Clean Room Validation and Certification

Clean Room Validation and Certification 

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

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

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

Testing and Commissioning of Clean Rooms

Cleanroom Testing and Commissioning

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

As Built

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

At Rest

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

Operational

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

I hope the above information was informative. If you would like some more information in regards to our cleanroom testing service please don’t hesitate to contact Darren directly on 07775623464.

APT Cleanroom Testing provides clients with a reliable and proactive clean room testing service. If you would like to know more about our particulate testing service and/or HEPA filter testing service to cleanrooms, please don’t hesitate to contact us at:  info@airpressuretesting.net

Air Handling Systems for Clean Rooms

Air Handling Systems for Clean Rooms

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

HEPA Filter Testing 

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

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

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

Particulate Testing to Clean Room

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

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

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

Building a Robust Cleanroom

Building a Robust Cleanroom

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

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

Designing a Robust Clean Room

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

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

Cleanroom Particulate Testing 

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

Testing Cleanroom Environments

Testing Cleanroom Environments

All Cleanroom process environments must remain unfailingly clean, so merely filtering the factory’s air is inadequate. To minimise particle contamination it is important to build separate environments, called cleanrooms. These areas allow particle limits to be maintained at measurable and controllable levels locally.

Testing Cleanroom Environments

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Clean rooms environments achieve these acute cleanliness levels by maximising laminar airflow and minimising particle traps. Laminar airflow is air moving in one direction, which allows particles to be swept away from an area within the cleanroom. Particle traps within a cleanroom environment are areas where particles gather and escape laminar airflow, such as the corners of the rooms and behind machinery and instrumentation, careful cleanroom design and placement of room furniture can minimise these areas.

In efficient cleanrooms HEPA filters installed in the ceiling allow filtered air to pass down toward the floor. The floor tiles have small holes that allow the air to pass under the floor, where air-returns (air ducts) transport the air back to the ceiling HEPA filters. This filtration process can exchange the clean room’s entire volume of air more than thirty times per hour, resulting in a very clean environment while minimising the movement of air particles.

Clean Room Commissioning 

To further reduce contamination within a cleanroom requires personnel to wear protective gowns, hair and beard covers, hoods, overshoes, and gloves. In the cleanest environments, personnel all the aforementioned clothing as cleanroom apparel is extremely important in controlling micro-contamination to contain the particles emitted by people.

We undertake the Following Cleanroom Validation Services:

  • Airborne Particulate Testing
  • Air Change Rate Calculations (ACR)
  • Air Volume Flow Rates
  • Differential Pressure Measurements
  • HEPA Filter Integrity Leak Testing – DOP Method
  • Temperature, Humidity, Light and Noise Level readings
  • Recovery Performance testing
  • Airflow Visualisation tests, supported by a full written report
  • We also provide temperature mapping of rooms and storage facilities, in order to meet customers regulatory and QA requirements.

APT can carry out your Clean Room Testing Requirements

I hope the above information was informative. If you would like some more information in regards to our Cleanroom Testing Service, please don’t hesitate to contact Darren directly on 07775623464 and/or email us at: info@aptcleanroomtesting.co.uk

 

Evaluation and Certification of Cleanrooms

Evaluation and Certification of Clean Rooms

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

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

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

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

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

APT Cleanroom Testing is a specialist clean room services company and we fully understand the importance of not just undertaking the validation testing and commissioning.

Evaluation and Certification of Clean Rooms

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APT has your Clean Room Validation Testing

I hope the above information was informative. If you would like some more information in regards to our cleanroom testing service please don’t hesitate to contact Darren directly on 07775623464.

APT Cleanroom Testing provides clients with a reliable and proactive clean room testing service. If you would like to know more about our particulate testing service and/or  HEPA filter testing service to cleanrooms, please don’t hesitate to contact us at:  info@airpressuretesting.net

Our Cleanroom Validation Services

Our Cleanroom Validation Services 

APT Clean Room Testing also carries out Air Change Rates for your facilities, in accordance with the Orange Guide and the current ISO standards. In the event of contamination it is important for customers to know that the air will be changed in accordance with site and regulatory requirements to remove the contamination in an expedient manner. Our proactive testing and clear and concise reportage help our customers and stakeholders quickly identify the performance of their cleanroom facility in this respect.

Clean Room Validation Services

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We can also undertake Airborne Particulate Cleanliness Counts (Particle Counts). These are performed in accordance with each client’s facility classification, whether it is to an ISO or GMP standard. We use state of the latest calibrated Particle Counters that are regularly serviced and calibrated to ensure optimum performance.

HEPA Filter testing is carried out using the industry standard DOP method, whereby each filter is subjected to an upstream aerosol challenge; the downstream side of the filter is scanned with a photometer to identify the presence of any leaks. It is also important to ensure that each filter has been installed correctly and the filter frame and its housing are also thoroughly checked.

Our engineers have lots of experience across numerous industries from automotive to medical and all our data is produced and recorded record in a clear, concise and comprehensive Cleanroom Reports. Our Cleanroom contain all of the relevant information and data as expected by customers and regulatory authorities, including:

  1. Detailed method statements explaining how each validation test is performed
  2. Detailed records of measurements recorded during the validation visit
  3. Copies of calibration certificates for all test equipment used
  4. Original print-outs from particle counters (where relevant)

We undertake the Cleanroom Validation Services:

  • Air Change Rate Calculations (ACR)
  • Air Volume Flow Rates
  • Airborne Particulate Cleanliness Counts
  • Differential Pressure Measurements
  • HEPA Filter Integrity Leak Testing – DOP Method
  • Temperature, Humidity, Light and Noise Level readings
  • Recovery Performance testing
  • Airflow Visualisation tests, supported by a full written report
  • We also provide temperature mapping of rooms and storage facilities, in order to meet customers regulatory and QA requirements.

APT can carry out your Fume Cupboard and LEV Testing

I hope the above information was informative. If you would like some more information in regards to our Fume Cupboard Testing Service and/or LEV Testing Service, please don’t hesitate to contact Darren directly on 07775623464 and/or email us at: info@aptcleanroomtesting.co.uk

Fume Cupboard Testing Methods

Fume Cupboard Testing Methods

APT Cleanroom Testing offer a wide range of testing services to meet the needs of our clients across all cleanroom industries from automotive to Nano Production. For every test we will issue a comprehensive test report. This will include the fume cupboard identification number, the date of the test, the type of test that has been carried out, the general room conditions at the time of the test, the results of our inspection and of the performance test, and any remedial actions that were needed or are required to meet the required standards.

Fume Cupboard Testing to Clean Rooms

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The type of Fume Cupboard Testing may include:

 Containment testing using tracer gas

We provide a quantitative measure of fume cupboard containment under normal working conditions. We undertake containment testing using tracer gas analyses the escape routes of sulphur hexafluoride (the gas tracer) from within the fume cupboard. This type of testing is particularly recommended for newly installed equipment and following any major repairs as its highlights any weaknesses in the fume cupboard envelope.

Face velocity measurements

We measuring the average rate at which air is drawn through the opening of the fume cupboard, face velocity measurements are the conventional method for measuring fume cupboard performance. This does not measure the containment ability of the fume cupboard which is undertaken using tracer gas.

 APT Clean Room LEV Testing Service

At APT Cleanroom Testing we believe in delivering a quality service in everything that we do. Whether you choose to work with us via an ongoing contract arrangement, which allows us scheduling the testing/servicing or whether you’d prefer to work with us on a job by job basis we always offer a proactive encompassing end to end service. We also offer an “out of hours” service to minimise disruption for our clients.

APT can carry out your Fume Cupboard and LEV Testing

As part of our Cleanroom Testing Service, we also provide particulate testing and HEPA filter testing as well as many other services.

I hope the above information was informative. If you would like some more information in regards to our Fume Cupboard Testing Service and/or LEV Testing Service, please don’t hesitate to contact Darren directly on 07775623464 and/or email us at: info@aptcleanroomtesting.co.uk

The Test Criteria for Fume Cupboards

The Test Criteria for Fume Cupboards

All fume cupboards should be maintained in line with manufactures recommendations and performance thresholds, including expected face velocity and containment values, recommended and confirmed by them at the time of commissioning.

Testing Fume Cupboards

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Sometimes it may be difficult to find the manufacturer’s performance specifications as the units may be old, in which case the best practice velocity guidelines for ducted fume cupboards carrying out standard work with hazardous substances, are that the face velocity should be 0.5m/s ±10% with the sash set to 500mm height, and if face velocities fall below 0.45m/s the unit should be removed from use until remedial work has been completed. If you are using radioactive materials that could result in a gaseous or aerosol release, these may require a higher airflow velocity, usually 0.7 m/s or an average SF6 containment of 0.01ppm, it is essential that these minimum requirements are met.

Fume Cupboard Testing Requirements

When it comes to fume cupboard and LEV testing, the HSE have updated their guidance in the second edition of their publication HSG 258 – ‘controlling airborne contaminants at work: A guide to local exhaust ventilation (LEV)’.

Clean Room Testing and Commissioning 

cleanroom-testing

While a variety of qualitative and quantitative methods may be employed for LEV testing, HSE guidance for fume cupboard testing states the need to measure face velocity and that any further testing should be carried out in accordance with BS EN 14175.

When it comes to testing recirculating fume cupboards, the fume cupboards must also include particular filter and seal integrity testing and gaseous phase filter capacity testing as outlined in BS 7989:2001.

Prior to the commencement of testing all equipment to be used must be appropriately calibrated and maintained and the performance specifications for the fume cupboard to be tested must be checked to ensure the correct ones are being used. Any visual inspections of the fume cupboard should be carried out in strict accordance with HSG 258 and BS EN 14175-4:2004.

 APT can carry out your Fume Cupboard and LEV Testing

I hope the above information was informative. If you would like some more information in regards to our 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

Fume Cupboard Testing

Fume Cupboard Testing

To ensure fume cupboards are in working properly and are in good repair, thorough examination and tests must be carried out at least once every fourteen months. In practice this frequency of testing may be increased in accordance with the risk assessment of the effects of system failure. The information below should help customers identify their type of fume cupboard/s.

Fume Cupboard-Testing

When it comes to fume cupboard there are two main types ducted, and recirculating (ductless).  Both work with the same objective – to draw air away from the open end of the cupboard and either expel it into the outside environment or pass it through filters and back into the room.

Ductless Fume Cupboards (Recirculating)

Recirculating fume cupboards are self-contained units that draw contaminated air away from the aperture, passing it through a filtration system and discharging it back into the room. The type of filter used is dependent upon the class of the chemicals being worked with and all filters have a maximum absorbency capacity. It is vital to ensure that the limit is not exceeded, as this can result in the release of hazardous substances into the work environment and cause a potential risk to the occupiers of the cleanroom.

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Recirculating fume cupboards are not suitable for work involving highly toxic, carcinogenic or sensitising substances or radioactive material. In fact the Health and Safety Executive (HSE) do not recommend using these fume cupboards for exposure control of vapours or carbon nanotubes (HSE Control Guidance note 201 and HSE Risk Management of Carbon Nanotubes 2009).

The selection and installation of recirculating systems must be carefully reviewed. Consideration should be given to whether such a unit can provide adequate, reliable control of the anticipated hazards and that the resources and a safe system of work are in place to ensure the unit is monitored and maintained throughout its life cycle.

Ducted Fume Cupboard

Fume cupboards that are ducted have externally located fan units connected to the fume cupboard via duct work. These fume cupboards generally pull air from their front aperture, through ducts to vent to a safe position on the roof of the building. This point of discharge is usually at least three metres above the roof line, so hazardous fumes can be safely diluted in the atmosphere.

The Two Fume Cupboard Testing Standards

There are two main fume cupboard and LEV testing standards – British Standards BS EN 14175 for industrial ducted systems, and British Standard BS7989:2001 for recirculating or ductless units.

British Standards BS EN 14175 and British Standard BS7989:2001 both specify the safety and performance requirements for general purpose fume cupboards and also outline the technical specifications required for their design, manufacture, installation and containment.

While historically, face velocity measurements have been used to demonstrate fume cupboard performance, current emphasis is on demonstrating containment, which is done by establishing a programme of regular tracer gas containment testing. The test methodologies suitable for fume cupboards are detailed in the British and European standard (BS EN 14175-2:2003), available from the British Standard Institute (BSI).

APT can carry out your Fume Cupboard and LEV Testing

I hope the above information was informative. If you would like some more information in regards to our 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

FUME CUPBOARD AND LEV TESTING

FUME CUPBOARD AND LEV TESTING

Fume cupboards are some of most important pieces of equipment within cleanrooms. Undertaking periodic testing of fume cupboards LEV are essential when it comes to protecting your personnel from hazardous or noxious vapours, gases and dust produced inside fume cabinets.

Fume Cupboard Testing 

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Due to the toxic nature of many of the processes carried out within fume cupboards that the Control of Substances Hazardous to Health (COSHH) 2002 Regulations apply. These regulations impose a duty of care on employers to manage (and reduce wherever possible) the exposure of their employees to hazardous substances and, where it is not reasonably practicable to prevent exposure, to employ control measures to reduce it to an appropriate level. This is where fume cupboards come into play as they are a common means of partially containing hazardous chemicals and preventing their release into the workplace environment.

Typical Cleanroom Construction

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The Control of Substances Hazardous to Health (COSHH) requires all Local Exhaust Ventilation (LEV) systems, including fume cupboards, to be maintained in effective and efficient working order and they are also subject to inspection and mandatory fume cupboard testing and LEV testing every 14 months; however this may require more frequently testing when risk assessments have identified a high risk of exposure and/or works have been carried out to the fume cupboard or LEV system.

The COSHH Code of Practice 5th edition 2002 as well as the HSE publication ‘Maintenance, Testing and Examination of Local Exhaust Ventilation’ provide detailed guidance for employers to help ensure fume cupboard testing and maintenance is carried out as required by the regulations to demonstrate LEV is operating as it is designed to and that it is adequately controlling exposure to hazardous substances to minimise risk within the workplace environment.

APT can carry out your Fume Cupboard and LEV Testing

I hope the above information was informative. If you would like some more information in regards to our 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