Potential Hazards In Clean Room Facilities

Potential Hazards In Clean Room Facilities

There are many potential hazards in clean rooms, so maintaining the health and safety and adhering to the high standards of a controlled cleanroom environment requires thorough training and routine testing and inspections. Maintaining safety standards scan be quite a challenge as the unpredictability of things that can go wrong and ultimately contaminate a cleanroom are quite extensive.

Clean Room Vailidation and Commissioning

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Some common examples cleanroom hazards include:

  • Electrical Outlets – check that your electrical outlets are properly sealed.  Sometimes, small insects can crawl through outlets as well as airborne duct and contaminates.
  • Electrical Trunking – ensure all electrical trunking is completely sealed where it terminates through the room/building envelope.
  • Mechanical Pipe Runs – check that your pipes etc. are properly sealed where they terminate through the room/building envelope.
  • Rubber Coving to Walls and Floors – where different finishes have been bonded together, i.e. walls and floors, ensure that the rubber bonding strip has not begun to de-bond from the finishing’s, this can lead to air leakage paths and also allow dust and other contaminates into the clean room environment.
  • Holes in the HEPA Filters – Sometimes employees accidentally damage HEPA filters by lifting mop handles to high and hitting the underside of the HEPA filter.
  • Double Doors – when you’re designing and building your cleanroom, do you have a double door installed? You should have a double door to bring things in and out, yes, even during the building process to bring equipment in and out of the area.
  • Pass Through Areas – do you have to bring a lot of equipment and parts into the cleanroom? If so products and supplies can go through the pass through in the form of a wall mounted or floor mounted cart pass through.
  • Flooring – what type of flooring has been installed within your cleanroom? If the floor is vinyl it is not an ESD floor. All equipment must be able to be properly grounded to the floor when you’re using ESD chairs, carts, chairs etc.
  • Mobile Phones – if you need your mobile phone and/or walkie-talkies in the cleanroom for communication purposes, it should not be clipped on the outside of your coveralls. They may fall off and damage microchips etc. in all instances if you do need communication devices you can wear small cleanroom waist bag etc. which reduce the risk of damage to your surrounding area.

Cleanrooms play critical roles in maintaining contamination free production environments for critical processes. To ensure your cleanroom is working as designed it is essential that a well planned and executed cleanroom testing,  certification and maintenance program is undertaken for operation and regulatory compliance.

Clean Room Testing Services

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We hope the above information had been useful to you, if you would like more information in regards to clean room testing and commissioning services please don’t hesitate to contact us. We offer a comprehensive and proactive validation service to the requirements of all current ISO standards and guidelines. We are customer driven and continually try to exceed our customers’ expectations, both in terms of price and service. Our careful attention to detail ensures that our reports and certificates are of the highest quality and customers can be confident that their external calibration and validation requirements have been met.

Our test engineers are well trained, highly motivated and flexible individuals who ensure constant and consistent delivery of our high standards.

If you would like more information on our cleanroom testing services please don’t hesitate to contact Darren directly on 07775623464 or email us at: info@aptcleanroomtesting.co.uk

Clean Room Testing Services

Clean Room Testing Services

Clean rooms play critical roles in maintaining contamination free production environments for critical processes. To ensure your cleanroom is working as designed it is essential that a well planned and executed cleanroom testing Services  and certification and maintenance program is undertaken for operation and regulatory compliance. APT cleanroom testing offers clean room testing and clean room certification. APT Clean Room Testing specialise in the testing and validation of all types of clean rooms from the Nano technology to the automotive industries.

Clean Room Commissioning 

Clean-room-testing-services

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 Validation

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Our primary cleanroom tests include:

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

Using our technical knowledge and experience in cleanroom testing coupled with our steadfast commitment to quality and the highest standards of customer service we provide our clients with reliable, accurate and thoroughly documented clean room testing results, ensuring optimal cleanroom performance, documented regulatory and quality compliance, and minimised facility down time as most companies clean rooms are their main critical asset.

APT Clean Room Testing can undertake all your cleanroom commissioning and validation requirements, from the smallest clean rooms to the largest manufacturing facilities.  If you would like more information on our cleanroom testing services please don’t hesitate to contact Darren directly on 07775623464 or email us at: info@aptcleanroomtesting.co.uk

Clean Room Testing

Clean Room Testing

Clean rooms play critical roles in maintaining contamination free production environments for critical processes. To ensure your clean room is working as designed it is essential that a well planned and executed clean room testing and certification and maintenance program is undertaken for operation and regulatory compliance. APT clean room testing offers clean.

A Typical Clean Room 

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

Using our technical knowledge and experience in cleanroom testing coupled with our steadfast commitment to quality and the highest standards of customer service we provide our clients with reliable, accurate and thoroughly documented clean room testing results, ensuring optimal cleanroom performance, documented regulatory and quality compliance, and minimised facility down time as most companies clean rooms are their main critical asset.

Particle Testing to Clean Rooms 

particle-testing-to-cleanrooms

APT Clean Room Testing is customer driven and we continually try to exceed our customers’ expectations, both in terms of price and service. Our careful attention to detail ensures that our reports and certificates are of the highest quality and customers can be confident that their external calibration and validation requirements have been met. Our commitment to quality is backed up by our UKAS accreditation. Our test engineers are well trained, highly motivated and flexible individuals who ensure constant and consistent delivery of our high standards.

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 all your cleanroom testing and certification. We can also offer maintenance programmes to ensure your cleanroom is in compliance with the corresponding ISO standards– it’s why we place such emphasis on the process of ‘expert intervention’.

APT has your Clean Room 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 or email us at: info@aptcleanroomtesting.co.uk.

Clean Room Testing and Validation Services

Clean Room Testing and Validation Services
There are varying standards that apply to different classes of clean room, and how to carry out the cleanroom testing in a consistent and reliable way.  The Cleanroom Validation Standards are as follows:

ISO 1 class (No GMP Classification)

ISO 1 class is the cleanest, with an allowable particle count of just 10 per m3 at 0.1µm and just 2 per m3 at 0.2µm. This type of facility is very uncommon would be used only for the most sensitive research and development work involving, for instance, semi-conductors or nano-technology.  ISO Class 1 is significantly cleaner than the cleanest cleanroom specified by either the BS 5295 standard or the EU GMP standard, whose highest grade cleanrooms equates approximately to ISO Class 3 and ISO Class 5 respectively.

ISO Class 5 (GMP classification A and B)

ISO Class 5 facility is considered a high grade cleanroom and is typically required for aseptic applications such as sterile filling of pharmaceutical products into containers, for example. It allows up to 100,000 particles of 0.1µm and up to 3520 particles of 0.5µm per m3. An ISO Class 5 cleanroom equates to EU GMP class A and B, and BS 5295 Class E and F.

ISO Class 7 (GMP classification D)

An ISO Class 7 facility can have an unrestricted number of small particles (0.1µm to 0.3µm) but must have no more than 352,000 particles at size 0.5µm and no more than around 2,900 particles at 5µm. This equates to an EU GMP Class C facility or a BS 5295 Class J facility and would typically be used for sub-sterile pharmaceutical processes.

ISO Class 8 (GMP classification D)

An ISO Class 8 cleanroom is permitted up to 3,520,000 particles at size 0.5µm and 293,000 particles at size 5µm, equating approximately to EU GMP Class D or BS 5295 Class K. This level of cleanliness would be used for less sensitive applications where sterility is not an issue but where it makes general sense to maintain a good level of hygiene, such as packaging or storage of pharmaceuticals.

Clean Room Testing and Validation Services

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It is worth noting that these classes provide a starting point for clarifying what standards are required for a particular cleanroom, they do not always give the full picture. Actual standards are set by a combination of different factors relating to the specific application, and may fall somewhere between the levels specified in these standards.

APT Cleanroom Testing is an independent  clean room services contractor, qualified to carry out clean room validation for all classes of facility, to ensure that not only are your facilities validated and maintained to the required levels, but that your customers and clients can have complete trust in the quality of your clean room processes.

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 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

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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

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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

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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

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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

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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.

 

Nanotech and Microelectronic Cleanroom Testing

Nanotech and Microelectronic Cleanroom Testing

Nanotech and Microelectronic Cleanrooms are designed to maintain temperature, humidity, particulate, static and pressure levels. This is due to the fact that these factors, as well as static forces, can easily affect or compromise the final product, taking into account the huge costs associated with these types of works there’s simply no room for error.

particle-testing-to-cleanrooms

A high level of cleanliness must be maintained at all times within nanotech and microelectronic cleanroom environments since defects can occur at any stage in this process. Many steps are involved in order to come to a final product, and a defect along the way might not be discovered until the very end. Most of these cleanrooms typically operate in a cleanroom classification range from ISO Class 1 to ISO Class 6 with various processes occurring at different levels of cleanliness.

Nanotech-Cleanroom-Testing

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

  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.
  2. 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.
  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. Particulate testing – Classification of air cleanliness by particle concentration. This ensures that your cleanroom continues to perform efficiently and enhance your ongoing business process.
  5. 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.
  6. 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.

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