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The Design & Classifcations for Pharmaceutical Cleanrooms

 

Cleanrooms are used in a broad range of industries to facilitate careful control of environmental factors such as air quality, pressure, temperature, and more. Liberty Industries is an industry leading pharmaceutical cleanroom manufacturer and a global distributor of accessories and supplies. We act as a single source supplier for any cleanroom needs. The quality of our products is matched only by our commitment to customer service.

At Liberty Industries, we’ve provided cleanrooms for customers in an expansive range of industries, including the pharmaceutical sector. Our experienced engineers will gladly customize any of our products to fit the unique needs for any application. With a great deal of experience designing and constructing pharmaceutical cleanrooms, you can be sure that our skilled team will provide a solution.

Designing a Pharmaceutical Cleanroom

A variety of products cannot be manufactured safely outside of a cleanroom. This is especially true for pharmaceutical products, which must maintain strict purity levels. Cleanrooms are designed to carefully control important environmental factors to mitigate the risk of product or sample contamination.

What Kind of Cleanroom Do I Need?

The level of cleanroom cleanliness required for a pharmaceutical cleanroom can vary depending on the product. Some pharmaceuticals are considered to be non-sterile medical products. This means that the cleanrooms used in their production typically only require filtered air and effective ventilation. Conversely, sterile medical products require much stricter environmental controls for their cleanrooms.

Clean and Dirty Corridors

Different product types face separate risks that can be addressed by applying positive and negative pressure to the cleanroom as required;

  • Clean corridors. Pills and tablets made from powders aren’t friendly to microorganisms, but they do pose a risk of cross-contamination between products. As such, most cleanrooms for these products are negatively pressurized to keep powders from drifting out of the room and into other parts of the manufacturing facility. This is known as a “clean corridor” system.
  • Dirty corridors. Cleanrooms for biopharmaceuticals, liquids, or aseptic will be positively pressurized to keep microorganisms from entering the space. This is known as a “dirty corridor” set up.

Of note, doors should always open into the area with the higher pressure to avoid contamination.

Keeping a Cleanroom Clean

There are many processes working in conjunction to maintain the desired environment and cleanliness in pharmaceutical cleanrooms. Some of these include:

  • Air filtration. Air handling systems are designed to maintain enough airflow within the space to keep particulates from settling on surfaces. The higher the cleanliness standards of the cleanroom, the more air must be used for this purpose. HEPA filters and ULPA filters are used to catch these particulates and filter them out of the airflow.
  • Air circulation. Excess moisture in the air of the cleanroom can be detrimental to the viability of many different types of pharmaceutical products. In instances where humidity must be controlled, air handling systems will be designed to recirculate less air. Instead, they supply fresh air into the room to push the moisture safely outside. The same process for removing humidity can also remove toxic elements created from production processes or raw materials.
  • Surfaces. It’s critical that all surfaces in a cleanroom are completely smooth. Microorganisms and other contaminants can build up in cracks and grooves, ultimately impacting the cleanliness of the cleanroom. Surfaces should be easy to wipe down, shouldn’t contain coatings that could peel or crack, and should be resistant to cracking or denting from impacts.

Pharmaceutical Cleanroom Classifications

No cleanroom is 100% free from contaminants. However, cleanrooms are defined by the concentration of particles per cubic meter within the cleanroom environment. ISO 14644-1 is the most widely followed classification system for pharmaceutical cleanrooms, with ISO 1 as the highest level of cleanliness and ISO 9 as the lowest.

Regulations

The U.S. Food and Drug Administration (FDA) strictly regulates cleanroom use within the United States. FDA rules for cleanrooms are adapted from Current Good Manufacturing Practices (CGMP) regulations. Pharmaceutical manufacturers are also subject to CFR 210 and 211 from the Current Good Manufacturing Practices for Finished Pharmaceuticals. When a rule exists that targets a specific drug product, that rule always supersedes CFR 210 and 211.

  • Design and construction. Regulatory enforcement begins with the design phase of the cleanroom to ensure that the finished product achieves appropriate clean air standards.
  • Monitoring. Beyond the cleanroom itself, the FDA also requires a separate room with monitoring and control equipment for air pressure, dust, humidity, microorganisms, and temperature.
  • Cleanliness levels. The FDA also requires the installation of a compliant air filtration system and written standard operating procedures for cleaning, sanitization, and contamination prevention within the cleanroom.

Ask the Cleanroom Experts

The regulations surrounding the design, construction, and operation of cleanrooms are highly complex. At Liberty Industries, we’ve been in the cleanroom business since our inception in 1953 and we understand all of the rules and challenges involved with installing a new cleanroom.

For more information about our cleanroom solutions or capabilities, please don’t hesitate to contact us or submit a request for information. To learn more about the design and construction of cleanrooms, please download our eBook.

 

The Advantages of Cleanroom Pass-Thrus

 

Since 1953, Liberty Industries has served as a global manufacturer and distributor of high-quality cleanroom and contamination control supplies and accessories. We offer a broad selection of cleanroom products, ranging from modular, softwall and hardwall cleanrooms to cleanroom components to personnel garments. Regardless of your cleanroom needs, our experienced engineers can design and deliver a custom-tailored solution that meets your specifications.

Cleanrooms are generally used in the manufacture of sensitive components that cannot tolerate contamination—e.g., medical devices, pharmaceuticals, and electronics. These structures provide control over the workspace, maintaining set levels of temperature, humidity, light, air pressure, and other environmental variables. They can also have additional features, such as sealed airlocks and decontamination areas, that facilitate the maintenance of sterile conditions.

Pass-thrus—also known as pass-thru cabinets, chambers, or windows—are a critical cleanroom component. These two-door structures are typically installed directly into the cleanroom’s walls and, when opened one door at a time, allow objects to pass into or out of the cleanroom while reducing the risk of contaminants. pass thru for cleanroom

​What Are the Benefits of Pass Thrus for Cleanrooms?

Pass-thrus are an affordable and easy-to-install way to protect the cleanroom environment and meet industry safety standards. In addition to preventing external contaminants from entering the cleanroom, they reduce the number of workers in the room at any given time and limit the frequency of room entries and exits. Both of these things help to further reduce the risk of contamination.

Integrating a pass-thru also means cleanroom personnel do not need to shower and gown up to place or remove materials from the cleanroom. This saves time and, ultimately can increase productivity.

Pass-thrus are durable, easy to clean and maintain. Additionally, they are highly customizable, coming in a range of materials, sizes, and designs to meet different cleanroom needs. For example, they are available with fireproofing for combustible material handling and with HEPA air filters for highly sensitive product manufacturing.

The integration of pass-thrus benefits virtually any industry that requires the use of cleanrooms, including the following:

  • Aerospace
  • Computer manufacturing
  • Electronics and technology
  • Medical
  • Military
  • Pharmaceuticals
  • Research
  • Solar power generation

​Types of Pass-Thrus Available at Liberty Industries

At Liberty Industries, we offer several pass-thru models for cleanroom construction projects, including:

  • Stainless steel pass-thru. Also known as a pass-thru window communicator or package transfer unit, this pass-thru system features stainless steel construction, acrylic doors, and stainless steel hinges. Customization options include interlock systems, fireproof doors, and custom sizes.
  • H-100SS pass-thru with a magnetic lock. This two-door cabinet uses a magnetic interlock system to keep both doors from opening at the same time. It is especially useful for hospital pharmacies and other organizations that require high levels of security.
  • H-100 PL series laminated pass-thru.This pass-thru chamber is made with high-pressure plastic laminate and has an acrylic door with chrome-plated hinges. It provides maximum protection from contamination while still allowing for the easy transfer of materials. Optional add-ons include a reverse-action interlock.
  • Motorized HEPA/ULPA-filtered pass-thru. This pass-thru unit has a high-velocity air wash and highly efficient filter. Custom sizes and filtration levels are available, as well as options for stainless steel shelves, laminated novaply, and fireproof doors. Customers can choose from recirculating or non-recirculating models.

Partner With Liberty Industries for Your Cleanroom Needs

Pass-thrus are critical cleanroom components that help keep your cleanroom contaminant-free for sensitive manufacturing operations. With over 65 years of experience designing and constructing cleanrooms, the Liberty Industries team can help you choose the right model and design to suit your cleanroom needs.

For additional information about pass-thrus or to discuss your cleanroom specifications with one of our experts, contact us or request a quote today.

Softwall Cleanrooms vs. Hardwall Cleanrooms

 

Liberty Industries is a manufacturer and distributor of industry leading modular cleanrooms. These controlled, free-standing environments allow experts in a variety of industries to perform delicate manufacturing, sensitive research, and other processes. Our team has more than 60 years of experience providing cleanrooms and other contamination control supplies.

We serve leading organizations from a wide variety of industries. Some of the industries that we serve include:

  • Medical equipment manufacturing. Cleanrooms help ensure that delicate, sensitive, and sanitary medical equipment does not become contaminated.
  • Assembly and packaging. Our cleanrooms are ideal for sterile packaging applications.
  • Electronics. The electronics industry relies on cleanrooms to ensure component cleanliness during the assembly of sensitive electronic devices. Particulate contamination as minor as a speck of dust on a microchip can compromise a system.
  • Aerospace. Aerospace manufacturing cleanrooms allow industry experts to deliver safe, effective aerospace components in an industry where even minor mistakes can lead to catastrophic equipment failure.
  • Research and development. Cleanrooms help ensure that research is accurate and study subjects remain sanitary.
  • Food preparation and processing. Many food preparation and processing applications require complete sterility. Our cleanrooms allow food manufacturers to achieve this level of sterilization with ease.
  • Pharmaceutical manufacturing. Creating life-saving medication requires sterile work surfaces with no chance of contamination.

What are the Different Types of Cleanrooms?

The potential uses for cleanrooms are quite varied, so they are available in multiple forms. The key to successful cleanroom implementation lies in selecting the cleanroom best for your individual application. Modular cleanrooms are often an ideal choice because of their versatility and adaptability to changing application needs.

At Liberty, we offer two varieties of modular cleanrooms: softwall and hardwall.

  • Softwall cleanrooms are built around steel superstructures. Their walls are engineered with visibility and flexibility in mind and typically feature soft, transparent vinyl walls and entrances.
  • Hardwall cleanrooms rely on prefabricated panels to form the walls and ceilings of the cleanroom. These panels may be constructed out of a number of materials, but most hardwall cleanrooms are acrylic with cabinet-style entrances.

Some features, however, persist in both hard and softwall cleanrooms. Both of these varieties are easy to transport and adapt to a variety of requirements. Custom or specialized elements like filters, furniture, and lighting are available regardless of cleanroom type. Hard and softwall cleanrooms can also both be certified to meet an array of industry standards, including US FED STD 209E and ISO Standard 14644-1.

Softwall Cleanrooms vs. Hardwall Cleanrooms

Softwall Cleanrooms

Softwall cleanrooms present a number of benefits. They are especially ideal for applications that require:

  • Easy installation and deconstruction. Softwall cleanrooms are simple to install and remove thanks to their flexible design. They also do not require underground preparations.
  • Emergency or short-term use. Softwall cleanrooms are not as ideal for ultra-sanitary applications as hardwall cleanrooms. They’re ideal for applications with less critical processes or as holdovers during other projects.
  • Flexibility and customization. Modifying these structures in order to put them into virtually any environment is always an option. Even though the structures are made of steel, they can be fitted to a wide variety of heights and widths.
  • Minimal cleanroom footprint. Softwall cleanrooms offer an ideal solution for facilities with limited available space.
  • Cost-effective. Due to the short installation process, softwall cleanrooms tend to be more affordable than their hardwall counterparts.

Hardwall Cleanrooms

Unlike softwall cleanrooms, the rigid structure of hardwall cleanrooms renders them more suitable for projects that require:

  • Stable structure. If a stable structure is required to protect people or products, a hardwall cleanroom will prove far more beneficial than a softwall alternative.
  • Permanent or semi-permanent use. Hardwall cleanrooms are built with permanent infrastructure, so they’re best suited to applications that can utilize them on a permanent or semi-permanent basis.
  • Pressure regulation. The harder wall panels make it easier to keep pressure regulated within the contained environment.
  • Prevention of airborne contaminants. Temporary structures are more prone to leaks or punctures that can contaminate the cleanroom. Permanent structures largely mitigate this risk.
  • Privacy and security. Hardwall cleanrooms are easier to secure and also contain sound better than softwall cleanrooms. This is ideal for applications where sensitive or classified research may be conducted.

Hardwall and Softwall Cleanrooms From Liberty Industries

At Liberty Industries, we’re proud to offer our clients an expansive range of cleanroom solutions and related products. Our product line includes:

  • Softwall and hardwall modular cleanrooms. We offer cleanrooms suitable for use in a variety of applications that are easily customizable to suit a wide range of requirements.
  • We offer a complete line of cleanroom furniture in order to ensure sterility and meet strict requirements.
  • Air filtering equipment. Our air filtering equipment includes charcoal, HEPA, and ULPA filters.
  • Cleanroom supplies. Cleanroom supplies range from wipes, mops, and sponges to disposable garments and shoe covers.

For more information about our cleanrooms and related products and services, please contact us or request a quote.