Q-1. 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”
Q-2. 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.
Q-3. 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
Q-4. 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.
Q-5. Cleanroom Classification Table
| Cleanroom Standard | Cleanroom Classification Guidelines | |||||
| ISO 14644-1 | Class 3 | Class 4 | Class 5 | Class 6 | Class 7 | Class 8 |
| Federal Standard 209E | 1 | 10 | 100 | 1,000 | 10,000 | 1,00,000 |
| EU GGMP | – | – | A/B | – | C | D |
| Air changes / hour | 360-540 | 300-540 | 240-480 | 150-240 | 60-90 | 5-48 |
Q-6. For Cleanrooms and clean zones shown in ISO 14644-1:1999
| ISO | ||||||
| Classification | Maximum concentration limits (particles/m³ of air) for particles equal to and | |||||
| Number | larger than the considered sizes shown below | |||||
| ≥0.1µm | ≥0.2µm | ≥0.3µm | ≥0.5µm | ≥1.0µm | ≥5.0µm | |
| ISO Class 1 | 10 | 2 | – | – | – | – |
| ISO Class 2 | 100 | 24 | 10 | 4 | – | – |
| ISO Class 3 | 1000 | 237 | 102 | 35 | 8 | – |
| ISO Class 4 | 10,000 | 2,370 | 1,020 | 352 | 83 | – |
| ISO Class 5 | 10,0000 | 23,700 | 10,200 | 3,520 | 832 | 29 |
| ISO Class 6 | 1,000,000 | 237,000 | 102,000 | 35,200 | 8,320 | 293 |
| ISO Class 7 | – | – | – | 352,000 | 83,200 | 2,930 |
| ISO Class 8 | – | – | – | 3,520,000 | 832,000 | 29,300 |
| ISO Class 9 | – | – | – | 35,200,000 | 8,320,000 | 293,000 |
Q-7. What is DOP testing?
* DOP testing is the process in which the integrity of your HEPA (High Efficiency Particulate Air) or ULPA (Ultra Low Penetration Air) filter is tested through the introduction of particulates. Oil is dispersed as an aerosol into the upstream flow of the filter media while the number of particles in the downstream flow is measured using a calibrated photometer
Q-8. Why have DOP tests?
** Equipment using a HEPA or ULPA filter should be tested every time the equipment is moved to ensure no damage due to transportation has occurred and at regular intervals. If your filter is not working efficiently you run the risk of contamination entering your cleanroom, potentially impacting on your processes and product quality and, in turn, affecting your cleanrooms classification. A DOP test can therefore reduce costly product recalls, saving money, time and preventing damage to your brand.
Q-9. How many filters should I install in my cleanroom?
* HEPA & ULPA filters used in most stringent cleanrooms are generally built in ceiling and can be installed in groups housed in a proprietary modular pressure plenum system. They can also be installed in single filter housings, individually ducted, suspended in an inverted “T” grid support system, and sealed to prevent unfiltered bypass air from entering the cleanroom. Cleanroom design conventionally follows the following guidelines for filter coverage.
| ISO Class | Fed 208 | Controls | HEPA Coverage as % of Ceiling |
| 1 | – | Stringent | 100 |
| 2 | – | Stringent | 100 |
| 3 | 1 | Stringent | 100 |
| 4 | 10 | Stringent | 100 |
| 5 | 100 | Stringent | 100 |
| 6 | 1,000 | Intermediate | 33 – 40 |
| 7 | 10,000 | Intermediate | 10 – 15 |
| 8 | 100,000 | Less Stringent | 05 – 10 |
Q-10. Why do I need a Cleanroom?
* The electronics, high-tech, semiconductor, pharmaceutical, aerospace, medical and many other industries rely on Cleanroom technology. As products such as cell phones and microchips get smaller, the chance for contamination during the manufacturing processes becomes higher. For these types of companies, clean, safe, contaminant-free products are essential to manufacturing and distributing a profitable product.
Q-11. Can I redesign my Cleanroom when my needs change?
* ? Yes. Every company’s needs change overtime, and their Cleanrooms can change right along with them. All our Cleanrooms are ‘backward compatible’, meaning they can be expanded or decreased in size, components can be added or removed or any change can be made to your existing room.
Q-12. What type of company should design, install and equip my Cleanroom?
* The electronics, high-tech, semiconductor, pharmaceutical, aerospace, medical and many other industries rely on Cleanroom technology. As products such as cell phones and microchips get smaller, the chance for contamination during the manufacturing processes becomes higher. For these types of companies, clean, safe, contaminant-free products are essential to manufacturing and distributing a profitable product.
Q-13. Will I need an engineer or architect to design my room?
* No. We’re not only Cleanroom experts, we’re engineers! Our Cleanroom specialists are experts in every part of Cleanrooms, including design. We can design the entire room for you, or work with your staff to create the perfect room for your needs. Our Cleanrooms are pre-fabricated, completely customizable and designed to your specs.
Q-14 What kind of Cleanroom do I need?
* That depends on what you will use it for. With so many different options, we can design a Cleanroom that fits your requirements now, and for years to come. Contact us today to discuss your options and find the perfect room.
Q-15. Can I use my existing building structure?
* Yes. Our hardwall and rigidwall Cleanrooms can be installed in a variety of environments as a free-standing or architecturally supported structure. Contact our Cleanroom specialists and we’ll visit you on-site to discuss your framework and recommend a Cleanroom to work within your existing structure. Softwall Cleanrooms are typically only designed as free-standing structures.
Q-16. How much will my Cleanroom cost?
* Again, it depends on what you will use it for and what class of Ceanroom you need. As your requirements get stricter, the cost usually gets higher. For instance, a class 100 Cleanroom will cost more than a class 10,000 cleanroom. Costs associated with filtration, temperature, humidity control and other factors increase or decrease the price. Because of all these variables, it is impossible to give an estimate for your project here on our website. Please fill out the ‘Cleanroom Quote Questionnaire’ and we’ll have a cost estimate for you as soon as possible.
Q-17. How does the cost of a modular Cleanroom compare with conventional construction?
* When you compare features, installation and maintenance of a modular Cleanroom to conventional construction, the modular room will always cost less. And consider that you can depreciate a modular room up to 5 times faster than a conventional room; there is no comparison.
Q-18. Does a Cleanroom control sound?
* Yes, it can. Depending on the type of room, and the type of walls, a Cleanroom can control sound in even the loudest manufacturing conditions. If sound control is an issue to your company, let us know and we can design a room just for your needs..
Q-19. Will the construction disrupt my facility?
* Any type of construction will disrupt your facility to some degree, however the more quickly you can install the Cleanroom, the less disruptive construction will be. Since Cleanrooms install more quickly than others, and delivery is customized to your needs, you’ll have less disruptions and more productivity.Any type of construction will disrupt your facility to some degree, however the more quickly you can install the Cleanroom, the less disruptive construction will be. Since Cleanrooms install more quickly than others, and delivery is customized to your needs, you’ll have less disruptions and more productivity.
Q-20. What is the process for designing and building a cleanroom?
* We’re cleanroom specialists familiar with all aspects of designing, building and maintaining a cleanroom. We’ll guide you through every step of this process and deliver exactly the room you need, on-time and within budget.
Q-22. What if I need to replace a major component of my cleanroom?
* We can help you with that too! We offer all the components of a cleanroom and can help you replace them quickly and easily.
Q-23. What is Federal Standard 209E?
* It’s a government document that outlines the classes for air cleanliness. Although it’s not specific to cleanrooms, the industry has adopted it as its own standards.
Q-24. Why Laminar Flow Cabinets?
* Laminar Flow Cabinets create particle-free working environments by projecting air through a filtration system and exhausting it across a work surface in a laminar or uni-directional air stream. They provide an excellent clean air environment for a number of laboratory requirements.
Q-25. Horizontal Laminar Flow Cabinets
* Horizontal Laminar Flow Cabinets receive their name due to the direction of air flow which comes from above but then changes direction and is processed across the work in a horizontal direction. The constant flow of filtered air provides material and product protection.
Q-26. Vertical Laminar Flow Cabinets
* Vertical Laminar Flow Cabinets function equally well as horizontal Laminar Flow Cabinets with the laminar air directed vertically downwards onto the working area. The air can leave the working area via holes in the base. Vertical flow cabinets can provide greater operator protection..
Q-27. How They Work Laminar Flow Cabinets
* The process of laminar air flow can be described as airflow where an entire body of air flows with steady, uniform velocity. Laminar Flow Cabinets work by the use of in-flow laminar air drawn through one or more HEPA filters, designed to create a particle-free working environment and provide product protection. Air is taken through a filtration system and then exhausted across the work surface as part of the laminar flows process. Commonly, the filtration system comprises of a pre-filter and a HEPA filter. The Laminar Flow Cabinet is enclosed on the sides and constant positive air pressure is maintained to prevent the intrusion of contaminated room air.
Q-28. Biological Safety Cabinet Uses
* Biological Safety Cabinets offer protection from microbiological contamination in the laboratory environment, including both operator and product protection. They are utilised by a wide range of scientific, research and development organisations within both the commercial and non-commercial sectors, including pharmaceutical, medical, clinical research, defence, education and general healthcare sectors. Biological Safety Cabinets safeguard users, materials and the environment from aerosol hazards and other types of environmental contamination.
Q-29. Biological Safety Cabinet Names
* As well as Biological Safety Cabinet, the most commonly used name for this product is microbiological safety cabinet. Other frequently used names include safety cabinet, bio-safety cabinet, biological cabinet and laboratory safety cabinet. Other associated products include clean rooms, laminar flow equipment and fume extraction systems.
Q-30. Choosing a Biological Safety Cabinet
* While several different types of Biological Safety Cabinet exist, including Class 1, Class 2, Class 3 (see below), all safety cabinets can be created and provided in accordance with the exact ergonomic and bio-safety usage requirements of the laboratory. This is recommended best practice. In all cases though speak to an experienced provider, ideally one which specialises in the production of biological safety cabinets, bio-technology and clean air products.
