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FAQs
Let Us Answer Your Questions
A cleanroom is an important investment, so no doubt you have a lot of questions. We've answered the questions we get asked the most here, but if you have any questions which aren't mentioned please Contact Us.
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.
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. The aluminium lid and body enclose a forward-inclined centrifugal-type fan/motor with permanently lubricated bearings. 2 x 4 models are UL listed; 220V models are CE marked.
- Provides an average air flow velocity of 0.45m/sec and air flow of 1102 m3/hour under filter load, creating up to 300 air changes per hour.
- Low noise level fan unit: 50dBA
- Low-Profile design
How long will the HEPA Fan Filter Unit last?
A HEPA filter can last two to five years or more in a standard cleanroom environment. Life of the HEPA also 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
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 class of the cleanroom you require. Please Contact Us with your requirements and we can draw up a detailed proposal.
Will I need to leave the cleanroom running all the time?
There is no requirement within ISO 14644-14 that says you need to leave your cleanroom running constantly. This can be regarded as best practice. A cleanroom from Connect 2 Cleanrooms Ltd comes with a variable speed controller, so you can lower air speeds when the room is out of operation to reduce running costs.
What's 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.
Do I need temperature and humidity control?
High humidity can affect a cleanroom as it could lead to a breeding ground for micro-organisms and 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.
Will your cleanroom satisfy the audits which I am subject to?
Following installation, a comprehensive validation report will be supplied detailing our agreed scope of works which can be adapted to suit your requirements; 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 and as such.
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.
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 supply the unit's model number or serial number.
Does my system need to be validated?
Upon installation of your room it will be validated and we will supply you with a full validation report. Your room will then need to be validated at regular intervals depending on your particular ISO class requirements. See classification chart. Our aftercare service can provide you with a service contract so we will take care of the maintenance of the room.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, or as a backup option. If you are interested in renting cleanrooms, please Contact Us
Why do you need to clean a cleanroom?
Although the level of contamination is hugely reduced in a cleanroom they do still need cleaning; as processes, operators and machinery inside the room will unavoidably introduce microbiological and airborne 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.
I have concerns about the ability of bugs to gain access; please advise.
The purpose of the cleanroom is to reduce and remove airborne contamination as the standard clearly says. 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.
Rentokil will set up a system that will be fully auditable and prove that you have sufficient controls in place. http://www.rentokil.co.uk/commercial-pest-control/your-business/civil-and-municipal/healthcare/index.html
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 call us to speak to one of our cleanroom experts on 015242 74170.