Answers to Frequently Asked Questions
Find answers to the questions CE is asked most often. Please contact us If you don’t see your question here.
Find answers to the questions CE is asked most often. Please contact us If you don’t see your question here.
Generally, we use these different air flow systems in cleanrooms:
- Pressurized Plenum or Interstitial Area — Air is pumped into the interstitial area and filters push the air down into the cleanroom.
- Ducted Supply and Ducted Return — The air is ducted to and from the cleanroom.
- Ducted Supply and Open Return — The air is ducted into the cleanroom and flows to an open return.
- Negative Pressure Design — This configuration prevents contaminants from entering the surrounding area. The air is exhausted to a safe location.
Cleanrooms are also referred to as “once-through” and “recirculating” design.
Because CE is a design/build contractor of clean and critical environments, we provide the best design for your situation. That means cleanrooms that offer compliance with all classes, from ISO Class 1 through ISO Class 9. We install hardwall cleanrooms, softwall cleanrooms or a combination of both.
CE’s modular cleanrooms significantly reduce your design, engineering and construction time as well as cost. They offer several distinct advantages over fixed-wall cleanrooms, including:
- Portability — Since it’s not a permanent part of your larger structure, a modular cleanroom can be disassembled and relocated, moved to another facility, or even sold as an asset.
- Expandability — Our modular cleanrooms are easy to expand; simply remove one (or more) walls and add another cleanroom module. Our prefabricated designs permit your cleanroom to be expanded, reconfigured in a different layout or divided into multiple, smaller rooms.
- Quick Turnaround — While building a fixed-wall cleanroom may take several months, CE will build and install a sophisticated, modular hardwall cleanroom in just a few weeks. On-site assembly of our modular cleanrooms is also significantly less disruptive to your day-to-day operations.
A white room, also known as a critical environment or environmental room, is similar to a cleanroom but with less stringent controls. Environmental rooms must be built separately and maintain temperature and pressurization — making them ideal for applications such as packaging rooms and coordinated measuring machine rooms. Because the requirements aren’t as strict, an environmental room typically costs less.
Yes. CE’s wall systems are designed to meet ISO 5 to ISO 7 standards for pharmaceutical cleanrooms and help maintain product sterility. Air filtration systems help reduce the risk of pollen and microbial contamination.
Yes, that is possible. Depending on the condition and structure of your facility, our cleanroom solutions can be installed utilizing the existing walls. Contact the CE for help in designing your project.
Yes. As companies grow, needs change and so can your cleanroom. Whether you need more space or need to change your current room configuration, you’re not locked into your original design. Many parts are interchangeable and can be reassembled and reused as required.
The CE will handle the design of your cleanroom using our in-house architectural and engineering services. These are included in our package.
Most cleanrooms are held in positive pressure (except when dealing with hazardous products, which must be held in negative pressure). This means that the air flows out of the room instead of into it, thus preventing unfiltered air or air particulates from entering the cleanroom.
The HVAC system is responsible for creating pressure differentials to keep pressure cascades between the divisions of the cleanroom and the outside of the cleanroom. The presence of a fume hood or a biosafety cabinet (BSC) must be taken into account in the design of the HVAC system, as some BSCs exhaust the air to the outside (hazardous drugs or other chemicals), which unbalances room pressure. To maintain the correct pressure in the cleanroom, the air output must be compensated with fresh air.
CE will help determine the correct pressure differential for your application.
An LAFW cannot be used for compounding an antineoplastic HD (see USP <800> 5.3.2 Sterile Compounding). However, for handling non-antineoplastic and reproductive-risk HDs, each facility may conduct an assessment of risk and implement alternative containment strategies and/or work practices.
An LAFW does not provide a worker with any protection from the HD. A LAFW or CAI may be used for non-antineoplastic HDs. However, alternative containment strategies and/or work practices must be determined during the assessment of risk.
Positive pressure rooms maintain a higher pressure inside the treated area than that of the surrounding environment. This means air can leave the room without circulating back in, meaning that any airborne particle that originates in the room will be filtered out. Germs, particles and other potential contaminants in the surrounding environment will not enter the room. In medical settings, a positive pressure room allows staff to keep vulnerable patients safe from infections and disease.
In contrast, a negative pressure room uses lower air pressure to allow outside air into the segregated environment, which traps and keeps potentially harmful particles within the negative pressure room by preventing internal air from leaving the space. Negative pressure rooms in medical facilities isolate patients with infectious conditions and protect people outside the room from exposure.
CE works with all sizes of critical environments — from small cabinets to full-size rooms requiring up to 10,000 cubic feet per minute (CFM).
The heat load determines the size of the environmental control system required to cool the space. Different heat loads may require a solution as small as a 1/4-ton electronic control unit (ECU) to a multi-system 25-ton capacity approach.
Similar to standard HVAC, the HVAC of a cleanroom controls the temperature and humidity to different levels of precision to create a comfortable environment. Cleanroom HVACs differ from conventional systems due to their increased air supply, air flow patterns, the use of high-efficiency filters and room pressurization. The increased air supply brings more air changes per hour with HEPA-filtered air circulating into the cleanroom many times per hour. A conventional HVAC system usually offers 2 to 4 air changes per hour, whereas a cleanroom HVAC system provides between 15 to 250+ air changes per hour.
Cleanroom HVAC designs require knowledge of regulations, cleanliness level guidelines, airflow, room pressurization, and temperature and humidity control, and must account for the processes taking place inside.
The ventilation ducts are also different and require engineering knowledge. The HVAC must also maintain the appropriate pressure differential to prevent air from leaking from a less clean zone to a cleaner zone inside the cleanroom.
Contact CE for help designing the right system for your application.
Absolutely. The location of the supply and exhaust (return) air grilles should take the highest priority when laying out the cleanroom. The supply (from the ceiling) and return air grilles (at a low level) should be at the opposite sides of the cleanroom to facilitate a “plug” flow effect. If the operator needs to be protected from a high-potency product, for example, the flow should be away from the operator.
For a sterile or aseptic process that needs Grade A air, the airflow typically mimics a plug flow from top to bottom and is unidirectional or “laminar.” Careful consideration should be given to ensuring that the “first air” is never contaminated before it comes into contact with the product. CE has decades of experience designing mechanical systems within critical environments. Contact us for help deigning your cleanroom.
An air shower is a hallway or room that leads to the entrance of the cleanroom. Often, the air shower is located between the gowning area or anteroom and the entrance to the cleanroom. Within the air shower, high-velocity air blows off debris that could contaminate the cleanroom environment. Sometimes de-ionizers are used to remove static, thereby increasing the effectiveness of hair and lint removal.
Contact CE for help determining the correct size and style of air shower that best fits your situation.
A pass-through (or pass-thru) is a chamber that allows items to be moved between cleanrooms or between cleanroom and non-cleanroom areas. Less traffic in and out of the cleanroom means fewer chances for contaminants to enter. Pass-throughs can also be designed so that only one door will open at a time. This, in conjunction with higher air pressure inside the cleanroom, forces particles out when the inner door opens.
Contact CE for help determining the correct size and style of pass-through that best fit your situation.
We supply many different components for cleanroom use — from hoods, laminar flow benches and cleanroom tables to workbenches, storage cabinets, garment racks and pass-through boxes.
Cabinets in a non-sterile compounding area must be smooth, impervious, free from cracks and crevices, and non-shedding, but the specific materials that may be used are not limited or specifically defined. CE will provide the proper cleanroom furnishings for your facility.
A typical time period for a turnkey project with a mechanical system is 10 to 12 weeks. However, smaller cleanrooms can be assembled and ready to use more quickly. The CE Installations division includes industry experts with years of experience in the construction of our systems. Our design/build method of construction improves the speed of design and installation.
Depending upon the use of the cleanroom, testing and certification are usually performed at initial installation and at specified intervals. In the medical field, certification is performed semi-annually or annually. Electronics firms may have independent testing initially and whenever problems occur, but they typically monitor their rooms daily with in-house personnel.
Contact CE for help getting your cleanroom certified.
Yes. CE has a system for tracking and logging pressure, temperature and humidity. It’s called our “Prism System.” Contact us for more information.
Yes. CE has several installation teams at work around the country installing our products. We offer assistance from the initial design through completion/validation.
Yes. Care must be taken to locate water sources and drains in areas where their presence does not interfere with required ISO classifications. Water sources and drains must be located at least one meter from the Containment Primary Engineering Control (C-PEC).
Within an ISO classified area, a handwashing sink must be placed in the anteroom at least one meter from the entrance to the HD buffer room to avoid contamination migration into the negative pressure HD buffer room.
Within an unclassified C-SCA, a handwashing sink must be placed at least one meter from C-PEC and may be either inside the C-SCA or directly outside the C-SCA.
Yes. Immediately following the installation, an extensive cleanroom validation report is prepared that contains certain variables such as particle counting, flow velocity, flow rate determination, sound pressure levels and lux levels (brightness). This report is in line with the ISO14644-1 standard and satisfies the requirements of customer audits.
We can. We offer the most comprehensive product offerings for USP <797> and USP <800> compliance. Our expert pharmacy cleanroom design team builds and implements compliant rooms nationwide. Our expertise in USP standards helps you avoid costly mistakes while assuring complete compliance with all requirements.
CE is your “cleanroom one source.” CE takes any cleanroom project from initial planning to complete turnkey construction and through final certification. We also modify existing facilities to meet current regulations and guidelines.
Yes. Sterile and non-sterile HDs may be stored together. However, HDs used for non-sterile compounding should not be stored in areas designated for sterile compounding in order to minimize traffic into the sterile compounding area (see USP <800> 5.2 Storage).
Additionally, antineoplastic HDs requiring manipulation (other than counting or repackaging of final dosage forms) and any HD with active pharmaceutical ingredients (APIs) must be stored separately from non-HDs in a manner that prevents contamination and personnel exposure. These HDs must be stored in an externally ventilated, negative pressure room with at least 12 air changes per hour (ACPH).
Non-antineoplastic, reproductive risk only, and final dosage forms of antineoplastic HDs may be stored with other inventory if permitted by entity policy. Refrigerated antineoplastic HDs must be stored in a dedicated refrigerator in a negative pressure area with at least 12 ACPH (e.g., storage room, buffer room or Containment Segregated Compounding Area (C-SCA).
Yes. A refrigerator must be dedicated to HD storage and located in a negative pressure room with at least 12 ACPH. Refrigerated antineoplastic HDs must be stored in this dedicated refrigerator. HD APIs requiring refrigeration must also be stored according to USP <800>.
Other HDs may be stored in this dedicated refrigerator or may be stored with other inventory if an assessment of risk has been performed and implemented.