What is a Cleanroom Testing and Validation Service?
For every cleanroom, testing and validation is an important process. A cleanroom testing and validation service is a process that ensures that the cleanroom is properly installed and designed for its intended classification and that the regulations and other defined standards for all components are met. The cleanroom testing and validation consist of several phases from the design to the final certification. Airflow and velocity tests, a HEPA/ULPA filter integrity leak test, air movement visualisation, airborne particle count tests, room pressure tests, relative humidity and temperature testing are some of the tests conducted in these phases.
The cleanroom must then be certified to a certain class that indicates its level of control, for example, to meet the standards of the ISO 14644 EU class.
Once you have completed the initial certification, it’s important to recertify regularly in order to keep your cleanroom operating as it was when it was built. It is recommended to obtain annual certification at a minimum. Twice or four times in year certification may be required, depending on your industry, products or level of certification required.
Need a cleanroom to meet ISO or other standards? Total Clean Air can design it and build it. Call 01737924700 today to find out more.
Total Clean Benefits
- All Work Is Guaranteed
- Full Manufacturer Warranty
- ISO Accredited Validation
- Operational Qualification
- Performance Qualification
- References Available
Air Change Rates
Control of air change per hour (ACH) is a critical factor in the design of a cleanroom. This denotes the number of times, measured in hours, that the existing volume in a chamber or building is replaced by filtered outside air.
An air conditioner for example, changes the air of a room 0.5 to 2 times an hour in a normal home. Air change occurs 10 to more than 600 times an hour in a cleanroom, depending on its classification and use. Specific air change rates for the regulation of internal temperature control and introduction of clean and oxygen-rich air and the removal of stagnant, wet air are necessary in all buildings.
The requirements depend on the type, occupation and usage, as well as the geographical location of the building, among other factors. Non-resident ventilation rates depend on the floor area and number of occupants, or on the dilution of known contaminants that is calculated.
It is important that you know that the air change rate in your cleanroom facility is appropriate for the work you do there and for this you need an expert. For more information on checking and getting the appropriate air change rate for your property, call 01737924700 to speak to a Total Clean Air expert today.
Air Velocities
Air is essential in cleanrooms and can be a source of pollution or as a control to minimise contamination. In fact, the air velocity rate of your cleanroom facility will, to a large extent, determine the classification of your cleanroom.
To control a cleanroom, the factors of air velocity, airflow and air filtration need attention.
It is therefore important, at commission and during the reclassification period, to measure airflow velocity so as to ensure consistency and to check that airflow remains within the approved parameters.
When airflow is found to be outside the range, it is important to conduct an air velocity study in order to evaluate whether air patterns have been changed, so much so that they may constitute a contaminant issue.
For detailed information on Air Flow Velocity testing, contact a Total Clean Air specialist to get specific answers to your project.
Pressure Differentials
If a door is opened in the cleanroom, impurities get in and pressure can drop. On the other hand, energy is wasted when the pressure is too high within the cleanroom.
Cleanroom parameters all need to be managed well, including airflow, pressure, temperature and humidity.
Pressure is critical and key; and when pressure is effectively combined with the two other parameters, cleanrooms operate correctly.
Given that the principal purpose of a cleanroom is to avoid any kind of particulate contamination, it is necessary to maintain a constant airflow and pressure.
Total Clean Air are cleanroom experts who offer applications and solutions that observe and verify the slightest differential pressure in cleanrooms. Get in touch to know more.
HEPA Filter Integrity Leak Testing
The test of the integrity of the HEPA filter is generally carried out using a photometer on cleanroom air filters, to scan the filter surface for pinhole leaks that would enable the passage and transmission of critically unacceptable contaminant particles.
Various international standards require the HEPA filter leak test and further guidance is given for cleanrooms in the ISO 14644-3. This means that the HEPA filter integrity leak test is a vital part of any cleanroom test and validation process. On completion of the test, a HEPA integrity test certificate is issued.
At Total Clean Air, we provide a range of specialised on-site test solutions including HEPA filter integrity leak testing as part of your cleanroom certification to the ISO 14644 standard.
For more details or to book a test, call 01737924700 at your earliest convenience.
Particle Counts (this is also known as ‘Airborne Particle Counts’ or ‘Non-viable Particle Counts’)
In order to establish whether a cleanroom meets the required concentration limits of particles within its ISO 14644 criteria, an airborne particle count is required.
This can be carried out with a particle counter and is included in a cleanroom validation check. It must also be carried out regularly to ensure that the cleanroom operates efficiently between validations.
Airborne particle counts are used extensively to check for signs of cleanroom air contamination and the data from particle counts are used in some cases to make decisions about different critical processes.
In order to develop strong environmental monitoring programmes for routine monitoring and certification, it is important that you understand the technology and how it applies to your processes.
Magnehelic Gauge Calibration Temperature, Humidity, Light and Noise Testing (collectively referred to as ‘Ambient’ condition testing)
Temperature and humidity affect processes such as material expansion or hardening, microorganism growth, corrosion, rust formation and disintegration, which can then damage the product produced in the cleanroom.
For this reason, it is of great importance to measure the relative air humidity and temperature in the cleanroom accurately.
In addition, everywhere in the room should also be measured for sound levels, light intensity and comfort. This is known as ambient condition testing.
Ambient Condition Testing entails the following:
- Making sure that there are the right ambient conditions in facilities to ensure quality standards are maintained.
- Making sure the required light intensity and light uniformity in a cleanroom is exactly complied with
- Checking the level of sound and background noise in cleanrooms so as to improve cleanroom staff comfort and safety.
To book an ambient condition testing for your facility, call Total Clean Air today on 01737924700 or use our feedback form to request a quote.
Cleanroom Recovery Rate
Cleanroom recovery rate test is performed to measure how long it will take cleanrooms to get their systems to achieve a specified level of constant cleanliness following a short particle generation in the clean area. The time it takes for the particle concentration to decrease, measured in minutes, is the recovery rate and it denotes the time each location takes to recover from the target concentration.
In the cleanroom, the slowest recovery situation determines the rate of recovery. The cleanroom recovery rate is essential in the testing and validation of cleanroom services and is best managed by certified experts with the appropriate certifications. Call Total Clean Air today to discuss the cleanroom recovery test and recovery rate today.
Microbiological Active Air Sampling
Microbiological monitoring of the air is important and well-established in facilities where pharmaceutical and medical devices are made.
It is a regulatory requirement in most countries and international standards for the control of bio-contamination in cleanrooms and other controlled environments and has been published in the ISO 14698. Active air sampling is an accurate way to measure any airborne contamination. To carry out active environmental monitoring, an air sampler draws a specified, known volume of air into a particle collection device.
The culture is then put in incubation and examined to give insight into details such as the count of bacteria or fungi and the units forming the colony. Total Clean Air are experts when it comes to microbiological active air sampling and can deploy a range of solutions for Active EM using state-of-the-art equipment. Why not contact us to find out more?
Settle Plate Testing
Effective air monitoring is increasingly needed in all areas where airborne microorganisms can contaminate industrial products and processes, or affect them. Therefore, air monitoring is especially important for all companies that work in cleanroom areas where there is filtered air. A predetermined volume of air is physically drawn using a microbiological air sampler and moved over agar in a process known as settle plate testing. The plate is then directly incubated after it is removed from the air sampler, allowing for the development and subsequent counting of visible colonies.
An estimate of the number of colonies forming units in the sampled air is given by the number of visible colonies.
Alternatively, standard Petri dishes containing culture media are exposed to the air for a given time and then incubated, using a passive air monitoring method, to allow discernible colonies to grow and be counted. Total Clean Air settle plates tests are ideally suited for microbial air monitoring systems.
They can handle high flow rates and the large sample volumes required to monitor air quality in highly critical cleanrooms where the number of microbes’ present is likely to be on the low side.
Contact Plate Testing
Cleanrooms are highly controlled environments but these near sterile manufacturing areas may be contaminated by personnel and equipment. Therefore, use of the best tools to identify any microbial activity is extremely important. One such is the contact plate test.
Contact plates are used for surface inspection by preparing the material for cultivation so that it protrudes above the sides of the plate. The plate is then placed against the surface you are attempting to analyse and track, and after incubation any pollutants will adhere to the media and be present.
These can also be used to determine how successful your gowning system is since you can monitor your workers by using contact plates to detect any microbial contamination.
The contact plates are used to monitor body areas which may be in contact with the facility’s sterile areas. This will show how well your staff adhere to the gowning program you’ve put in place.
Get in touch with Total Clean Air to design a vigorous and stringent monitoring programme that will provide you with critical data that will help you avoid possible future contaminations.
Airflow Visualisation (Smoke Visualisation)
Because a cleanroom is designed to control the airborne particle concentration, it requires a large amount of clean (filtered) air to remove or dilute contaminants in a critical cleanroom environment for satisfactory operations.
While this is controlled by heating, ventilation and air conditioning or HVAC systems and evaluated by measuring physical parameters, e.g. airflow rates, a visualisation of the air movement is required for critical operations.
Studies of airflow visualisation can help in knowing how air moves in a cleanroom and how it results in any possible contamination.
Total Clean Air raises the bar when it comes to airflow visualisation studies of cleanrooms and controlled environments.
Our experts provide airflow visualisation tests which record actual airflow patterns using our unique techniques. Book a study today.
Rebalancing
A cleanroom is usually a facility with a high-efficiency containment facility or filter supply, where the product is contained through a negative pressure system. Sometimes, cleanrooms’ HVAC systems are combined with dryers and additional equipment to maintain lower humidity. In some cases, high-grade cleanrooms or enclosures are fitted with a laminar airflow system designed to provide unidirectional airflow over the work surface. All of these require thorough knowledge and understanding of the air system, whatever kind it is, so that the system can be controlled and the required performance can be achieved.
At Total Clean Air, we use the most accurate electronic equipment for flow and pressure measurement. We’ve experienced technicians who are experts in all air systems, can make any necessary changes and can achieve the rebalancing of the system.
ISO 14644
ISO 14644 is the non-governmental standard developed by the International Organisation for Standardisation also known as ISO. In general, it applies to cleanrooms, especially where biocontamination may not be an issue. At Total Clean Air, our solutions, designs and applications all adhere to the ISO 14644 standard where required.
EU GMP
The EU GMP guidelines are stricter than ISO 14644, requiring that cleanrooms meet the required particle counts during operation, during the manufacturing process, and at rest when the manufacturing process is not in process but the room’s air handling unit is on. Total Clean Air designs cleanroom solutions that adhere to the approved EU GMP standard where required.
Eudralex, Vol 4
EudraLex is the collection of European Union rules and regulations governing medicinal products. Volume 4, also known as Good Manufacturing Practices (GMP), are the practices required to comply with the guidelines recommended by agencies controlling the authorisation and licensing of the production and sale of food and beverage, dietary supplements, pharmaceutical products, cosmetics, and medical devices. These guidelines provide minimum requirements that a manufacturer must meet to ensure their products are consistently of high quality for their intended use, from batch to batch. Total Clean Air is proud to proffer designs and applications for cleanrooms that meet the Eudralex standards.
Annex 1 BS EN
A BS is the British or UK regulatory standard that is used for construction of UK engineering equipment. EN standard is the European regulatory standard, again used by the European Union countries for designing and servicing engineering equipment. Such specifications are a broad set of rules and regulations that are used in engineering equipment and must be satisfied in order to have the specification accepted by the appropriate regulators. At Total Clean Air, all our cleanroom designs and solutions are built to meet the relevant BS and EN standards, so you can trust them for high-quality and improved value delivery.
ISO 14644 FS209E
Total Clean Air is a leading UK design and manufacture expert for critical-environment applications. We offer a complete range of cleanroom and laboratory equipment, applications and solutions, all designed and built to stringent ISO 14644 FS209E standards. To find out more about our solutions and services or simply make an inquiry, call 01737924700 to speak with an expert at your earliest convenience. We look forward to hearing from you.
