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

 

Changes to ISO 14644-1: 2015 for Clean Room Testing

Changes to ISO 14644-1: 2015 for Clean Room Testing

If you are stakeholder in regards to a clean room facility it is worth noting that ISO 14644-1: 1999 has recently been updated to the 2015 version. It requires changes to sampling procedures and monitoring plans for cleanrooms and clean zones, all of which is outlined in the revised ISO 14644-1:2015 standard. Organisations will be required to redefine their validation sampling plans and data evaluation and will obviously affect the clean room testing reportage.

Cleanroom-Testing-and-Certification

The updated ISO 14644-1:2015, specifies the classification of air cleanliness in terms of concentration of airborne particles in cleanrooms and clean zones and is the first significant revision since its original release in 1999.

The major change from ISO 14644-1:1999 publication is the adoption of a more consistent statistical approach to the selection and number of sampling locations; and thereafter the evaluation of the data collected.

This new approach allows each location to be treated independently with at least a 95 % level of confidence that at least 90 % of the cleanroom or clean zone areas will comply with the maximum particle concentration limit for the target class of air cleanliness.

Particulate-Testing-Cleanrooms

Cleanroom users will have to make changes to the cleanroom validation procedures to meet the requirements laid out in the latest version of ISO 14644-1:2015 and ISO 14644-2:2015.  It is possible that the revised standard will require cleanroom owners to make changes to their cleanroom to ensure they continue to achieve the required classification and remain compliant.

The main Changes the changes to ISO 14644-01:

  • Each sampling point is to be evaluated separately and all sampling locations must pass for a cleanroom to comply.
  • The 95% UCL (upper confidence limit) evaluation for 2-9 sampling locations has been removed.
  • The calculation used in ISO 14644-1:1999 to determine the minimum number of sampling locations has been replace with a look-up table. The table provides at least 95% confidence that at least 90% of the cleanroom or clean zone will comply with the ISO Class limit.
  • The removal of 5 size micron in class 5 areas. This can still be considered as a reference for continuity but will not form part of a pass/fail validation outcome.

APT Cleanroom Testing Services

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

APT Clean Room Testing Services

APT Clean Room Testing Services

With APT Clean Room Testing you can be sure of complete proactive service from start to finish. We specialise in the testing and validation of all types of clean rooms from the Nano Technology to the Automotive industry.

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 Test Services

APT-Cleanroom-Testing

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.

Issuing Clean Room Reports

cleanroom-testing

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.

If you would like more information on our cleanroom testing services 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

Medical Device Cleanroom Testing

Medical Device Cleanroom Testing

Clean-rooms for medical device technology typically fall under ISO Class 7 and ISO Class 8 range. As you can imagine the manufacturing process for these products ensures that the surface of the product does not have particulate contamination when it is completed. So, it is imperative that the cleanliness level inside the room is maintained both from a cleanroom standpoint.

medical-clean-room-testing

In many cases people/personal is the major contaminator in most processes. This is why personnel are required to wear full gowns, booties, gloves, and hairnets in medical device manufacturing, as well as the biotech, pharmaceutical and semiconductor industries. While some medical device cleanrooms may not always adhere to the same stringent gowning practices as pharmaceutical cleanrooms, the protocol and cleaning process is just as important. The cleanroom environment for medical devices usually aims to eliminate surface contamination, or viable particulate, on their products.

Cleanroom-Particle-Testing

We undertake a wide range of clean room testing service for the Biotechnology and Pharmaceutical industries such as:

  1. Viable Particle Detection – Classification of air cleanliness by particle concentration. This ensures that your cleanroom continues to perform efficiently and enhance your ongoing business process,
  2. HEPA Filter installation leak 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.
  3. 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.
  4. Differential pressurebetween cleanrooms – 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.
  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 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

Defence and Optic Industry Cleanroom Testing

Defence and Optic Industry Cleanroom Testing

The previous blog concentrated on biotechnology and pharmaceutical cleanrooms testing. this blog is devoted to the defence and optic industries.

The defence and optic industries use cleanrooms for many of their applications, including biotech, pharmaceutical, and medical device. These applications may also include items such as like chip making for controlling missiles and electronic and radar components, laser technology for guidance systems and even biological components for vaccines etc.

Defence and Optic Industry Cleanroom Testing

clean-room-testing-to-Defence-facilities

Defence Industry Cleanrooms usually require the highest levels of security and clearance. Due to the sensitive/high security nature of various defence industry operations, this typically leads to the stick-built type of construction to allow for the perimeter to meet government security requirements.

We undertake a wide range of clean room testing service for the Biotechnology and Pharmaceutical industries such as:

  1. Particulate testing – Classification of air cleanliness by particle concentration. This ensures that your cleanroom continues to perform efficiently and enhance your ongoing business process.
  2. Filter installation leak 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.
  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, with your clean room having a higher pressure than adjacent less clean areas.
  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.

cleanroom-testing

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

Biotechnology and Pharmaceutical Cleanroom Testing

Biotechnology and Pharmaceutical Cleanroom Testing

There are many different types of industries that use cleanrooms, so what makes a cleanroom in one industry different than another? It’s quite a common question. Let’s have a look at the different cleanroom industries in more detail along with varying ISO requirements.

Many biotechnology and pharmaceutical cleanrooms are specified at ISO Class 5 to ISO Class 8 and apply to a large portion of the cleanroom standards. If you’re not familiar, ISO classes and standards are set by the International Organisation for Standardisation.

clean-room-testing

The many ISO standards provide various requirements, specifications, guidelines and characteristics that can be used consistently to ensure that materials, products, processes and services are fit for their intended purpose.

In all cleanrooms, particulate matter is a great concern. Specifically, viable particulate contamination should receive careful consideration and attention. Viable particulate contamination refers to the ability to keep the room clean by typically using modular or stick-built components with integral cove bases and corners, as well as coved ceilings in order to maintain a cleanable surface condition. This high grade finish is crucial for biotechnology and pharmaceutical cleanroom standards.

In all instances concealed areas may allow for bacterial growth which is unacceptable. These clean rooms typically use cleanroom technology that keeps the seal unbroken during sanitation and filter changes. Biotechnology and pharmaceutical cleanrooms typically have a heavy focus on pressurisation control, the elimination of cross contamination and the ongoing filtration of outdoor air and indoor air.

We undertake a wide range of clean room testing service for the Biotechnology and Pharmaceutical industries such as:

  1. Filter installation leak 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.
  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. 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.
  4. 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.
  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.

Particulate-Testing-Cleanrooms

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

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

A Brief History of Cleanrooms

A Brief History of Cleanrooms

The first cleanroom identified by historian’s dates back to the mid-19th century, where sterilised environments were being used in hospital operating rooms, although not clean by today’s standards they were none-the less clean for their time. Modern cleanrooms were created during World War 2 where they were created to produce and manufacture state of the art weaponry in a clean and sterile environment.

During the war, US and UK industrial manufacturers designed a colossal amount of hardware such as guns, tanks and aeroplanes this contributed to the success of the war by providing the military with weaponry that was needed at each juncture of the war. Often major scientific breakthroughs are made during wartime.

Modern Cleanroom Design 

clean-room-testing

It is known that the HEPA filters were being used throughout cleanrooms by the early 1950s. Some believe that cleanrooms date back to World War I when there was a need to segregate the work area to reduce cross-contamination between manufacturing areas; however no exact date can be found for the introduction of the first cleanroom.

Regardless of when they were introduced into the manufacturing world, contamination was one of the main problems and cleanrooms were the solution. Continually growing and constantly changing for the betterment of projects, research, and manufacturing, cleanrooms as we know them today are recognised for their low levels of pollutants and contaminants allowing for incredible scientific breakthroughs such as Nano Technology etc.

Prior to the creation of modern cleanrooms, early cleanrooms had contamination due to particles and unpredictable airflow throughout the room.  With this in mind cleanrooms were created allowing for a constant, high-filtration airflow, which is what is used throughout cleanroom design and construction today.

Cleanroom Testing 

Cleanroom-testing

APT Cleanroom Testing provide our clients with reliable and proactive clean room 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  or call Darren direct on 07775623464.

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.

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.