Our Testing Process for Clean Rooms

Our Testing Process for Clean Rooms

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

Our most popular types of cleanroom testing include:

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

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 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.

Clean Room Testing and Commissioning

In order to carry out these 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.
  2. Air Supply and Extract Quantities – If your air supply is unidirectional we will measure and record the air velocity.
  3. Differential Pressure – Here we will be testing to ensure that the air in your clean room always moves from clean to less clean areas.
  4. Filter Installation Leak Testing – Your ventilation system’s high efficiency particulate air (HEPA) filter can be tested to ensure their integrity.
  5. 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.
  6. 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.
  7. 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.
  8. 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.
  9. 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.

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.

Airborne Particulate Testing on Clean Rooms

Airborne Particulate Testing on Clean Rooms

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.

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 Certification guarantees that the facility has met the requirements for a statistically-valid maximum concentration of specified-size airborne particles.

Airborne Particulate Testing on Clean Rooms

Following our clean room testing and/or validation service, we present you with a clear, well-structured reportage that can be compiled, quality checked and issued to you while still on site, minimising the down time of your operations. We will also take time to explain the process and reportage to ensuring that you fully understand the testing process and your final results.

We will issue you with test certificates, as well as calibration certificates for all of the equipment used and we will also document any recommendations for improvements that could be made to make the clean room more efficient in regards to its operation.

APT Clean Room Testing provide trained clean room test engineers, offering comprehensive and proactive validation service to the requirements of all current ISO standards and guidelines.

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

Clean Room Validation and Certification

Clean Room Validation and Certification 

Clean Rooms play a crucial role in maintaining contamination free environments for critical processes. A well-executed cleanroom testing and certification program is essential to proper cleanroom maintenance, operation and regulatory compliance APT offers comprehensive clean room testing to attain clean room certification and validation. We can do this by offering a complete package including Particle level testing, Airflow testing, HEPA filter integrity testing and room air exchange rate testing. We can also offer cleanroom construction, advice and consultation in regards to the cleanroom envelope.

For most cleanrooms the usual testing program will usually include the following testing programmCleanroom Validation and Certification

  1. HEPA filter installation leak test – This test is performed to verify that the filters have been properly installed and are free of leaks.
  2. Airflow volume, velocity, and uniformity tests – This test is performed to check the uniformity of the clean air and to verify that there is enough air supply to provide the proper room pressures.
  3. Room pressurisation test.This test is to verify that there is a proper amount of positive/negative room air pressure.
  4. Airborne particle count test – This testing verifies that the cleanroom, the personnel, and process equipment is performing to the intended clean level.
  5. Room pressurisation test – This test is to verify that there is a proper amount of positive/negative room air pressure.

Testing and Commissioning of Clean Rooms

Cleanroom Testing and Commissioning

There are many different clean room testing certifications, all of which may occur in any of three different stages:

As Built

A cleanroom certified “As-Built Facility” defines a cleanroom fully constructed and operational, with all services connected and functioning, but has no production equipment or operating personnel within the facility. This certification is most common because any failures can be immediately addressed, and corrected by the cleanroom designers and construction Companies.

At Rest

A cleanroom certified “At-Rest Facility” defines a cleanroom fully constructed and operational, with production equipment installed and operating (or operable), but has no personnel within the facility. This certification demonstrates continued compliance from the “As Built” certification. Cleanrooms that were constructed but sat idle, or cleanrooms that were modified, would require “At Rest” certification.

Operational

A cleanroom certified “Operational Facility” defines a cleanroom in normal manufacturing operations, including equipment and personnel. This certification may occur after a partial—or full—complement of equipment is installed within the cleanroom. The intent is to demonstrate continued cleanroom compliance and maintain cleanliness standards. Cleanroom management personnel will determine if, and when, the cleanroom should meet “Operational” certifications.

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

Air Handling Systems for Clean Rooms

Air Handling Systems for Clean Rooms

Clean rooms need a lot of air and usually at a controlled temperature and humidity. This means that in most clean room facilities the Air Handling Units (AHU) consume over 60% of all the site power. As a general rule of thumb, the cleaner the cleanroom needs to be, the more air it will need to use. AHU systems can be designed to recirculate (if product characteristics permit) about 80% air through the room, removing particulate contamination as is it generated, whilst keeping the temperature and humidity stable.

HEPA Filter Testing 

In a nutshell a well-designed air handling system should be able to deliver both “fresh” and “recirculated” filtered clean air into the cleanroom in such a way and at a rate so that it flushes the particles from the room. Depending on the nature of the operations, the air taken out of the room is usually recirculated through the air handling system where HEPA filters remove the particulates out of the air.

In some cases the room may encounter high levels of moisture, noxious vapours or gases from the onsite processes, raw materials or products and therefore cannot be recirculated back into the room. When this happened the air in these types of cleanrooms is usually exhausted straight to atmosphere and 100% fresh air is then introduced into the facility.

The volume of air introduced into a cleanroom is often tightly controlled and so is the volume of air that is removed. Most cleanrooms are operated at a higher pressure to the atmosphere, which is achieved by supplying a higher supply volume of air into the cleanroom than the supply of air being removed from the room. The higher pressure then causes air to leak out under the door or through the tiny cracks or gaps that are inevitably in any cleanroom.

Particulate Testing to Clean Room

Any good air handling system will make sure that air is kept moving throughout the cleanroom. The key to good cleanroom design is the appropriate location of where the air is brought in via the supply and taken out via the exhaust. Although careful design of the cleanroom is important, it still remains that people are one of the biggest contaminants in any cleanroom environment. If a person is just standing still in a clean room they still emit up to 100,000 particles a minute into the clean room environment. Therefore you should try to reduce the amount of exposed skin in any cleanroom environment.

We at APT Clean Room Testing, hope that this article was helpful in helping some of you to understand the basics, necessities, and complexity of a cleanroom.

APT Clean Room Testing provides a comprehensive and proactive cleanroom validation service to the requirements of all current ISO standards and guidelines. If you would like more information on our cleanroom testing services please don’t hesitate to contact Darren directly on 07775623464.

Building a Robust Cleanroom

Building a Robust Cleanroom

Here at APT Clean room Testing we often get asked questions such as such as what is a cleanroom?  and what are the essential elements that one needs to know about a cleanroom?

Basically, a cleanroom is a controlled environment where products are made and manufactured in a controlled and clean environment. In a cleanroom, the airborne particles can be controlled and contained at very specific limits depending on the standards required for the equipment. The only way to stabilise potential contamination is to have control over the whole working environment. Particles can be move around by slight movements on air pressure, temperature, and even humidity. Even a single particle that is just 100 times smaller than a human hair can disrupt an entire cleanroom and cause major damage.

Designing a Robust Clean Room

Here’s were it can get quite tricky, much of the contamination can come from the facility itself (walls, floors ceilings, paints, room air, window leaks etc.) Also, peoples own skin, hair, makeup can cause contamination, tools. Even the products themselves can cause contamination via debris, flakes, chips which may cause you to fail your particulate test.  With this in-mind it is extremely important that all cleanrooms must be carefully planned out and designed right from the start of the project.

To achieve the cleanliness specification, all surfaces in a cleanroom should be smooth and impervious and not generate their own contamination such as dust, or peel, flake and allow a place for microorganisms to proliferate. It is important to design the cleanroom to negate ledges or recesses and all surfaces should be easily and safely accessible.  There are also many different material choices, ranging from glass panelling, or a cheaper option such as plaster-board with a two pot epoxy coating, and there are a range of other options available.

Cleanroom Particulate Testing 

APT Clean Room Testing provides a comprehensive and proactive cleanroom validation service to the requirements of all current ISO standards and guidelines. If you would like more information on our cleanroom testing services please don’t hesitate to contact Darren directly on 07775623464.

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

 

Evaluation and Certification of Cleanrooms

Evaluation and Certification of Clean Rooms

There are many different clean room testing certifications, all of which may occur in any of three different stages:

As Built: A cleanroom certified “As-Built Facility” defines a cleanroom fully constructed and operational, with all services connected and functioning, but has no production equipment or operating personnel within the facility. This certification is most common because any failures can be immediately addressed, and corrected by the cleanroom designers and construction Companies.

At Rest: A cleanroom certified “At-Rest Facility” defines a cleanroom fully constructed and operational, with production equipment installed and operating (or operable), but has no personnel within the facility. This certification demonstrates continued compliance from the “As Built” certification. Cleanrooms that were constructed but sat idle, or cleanrooms that were modified, would require “At Rest” certification.

Operational: A cleanroom certified “Operational Facility” defines a cleanroom in normal manufacturing operations, including equipment and personnel. This certification may occur after a partial—or full—complement of equipment is installed within the cleanroom. The intent is to demonstrate continued cleanroom compliance and maintain cleanliness standards. Cleanroom management personnel will determine if, and when, the cleanroom should meet “Operational” certifications.

Clean room Certification guarantees that the facility has met the requirements for a statistically-valid maximum concentration of specified-size airborne particles.

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.

Evaluation and Certification of Clean Rooms

cleanroom-testing-and-validation

APT has your Clean Room Validation 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@airpressuretesting.net

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

cleanroom-validation-services

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

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

clean-room-testing-and-validation

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