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 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.

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.

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.