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.

HEPA Filter Maintenance and Testing

HEPA Filter Maintenance and Testing

Once ventilation equipment has been installed, it is vital to ensure it is working properly at all times and this includes checking and maintaining all filters in good condition via a HEPA Filter Maintenance and Testing Regime. This is essential for the proper operation of a cleanroom and for regulatory compliance

Filters are tested by the manufacturer before they are supplied, to ensure they meet set relevant standards. However, initial clean room testing also needs to be carried out on-site as soon as they have been installed; this is to check that damage has occurred since manufacture, such as during the installation and/or transportation.

cleanroom-testing

Regular HEPA filter testing is necessary to ensure the integrity of the filters. Normally filters are built to last between 1 and 4 years, but various faults can occur which mean they are no longer providing the intended protection.

We can advise you on how frequent testing needs to be for your specific cleanroom. Systems which come under the COSHH regulations, providing protection to people from hazardous airborne particles, will require testing at least once a year. Some Hepa systems need to be tested more frequently, in some cases every six months. The level of risk usually dictates the frequency of the required testing.

hepa-filter-integrity-testing

 As an integral part of your ventilation system, high efficiency particulate air (HEPA) filters require regular maintenance and validation, and DOP testing plays an essential role in this. HEPA filter testing forms a part of the regulatory requirements for operations relying on specialist ventilation, and needs to be carried out in a consistent way to ensure reliability.

Dispersed oil particulate (DOP) testing needs to be carried out to check whether filters are working correctly. This test involves releasing DOP into a cleanroom’s airstream and then carrying out measurements to check that the filter has dealt with it correctly. The integrity of every filter component is fully checked during the testing process.

APT Clean Room Testing carry out DOP (dispersed oil particulate) Hepa filter testing to industry standards to ensure clean rooms and other specialist or critical environments are operating to the highest standards and to identify any potential air leakage paths.

Using our vast technical knowledge along with our steadfast commitment to quality and the highest standards of customer service we provide our clients with reliable and proactive clean room testing service.

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

HEPA Filter Testing

HEPA Filter Testing

High Efficiency Particulate Air filters (HEPA Filters) are devices which remove solid particles such as pollen, dust and bacteria from the air.  HEPA Filters are used to remove ultrafine dust, aerosols and viable organisms. High Efficiency Particulate Air filters are most commonly found within operating theatres and patient isolation rooms within hospitals, cleanrooms and laboratories but also for micro-electronics, optical and pharmaceutical production.

Why HEPA Filters are Installed in Cleanrooms

Good quality Filters are necessary in a cleanroom to remove various different types of contaminant from the air and ensure the right level of air purity is maintained consistently. Filtration provides protection for people working in the confined space, as well as for production and the surrounding environment.

hepa-filter-integrity-testing

The choice of a ventilation system for a cleanroom is a major decision and must be carefully considered. In many instances design advice from experts will be required to highlight which equipment is most appropriate. As well as the design and layout of the area, other key points to bear in mind include the type of application and the direction of airflow which is needed.

A critical ventilation system must have the right filters installed within it. High efficiency particulate air (HEPA) filters have to meet official standards including the British and European standard BS EN 1822-1: 2009. This means that, in factory testing, these filters must have an efficiency level of more than 99.995%.

A high quality HEPA filter will remove particles of solid contaminants including dust, mould, and bacteria room the air. It can screen tiny particles above 0.3 micrometres in size. There are various different types of HEPA filter available and they are frequently used in cleanroom settings within pharmaceutical and electronics production, as well as in hospitals and healthcare facilities.

clean-room-testing

HEPA Filter Testing Services from APT Cleanroom Testing.

Using our vast technical knowledge along with our steadfast commitment to quality and the highest standards of customer service 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 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.

 

Our Cleanroom Testing Process

Our Cleanroom Testing Process

To ensure that your clean room environment is working effectively a number of factors relating to the air supply coming from your ventilation need to be tested. These tests apply to every type of clean room, whether used for the manufacture of pharmaceutical products, sterile and aseptic or food production.

We will need to test the quantity of air to ensure that there is enough to dilute or remove any contamination generated within your clean room, and we will need to test the quality of the air to ensure that it is not adding to any contamination, rather than removing it.

clean-room-testing

We also need to test the flow of the air to ensure that it is moving from clean to less clean areas, minimising the movement of any contaminated air into your clean area, and also to ensure there are no areas of the room with high concentrations of pollutants.

In order to carry out these cleanroom tests, for every clean room we are working in, we will measure and check:

  1. Air Tightness Testing – to check your room envelope is air tight and not leaking.
  1. Air Supply and Extract Quantities – If your air supply is unidirectional we will measure and record the air velocity.
  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.
  1. Filter Installation Leak Testing – Your ventilation system’s high efficiency particulate air (HEPA) filter can be tested to ensure their integrity.
  1. 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.
  1. 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.
  1. Room Recovery – Reviewing the effectiveness of airflow we will measure how quickly a clean room recovers to its normal operating cleanliness following a release of particulate contaminant.
  1. Airborne particles and microbial concentrations – Finally, we will carry out measurements to ensure that the concentration of particles and micro-organisms is compliant with the specification set out for your clean room.
  1. Temperature, Relative Humidity – We may also need to carry out tests on temperature, relative humidity, and the heating and cooling capabilities of the room, as well as noise, lighting and vibration levels.

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 your cleanroom testing and cleanroom certification.

hepa-filter-integrity-testing

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’.

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.

The Pathway to Good Acoustic Design

The Pathway to Good Acoustic Design 

There are many important acoustic design considerations when designing for apartment blocks, which require both airborne wall and floor and impact floor testing. here are a few of the main considerations:

  • Ensure all penetrations are fully sealed where they terminate through floors and they are adequately boxed with acoustic quilt and two layers of plasterboard.
  • Avoid the use of lightweight blocks in the inner envelope construction as sound will travel both vertically and horizontally from dwelling to dwelling.
  • The use of resilient suspended ceilings will help improve the performance of the floor partition.
  • Ensure all support steels/timbers are carefully boxed out where they travel from flat to flat vertically and horizontally.
  • Use a high quality resilient acoustic membrane on top of the floor to improve the impact performance of a floor.

Sound_Testing_Flats

By simply constructing a good separating wall or floor this may not in itself provide sufficient sound insulation to comply with Building Regulations Part E as the junctions of each separating wall and/or floor with other parts of the building are as equally important. One of the main problems with partition failure is down to noise flanking, this can occur via construction components such as:

  • The internal partitions
  • The inner leaf of the external wall
  • The external wall cavities
  • The external façade or outer leaf
  • The roof structure
  • The foundations.

The overall design and construction system should therefore be considered and not just the separating wall or floor partitions.  Flanking sound transmission may in some cases be the dominant pathway between adjoining dwellings, especially in existing buildings where you are planning to convert offices/large houses into flats.

architect drafting a house blueprint

architect drafting a house blueprint

In our experience if the acoustic design is taken into consideration from the offset of the project, then it usually results in compliance with Building Regulations Part E.  In Some cases, sound test failure can also be down to the poor workmanship rather than the acoustic design, that is why we offer a full acoustic package which includes for site survey visits; that way we have the acoustic design and onsite construction covered, reducing the chance of sound test failure.

If you have a project that’s needs acoustic design advice or sound testing in London, then please contact us at: info@aptsoundtesting.co.uk or phone us directly on 07775623464.