and executed clean room testing and certification and maintenance program is undertaken for operation and regulatory compliance. APT clean room testing offers clean.

A Typical Clean Room 

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We undertake the testing of cleanrooms in accordance with international standards and customer quality specifications. Cleanroom test protocols and report documentation can be customised to customer specifications.

Using our technical knowledge and experience in cleanroom testing coupled with our steadfast commitment to quality and the highest standards of customer service we provide our clients with reliable, accurate and thoroughly documented clean room testing results, ensuring optimal cleanroom performance, documented regulatory and quality compliance, and minimised facility down time as most companies clean rooms are their main critical asset.

Particle Testing to Clean Rooms 

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APT Clean Room Testing is customer driven and we continually try to exceed our customers’ expectations, both in terms of price and service. Our careful attention to detail ensures that our reports and certificates are of the highest quality and customers can be confident that their external calibration and validation requirements have been met. Our commitment to quality is backed up by our UKAS accreditation. Our test engineers are well trained, highly motivated and flexible individuals who ensure constant and consistent delivery of our high standards.

If you have a clean room that requires particulate monitoring or any of the above testing then please get in touch with us as soon as possible as we should be able to offer you an expedient solution for all your cleanroom testing and certification. We can also offer maintenance programmes to ensure your cleanroom is in compliance with the corresponding ISO standards– it’s why we place such emphasis on the process of ‘expert intervention’.

APT has your Clean Room Testing Covered.

I hope the above information was informative. If you would like some more information in regards to our cleanroom testing service please don’t hesitate to contact Darren directly on 07775623464 or email us at: info@aptcleanroomtesting.co.uk.

CLEAN ROOM VALIDATION SERVICES

CLEAN ROOM VALIDATION SERVICES

It is vitally important that cleanroom validation is an essential part of ensuring that cleanroom facilities are operating at the levels of cleanliness required by facility owners, their customers and where required perhaps external regulatory bodies.

However, there are multiple standards for clean room performance; in addition, facility owners can specify variations from the main classes of cleanroom to meet the needs of specific applications.

The Purpose of Clean Room Validation
Cleanroom validation or cleanroom certification can be seen as “passing a cleanroom test”; thus allowing the facility to continue to operate and be productive as designed. In most instances cleanroom validation is really about quality control, for instance:

  1. Preventing external contamination of samples by ensuring reliable test or experimental results.
  2. Ensuring a clean sterile environment for pharmaceutical or food production.
  3. Ensuring a low particulate environment to preventing damage to sensitive electronics.

For many facilities a cleanroom is the top of the critical asset chain; therefore, cleanroom compliance is also business critical factor; not just for profitability but also business reputation which is just as important.

Cleanroom Validation Services

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APT Cleanroom Testing is a specialist clean room services company and we fully understand the importance of not just undertaking the validation testing and commissioning, but in helping facility stakeholders maintain high ongoing levels of cleanliness.

For APT Cleanroom Testing ongoing clean room validation is therefore part of a much wider process of ongoing monitoring, testing and maintenance.

Facility managers have to weigh up the costs of maintaining a higher grade of cleanroom against the costs of having to repair or replace a contaminated product; however they also have to attain the cleanroom ISO standard and regulatory requirements. It is critical that any judgement is carefully made, so that the agreed standards that have been decided sand agreed are rigidly enforced and validated, it’s worth noting that even small drops in quality may lead to an increase in contamination which may affect the bottom line and set experimental programmes/production by back by months.

A Typical Cleanroom

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APT has your Clean Room Validation Testing Covered 

I hope the above information was informative. If you would like some more information in regards to our cleanroom testing service please don’t hesitate to contact Darren directly on 07775623464.

APT Cleanroom Testing provides clients with a reliable and proactive clean room testing service. If you would like to know more about our particulate testing service and/or  HEPA filter testing service to cleanrooms, please don’t hesitate to contact us at:  info@airpressuretesting.net

Changes to ISO 14644-2: 2015 for Clean Room Validation Testing

Changes to ISO 14644-2: 2015 for Clean Room Validation Testing

If you are stakeholder in regards to a clean room facility it is worth noting that Part 2, 14644-2:2015 has also been updated, it is now much more focussed on customers deciding what is standards need to be rehired via risk assessments and monitoring plans.

Clean Room Validation and Testing

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The updated ISO 14644-2:2015 – requires cleanroom stakeholders undertake careful monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration and recommends customers to complete risk assessments and monitoring plans to determine the frequency of testing and validation to their individual cleanroom processes.

The updates standard states the maximum time interval between airborne particle concentration testing of a cleanroom of ISO class 5 and below is 6 months and ISO class 6 and above is 12 months. Although these guides are in place for validating your controlled environment you may need to undertake more frequent testing to comply with the scope of your validation as defined by your process specific risk assessment.

Changes to ISO 14644-2: 2015 for Clean Room Validation Testing

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We undertake a wide range of clean room testing service for all types of industries from the Pharmaceutical through to the automotive industries. Our full range of services includes:

  1. Differential pressure– Here we will be testing to ensure that the air in your clean room always moves from clean to less clean areas, with your clean room having a higher pressure than adjacent less clean areas.
  2. Particulate testing – Classification of air cleanliness by particle concentration. This ensures that your cleanroom continues to perform efficiently and enhance your ongoing business process
  3. HEPA Filter Integrity Testing– Your ventilation system’s high efficiency particulate air (HEPA) filter, and its housing will be tested with DOP (Dispersed Oil Particulate) to ensure their integrity.
  4. Air supply and extract quantities– If your air supply is unidirectional we will measure and record the air velocity, while for non-unidirectional systems we will measure air supply.
  5. Air movement control– Studying the movement of the air within your clean room we will check that there is sufficient air movement to dilute or remove pollutants, preventing any contamination build-up.
  6. Containment leak testing– We will check the construction of your clean room to ensure that no airborne contamination can occur via leaks from higher pressure work areas adjacent to it.

APT Clean Room Testing offers peace of mind from a UKAS accredited test laboratory.

If you have a cleanroom and you need to discuss the changes to ISO 14644-01 & ISO 14644-02, and/or you wish to discuss your cleanroom monitoring and testing validation requirements, please contact Darren Helliwell on 07775623464 or email info@aptcleanroomtesting.co.uk