Posted by Liberty Industries on | Comments Off on What Equipment is Actually Required for a USP 797 Compliant Cleanroom?
USP 797 compliance is a federal standard for healthcare facilities and is subject to regulatory oversight. If you’re setting up or auditing a pharmacy compounding cleanroom, the equipment decisions you make now can impact whether you pass certification or end up with a costly retrofit. This guide covers the specific controls USP 797 requires and how the right equipment can contribute to safe, compliant operation.
What is a USP 797 Compliant Cleanroom?
USP 797 establishes the standard for sterile compounding in the U.S. It defines how facilities must be designed and maintained to prevent microbial contamination in compounded sterile preparations (CSPs). The regulation mandates a sterile compounding environment and defines environment-specific requirements:
ISO Class 5. Classification specific to the direct compounding area (DCA), where actual sterile preparation occurs.
ISO Class 7 and 8. Classifications for the anteroom and buffer room surrounding the DCA.
The ISO Class 5 zone is where contamination risk is highest and where Primary Engineering Controls (PECs) must be operating at all times.
What is Essential Cleanroom Equipment for USP 797 Compliance?
A laminar airflow workbench (LAFW) is a core piece of Class 5 cleanroom equipment in any USP 797-compliant setup. It delivers HEPA-filtered unidirectional airflow across the work surface, which is important for maintaining ISO Class 5 conditions for non-hazardous sterile compounding.
Key specs to verify when choosing laminar flow hoods include:
ISO Class 5 certification (≤3,520 particles ≥0.5 µm per cubic meter)
Horizontal or vertical unidirectional airflow, depending on product/worker protection requirements
Continuous operation during all compounding activity
Another important part of maintaining compliance in a pharmacy compounding cleanroom is factoring for material transfer. Every time supplies move from an uncontrolled area into the buffer room, this can create a contamination pathway.
An interlocked pass-thru can address this concern. These can feature stainless steel construction and magnetic interlocks to prevent both doors from opening simultaneously, maintaining airlock integrity during material transfer without requiring personnel to break the sterile environment boundary.
Air Filtration Systems
USP 797 requires that air supplied to the ISO Class 5 zone pass through a HEPA filter rated to capture 99.97% to 99.99% of particles 0.3 µm and larger, with 300-480 air changes per hour of filtered air. The buffer room must also maintain HEPA-filtered supply air with a minimum of 30 air changes per hour (ACPH).
By minimizing environmental particulates, the risks of product contamination, recalls, and liability are significantly reduced. Air filtration systems can include pre-filters to extend the life of the HEPA filters.
Gowning/PPE
USP 797 specifies gowning requirements for anyone entering the buffer room or DCA. This can include:
Shoe covers or dedicated shoes
Head and facial hair covers
Face mask
Non-shedding gown
Sterile, powder-free gloves (donned last, after hand washing)
Gowning happens in the anteroom, in a specific sequence to prevent contamination upon entering the workspace.
How Do I Maintain Pressure Differentials in Class 5 Zones?
USP 797 requires positive pressure in the buffer room relative to the anteroom and positive pressure in the anteroom relative to the cleanroom. This is maintained through:
Controlled ACPH
Continuous pressure monitoring with gauges or alarms
Sealed penetrations in walls, ceilings, and floors
Pressure differentials need to be monitored continuously and logged, such as a drop in differential due to sealing concerns or a door remaining open.
Certifications & Standards Required for USP 797 Compliance
Beyond the physical equipment, USP 797 requires documented certification at defined intervals, including semi-annual cleanroom certification, regular environmental monitoring, and comprehensive personnel training. Relevant certifications include:
Air quality (per ISO classification)
HEPA filter integrity
Pressure differential testing
Contact Liberty Industries to Learn More
Setting up a sterile compounding environment that meets USP 797 requires having the right Class 5 cleanroom equipment specified and installed correctly the first time. Liberty Industries has worked with pharmaceutical facilities since 1953, and our team can help you select the right laminar airflow workbench, pass-thrus, and supporting equipment for your cleanroom environment.
Posted by Liberty Industries on | Comments Off on ISO Cleanroom Standards Explained: ISO Classes 1–9
Understanding ISO cleanroom classifications is essential when specifying, designing, or evaluating controlled environments. Classifications such as ISO 7 and ISO 8 directly impact product quality, regulatory compliance, and operating costs.
Cleanroom classifications, such as ISO 7 and ISO 8, have direct implications for product quality, compliance, and operating costs. The following overview explains ISO 1 through ISO 9 classifications, typical applications, and the equipment required to support each environment.
Introduction to ISO Classes
ISO cleanroom standards are defined in ISO 14644-1, which classifies cleanrooms by airborne particle concentration per cubic meter of air. These ISO classifications range from ISO 1, the cleanest environment with the strictest particle limits, to ISO 9, which is comparable to typical indoor air.
An ISO cleanroom is classified by the maximum allowable particle count at defined particle sizes, most commonly 0.1 µm, 0.2 µm, 0.3 µm, 0.5 µm, and 5.0 µm. The lower the ISO class number, the fewer particles permitted and the cleaner the environment.
Understanding ISO cleanroom standards is critical when specifying HVAC systems, air changes per hour, filtration levels, gowning procedures, and cleaning protocols. A mismatch between your process and your ISO classification can lead to contamination risks, audit findings, and unnecessary capital expense.
For example:
ISO 1 cleanroom environments enable extremely low particle concentrations and are used in advanced research and nanotechnology.
ISO 8 cleanrooms allow higher particle counts and are common in medical device assembly and certain pharmaceutical processes.
Key Benefits of ISO Cleanroom Classifications
Cleanroom equipment, apparel, and contamination-control products must align with ISO cleanroom standards to meet regulatory and operational requirements across multiple industries.
Regulatory compliance. Regulatory compliance with standards such as FDA and GMP requirements.
Product protection. Reduced contamination risk in sensitive processes.
Process stability. Consistent environmental control, including airflow and filtration.
Risk mitigation. Reduced risk of rework, scrap, and recalls.
Scalable design. Ability to size cleanrooms based on process requirements.
Use Cases For Each ISO Class
Below is a practical overview of ISO 1 through ISO 9 cleanrooms and the typical applications of each classification.
ISO 1 Cleanrooms
ISO 1 cleanroom environments represent the highest level of air cleanliness defined by ISO classifications. These environments require ultra-high-efficiency filtration, tightly controlled airflow, and strict gowning protocols. Equipment used in ISO 1 cleanrooms must generate minimal particulates and meet stringent material-compatibility requirements.
In ISO 1 cleanrooms, particle concentrations are extremely limited, which means these spaces are suitable for tasks like:
Advanced nanotechnology research
Quantum computing component development
Specialized semiconductor processes
ISO 2 Cleanrooms
ISO 2 cleanrooms support processes that require a near-zero risk of contamination. At this level, facility design must account for vibration control, material off-gassing, and micro-contamination control in addition to airborne particles.
Typical applications include:
Precision optics manufacturing
High-end semiconductor fabrication
Aerospace component research
ISO 3 Cleanrooms
ISO 3 environments are used in semiconductor and microelectronics manufacturing. Maintaining compliance requires strict gowning procedures and controlled equipment placement.
These cleanrooms often feature:
Laminar airflow systems
High air change rates
Strict personnel entry protocols
ISO 4 Cleanrooms
ISO 4 cleanrooms maintain low particle counts and are used in a range of industrial applications. These spaces typically use HEPA or ULPA filtration and high air change rates to control airborne contamination.
Applications may include:
Microelectronics assembly
Sensitive optical component production
Advanced research laboratories
ISO 5 Cleanrooms
ISO 5 cleanrooms use laminar airflow hoods or cleanroom modules to control particle levels at critical locations. Defined gowning procedures and environmental monitoring are required to maintain compliance.
They are often found in:
Aseptic pharmaceutical filling operations
Sterile compounding pharmacies
Biotechnology research labs
Semiconductor manufacturing zones
ISO 6 Cleanrooms
ISO 6 cleanrooms are used as transitional spaces between higher and lower stringency areas. Facilities may combine ISO 6 and ISO 5 zones for specific process needs. Equipment and furnishings must support contamination control and daily operational requirements.
Common uses include:
Medical device manufacturing
Pharmaceutical support spaces
Electronics assembly
ISO 7 Cleanrooms
ISO 7 cleanrooms are commonly specified in industrial and pharmaceutical settings. Routine environmental control includes scheduled cleaning, approved disinfectants, and validated procedures. Personnel follow documented gowning and entry protocols specific to ISO 7.
Typical use cases include:
Medical device assembly
Pharmaceutical manufacturing support areas
Electronics manufacturing
Aerospace component assembly
ISO 8 Cleanrooms
ISO 8 cleanrooms permit higher particle counts than ISO 7 and are used in regulated industries that require basic contamination control. Gowning and entry procedures are less restrictive but still defined. Typical attire includes hair covers, lab coats or coveralls, gloves, and shoe covers.
Applications include:
Medical device packaging
Nutraceutical production
Certain pharmaceutical processing areas
Component assembly
ISO 9 Cleanrooms
ISO 9 environments are the least restrictive ISO classification and are similar to standard indoor air. ISO 9 may serve as a baseline before adding filtration and airflow control for higher classifications.
While they are not typically considered “cleanrooms” in the traditional sense, ISO 9 classifications can apply to applications like:
Controlled warehouse environments
General manufacturing spaces with minimal contamination risk
How Liberty Industries Supports ISO Cleanroom Standards
Meeting ISO cleanroom standards requires compatible equipment, furnishings, and contamination control products. Liberty Industries supplies cleanroom equipment and consumables designed to support ISO classifications from ISO 1 through ISO 8.
Cleanroom solutions are available to support ISO classifications from ISO 1 through ISO 8, including:
Cleanroom apparel and gowning systems
Gloves, wipes, and cleaning supplies
Cleanroom furniture, pass-throughs, and accessories
Environmental monitoring and airflow support equipment
Product selection should align with cleanroom classification, regulatory requirements, and operational objectives.
Build With Confidence
Selecting the appropriate ISO cleanroom classification impacts compliance, product quality, and operating costs. Understanding ISO classes supports facility design aligned with process requirements and cost control.
For questions about cleanroom classification or facility requirements, consult with a cleanroom specialist to ensure compliance and operational efficiency.
Posted by Liberty Industries on | Comments Off on Cleanroom Airlocks vs Cleanroom Air Showers
In specialized manufacturing, semiconductor, pharmaceutical, medical, or food and beverage production facilities, cleanrooms maintain contaminant-free, temperature- and humidity-controlled conditions for sensitive items and processes. As workers and equipment enter and exit the cleanroom environment, it’s critical to provide a suitable transition point to prevent outside contaminants from entering. Airlocks and air showers are two common ways of maintaining this control.
When selecting between cleanroom airlocks vs. air showers for your cleanroom setup, it’s important to understand how each operates and how they differ. This will make it easier to know which option is best for your application, or if a combination of both is necessary. Here we’ll look at what they are, how they’re used, and how they differ so you can make an informed selection.
What Are Cleanroom Airlocks?
An airlock is a specialized point of entry and exit that uses a system of doors to minimize the transfer of outside contaminants into the cleanroom. The first door opens so personnel can enter an intermediate chamber, then the door closes behind them before the next door opens. Because both doors are never open at the same time, particles are briefly trapped between them so a HEPA filter can collect them.
How Airlocks Maintain Pressure Integrity
An airlock uses positive pressure to keep the cleanroom free of contaminants. The pressure in the cleanroom is higher than that in the airlock, and the airlock pressure is higher than that of the space outside the cleanroom. Because air flows from higher to lower pressure areas, when one of the interlocked doors opens, the air flow travels toward the space outside the cleanroom and airlock, keeping outside particles from entering.
Industries That Commonly Use Airlocks
Many different industries use airlock systems to keep cleanrooms and similar workspaces sanitary and free from contaminants, including:
Pharmaceuticals.
Biotechnology.
Semiconductor and microelectronics manufacturing.
Food and beverage production.
Laboratories.
Material handling.
Healthcare.
What Are Cleanroom Air Showers?
In contrast to an airlock system, a clean room air shower uses high-velocity filtered air to remove particulates from personnel and equipment before entering a cleanroom.
How Air Showers Remove Contaminants
Air showers use air jets to blow away contaminants and particles that may be transferred in on equipment and articles of clothing. They can be used instead of or in conjunction with an airlock to create a highly sanitary and controlled environment.
Applications and Use Cases
Many different facilities use air showers, including many that also use cleanroom airlocks. For example, pharmaceutical and biotechnology facilities may have cleanroom air showers for cleaning personnel’s clothing prior to entering the cleanroom, and for removing hazardous particles when they exit. Carts, tools, and other materials that are about to enter or exit a cleanroom may also undergo cleaning from air showers.
Airlocks vs. Air Showers: Key Differences
Although both of these systems serve a similar function, there are some critical differences between them to keep in mind.
Compliance Considerations by ISO Class
Whether you use airlocks or air showers, or a combination of both, will largely depend on the level of ISO compliance you need to meet. ISO classifications for cleanrooms set upper limits for the number and size of particles allowed per cubic meter of air in the room. Lower ISO class numbers, like ISO 1 through 5 are considered the “cleanest” and allow only very few and very small particles. These are more likely to require an air shower or both an air shower and airlock. Higher classification numbers, such as 7 through 9, are permitted to have more and larger particles, and may only require an airlock.
Installation and Cost Factors
There are different options for these systems, which affects installation complexity and costs. For example, does your airlock system require manual or motorized doors? Which type of HEPA filter is suitable for your ISO classification level? Air showers include blowers, filters, adjustable nozzles, and computerized control systems. Installation is generally more involved and may require more frequent maintenance and upkeep. It’s important to remember that in some situations, an air shower system is required.
When to Use Both Systems Together
Many cleanrooms use airlocks and air showers together for extra-thorough cleaning and decontamination. For example, in semiconductor or pharmaceutical production cleanrooms, an airlock and air shower may be installed, along with a separate gown room for donning and doffing protective clean coverings for clothes, hair, hands, and shoes.
Reliable Air Showers From Liberty Industries
If you’re not sure whether you need an airlock, air shower, or both for your cleanroom environment, the experts at Liberty Industries can help. We offer a range of cleanroom products, including air showers, mats, pass thru units, cleanroom structures, and supplies. We serve multiple industries, such as the pharmaceutical, medical, government, industrial, automotive, and aerospace industries.
For additional information about our offerings and to find the right solution for your cleanroom facility, contact us today, and we’ll connect you with one of our experts.
Posted by Liberty Industries on | Comments Off on HEPA vs. ULPA Filters
Depending on your cleanroom setup and filtration needs, you can opt for either a HEPA or ULPA filter. Knowing the differences between ULPA vs. HEPA filters can help you make the right selection for your facility and production process.
What Is a HEPA Filter?
High Efficiency Particulate Air (HEPA) is a specific air filter efficiency standard that certifies filter performance. These filters are capable of capturing up to 99.97% of particulates as small as 0.3 microns. The Institute of Environmental Sciences and Technology’s (IEST) IEST‐RP‐CC034.5 standard and ISO 14644-3 provide detailed guidance for testing HEPA filters.
What Is an ULPA Filter?
Ultra-low Penetration Air (ULPA) is another standard for air filter efficiency that can capture an even higher percentage of particles of sizes even smaller than those that HEPA filters capture. Specifically, ULPA filters capture a minimum of 99.9995% of particles with diameters as small as 0.12 micrometers. Different ULPA filters come with varying most penetrating particle sizes (MPPS), but they’re generally more efficient than HEPA filters.
Part of what makes ULPA filters superior to HEPA filters is their finer mesh and increased fiber density, which work in conjunction to capture much smaller particles during air filtration.
Differences Between HEPA Filters vs. ULPA Filters
While both HEPA and ULPA filters are effective for cleanrooms, there are some key differences between ULPA filters vs. HEPA filters to keep in mind.
Filtration Efficiency
ULPA filters offer more efficiency than HEPA filters, capturing up to 99.9995% of particles down to 0.12 micrometers in size while HEPA filters capture 99.97% of particles down to 0.3 micrometers.
HEPA filters offer sufficient filtration for plenty of facilities, but some cleanroom spaces may need the added efficiency of ULPA filters. For example, cleanrooms may need ULPA filters to meet ISO standards for Class 1 through 5 environments.
Airflow Resistance
The tradeoff of higher-efficiency ULPA filtration is reduced airflow. While both HEPA and ULPA filters affect airflow to a certain degree, ULPA’s finer mesh and denser fibers create more airflow resistance.
In addition to making your HVAC system work harder, the significant airflow resistance of ULPA filters can reduce the number of air changes per hour (ACH). ACH is the number of times per hour that the air in a space is replaced, and cleanrooms generally need to have a high ACH to remain clean. Thus, choosing ULPA filtration requires careful consideration of your production requirements and specific cleanroom space.
Cost and Maintenance
You must also consider the cost of ULPA vs. HEPA filters. Because of their increased efficiency, ULPA filters generally cost up to 30% more than HEPA filters. ULPA filters also don’t last as long as HEPA filters, which can make replacements more frequent and costly in the long run.
Lifespan
ULPA filters generally last around seven to eight years, whereas HEPA filters can last up to 10 years in similar environments.
Applications
The specific cleanroom application for HEPA and ULPA filters depends on the cleanroom’s required ISO Class. Class 1 through 5 cleanrooms require ULPA filters that can meet stricter standards for the following types of processes:
Medical laboratories
Microelectronics manufacturing
Aerospace manufacturing
Semiconductor manufacturing
Pharmaceutical manufacturing
Class 5 through 8 cleanrooms use HEPA filters in the following applications:
Semiconductor research
R&D labs
Media preparation, such as DNA experimentation and cell culture growth
Food and beverage manufacturing
Cleanroom Filters at Liberty Industries
Select between HEPA filters and ULPA filters based on your cleanroom’s specifications and ISO Class. Liberty Industries manufactures and distributes a variety of cleanroom supplies, including ULPA and HEPA filters, modular cleanrooms, laminar flow equipment, and many other products. Whether you need products for an ISO Class 1 to 5 or 6 to 8 cleanroom, we’ll direct you to the right supplies to maintain a consistently clean and efficient production environment. Our products are also proudly Made in the USA!
Posted by Liberty Industries on | Comments Off on Cleanroom Certification for Critical Manufacturing
Items including semiconductors, pharmaceuticals, medical devices, aerospace components, and others are easily damaged or compromised by dust, dirt, and temperature or humidity fluctuations. These highly sensitive products and components are often handled in controlled cleanroom environments to protect them from contaminants and adverse environmental conditions.
Cleanrooms are designed and built to limit the size and amount of particles present in the air and on surfaces. Temperatures, air pressure, and relative humidity are carefully controlled, and personnel often wear special protective garments to avoid transferring dust, dirt, or stray fibers into the workspace. Entry to and exit from these rooms is restricted, and airlock systems may be used to limit contamination.
Some common cleanroom requirements may include, but are not limited to:
Keeping doors closed at all times
Cleaning equipment before bringing it inside
Prohibiting extraneous items, food, and beverages
Wearing protective clothing including gowns, shoes, and head coverings
Not exceeding a specified number of personnel in the room at any given time
Continual HEPA filtration
Separate chambers for donning and doffing of protective garments
Specialized walls, flooring, fixtures, and furniture
Not all cleanroom environments are alike, and depending on the application they may have more or less strict requirements for things like walls, temperature and humidity ranges, airflow, protective equipment, and the allowable amount of particulate matter present. How strict the requirements are corresponds to different cleanroom classifications, as outlined in ISO 14644-1. ISO classes 3-8 also overlap with US federal standard 209E classes 1 through 100,000. Here, we’ll look at what ISO cleanroom certification entails, and why it’s important for several industries and applications.
What is Cleanroom Certification?
To be certified to a specific ISO cleanroom class, a cleanroom must be inspected and tested by a third-party organization to verify if all criteria are met. There are 9 ISO cleanroom classes, each corresponding to a specific allowable range of particle quantities and sizes per square meter of space. Classifications range from ISO 1 (i.e., the smallest and lowest allowable number of particles) to ISO 9 (i.e., the largest and greatest allowable number of particles).
For example, in a class 7 cleanroom, there may be no more than 325,000 particles over .5 microns in diameter, no more than 8,320 particles over 1 micron in diameter, and no more than 2,930 particles over 5 microns in diameter. Class 7 does not establish a maximum threshold for smaller particles, though some of the others do.
Each class also specifies airflow and air change rates to ensure proper ventilation is maintained. A class 7 cleanroom must have a minimum of 60 air changes per hour. In addition, gowns, shoe covers, and head coverings are likely to be worn inside the room, and special airlock entryways and pass-throughs are often used.
The Importance of Cleanroom Certification
Cleanroom certification is important for critical applications in the electronics, medical, pharmaceutical, and other industries because it guarantees that products are manufactured without exposure to potentially harmful contaminants. This helps to reduce the risks of spoilage, malfunction, or failure of items like medications, medical devices, electronic equipment, and even vehicles.
Once a cleanroom is certified initially, it must be audited periodically to ensure ongoing compliance. If a cleanroom ceases to meet requirements, a manufacturer’s products and reputation are at risk.
Benefits of Cleanroom Certification
Cleanroom use and certification are often mandatory in certain industries and applications, and optional in others. In addition to meeting industry requirements, cleanrooms offer various other advantages for manufacturing, including:
Reduced contamination. Maintaining close control over filtration, airflow, temperature, and humidity in certain areas of the manufacturing environment keeps tools, equipment, and components clean and in good working order. This can contribute to overall product quality and reliability.
Cost reduction and risk management. When the environment in a cleanroom or workspace exceeds the required or preferred conditions, products may require additional processing or cleaning. Maintaining proper cleanroom class conditions reduces the need for extra cleaning as well as contamination risks that can lead to product or component spoilage, damage, or failure.
Government compliance. Domestic and international government regulations change over time, often becoming more strict in an effort to protect consumers. In particular, strict rules help control food quality, protect the environment, and ensure medications are safe. Certified cleanrooms help manufacturers meet or even exceed product regulations and be prepared for future changes.
Cleanrooms from Liberty Industries
As a manufacturer of products or components that require cleanroom conditions, one of your most important steps is choosing a cleanroom provider with expertise and a range of experience. Liberty Industries has designed and built cleanrooms since 1953, and can provide complete rooms, air and filtration systems, equipment, and accessories to meet ISO certification requirements. Our products are also proudly Made in the USA!
Contact us to learn about our cleanroom services and solutions!
Posted by Liberty Industries on | Comments Off on How Often Do You Need to Change HEPA Filters in Cleanrooms?
Click to Expand
High-efficiency particulate air (HEPA) filters are mechanical air filters designed to remove undesirable airborne particles from a space. They’re highly effective in cleanroom environments where clean air is critical to operations, such as in hospitals, laboratories, manufacturing facilities, and pharmaceutical processing plants.
Filters must be able to capture at least 99.97% of airborne particles as small as 0.3 microns in order to be classified as true HEPA filters. These filters capture dust, pollen, mold spores, bacteria, and viruses that would otherwise contaminate the air. Knowing when to replace them, however, is crucial to ensuring their continued performance and maintaining the integrity and safety of your operations. This guide will give insight into how often you should change HEPA filters for cleanrooms and what to look for to retain their effectiveness.
How Often Should You Change Your Cleanroom’s HEPA Filter?
When HEPA filters are performing as they should, they successfully manage air cleanliness and contamination levels in cleanrooms and pass thru boxes while helping your systems run more efficiently and cost-effectively. Checking your filters regularly will help ensure optimal filtration and functionality.
Companies often advise changing your HEPA filters once every three to five years, on average. However, it really depends on the use of your cleanroom. If your systems are operating around the clock, for example, you’ll likely have to replace your filter more frequently than a cleanroom that runs only a few days each week. The level of contamination in the air and the class of the cleanroom can also impact replacement frequency.
While they don’t stipulate the exact lifecycle of a HEPA filter, the International Organization for Standardization (ISO) 14644-3 guidelines and Good Manufacturing Practices (GMP) do require that you leak-test your filters periodically. Ideally, this should be done by an independent professional at a frequency of every six months to one year at a minimum. ISO 1-5 zones require these tests every six months, while in ISO 6-9 environments, annual leak testing is acceptable. GMP simply requires that filters be free of leaks. Should your filter fail to pass the test or if the industry professional observes any issues, it’s time to replace the HEPA filter.
However, there are additional factors to keep in mind when deciding how frequently to change the HEPA filter, such as filter load and pressure drop. As particulate matter builds up on a HEPA filter, its resistance to airflow increases. This can result in premature failure, allowing contaminants to enter the space. A clogged or damaged filter can also lead to pressure drop, decreasing airflow. If your ventilation system experiences excessive pressure drop, it will have to run at greater speeds to retain optimal rates of air exchange, increasing both energy consumption and costs in your operation. Should this occur, you can replace your filter for better performance and cost-efficiency and to put less strain on your system.
Extending Your HEPA Filter’s Lifespan
The factors that impact the lifespan of HEPA room air filters include:
Volume of external air you’re filtering
Level of contamination in that external air
Any prefiltration methods and their level of effectiveness
Volume of filtered recirculated air
Aerosol challenge exposure duration and frequency
Proactive measures in the form of regular inspections and preventive or condition-based maintenance (CBM) will help to extend the life and ensure the efficiency of a HEPA filter. For example, through recent advancements in technology, manufacturers can monitor their equipment’s condition using sensors, carrying out maintenance only when the sensors signify there’s an issue or change in performance.
The proactive approach also benefits companies with custom-made filters, as these products typically take longer to arrive. If you use customized HEPA filters, periodic inspections will help you plan ahead for reorders.
Liberty Industries: The Contamination Control Experts
Liberty Industries, Inc. manufactures and distributes cleanroom and contamination control equipment and supplies for customers in industries such as healthcare, pharmaceuticals, cannabis production, aerospace, automotive, industrial, government, and academia. Since 1953, we’ve provided our clients with turnkey solutions and well-honed capabilities ranging from cleanroom design and construction to particle counter, airflow equipment, and even protective garb manufacturing.
Whether you need HEPA filters, modular cleanrooms, air showers, laminar flow equipment, Tacky Mats®, or another of our quality product offerings, our engineers can help you customize it to meet your unique needs. Contact us today for more information on how Liberty Industries can support your cleanroom operations. Our products are proudly Made in the USA!
Posted by Liberty Industries on | Comments Off on Understanding the Design & Construction of Cleanrooms
Cleanrooms are specialized workspaces for critical processes and operations. They are designed to maintain strict standards of cleanliness for certain types of manufacturing and product preparation. Cleanrooms are commonly used for some applications in the manufacture of electronics, semiconductors, pharmaceuticals, medical devices, and aerospace equipment, as well as in labs and research settings.
Here, we’ll look at the major goals of cleanroom design, how they are constructed to meet those goals, and some of the standards cleanrooms must meet.
Click to Expand
Understanding the Design & Construction of Cleanrooms
Cleanroom design is focused on controlling the environmental conditions in an enclosed space, as well as the size and number of particles (i.e., contaminants) in the area. Strict guidelines and classifications are set by international standards for cleanrooms. For these reasons, when constructing a new cleanroom, it is critical to consider environmental conditions and requirements like temperature, ventilation and filtration, airflow, and air pressure.
Working with an experienced cleanroom contractor is the best way to ensure all systems are designed and installed correctly and that they function as intended.
Begin by analyzing workflow and patterns of movement within and into and out of the room (this includes people and equipment). These impact airflow, temperature and humidity, and particle or contaminant levels. Materials used for ceilings, walls, and flooring can also have an effect on airflow, dust accumulation, and moisture levels. All of this information is used to plan HVAC and filtration systems that create and maintain the right conditions when the room is at rest and in use.
Many systems and equipment can be used in a cleanroom to achieve the required conditions, and not all cleanrooms are designed and built identically. Some examples of the components that may be used in a cleanroom include:
Air showers
Air pressure monitoring equipment
Airlock entry and exit systems
Gown rooms, donning/doffing space, and storage for protective equipment
HVAC systems
Fans equipped with high-efficiency particulate air (HEPA) filters
Sticky mats to trap particles on shoes or that fall from above
A new cleanroom is evaluated at three points during construction to ensure proper conditions can be maintained:
As built, when construction is complete but equipment and machinery are not moved in yet.
At rest, when all equipment and systems are installed but not yet operational.
In operation, when employees and equipment occupy and use the room for regular operations.
Cleanroom Classifications
The current international cleanroom design standards are ISO Standard 14644-1. It sets nine classifications (i.e., ISO 1 through ISO 9), each designating positive pressure requirements and the allowable number of particles of different sizes per cubic meter within the room. Particle sizes are grouped into six ranges from ≥ 0.1µ to ≥5µ.
For example, an ISO class 1 cleanroom, the most “clean” environment, requires that there be no more than 10 particles ≥ 0.1µ per cubic meter and no particles larger than that at all. In contrast, an ISO class 7 cleanroom allows more particles of different sizes per cubic meter, resulting in a slightly less “clean” setting:
No requirements for particles ≥ 0.1µ to ≥ 0.3µ
Up to 352,000 particles ≥ 0.5µ
Up to 83,200 particles ≥ 1µ
Up to 2,930 particles ≥ 5µ
ISO 14644-1 standards are very similar to the former US Standard 209 requirements, which have not been in use since 2001.
Different applications and manufacturing processes must comply with different cleanroom classifications, and this plays a major role in the design and construction of the room. Some applications may have additional requirements, such as sterile drug compounding. This process is subject to USP chapter 797 requirements, which include limits on particle sizes and counts and sets air pressure requirements, along with guidance for equipment and personnel procedures.
Since 1953, Liberty Industries has specialized in cleanroom equipment, supplies, and construction services for customers in a range of industries. We provide everything required for your cleanroom or contamination control applications from cleanroom design engineering to protective garments, and from airflow equipment to particle counters.
Contact us today to learn more about our capabilities or to discuss the requirements of your cleanroom application.
Posted by Liberty Industries on | Comments Off on A Guide to Essential Cleanroom Equipment
Cleanroom environments are ideal for safely handling specimens, conducting tests, and manufacturing and assembling sensitive goods. Properly maintaining air purity and protecting workers, devices, and products within the space, however, requires a combination of essential cleanroom equipment and protective garments to achieve. In this guide, we’ll review air handling and filtration, PPE, and cleaning equipment solutions to help ensure your cleanroom remains compliant with industry standards.
Air Handling and Filtration Systems
Supplying and maintaining clean air within a cleanroom is a top priority. Four common types of air handling and filtration equipment that make this possible include the following:
High-Efficiency Particulate Air (HEPA) Filters.HEPA filters are a critical component of a successful cleanroom for reliably purifying the air. These filters remove 99.99% or more of particles sized 0.3 microns and up.
Air Handling Units (AHUs). These systems help ensure the consistent circulation of purified air while carefully controlling cleanroom conditions. Based on the needs of your application, AHUs effectively manage certain aspects of the air within the space, such as its flow, humidity level, and temperature.
Laminar Flow Equipment. Managing air’s flow direction and velocity can be just as important as controlling its humidity and temperature. Laminar flow equipment creates continuous streams of filtered air through a space and across surfaces in a particular direction, such as away from equipment for sterile operations.
Pass Thrus. Also called pass-through airlocks or communicators and package transfer units, cleanroom pass thrus allow you to safely transfer items from an exterior space to your controlled interior environment to limit contamination.
Personal Protective Equipment (PPE)
Head and face coverings, clothing, and other equipment help protect workers from breathing in or coming into contact with harmful substances. At the same time, PPE minimizes the chance of cleanroom contamination from dirt, fibers, hair, or skin cells. Some common examples of PPE include:
Caps, Hoods, and Related Coverings. These garments keep loose hair from falling onto equipment and work surfaces.
Safety Goggles or Glasses. This eye protection keeps airborne particles from entering your eyes, along with any splashed substances.
Face Masks. Fully covering your mouth and nose, these masks serve a dual purpose. Face masks protect a cleanroom environment from contaminants you exhale while preventing you from inhaling harmful particles into your respiratory system.
Coveralls. These cleanroom garments will provide full-body coverage, from your neck to your wrists and ankles. Usually consisting of materials that develop and shed minimal lint, they protect you and your clothes while reducing fiber and particle contamination in the cleanroom.
Gloves. Gloves are another example of PPE offering dual protection. They provide you with a layer of protection between your hands and harmful substances, and gloves lessen the chance of particle transfer onto handled materials.
Booties and Overboots. This PPE prevents you from tracking dirt and other contaminants into a cleanroom on the soles of your shoes.
Maintenance and Cleaning Equipment
Proper air filtration and strict PPE use will prevent many potential sources of contamination from compromising your cleanroom. However, additional equipment options are available to help you maintain your cleanroom space.
For example, you can place shoe brush machines near a cleanroom entrance. These units scrape dust and dirt off the bottom of shoes using stiff bristles to reduce the risk of contamination from footwear. Sticky mats, or tacky mats, supplement shoe brush machines, their sticky surfaces pulling contaminants from the bottom of your shoes as you cross over the mat. Wipes, disinfectant solutions, and roll mops also allow your cleaning teams to wipe away and remove contaminants that made their way to surfaces within the cleanroom.
Essential Cleanroom Equipment From Liberty Industries
For a reliable cleanroom environment that meets or exceeds your required standards, Liberty Industries is here to help. We have numerous guides on subject matter related to the above, please feel free to download our free eBook on essential cleanroom equipment here.
Since 1953, we’ve been manufacturing and distributing contamination control equipment and accessories to clients worldwide. We aim to be your one-stop shop for customizable cleanroom product solutions, offering everything from Tacky Mats® and shoe brush machines to air showers and laminar flow benches. Our engineering team can even help you with the cleanroom itself, providing modular, hard- and soft-wall, and mini-micro cleanroom options.
Contact us to learn more about our extensive cleanroom equipment selections or request a quote today.
Posted by Liberty Industries on | Comments Off on How Do Cleanrooms Differ by Industry?
Click to Expand
Not all cleanrooms are created equally. Depending on the particular industry, cleanroom classifications and specifications vary, as different manufacturing processes have unique standards and sterility requirements. Here, we’ll take a look at the various industries that rely on cleanrooms and how each one differs.
Pharmaceutical and Biotechnology Cleanrooms
In the biotechnology and pharmaceutical industries, cleanrooms are specified at ISO Class 5 through Class 8. ISO, or the International Organization for Standardization, is responsible for providing the requirements, guidelines, characteristics, and specifications that are used to ensure services, products, and processes are suitable for the intended purpose.
Particulate matter is the primary concern for any cleanroom, specifically when it comes to viable particulate contamination. It’s possible to prevent viable particulate contamination by installing cleanrooms with cove corners, cove ceilings, and cove bases in stick-built or modular designs, all of which help to maintain cleanable surface conditions. These design elements are especially crucial for meeting cleanroom standards for biotechnology and pharmaceutical applications.
Cleanrooms in the pharmaceutical and biotechnology industries prioritize the prevention of cross-contamination, filtration of indoor and outdoor air, and pressurization control. Because these cleanrooms are used to produce drugs and other pharmaceutical products, they must meet stringent guidelines and comply with regulations set forth by the FDA, including Current Good Manufacturing Practice (CGMP) requirements.
According to the CGMP requirements under the FDA, cleanrooms facilitating aseptic processing must include:
Controls for temperature and humidity
Highly cleanable walls, flooring, and ceilings with hard and smooth surfaces
Filtered air supplies using high-efficiency particulate air (HEPA) filters under positive pressure for both nonlaminar and laminar flows
Medical/Hospital Cleanrooms
Cleanrooms in medical and hospital applications must meet many of the same requirements as those in the biotechnology and pharmaceutical industries to avoid contamination. Medical and hospital cleanrooms are specifically designed with cross-contamination in mind, incorporating cleanable surfaces and filters that prevent particulates from entering. In addition, professionals working in these cleanrooms must wear the proper apparel, including gloves, plastic clothing, hairnets, and shoe coverings. This protective gear can help maintain a safe environment that prevents bacteria from infecting patients.
Many cleanrooms in the medical industry function as isolation rooms for patients. These spaces require negative pressure that prevents the spread of contaminants between rooms caused by breathing, coughing, or sneezing. To avoid contamination, medical cleanrooms don’t allow for circulating air, and they utilize HEPA filters, alarms that detect any loss of pressure, and hands-free toilets and showers. The HEPA filters in these applications can remove dust and other particles as small as 0.3 µm.
Some specific applications for medical and hospital cleanrooms include the following:
RNA / MRNA research
Laboratory, veterinary, and hospital pharmacies
Isolation wards
T-cell and gene
Medical equipment, devices, and tooling
Aerospace & Automotive Industry
The automotive and aerospace industry uses various manufacturing processes to produce parts and components, many of which require the use of cleanrooms to maintain better quality and prevent defects. These industries utilize cleanrooms to perform processes such as glass coating, painting, and the production of various electrical components. Because humidity, pressure, and temperature control are especially important for these processes, cleanrooms are typically specified at ISO Class 7 or Class 8.
Many vehicle components require specialized manufacturing processes that can’t be performed on factory lines. As vehicles become more technologically advanced, their components become increasingly delicate and small. These tiny components are critical to vehicle safety and operation; therefore, defective parts can lead to costly and dangerous accidents. As such, the need for automotive and aerospace cleanrooms has grown.
Cleanrooms in these industries not only can reduce errors but also allow for temperature and humidity control as well as the reduction in particulate, pressure, and static levels. Reliable cleanrooms also maintain foreign object debris (FOD) control, which has become increasingly critical in this industry.
Compliant Cleanrooms from Liberty
If you need dependable, high-quality cleanroom products and contamination control supplies for your application, Liberty Industries offers numerous solutions to meet the needs of nearly any industry. As contamination control experts, we provide various products to solve your critical environmental challenges. We offer softwall cleanrooms and modular cleanrooms as well as a wide range of cleanroom supplies and accessories. Our products are also proudly Made in the USA!
Contact us today to get started with the ideal cleanroom solution for your industry.
Posted by Liberty Industries on | Comments Off on What Is an Air Shower?
Air showers are an essential part of any cleanroom operation, addressing the biggest potential containment breach at its source. These chambers or tunnels are a key preventative measure that any cleanroom manager should consider. In this blog, you’ll learn more about air showers and why they’re integral to critical cleanroom applications across many industries.
How Do Air Showers Work?
Air showers are tunnels or chambers containing air jets that blow off personnel entering or departing a cleanroom. The pressured jet nozzle air streams drive dirt and dust particles away from the people or objects in the chamber. It then filters out contaminants and redirects them out of the chamber.
Air showers are positioned at the entrances and exits to cleanrooms or other highly controlled environments. As entrances and exits can be the biggest source of containment breach or contamination, having air showers as an extra layer of security for products and workers is a worthy investment.
A one-person air shower has two doors that cannot open simultaneously. When the employee enters the air shower chamber from the outside, both doors lock, and then the air jets blow air in high-velocity streams for 4 to 8 seconds. This process blows potential contaminants to a low-pressure section of the chamber. After waiting another 2 to 4 seconds for the room to be cleared of contaminants, the second door leading to the cleanroom will be unlocked and allow the employee to enter.
Why Air Showers for Cleanrooms
Cleanroom entrances and the people entering through them pose the greatest risk of contamination and must be managed accordingly. Air showers reduce pollutants that stick onto personnel and equipment despite prior gowning or disinfection procedures. Entrances and pass-throughs with an air shower act as a barrier between critical and non-critical regions.
By dislodging particulates before they get into the cleanroom, air showers also minimize particle accumulation to reduce cleanroom maintenance needs. They help to decrease energy consumption because HEPA filters do not have to work so hard. In fact, the filters last considerably longer when personnel utilize air showers.
Applications of Air Showers
When utilized correctly, an air shower can eliminate the majority of harmful contaminants before they even enter your cleanroom, ensuring your product stays safe and uncontaminated. Here are examples of where air showers can be applied.
Aerospace Cleanrooms: The aerospace industry consists of complex aircraft that require failproof components made to the highest standards. Excess particles may degrade an aerospace sensor or cause electrical equipment to malfunction. To guarantee worker safety and project success, all equipment must be made in optimal cleanroom conditions. Aerospace cleanrooms utilize large air showers at the entry and exit to remove particles from people and components, keeping the production area clean and free of contaminants.
Pharmaceutical Cleanrooms: Pharmaceutical cleanrooms are essential for developing, testing, and manufacturing life-saving drugs. Contamination in pharmaceutical processes might influence test results or consumer health. Since these cleanrooms must meet stringent cleaning standards, they frequently rely on air showers. The extra degree of security guarantees that individuals passing from outside to inside the compounding room do not bring in potentially harmful contaminants.
Medical Research Cleanrooms: Air showers are often found in medical research cleanroom applications involving sensitive equipment. In research studies involving toxic fumes or biohazards like infectious diseases, the inside of the cleanroom may pose more of a threat than the outside. In addition to negative pressurization, air showers are key to removing particles from workers as they exit the cleanroom.
Precision Manufacturing Cleanrooms: Although not all production environments have strict particle control specifications, sensitive products like sensors, radar systems, and computer hardware must be produced in a controlled environment. For example, producing defense industry components like weapons, security devices, and other complex equipment requires a highly controlled cleanroom environment.
Air Showers From Liberty Industries
Air showers are worth the investment in safeguarding your cleanroom operation. The method is highly effective at addressing the source of the most major potential containment breach—the entrance to the cleanroom. Liberty Industries offers a comprehensive selection of air showers made of different materials and for various cleanroom applications. Our air showers are optimized for low traffic areas, high traffic areas, height restricted areas, and other operational conditions. Our products are also proudly Made in the USA!
