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

clean room header.indd

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

 

The Evolution of Cleanrooms

The Evolution of Cleanrooms

Cleanrooms come in all shapes and sizes from small laboratories through to large manufacturing buildings. Cleanrooms are used  for a variety of industries such as pharmaceutical production, scientific research, software engineering and manufacturing and aerospace engineering .

Though the cleanliness standards may have changed throughout the years, their purpose has always remained the same. Cleanrooms will continue to evolve as more and more research is conducted and air filtration mechanics and room envelope construction continues to improve.

Cleanrom-Testing-on-data-centre

Six things you didn’t know about cleanrooms:

  1. More and more food industries are using cleanrooms to manufacture products that rely on high sanitation standards, thus improving the quality of their products.
  2. Cleanrooms are rated by their class, which is dependent on the number of particles found in the room at any given time.
  3. Did you know that a motionless person standing in a cleanroom still emits more than 100,000 particles per minute? That’s why it essential that the correct clothing is worn at all times.
  4. The top four things that you need to wear in a cleanroom should be a cap, cover/apron, mask, and gloves.
  5. NASA relies on cleanrooms to continue growth for the space program as well
  6. There are many different types of contamination that can contribute to product failure and inaccurate testing and results, such as micro-organisms, inorganic materials, and air particles.

I hope this information helps to provide you with everything you need while working in a cleanroom; however if you would like some more information please don’t hesitate to contact me directly on 07775623464.

Particulate-Testing-Cleanrooms

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

The Importance of Cleanroom Particle Testing

The Importance of Cleanroom Particle Testing

Clean room facilities such as Semiconductor and pharmaceutical manufacturers are examples of environments that require extensive and detailed air monitoring and periodic certification.  An accurate air monitoring and testing system is the only method for these clean room facilities to maintain that level of cleanliness needed during environmentally sensitive production.

In Jan 2016, ISO introduced an update to standards ISO 14644-1:2015 – Classification of air cleanliness by particle concentration and ISO 14644-2:2015 and monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration.

APT Cleanroom Testing have received many questions in regards to what impact the updated standard has on validation and testing frequency. To try and help our clients we have tried to answer those questions here.

It is essential that your undertake clean room particle testing to prove it complies with ISO 14644-1:2015 – Classification of air cleanliness by particle concentration. This ensures that your cleanroom continues to perform efficiently and enhance your ongoing business process.

Clean Room Particle Testing 

Cleanroom-Particle-Testing

Within 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 cleanroom processes.

It states the maximum time interval between airborne particle concentration testing for  cleanrooms of ISO class 5 and below at six months and ISO class 6 and above at 12 months.

Cleanroom Particle Testing Software 

cleanroom-testing

Using our vast technical knowledge we provide our clients with reliable and proactive clean room testing service. We ensure that we provide accurate and thoroughly document clean room testing results, ensuring optimal cleanroom performance and minimised facility down time.

If you would like to know more about our particulate testing service to cleanrooms or our full clean room testing services, please don’t hesitate to contact us at:  info@airpressuretesting.net  or call Darren direct on 07775623464.

Particulate Testing to Cleanrooms

Particulate Testing to Cleanrooms

Clean room environments such as pharmaceutical and Semiconductor and manufacturers are examples of facilities that require demanding ongoing air monitoring and periodic certification.  An accurate air monitoring and testing system is the only method for these clean room facilities to maintain that level of cleanliness needed during environmentally sensitive production. Particle counters can activate alarms when contamination poses immediate threats to manufacturing processes thus warning the end user of potential risk from contamination.  Also, these cleanroom particle counters can document emerging contamination trends and weak spots within the process to guide cleaning personnel in maintaining air quality in their critical environments.

Cleanroom Testing with a  Handheld Particle Counter

Particulate-Testing-Cleanrooms

As the manufacturing becomes more efficient and refined i.e. more products are produced in the same space during the same amount of time, the greater potential monetary loss in the event of contamination in a clean-room environment. The greatest threat used to be the human component of the process. In a mini-environment, numerous sources of contamination can exist including fan filter failure, excess contamination build up or mini-environment integrity failure. As your main critical asset you cannot afford your cleanroom to go off line, that is where clean room testing comes into play.

Particulate Testing on Data Centres 

Cleanrom-Testing-on-data-centre

In all these instances the only way to prevent losses is to catch a contamination event as it happens via particulate testing.  As production evolves, so must we monitor and evolve with it. To keep up with manufacturing efficiencies, we can check the particulate counts using the latest equipment to accurately and continuously monitor several locations within each mini-environment.  To remedy clean room contamination, a highly sensitive handheld particle counter can be used to locate the source of particle emissions. We can also carry out the periodic particulate testing and forward the necessary certification.

Using our vast technical knowledge we provide our clients with reliable and proactive clean room testing service. We ensure that we provide accurate and thoroughly document clean room testing results, ensuring optimal cleanroom performance and minimised facility down time.

If you would like to know more about our particulate testing service to cleanrooms or our full clean room testing services, please don’t hesitate to contact us at:  info@airpressuretesting.net  or call Darren direct on 07775623464.

 

How often should I undertake Cleanroom Particle Testing

How often should I undertake Cleanroom Particle Testing 

In January 2016, ISO introduced an update to standards ISO 14644-1:2015 – Classification of air cleanliness by particle concentration and ISO 14644-2:2015 and Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration.

Cleanroom-Particle-Testing

APT Cleanroom Testing have received many questions in regards to what impact the updated standard has on validation and testing frequency. To try and help our clients we have tried to answer those questions here.

It is essential that your undertake clean room particle testing to prove it complies with ISO 14644-1:2015 – Classification of air cleanliness by particle concentration. This ensures that your cleanroom continues to perform efficiently and enhance your ongoing business process,

Within 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 cleanroom processes.

clean-room-testing

It states the maximum time interval between airborne particle concentration testing for  cleanrooms of ISO class 5 and below at six months and ISO class 6 and above at 12 months. Here is a quick table showing this in more details.

Test Parameter Class Maximum Time Interval
Airborne particle concentration ISO Class 5 and below     6 months
ISO Class 5 and above

 

    12 months
Schedule of additional tests
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

Using our vast technical knowledge along with our commitment to quality we provide our clients with reliable and proactive clean room testing service. We ensure that we provide accurate and thoroughly document clean room testing results, ensuring optimal cleanroom performance, documented regulatory and quality compliance, and minimised facility down time.

If you would like more information on our clean room testing please contact APT Cleanroom Services at info@airpressuretesting.net or call Darren direct on 07775623464.

What is Clean Room Particulate Testing?

What is Clean Room Particulate Testing?

Clean room facilities such as Semiconductor and pharmaceutical manufacturers are examples of environments that require demanding ongoing air monitoring and periodic certification.  An accurate air monitoring and testing system is the only method for these clean room facilities to maintain that level of cleanliness needed during environmentally sensitive production. Particle counters can activate alarms when contamination poses immediate threats to manufacturing processes thus warning the end user of potential risk from contamination.  Also, these cleanroom particle counters can document emerging contamination trends and weak spots within the process to guide cleaning personnel in maintaining air quality in their critical environments.

Cleanroom-Particle-Testing

As the manufacturing process becomes more efficient and refined, along with the onset of Nano technology with more products produced in the same space during the same amount of time, the greater potential monetary loss in the event of contamination in a clean-room environment. The greatest threat used to be the human component of the process. In a mini-environment, numerous sources of contamination can exist including fan filter failure, excess contamination build up or mini-environment integrity failure.

In all these instances the only way to prevent losses is to catch a contamination event as it happens.  As production evolves, so must monitor evolve with it. To keep up with manufacturing efficiency, we can check the particulate counts using the latest equipment to accurately and continuously monitor several locations within each mini-environment.  To remedy clean room contamination, a highly sensitive handheld particle counter can be used to locate the source of particle emissions. We can also carry out the periodic particulate testing and forward the necessary certification.

cleanroom-testing

Using our vast technical knowledge we provide our clients with reliable and proactive clean room testing service. We ensure that we provide accurate and thoroughly document clean room testing results, ensuring optimal cleanroom performance and minimised facility down time.

If you would like to know more about our cleanroom testing service, please don’t hesitate to contact us on info@airpressuretesting.net or call Darren direct on 07775623464.

How is a DOP HEPA Filter Test Carried Out?

How is a DOP HEPA Filter Test Carried Out?

HEPA Filter testing is carried out using the following procedure.

Our engineers carry out an inspection of the air supply system to identify a smoke injection point; and a safe means of injection ascertained. If it’s found that pre and secondary filters need to be removed, power to the air handing unit must be isolated before the filter removal. If the DOP is to be injected downstream of the fan unit or in a positive pressure section of duct-work a blower pump will be set up adjacent to the injection point. Thereafter, an aerosol generator will be set up adjacent to the blower pump and power up the generator to warm up. If extension leads are required, we will ensure all cables are secured as not to present a tripping hazard.

hepa-filter-integrity-testing

Then an aerosol photometer will be set up in accordance with the filter manufacturer’s instructions and attached to sample points; this will be fitted upstream of each HEPA filter under test. Whilst working in pairs our engineer operating the photometer will maintain regular communication with the support engineer controlling the smoke generator by means of site radio and/or mobile phones.

Using a photometer instrument, our engineer will measure upstream concentration of aerosol, calibrating as required. The DOP may need to be increased or decreased. The penetration of aerosol will then be measured using a photometer, scanning the filter face with measured overlapping strokes at a speed no greater than 5cm/s.  The ISO 14644 Part 3 standard permits a maximum downstream limit of 0.01% penetration. Filter differential pressures and airflow volume will be measured using a micro manometer and an anemometer at suitable positions.

DOP HEPA Filter Test

Using our vast technical knowledge along with our steadfast commitment to quality we provide our clients with reliable and proactive clean room testing service. We ensure that we provide accurate and thoroughly document clean room testing results, ensuring optimal cleanroom performance, documented regulatory and quality compliance, and minimised facility down time.

If you would like to know more about our cleanroom testing service please don’t hesitate to contact us on info@airpressuretesting.net or call Darren direct on 07775623464.

What is DOP Filter Testing?

What is DOP Filter Testing?

We often get asked what is DOP (dispersed oil particulate) Filter Testing?. In most specialist clean room ventilation systems, there will be a high efficiency particulate air (HEPA) filter. This works to remove fine powder and dust from the environment, providing particulate free, clean air in its place. A DOP HEPA test is used to determine whether these filters are performing to the standards deemed acceptable by your regulatory bodies, keeping your operations running cleanly and smoothly.

DOP HEPA Filter Test

DOP testing involves releasing a cloud of dispersed oil particulate as an aerosol into the airstream, upstream of the filter. Measurements can then be taken to ensure that no seepage has occurred, either the filter casing/housing or through the filter itself.

Hepa Filter integrity testing provides assurances for all parts of the filter, including the seals, the housing of the filter, and the joints onto the duct work itself. During the Hepa Filter test, a check is also made to ensure that all of the air within the clean room is passing successfully through the filter, ensuring  there is minimal contamination build up due to dead spots etc.

HEPA Filter Integrity Test

As well as being a part of your regulatory obligations, the HEPA filter testing for your specialist ventilation system should be carried out by qualified engineers to avoid costly mistakes. We are fully trained using the latest equipment to carry out your DOP filter test.  Also, due to our air leakage experience and construction design experience we can quickly identify any potential air leakage paths as part of your clean room testing programme.

DOP HEPA Filter Testing Services from APT Cleanroom Testing.

We provide accurate and thoroughly document clean room testing results, ensuring optimal cleanroom performance and quality compliance, and minimised facility down time.

If you would like to know more about our cleanroom testing service please don’t hesitate to contact us on info@airpressuretesting.net or call Darren direct on 07775623464.

Clean Room Monitoring

Clean Room Monitoring

Important environmental measurements, like airborne viable particle measurements and testing, assist with keeping processes in control and with helping to find the root cause of unwanted events to monitor cleanrooms for viable particles and other potential contaminants to ensure a clean environment is maintained at all times.

Following the clean room testing or validation service, we will present you with clear, easy to follow reports that can be compiled, quality checked and issued to you while still on site, minimising the down time of your operations.

clean-room-testing

We are customer driven and 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.

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.

Cleanroom-Particle-Testing

If you have a clean room that requires particulate testing monitoring or Hepa Filter Integrity 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’.

If you have a clean room that requires particulate monitoring and/or Hepa Filter Integrity 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.

Please contact us at: info@airpressuretesting.net  or phone Darren directly on: 07775623464.

 

Cleanroom Testing

Cleanroom Testing

Cleanrooms 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 and certification and maintenance program is undertaken for operation and regulatory compliance.

cleanroom-testing

In Pharmaceutical, Biotech, and Medical Device cleanrooms, it is imperative that companies know if any airborne contaminants put products at risk.  It is also very important to understand what the contaminants are, and their origin.  Important environmental measurements, like airborne viable particle measurements, assist with keeping processes in control and with helping to find the root cause of unwanted events to monitor cleanrooms for viable particles and other potential contaminants to ensure a clean environment is maintained at all times.

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.

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.

Cleanroom-Particle-Testing

Ensuring that you fully understand our process and your results, following any clean room testing or validation service, we will present you with clear, easy to follow reports that can be compiled, quality checked and issued to you while still on site, minimising the down time of your operations.

If you have a clean room that requires particulate monitoring and/or Hepa Filter Integrity 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.

Please contact us at: info@airpressuretesting.net  or phone Darren directly on: 07775623464.