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

 

Our Cleanroom Validation Services

Our Cleanroom Validation Services 

APT Clean Room Testing also carries out Air Change Rates for your facilities, in accordance with the Orange Guide and the current ISO standards. In the event of contamination it is important for customers to know that the air will be changed in accordance with site and regulatory requirements to remove the contamination in an expedient manner. Our proactive testing and clear and concise reportage help our customers and stakeholders quickly identify the performance of their cleanroom facility in this respect.

Clean Room Validation Services

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We can also undertake Airborne Particulate Cleanliness Counts (Particle Counts). These are performed in accordance with each client’s facility classification, whether it is to an ISO or GMP standard. We use state of the latest calibrated Particle Counters that are regularly serviced and calibrated to ensure optimum performance.

HEPA Filter testing is carried out using the industry standard DOP method, whereby each filter is subjected to an upstream aerosol challenge; the downstream side of the filter is scanned with a photometer to identify the presence of any leaks. It is also important to ensure that each filter has been installed correctly and the filter frame and its housing are also thoroughly checked.

Our engineers have lots of experience across numerous industries from automotive to medical and all our data is produced and recorded record in a clear, concise and comprehensive Cleanroom Reports. Our Cleanroom contain all of the relevant information and data as expected by customers and regulatory authorities, including:

  1. Detailed method statements explaining how each validation test is performed
  2. Detailed records of measurements recorded during the validation visit
  3. Copies of calibration certificates for all test equipment used
  4. Original print-outs from particle counters (where relevant)

We undertake the Cleanroom Validation Services:

  • Air Change Rate Calculations (ACR)
  • Air Volume Flow Rates
  • Airborne Particulate Cleanliness Counts
  • 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 Fume Cupboard and LEV Testing

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 Services

Clean Room Testing Services

Clean rooms play critical roles in maintaining contamination free production environments for critical processes. To ensure your cleanroom is working as designed it is essential that a well planned and executed cleanroom testing Services  and certification and maintenance program is undertaken for operation and regulatory compliance. APT cleanroom testing offers clean room testing and clean room certification. APT Clean Room Testing specialise in the testing and validation of all types of clean rooms from the Nano technology to the automotive industries.

Clean Room Commissioning 

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We offer the complete range of performance tests, including non-viable airborne particulate monitoring and HEPA filter testing, through to airflow volume flow measurement and air change rate calculations for non-unidirectional systems. We also offer airflow velocity measurements for unidirectional systems and room differential pressure measurement. Using our latest smoke survey equipment we also offer accurate airflow visualisation testing.  We also offer temperature and humidity monitoring and air tightness testing to check for air leakage paths through the clean room envelope.

Clean Room Validation

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Our primary cleanroom tests include:

  • Non-viable particulate monitoring
  • Airflow volume/velocity profiling
  • Room air exchange rates
  • HEPA filter integrity testing
  • Room pressurisation monitoring
  • Temperature and humidity monitoring

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.

APT Clean Room Testing can undertake all your cleanroom commissioning and validation requirements, from the smallest clean rooms to the largest manufacturing facilities.  If you would like more information on our cleanroom testing services please don’t hesitate to contact Darren directly on 07775623464 or email us at: info@aptcleanroomtesting.co.uk