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The core product for many modular manufacturers and suppliers consists of an “all-purpose” system that can be utilized for a variety of applications from GMP rooms to specific ISO classes. These systems offer a high level of versatility and can be used to outfit existing facilities or to create larger freestanding envelope structures to house separate compartmentalized processes.

Due to the critical environmental conditions that are demanded in precision microelectronics manufacturing and nanotechnology applications, cleanrooms in these industries have typically required systems that integrated well with the equipment needed to run these operations. Framing systems tended to be the ideal solution for these types of cleanrooms. These systems feature both vertical and horizontal members that easily connect to each other to simplify bulk heading and create air tight seals around equipment and tooling. Plus, the non-progressive design allows for easy removal of the walls without the need to remove adjacent panels, framing studs, or ceiling grids.

Due to the unique needs and requirements found within the biomedical, life science, medical device, and pharmaceutical industries, modular cleanroom manufacturers have developed systems exclusively for these markets.

There are six major cleanroom contaminants. All of these are treated in a clean environment to reduce the level of contamination that they cause. These major contaminants are:

A remarkable number of chemicals are used in many cleanroom manufacturing environments. Chemical contamination generally occurs when unwanted chemicals get accidentally added to the desired processing materials.

Another major source of contamination in cleanroom manufacturing is bacteria. Bacteria are a natural part of the environment and may act as either a chemical or a particulate contaminant, or in the worst case both.

The discussion will now focus on the sources of contamination encountered in cleanroom manufacturing, and briefly discuss some of ways that these contaminants are minimised and why this minisization is important. The major sources of contamination in cleanroom manufacturing are:

In some cleanroom manufacturing environments a fairly large number of chemicals are used. Each individual chemical could be a source of contamination. To keep chemicals clean and particulate free highly purified variants are required. These will need to be delivered in clean, non-corrosive containers, transported ‘cleanly’ and not cross contaminated.

Clean rooms need a lot of air and usually at a controlled temperature and humidity. This means that in most facilities the cleanrooms Air Handling Units (AHU) consume over 60% of all the site power. As a general rule of thumb, the cleaner the cleanroom needs to be, the more air it will need to use. To reduce the expense of modifying the ambient temperature or humidity, AHU or systems are designed to recirculate (if product characteristics permit) about 80% air through the room, removing particulate contamination as is it generated and whilst keeping the temperature and humidity stable.

Cleanrooms are defined as a room or suite of rooms, in which the concentration of airborne particles is maintained within established parameters and where other factors are controlled to within specified limits. The most effective way of maintaining the air quality in a cleanroom is to operate and maintain it correctly.

Cleanrooms and clean areas are defined in the GMP’s as having the following characteristics. There are three things that keep a cleanroom “clean”:

design, which we will now explain through an example. Typically, low moisture medicinal products such as tablets or capsules are dry and dusty, therefore more likely to be a significant cross-contamination risk. If the “clean” area pressure differential was positive to the corridor, the powder would escape out of the room and enter the corridor, and is likely then to be transferred into the next door cleanroom. Thankfully, most dry formulations do not readily support microbial growth, so as a general rule, tablets and powders are made in “clean corridor” facilities, as opportunistic microorganisms floating in the corridor don’t find environments in which to thrive. This means that the rooms are negatively pressurised to the corridor.

A clean room, in my mind are a combination of engineering design, fabrication, finish and operational controls (control strategy) that are required to convert a “normal” room to a “clean room”. In this blog I will attempt to explain the necessary characteristics of a regulated company clean room not producing potent chemicals or active or hazardous biologicals. If there are significant containment requirements, the requirements would be outside the scope of a “simplistic” blog like this. In a pharmaceutical sense, clean rooms are those rooms that meet the code of GMP requirements as defined in the sterile code of GMP, i.e. Annex 1 of both the EU and PIC/S Guides to GMP and other standards and guidance as required by local health authorities.

Small particles are all around you. Dust, bacteria, chemicals and other microscopic debris pollute the air and make it difficult to achieve a controlled environment. This can be detrimental to medical research, electronics manufacturing, aerospace engineering and other projects that require a low-pollutant work area. For this reason, many industries utilize cleanrooms in order to reduce the amount of air particles and contaminants. In particular, hardwall cleanrooms have proven beneficial to many businesses, and are now used in everything from pharmaceuticals to semiconductor manufacturing.

Modular cleanrooms are becoming increasingly popular in a wide range of industries. Quick to install and easy to maintain, this type of cleanroom can be suitable for many applications, ranging from medical and pharmaceutical work to manufacturing. If you're not sure whether a modular cleanroom design is right for your organization, why not take the time to learn about the benefits of this type of environment? The following could convince you to try out this type of cleanroom in your own company.

Contamination control depends on a reliable filter system. A malfunctioning filter can introduce contaminants into a controlled environment. Filters need to remove impurities from the process stream but avoid transferring impurities that could wind up on a device’s or product’s surface. The filters themselves must be manufactured and packaged in a controlled environment.

Repairing or replacing inadequate filters can be costly. In particular, custom filters can be expensive and may take weeks or months to be delivered, so adequate planning is a must. Following good protocols will keep filters working right and minimize premature change-outs, with the associated expenses for parts and labor as well as disruption and potential contamination.

Preventive maintenance is obviously the first step to ensure that a cleanroom’s filters function properly, and that the amount of time and money spent on them is minimal.

Laminar Flow Hoods are at times considered an effective alternative for cleanrooms, whereby the installation of cleanrooms is not possible not only in laboratory environments but also in the industrial environments. Laminar flow hoods are also installed within cleanrooms to ensure highly protective environments in sensitive work areas. You will be able to significantly minimize the level of airborne contaminants through the use of laminar flow hoods.

Keep your sensitive cleanroom areas free from contaminants with our cleanroom curtains. Our Anti-static curtains will provide you with the additional protection that your cleanrooms need. We have been a leading supplier of cleanroom anti-static curtains to healthcare facilities and other institutions that work with contaminant sensitive projects, and we take great pride in bringing you an outstanding range of clean room curtain products.

There are two standard types of modular hardwall cleanrooms: recirculating and non-recirculating. Your product and process requirements will determine which type is best-suited to your company’s needs. Click here for information on common industry standards and cleanroom performance requirements.

We offers both recirculating and non-recirculating modular cleanrooms, and will help you decide which option is right for you.

Pass-through cabinets, also called pass-through chambers and pass-through windows, allow for the transfer of parts and equipment into and out of a cleanroom. These specialized entry systems reduce the need for people to enter your cleanroom, and, thanks to lower traffic within the cleanroom, contamination is significantly reduced.

Pass Thru Cabinets help control contaminants entering the clean room during pick-up and delivery of products or supplies. Maintaining a clean environment, yield and productivity are increased as delivery personnel and contaminants remain outside the clean room.

Standard doors are 1/2” thick clear acrylic with T-handle mechanical interlock, full length piano hinge and are gasketed for positive seal. Doors 30” and wider are equipped with a structural integrity bar.

Cleanroom fan filter units are self-contained devices that utilize HEPA or ULPA filters. We offer a full line of standard and custom fan filter units, with numerous options available to meet your specific cleanroom requirements.

For facilities that process clean-critical products in quantities too low to justify the cost of a full cleanroom, a cleanroom bench is the perfect solution. For others, it may be more cost-efficient to build a lower-class cleanroom and supplement it with clean benches that are rated to a higher class.

Whatever your need, laminar flow cleanroom benches can be used to create high purity micro-environments inside or outside a cleanroom. We offer a range of both horizontal and vertical laminar flow benches, in standard and custom styles, to meet your cleanroom needs.

Desiccator cabinets, or desiccators, are sealable enclosures that contain desiccants or nitrogen gas. Desiccators are used to prevent reactions between moisture-sensitive materials and atmospheric humidity. We designs and manufactures a full line of desiccator storage cabinets to meet your needs. Or, we can provide customized desiccators that are tailored to your specifications.

For those in laboratory design, we are aware that cleanrooms can be among the most complicated spaces to design. Cleanrooms offer an area where the particulate count from the atmosphere is regulated. A huge array of clients need clean spaces to run their business, whether it's based on their own SOPs (standard operating procedures) or required by regulatory agencies. Cleanrooms provide an indoor environment unique to any other indoor environment--and with it, pose some special design challenges.

Does the nature of your operations demand that you install modular cleanrooms? Installation of modular cleanrooms does not automatically guarantee the level of contamination prevention that you desire. Here are few important tips that will help you enhance the effectiveness of your modular cleanrooms and thereby achieve the desired results.

Worker cleanliness is essential in any workplace where contamination control is the norm. Although water showers can help you reduce soil on your body, air showers are an effective means of removing contamination from your work clothes.

Air showers are one of the most effective approaches to fight contamination. Though there are diverse views about the effectiveness of air showers in contamination control, it is used widely in industrial environment and in healthcare industries. If you are considering air shower installation for your facility then it is important to have a clear understanding of the functionality of the entire system.

Setting up a cleanroom comes with numerous challenges. When you are setting up a cleanroom you will need to take into account a number of factors such as the size of the cleanroom, type of cleanroom, pass through chambers, nature of the fixtures used within the cleanroom, etc. One of the most important cleanroom setup considerations is the cleanroom lights.

Most basic protocol programs for cleanrooms are based on the Institute of Environmental Science and Technology (IEST) recommended practices for contamination control and the ISO 14644 series of international standards for cleanrooms and associated controlled environments. The focus of any protocol program is to protect the integrity of the cleanroom and the products and processes in the cleanroom from the people working in the cleanroom. Whereas contamination may be due to the product, processes, or equipment in the clean-room, the people working in the cleanroom exercise the greatest control over the cause of and elimination of contamination. Therefore, all protocol programs address the functionality of the cleanroom, the behavior of the people working in the cleanroom,and the cleaning and maintenance of the cleanroom.

After the cleanroom has passed certification, cleanroom personnel must don the required cleanroom apparel applicable to the classification of the cleanroom. IEST-RP-CC003.3 contains a chart of recommended gowning configurations and frequency of change of garments based on the Air Cleanliness Classes of ISO 14644-1. Many clean-room operations require the cleanroom personnel to change from street clothes to 100% polyester building suits or tech suits to reduce the amount of particle contamination in the cleanroom environment. The garment system selected must meet the specifications for the clean-room applications. Facility requirements for changing areas, lockers, in-use garment storage, soiled garment storage, garment inventory storage, and internal inventory transit must be defined. Additionally cleanroom garment laundering and othergarment management services must be defined and subcontracted. 

Meticulous hiring practices for cleanroom personnel include screening potential operators for physical characteristics such as: smoker hiring policy, overweight or obese personnel, facial hair, sensitivity to heat, cold and humidity, and seasonal allergies including skin allergies. Also, when evaluating personal skills and language skills, the human resources department must also evaluate potential cleanroom candidates for mental characteristics such as claustrophobia. Recommendations for personnel behavior in the cleanroom are found in IEST-RP-CC027.2, “Personnel, Practices and Procedures in Cleanrooms and Controlled Environments.”

Garments may be stored inside the cleanroom gowning area as well as the many cleanroom consumable supplies to support the cleanroom operators and the processes inside the cleanroom. Cleanroom supplies should be stored in cleanroom packaging until use. All chemicals and supplies used to clean the cleanroomshould also be stored in original cleanroom packaging until use. Used mops and mop heads should be properly disposed after use. It is recommended that the cleanroom supplies storage area be ventilated under vertical unidirectional air flow. Prior to introduction of any supplies into the cleanroom storageareas, proper wipe down of the exterior packaging should be performed. 

There is no GMP requirement in the EU and PIC/S (i.e. TGA) GMP guidance’s for the manufacture of non-sterile medicinal products in a “clean room”, but we do use clean areas that are effectively ventilated with filtered air where the products or open clean containers are exposed. On the other hand, for the manufacture of sterile medicinal products, clean rooms are mandatory, as defined in Annex 1 of the EU and PIC/S GMPs. This Annex defines a number of additional requirements besides the airborne particulate concentration limits used to classify clean rooms. 

In clean rooms, precision matters. To prevent contamination, the materials, including lighting, must be germ free and the professionals who perform work in clean rooms must be able to conduct their business without introducing contamination into the environment. Cleanroom lighting must meet these rigorous requirements and facilitate the work conducted in the room.

Foot candle (fc) requirements vary throughout cleanroom facilities, from 30 fc in mechanical/electrical rooms to 100 fc or more in the cleanroom. Some cleanroom applications that involve food inspection and grading require at least 150 foot-candles. The engineer should work with the cleanroom staff to determine the proper foot-candle requirements in each of the areas within the space.

The basic cleanroom fixture types are teardrop, recessed, surface mount and integral ceiling grid. The selection of fixture type usually depends on the cleanroom classification.

Contamination control is the primary design goal of any cleanroom. Any potential source of contamination into the cleanroom must be thoroughly evaluated and minimized. Lighting fixtures should be subjected to contamination evaluation. Unfortunately, there are no established standards to prequalify fixtures for a particular cleanroom class. The National Sanitary Foundation (NSF) does provide listing and testing of materials used in food, pharmaceutical, medical or other FDA applications. Fixtures used in these applications should be required to carry the NSF listing mark. Manufacturers often advertise fixtures as being suitable for cleanroom use with no data or standard qualifications to substantiate their claims.

Everything in the cleanroom, including the lighting fixtures, is designed to ensure successful air filtration and maintain the laminar airflow in a contamination-free environment. Depending on the function of the controlled environment, a cleanroom will use either HEPA or ULPA filtration. These air-filtering systems are typically an expensive component and one of the first to be considered in construction. They take up a majority of the ceiling space, which leaves a real challenge for lighting the environment.

Contamination control is the generic term for all activities aiming to control the existence, growth and proliferation of contamination in certain areas. Contamination control may refer to the atmosphere as well as to surfaces, to particulate matter as well as to microbes and to contamination prevention as well as to decontamination.

Contamination poses a significant risk to technical processes, experiments or production activities, as well as to the individuals involved. Unguarded proliferation of contamination can quickly lead to product damage, yield reduction, product recalls and other outcomes highly detrimental to business. Products in a range of industries are recalled due to ineffective contamination control systems.

High efficiency particulate air (HEPA), originally called high-efficiency particulate absorber but also sometimes called high-efficiency particulate arresting or high-efficiency particulate arrestance, is a type of air filter. Filters meeting the HEPA standard have many applications, including use in medical facilities, automobiles, aircraft and homes. The filter must satisfy certain standards of efficiency such as those set by the United States Department of Energy (DOE).

HEPA filters, as defined by the United States Department of Energy (DOE) standard adopted by most American industries, remove at least 99.97% of airborne particles 0.3 micrometers (µm) in diameter. The filter's minimal resistance to airflow, or pressure drop, is usually specified around 300 pascals (0.044 psi) at its nominal flow rate.

For a little over a century, emphasis on performing industrial and medical work in germ and contaminant free environments has risen dramatically following advances in our understanding of these contaminants’ effects. Additionally, as improvements in the sophistication and delicacy of components used in computers and other complex products progresses, the need to keep them contaminant free grows. As such, the development of cleanrooms has been as important to scientific research as it has been to the manufacturing of technology resulting from this research.

For those of us in lab design, we know that cleanrooms can be one of the most complex spaces to design. Cleanrooms provide a space where the particulate count in the air is regulated. A wide variety of clients require clean spaces to conduct their business, whether it’s based on their own SOPs (standard operating procedures) or required by regulatory agencies. Cleanrooms offer an indoor environment unique to any other indoor environment—and with it, pose some unique design challenges.

Low-humidity storage of sensitive samples and supplies can now be done in a pass-through chamber. Desiccators in plastic or stainless steel to comply with ISO cleanliness requirements.

Desiccator storage has become critical in more and more manufacturing operations. A look at the costly effects of moisture exposure explains why. As critical components become smaller and more sophisticated, their susceptibility to moisture damage increases. Once absorbed by sensitive components, water creates a number of potentially disastrous conditions. Even minute traces of oxidation, the most notorious result of moisture exposure, can degrade soldering and other manufacturing processes.

One common method of dealing with moisture contamination is to remove it before each manufacturing step. In the semiconductor industry, vacuum processing and bake-and-bag methods of IC drying accomplish this, but these operations slow down production, particularly if they must be repeated several times in the course of circuit manufacturing. Further, these baking and sealing processes themselves expose parts to thermal extremes that can cause damage.

In a large, multi-chamber enclosure with a single exit bleed valve, it might take 30 min or more to remove this moisture and recover the relative humidity setpoint. If another door is opened during this time, this recovery time will be extended. In fact, during periods of frequent parts access, the desiccator may never attain the humidity setpoint, and parts could be seriously threatened.

In order for a pharmacy compounder to safely and properly mix prescriptions according to legal regulations, a compounding cleanroom is required. The cleanroom, also referred to as a secondary engineering control (SEC) room, is where you will use and house specific equipment such as a laminar air flow workstation (LAFW) and a compounding aseptic isolator (CAI).

Pharmacies are governed under Section 503A of the Compounding Quality Act and must meet minimum cleanliness requirements in order to pass regulation and ensure sterile conditions for compounding. Following and adhering to these requirements is pertinent to providing safe conditions both for you and for the recipients of the prescriptions, especially when compounding prescriptions that are considered hazardous.