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Let Connect 2 Cleanrooms answer your questions

A cleanroom is an important investment, so you probably have a lot of questions.

Here we've answered the questions we get asked the most, but if you have any questions which aren't covered please Contact Us.

What is an FM Approval 4882 for the Puracore Aluminium Honeycomb panel?

FM Approval 4882 - FM Global: are a leading international Auditor providing global commercial and industrial insurance. FM Approvals are a third party certification issued by leading auditor FM Global. They ensure a consistently uniform and reliable product and service conformity to highest industry standards. The certificate safeguards against loss. FM Approval 4882 is an approval standard for Class 1 Interior Wall and Ceiling Materials or Systems for Smoke Sensitive Occupancies Class Number 4882. FM Approval 4882 ensures that the product does not contribute to fire in case fire breaks out. Testing procedure - In order to meet the FM 4882 criteria, the Puracore Aluminium Honeycomb panel had to pass the FM 4880 standard Fire Test, the ASTM E84 test and a 16ft High parallel panel test. This process involved a detailed factory audit where the FM surveyors followed each part of Puracore’s manufacturing process and materials used. Following the initial site inspection, full size samples of the Puracore Aluminium Honeycomb panels were then taken to the FM’s test centre in Boston, USA and were rigorously tested for smoke emission and fire performance. The Puracore cleanroom system outperformed all expectations and have proven to omit low levels of smoke and minimal spread of flame under test.

I’ve just seen a documentary showing V W diesel engines being assembled within a cleanroom environment similar to what would be used for semiconductor fab. Is there real benefits to this or is it 100% marketing?

Absolutely no question that cleanroom conditions are ESSENTIAL for diesel injection components, but they are more like recommended than necessary" for engine assembly. Temperature control can help maintain dimensional tolerances during assembly and inspection. Delphi, Bosch, Ford, Perkins and Nissan are all clients that utilise cleanrooms at various stages of manufacture to ensure quality and reduce the risk of failure.

What is a cleanroom?

As defined in the International Organisation for Standardisation ISO 14644-1, A cleanroom is a, "room in which the concentration of airborne particles is controlled and which is constructed and used in a manner to minimise the introduction, generation and retention of particles inside the room and in which other relevant parameters e.g. temperature, humidity and pressure are controlled as necessary"

How can Connect 2 Cleanrooms & cleanroomshop.com help our organisation achieve the Standard BS 8568:2013 - Energy reduction opportunities in cleanrooms?

We have been through the standard thoroughly and as it stands we have a lot to offer. Clauses within the standard cover many areas for example airflow, occupancy levels, Building Management Systems (BMS) which are areas that we can facilitate via our ECO-1 Closed Loop Control System. Another important Clause covers Garment Requirements and we offer all forms of cleanroom clothing, cleaning and furniture through cleanroomshop.com. Operator Competence is featured in the BS 8568:2913 Standard and we are pleased to promote our Cleanroom Training Course in September 2013. Visit our Cleanroom Training Page or Contact Us for more information on the next Cleanroom Training Day and for further information on how we can help you meet BS 8568:2013.

We are interested in working with graphene - are your cleanrooms suitable for our application?

Graphene is a newly discovered 2D material, one-atom thick, bonded in a hexagonal pattern. It is being produced by a Manchester University spin off, as its properties make it suitable for applications, such as transistors, gas sensors, membranes and coatings. Our cleanrooms are suitabe to protect the work with similar organisations, such as Nanoco Technologies, that produce 0D quantum dots (see our case study on working with Nanoco).

Have you any information on the recent meningitis outbreak in the US?

Yes we have the FDA Report (PDF) on their findings at the New England Compounding Center. The American pharmaceutical compounding company have been linked to the outbreak and it is thought sterile injectable drugs were contaminated. If you are concerned about contamination, please see our cleanroom supplies division Cleanroomshop.com's cleaning range.

What is laminar airflow?

Laminar airflow is a controlled airflow in which the entire volume of air within a designated space moves at a uniform velocity in a single direction along parallel flow lines. Our cleanrooms and laminar flow cabinets use vertical laminar airflow, which means air moves from the top of the room, down to the bottom. Why not click here for more information?

What are HEPA filters?

High Efficiency Particulate Air (HEPA) filters are 99.99% efficient in removing particles 0.3 micron and larger. HEPA filters utilise glass fibre rolled into a paper-like material. This material is pleated to increase the fibre surface area and bonded, or potted, into a frame. Hot melt is used to hold the pleats far enough apart to allow air to flow between them.

Fan Filter Units (FFUs) enclose the HEPA filter in an aluminium lid and body and use a forward-inclined centrifugal-type fan/motor with permanently lubricated bearings to draw through the volume of air. 2 feet x 4 feet models are UL listed; 220V models are CE marked. The FFUs also contain a prefilter which filters out larger particles before they get to the HEPA filter, which prolongs the life of the HEPA.

  • Provides an average air flow velocity of 0.45m/sec and air flow of 1102 m3/hour under filter load.
  • Low noise level fan unit: 50dBA
  • Low-Profile design

How long will the HEPA Fan Filter Unit (FFU) last?

A HEPA filter can last two to five years or more in a standard cleanroom environment. Life of the HEPA depends on ambient conditions and maintenance of the prefilters. One of the many advantages of the FFU is that since airflow capacity decreases and static pressure increases over time, HEPA filters actually become more efficient as the filter loads. The filter should be changed once it has reached its capacity. For example, if a HEPA unit is set to for 90 ft/min (0.45 m/sec) on the setting, but is only achieving 70 ft/min (0.35 m/sec), then the HEPA filter should be changed. For further information contact us today and our qualified Engineers will be happy to speak with you.

How many HEPA fan filter units (FFU) will I need in my cleanroom?

This will vary from room to room as it is dependant on the size and cleanroom classification you require. Please contact us with your requirements and we can design a detailed proposal.

Will I need to leave the clean rooms running all the time?

There is no requirement within ISO 14644-14 that says you need to leave your cleanroom running constantly. Every cleanroom solution from Connect 2 Cleanrooms comes with a variable speed controller, so you can lower air speeds when the room is out of operation to reduce running costs. Our Control Panel allows you to vary the airflow in a way which will reduce energy consumption, without compromising on air quality.

What is a micron?

A micron is equal to one-thousandth of a millimetre. The smallest particle the human eye can see is 50 microns.

When should I change the prefilter?

In dirtier environments, the prefilter may need to be changed as often as every one to three months. Frequency will depend on ambient conditions. Contact us today to discuss your prefilter management.

Do I need temperature and humidity control?

High humidity can affect a cleanroom as it could be a breeding ground for micro-organisms; whereas low humidity can cause static. However, this is in extremes. Typically air conditioning and humidity control are only needed for operator comfort or process control and are not a specific requirement of ISO 14664-1. Follow this link for more information on air conditioning and temperature control.

Will your cleanroom satisfy the audits which I am subject to?

Following installation, a comprehensive cleanroom validation report will be made available detailing our agreed scope of works; including filter scan certificates, airborne particle counts, air flow, air changes and lighting lux levels if required. The format of the report will meet the requirements for your customers and any nominated regulatory body as it is in line with the ISO standards. Please follow this link for more information on the importance of cleanroom validations.

Does a cleanroom need a pressure differential?

To prevent the introduction of unclean air to a cleanroom, air needs to flow from the cleanest to the dirtiest area. Air will always flow from a higher to a lower pressured area; so a pressure differential is a consequential measure of this airflow. ISO 14644-1 relates only to particle size and concentration, so to adhere to this standard a pressure differential is not required, but can be used as a reliable indicator that the cleanroom is functioning. Sufficient air changes with an outward airflow are also required to ensure that particles are being removed from the room, not retained. Connect 2 Cleanrooms demonstrate a cleanroom smoke visulisation test portraying an outward airflow.

How can I order replacement parts?

Connect 2 Cleanrooms can supply replacement parts for both of the units that we have manufactured. To identify the correct unit and the proper parts, please contact us and supply the unit's model number or serial number.

Does my cleanroom need to be validated?

Upon installation of your cleanroom it will be validated and we will make your validation report available to you. Your cleanroom will then need to be validated at regular intervals depending on your particular ISO cleanroom classification requirements. Our aftercare service offer can provide you with a service contract which means that we will take care of your cleanroom maintenance taking that worry away from you. Please visit the cleanroom validation area on our web site or contact us today to speak to one of our qualified Engineers about your validation requirements.

How soon can I have a cleanroom?

Our cleanrooms have an extremely short lead time compared to traditional build cleanrooms. On average they take just 2 weeks from approval of drawings with only a couple of days required for installation.

Can I rent a clean room from you?

Looking for modular cleanroom rental? We do have a number of different sized cleanrooms which are available for rent. This is useful if you only require a cleanroom temporarily. If you are interested in renting cleanrooms, please contact us today and we will be happy to discuss your requirements.

Why do you need to clean a cleanroom?

Although the level of contamination is hugely reduced in a cleanroom they still need cleaning as processes, operators and machinery inside the room will unavoidably introduce microbial and airborne particulate contamination. Every cleanroom will need a tailored cleaning regime. For example, if you are concerned about microbial contamination, you may need to introduce a rotational cleaning programme. On completion of installation Connect 2 Cleanrooms Ltd will supply you with recommended cleaning protocols to help you determine the correct cleaning regime for your cleanroom. Our consumables division cleanroomshop.com offer ongoing support and supplies.

I have concerns that pests may gain access to my cleanroom; please advise.

The purpose of the cleanroom is to reduce and remove airborne contamination. Irrespective of which design of cleanroom you use you will always be asked to provide pest control documentation for any medical / Pharmaceutical producer.

The best approach is to organise a site survey for pest control (flying and crawling insects in this case) The pest control company will recommend the measures to control and leave and attend site to inspect and log findings and visits, the flying insect controls should be the sticky rotating role type and not the zap type that leaves debris.

Ensure that your chosen supplier will be fully auditable and be able to prove that you have sufficient controls in place.

We can fit solid walls with grills but this would reduce the effectiveness of the room and will not prevent insects getting into the room.

The addition of BS EN ISO 13485:2003 to ISO 9001:2000 will also help with additional systems for the medical device manufacture.

An external auditor has advised that we need to be achieving at rest particle counts whilst in operation, is this correct?

No this is not correct; the GMP guidelines state 2 particle count requirements. One of the particle counts is taken at rest and the other is taken in operation.

Example: Particle counts at rest ≥0.5µm for a GMP Grade B Cleanroom are 3,250 whilst in operation ≥0.5µm the guidelines state you are allowed up to 352,000. The in operation particle count is showing that an allowance is made for activity in the room but at rest the count would need to fall to the lower requirement.

For even more information please see the chart on the Cleanroom Information page or contact us today to speak to one of our cleanroom experts on 01524 813020.

 
 
 

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