CLEAN ROOM VALIDATION SERVICES

CLEAN ROOM VALIDATION SERVICES

It is vitally important that cleanroom validation is an essential part of ensuring that cleanroom facilities are operating at the levels of cleanliness required by facility owners, their customers and where required perhaps external regulatory bodies.

However, there are multiple standards for clean room performance; in addition, facility owners can specify variations from the main classes of cleanroom to meet the needs of specific applications.

The Purpose of Clean Room Validation
Cleanroom validation or cleanroom certification can be seen as “passing a cleanroom test”; thus allowing the facility to continue to operate and be productive as designed. In most instances cleanroom validation is really about quality control, for instance:

  1. Preventing external contamination of samples by ensuring reliable test or experimental results.
  2. Ensuring a clean sterile environment for pharmaceutical or food production.
  3. Ensuring a low particulate environment to preventing damage to sensitive electronics.

For many facilities a cleanroom is the top of the critical asset chain; therefore, cleanroom compliance is also business critical factor; not just for profitability but also business reputation which is just as important.

Cleanroom Validation Services

cleanroom-validation-testing

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, but in helping facility stakeholders maintain high ongoing levels of cleanliness.

For APT Cleanroom Testing ongoing clean room validation is therefore part of a much wider process of ongoing monitoring, testing and maintenance.

Facility managers have to weigh up the costs of maintaining a higher grade of cleanroom against the costs of having to repair or replace a contaminated product; however they also have to attain the cleanroom ISO standard and regulatory requirements. It is critical that any judgement is carefully made, so that the agreed standards that have been decided sand agreed are rigidly enforced and validated, it’s worth noting that even small drops in quality may lead to an increase in contamination which may affect the bottom line and set experimental programmes/production by back by months.

A Typical Cleanroom

clean room header.indd

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

Changes to ISO 14644-2: 2015 for Clean Room Validation Testing

Changes to ISO 14644-2: 2015 for Clean Room Validation Testing

If you are stakeholder in regards to a clean room facility it is worth noting that Part 2, 14644-2:2015 has also been updated, it is now much more focussed on customers deciding what is standards need to be rehired via risk assessments and monitoring plans.

Clean Room Validation and Testing

Cleanroom-commissioning-02-02-18

The updated ISO 14644-2:2015 – requires cleanroom stakeholders undertake careful monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration and recommends customers to complete risk assessments and monitoring plans to determine the frequency of testing and validation to their individual cleanroom processes.

The updates standard states the maximum time interval between airborne particle concentration testing of a cleanroom of ISO class 5 and below is 6 months and ISO class 6 and above is 12 months. Although these guides are in place for validating your controlled environment you may need to undertake more frequent testing to comply with the scope of your validation as defined by your process specific risk assessment.

Changes to ISO 14644-2: 2015 for Clean Room Validation Testing

cleanroom-testing-and-validation

We undertake a wide range of clean room testing service for all types of industries from the Pharmaceutical through to the automotive industries. Our full range of services includes:

  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, with your clean room having a higher pressure than adjacent less clean areas.
  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. HEPA Filter Integrity 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.
  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.

APT Clean Room Testing offers peace of mind from a UKAS accredited test laboratory.

If you have a cleanroom and you need to discuss the changes to ISO 14644-01 & ISO 14644-02, and/or you wish to discuss your cleanroom monitoring and testing validation requirements, please contact Darren Helliwell on 07775623464 or email 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

Automotive Cleanroom Testing

Automotive Cleanroom Testing

Since the early invention of the assembly line, the automotive industry has made incredible strides in their manufacturing processes. Indeed, a wide range of attention is given to mass defects, or preventing them. Like other industries the need for manufacturing auto components inside cleanrooms has become a key factor in the automotive industry. .

In Automotive Cleanrooms factors like pressure, temperature and humidity are just as important to other rooms designed in the cleanroom classification range of ISO 7 and ISO 8. The defects that can (and do) occur in the automotive manufacturing industry are vast, including costly errors like glass coatings, electrical components, and painting to the bodywork.

Automotive- Cleanroom- 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 tests, for every clean room we are working in, we will measure and check:

  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. 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.
  1. Airborne particulate testing – 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. 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.
  1. 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.
  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.

APT Cleanroom Testing will always try to ensure 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 cleanroom test reports that can be compiled, quality checked and issued to you while still on site, minimising the down time of your operations.

Particulate-Testing-Cleanrooms

If you have a clean room that requires a cleanroom testing service then please get in touch with us as soon as possible. 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.

For more information please contact us at: info@aptcleanroomtesting.co.uk or phone Darren directly on: 07775623464.

 

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.