Frequently Asked Questions About Medical Cleanroom Filtration

Frequently Asked Questions About Medical Cleanroom Filtration

The medical cleanroom filtration system is responsible for removing particles from the air thoroughly and consistently. From toxic substances to large particles that interfere with tests and research, restricting and controlling air quality through proper filtration is essential to protect both your work and your workers.   When it comes to designing and implementing an effective and efficient cleanroom filtration system, it can be complicated to know what your medical cleanroom needs to be successful — from what types of filters you’ll use to how to design the ideal filtration system for your application. Read on for the answers to these frequently asked questions and more.

What Are the Different Types of Cleanroom Filters?

There are three main types of filters employed in cleanroom filtration systems: HEPA filters, ULPA filters, and pre-filters.

  • HEPA Filters: High Efficiency Particulate Air filters remove particles 0.3µm or larger. They are the most commonly used filters in medical cleanrooms.
  • Pre-Filters: remove the largest particles from the air, extending the life of the more valuable HEPA and ULPA filters.
  • ULPA Filters: Ultra Low Particulate Air filters are even more powerful and expensive than HEPA filters, removing virtually all particles 0.12µm or larger.

Medical cleanrooms with highly sensitive processes may require more powerful cleanroom filtration in order to reach strict cleanroom classification standards. 

How Many Filters Does My Medical Cleanroom Need?

The number of filters your medical cleanroom needs will depend on your cleanroom classification. Each ISO Class defines the maximum allowed particles, air change velocity, and percentage of ceiling coverage dedicated to filter/fan units. The number of filters you need will be what allows you to easily reach your stringent standards during cleanroom operation.   In general, the “cleaner” your cleanroom has to be, the more filters you’ll need to achieve quality standards. However, filters alone won’t help you reach your classification requirements — the way you use them also matters.    Employing an efficient airflow pattern will help your filters clean the air more efficiently. It can also extend the lifespan of your expensive HEPA filters by reducing the strain on just a few filters by evening out the filtering power across your cleanroom.

How Often Do Cleanroom Filters Need to Be Replaced?

Your specific filter replacement schedule may vary across your cleanroom, as one location may be dirtier than another — but having a clear schedule is essential for maintaining your medical cleanroom. Filter replacement every 3-5 years is common, but critical applications may find they need to replace filters every 1-2 years to ensure safety and quality.   In addition to facility use, the type of filter in your cleanroom will affect the filter replacement schedule. Pre-filters, which form the frontline defense against particles in the cleanroom, need to be replaced much more frequently than the more expensive HEPA filters they protect. 

HEPA Filter Replacement

While HEPA filters can last up to 10-12 years depending on the volume and air quality of the room, pre-filters are typically replaced biannually and inspected at least quarterly. Although HEPA filters are longer-lasting, there are many reasons you might need to replace them sooner, including:

  • Evidence of filter plugging, such as a notable drop in pressure 
  • Leak-test failure 
  • Buildup of radiation
  • Damage from handling or installation 
  • Media rupture 
  • Filter-frame or seal failure

Although valuable HEPA filters are not cheap to replace, it’s more cost effective to replace them too early than to pay for the extra power usage or damage to the facility should a faulty or loaded filter be left unaddressed.

Are My Medical Cleanroom Filters Working Effectively? 

Your medical cleanroom filtration system should be inspected regularly — at least 4 times per year — to ensure it is effectively cleaning and changing the air in your cleanroom. Per ISO 14644-2, all cleanrooms must perform quality checks annually to check that the particle count allowances are met. If your medical cleanroom is ISO Class 5 or lower, these quality checks need to happen every 6 months.   To test your cleanroom classification yourself, you can use a handheld particle counting device to measure particle size and number at varying zones in your cleanroom, then average the totals. If your findings exceed the allowed maximum count, your cleanroom filtration system likely needs an upgrade.

How Do I Design an Efficient Cleanroom Filtration System?

In a medical cleanroom, your filtration system is one of the most important defenses against contamination. In some critical applications, this can be a life-saving system. When designing your cleanroom filtration system, you’ll need to incorporate it with an airflow pattern and your cleanroom HVAC, using the ceiling space efficiently to reach the percentage requirements of your cleanroom classification.    Cleanroom filtration is central to all cleanroom components and systems — from the type of medical cleanroom itself to the cleanroom furniture it contains, the employees who work in it and the cleanroom garments they wear. When properly designed, all cleanroom systems should work together to reach your cleanroom classification and create the best environment for you to complete your work.    If you need to design a cleanroom filtration system or update your cleanroom filters, Angstrom Technology can help. We design multi-stage HEPA filtration systems for medical cleanrooms and can help you assess and maintain your cleanroom filtration system to ensure your cleanroom is always meeting its classification standards. Give us a call or reach out online to learn more.

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Medical Cleanroom Classifications Explained

Medical Cleanroom Classifications Explained

Medical cleanrooms require strict cleanroom conditions, and so usually fall within ISO 14644-1 Classes 5-8.  All medical cleanrooms must comply with their classification standards to ensure employee safety, guarantee product quality, and limit risk to the consumer or patient receiving products created, developed, or tested within a medical cleanroom. 

Let’s break down medical cleanroom classifications a bit further. We’ll take a look at how medical cleanroom classifications work, the differences in standards between medical cleanroom applications, and how classifications affect medical cleanroom design.

What Are Medical Cleanroom Classifications?

Cleanroom classifications regulate the medical cleanroom’s degree of cleanliness and are defined by the allowed amount of contamination by particle count and size, as well as the necessary air change rates depending on the cleanroom’s classification level. 

The International Standards Organization (ISO) developed the set of standards by which all cleanroom industries and applications must follow. Medical cleanrooms may also be governed by additional regulations by the International Standards Organization (ISO), US Pharmacopeia (USP), or other industry-specific standards.

ISO Classification Standards

ISO 14644-1 outlines the requirements for all cleanroom environments. To do this, the standards are grouped into Classes 1-9, where Class 9 is equivalent to room air and Class 1 represents the cleanest possible cleanroom environment. As the classification number falls, cleanrooms must comply with stricter standards to reach a cleaner, more controlled environment. The majority of medical cleanrooms fall within ISO Classes 5-8. 

ISO 14644-1 proscribes cleanliness standards for cleanrooms by describing allowed contamination levels in terms of air particle size and count, air change rates or airflow velocity, and percentage of ceiling coverage for filtration. 

Particle Count: Particle count refers to the number of particles of a certain size per cubic meter. Stricter ISO classes allow fewer particles, and also restrict the size of those particles. Cleanroom design should include a  special airflow pattern that makes use of filters in the most efficient and effective way possible to trap and remove particles, and replace the air in the room with air that is fresh and contaminant-free. 

Air Change Rate: The air change rate at which air is removed, filtered, and replaced. While less stringent environments may only require an air change rate of 5-40, cleanrooms with strict air quality standards may require hundreds of air changes per hour — at which point it’s expressed in terms of air velocity, because the clean air needs to be constantly filtered out and replaced.

Ceiling Coverage: Ceiling coverage refers to the percentage of ceiling coverage for HEPA filter/fan units, or FFUs. The more stringent your medical cleanroom classifications, the higher percentage of ceiling coverage required to filter air properly. Ceiling fan coverage is closely related to air change rate, as more FFUs will allow for more air changes to occur. 

Medical Cleanroom Classifications by Application 

Medical cleanrooms have some of the most stringent cleanroom classifications of any cleanroom type. Specific classifications and requirements change depending on the application of the cleanroom. Whether you’re working with biological, pharmacological, or mechanical elements, here is a breakdown of the medical cleanroom classifications for each application.

Medical Research Cleanrooms

Medical research laboratories require strict cleanroom conditions, and usually fall within ISO Class 5-7. The rigorousness of the standard is dictated by the risk level of contaminants to cleanroom operations and safety. For example, for research involving blood or stem cells, an ISO Class 5/Fed Std 209E Class 100 to ISO Class 7/Fed Std 209E Class 10,000 cleanroom environment is necessary, per ISO 14644 standards. Other medical laboratories are subject to ISO 15189, which also has regulations of control of the laboratory environment.

Pharmaceutical Cleanrooms

The minimum standard for pharmaceutical cleanrooms is generally ISO 5 (Federal Standard 209 Class 100), which requires 240-600 air changes per hour and 35-70 percent ceiling coverage to maintain an environment of 100,000 0.1μm particles per cubic meter.

Pharmaceutical cleanrooms are also governed by additional regulations by US Pharmacopeia, or USP Standards. Pharmaceutical compounding spaces follow USP Standards 797 for sterile non-hazardous compounds, or the stricter USP 800 for sterile hazardous compounds. 

Medical Device Cleanrooms

Most medical device manufacturing cleanrooms must comply with ISO 5-8 standards, but the different stages of medical device production, assembly, and packaging have different cleanliness requirements, and often fall under separate classifications. 

The stringency of requirements increases as device part sizes become smaller and more intricate, or the use of the device is more critical to health and survival. Specifically, medical devices cleanrooms that fall under more critical distinctions require a quality management system, as designated under the unique ISO 13485:2016 classification system. The quality management system is designed to follow the device through its lifecycle to determine quality and risk level and validate that it meets all necessary standards of quality and performance, and remains free of contamination.

Medical Cleanroom Design

Most medical cleanrooms have stringent cleanliness standards that require a high level of control in the cleanroom environment, with supporting systems to regulate temperature, humidity, pressure, static, air flow, and particulate matter.

HardWall cleanrooms are the most common type of cleanroom used in medical applications, as they offer a high level of control over environmental, can be highly customized to include all the special features each application requires, and can be designed to comply with the strictest medical cleanroom classifications. Medical cleanroom design also includes a powerful HVAC system as well as cleanroom lighting and furniture that fit seamlessly with the cleanroom layout and facilitate laminar airflow patterns. 

Medical cleanrooms have some of the most stringent requirements of any other industry. If you’re unsure if your cleanroom can reach its classification standards, reach out to Angstrom Technology. Our cleanroom experts can design, build, and install medical cleanrooms that meet all of your specifications and requirements. 

Waste Management in Medical Cleanrooms

Waste Management in Medical Cleanrooms

Particularly in medical research cleanrooms and pharmaceutical cleanrooms, proper waste management and disposal is important for keeping the environment safe for products and people. Medical cleanroom design should be informed by this system to ensure waste handling protocols are easy to follow and that adequate storage is available for a safe and sterile environment. 

A waste management system in medical cleanrooms covers three areas: waste handling protocols, personal protective equipment, and proper waste storage and disposal.

 

Medical Cleanroom Protocols for Handling Waste

 

To develop protocols for your medical cleanroom waste management system, look at the materials you work with and the waste your facility generates. This includes how you handle and dispose of used cleaning materials, protective equipment that cannot be sanitized, the specific materials you use to conduct your work, and the byproducts of your work: substances or used materials you can’t recycle or put in a landfill. Make sure your cleanroom follows best practices for handling waste, and develop a set of protocols employees understand and can easily follow.

Your waste management protocols will be facilitated by your medical cleanroom design, which should include places to safely store cleaning materials, the chemicals used in your work, and the waste generated by your cleanroom. The protocols and cleanroom design solutions work together to prevent waste from interfering with or contaminating your processes and keep your people and products safe.

 

What Counts as Medical Cleanroom Waste?

 

In order to understand the best ways to handle and dispose of medical cleanroom waste, we must first understand the different types of waste that can be generated in a cleanroom setting. Medical cleanroom hazardous waste materials may be considered toxic, corrosive, ignitable, infectious, biohazardous, or otherwise unsafe to be disposed of in normal ways.

Some waste generated from pharmaceutical cleanrooms is considered a controlled substance. In such situations, the disposal of pharmaceutical waste must take place in compliance with additional DEA regulations.

 

How Much Waste Does Your Medical Cleanroom Generate?

 

Depending on how much waste your facility generates, you may need to follow certain regulations from the Environmental Protection Agency. The EPA divides waste generators into three main types: 

  • Very Small Quantity Generators (VSQGs) create less than 100 kg of hazardous waste per month
  • Small Quantity Generators (SQGs) create between 100 and 1,000 kg per month
  • Large Quantity Generators (LQGs) creates over 1,000 kg of hazardous waste

Employees should understand the difference between types of waste and be trained to follow protocols for handling, labeling, and disposing of waste responsibly. Whether your facility is a VSQG or a VLQG, your cleanroom design should include an adequate waste management system to keep your employees safe and your project protected. 

 

Personal Protective Equipment

 

To keep employees safe from the sensitive or hazardous products or waste they’re handling, they must be properly equipped. Personal protective equipment like gloves, garments, and masks, not only keeps harmful substances from reaching personnel, but it also works to prevent contamination by employees. Depending on the application and the threat of contamination or harm to the employee, different types of garments and PPE may be required. Additional items could include: pants, coveralls, goggles, boots, ventilated hoods, hairnets, and more.

While some of these supplies can be sanitized and reused, others, like nitrile gloves, for example, must be disposed of after each use to prevent any kind of contamination. Your cleanroom design will likely need to include a gowning room to provide space for employees to properly equip themselves and limit the entrance of contaminants to the cleanroom, storage for garments and PPE, a sanitation area for employees to wash their hands before entering and after leaving the cleanroom, and storage for used equipment needing to be sanitized or destroyed.

 

Medical Cleanroom Design: Waste Storage and Disposal 

 

Containers used to store waste for disposal can be reusable but must be antimicrobial, corrosion-resistant, and able to be thoroughly cleaned and sanitized on a regular schedule. Particularly for highly sensitive materials, a puncture-resistant and leak-proof container may be necessary. All waste must be properly separated, bagged, and labeled prior to disposal.

In some cases, medical waste cannot be immediately discarded. Some types of waste must be stored until they can be transported to a facility where they will be recycled, deposited in a landfill or incinerated, or treated until they’re safe to throw away. Proper waste storage is an important part of medical cleanroom design. It needs to be safely contained where it can’t contaminate your work or risk employee safety. The waste receptacles themselves need to be non-particle shedding, corrosion-resistant, and can’t be placed where they could interrupt your cleanroom’s airflow and reduce the effectiveness of air changes and filters. 

Keeping a clean environment in all areas of the cleanroom is important, and that includes how and where you store and dispose of used medical cleanroom supplies and waste. Angstrom Technology’s cleanroom design experts can help build sterile waste management into your cleanroom’s design. We can add you to our regular maintenance schedule to make sure your facility is operating safely and protecting your products and staff. To learn more, give us a call or reach out online.

Medical Cleanroom Garment Storage: How to Keep Cleanroom Garments Clean

Medical Cleanroom Garment Storage: How to Keep Cleanroom Garments Clean

Cleanroom garments are as clean as the places where they are kept. They play a vital role in protecting your cleanroom and employees, so it’s essential to take care of them properly. Let’s dive into the importance of keeping cleanroom garments clean, the difference between reusable and disposable garments, and the cleanroom garment storage you’ll need to always have sterile and fresh items on hand.

Medical Cleanroom Garments

Cleanroom garments are an essential part of medical cleanroom operations. Garments are meant to prevent particles from the wearer from shedding and contaminating the cleanroom. In many medical cleanroom applications, they also protect the wearer from contaminants or harmful substances.

Wearing garments outside of the sterile environment of a cleanroom can attract contaminants. The inside of the garment is also contaminated by particles from the wearer. It’s important to use clean garments each time a worker enters the cleanroom environment to protect sensitive products and processes within the controlled space from these particles. 

Properly cleaning protocols and cleanroom garment storage — whether for reusable garments or new disposable ones —  are important to protect workers and the cleanroom from possible contamination. If garments are contaminated, both the integrity of your work and the safety of your employees are at risk. Particularly in medical cleanrooms, there’s no room for error. Contamination could interfere with test results, corrupt substances, compounds or devices, and potentially endanger patients’ lives.

Reusable vs. Disposable Cleanroom Garments

Reusable cleanroom garments can be cleaned in-house or by a third-party cleaning service. Disposable garments are typically meant to be worn once, though it depends on the product and the manufacturer’s recommendations.

 

Reusable Cleanroom Garments

Reusable garments must be washed with a special process (and extremely hot water) to remove particles and sanitize them safely without compromising or degrading the protective material. If cleaned by a third party, you’ll also need to ensure transport to your facility is sterile and that no contaminants are introduced to your cleanroom from an outside source.

Disposable Cleanroom Garments

Some medical cleanrooms with critical sterilization protocols and stringent requirements opt for disposable garments because it is the safest and most cost-effective option. Disposable garments should be high quality so they are comfortable for workers and won’t break down when in use. Be sure to buy quantities and sizes that are appropriate for all personnel.

Many medical cleanrooms use a combination of both reusable and disposable garments. For example, gowns and face shields may be cleaned, sanitized, and reworn, but disposable nitrile gloves and boot covers are replaced after each use. All garments, whether reusable or disposable, must be kept in appropriate cleanroom garment storage.

 

Medical Cleanroom Garment Storage

Adequate cleanroom garment storage is just as important as how the garments are used. Cleanroom garments are stored in the gowning room for immediate use, though your facility may also have an area to keep overstock items. 

In the gowning room, cleanroom garment storage takes the form of specialized cabinetry, shelves, and containers arranged in a way that facilitates the gowning procedure. 

A proper gowning procedure will ensure your employees suit up properly without contaminating their garments. This process involves cleaning exposed skin before donning garments in the correct order to contain any particles and not contaminate other items or parts of the garment.

Medical cleanroom cabinets and shelves are used to display all garments for easy access as well as store them before use. Garments for use in critical applications may need to be housed in their own HEPA-filtered cabinets or showered with air to dislodge any particles that may have adhered to the material. 

Cleanroom garment storage may also need anti-static safeguards in place to prevent the attraction of particles due to imbalanced charges. All new garment items must be sealed and packaged individually to prevent contamination. 

The purpose of cleanroom garment storage is to make all items accessible to employees while staying isolated from contaminating particles as much as possible. The use of sticky mats, air showers, and benches can help limit contamination, along with the enforcement of the proper gowning procedure. 

All used garments must be placed in separate cleanroom garment storage to ensure no contamination reaches the fresh, untouched garments. Until they can be cleaned and returned to the gowning room or disposed of responsibly, there should be no contact with the areas used for clean garments.

Cleanroom garment storage is essential to protecting your operations and workers. Does your cleanroom have appropriate garment storage space? If not, give us a call. We’re happy to help design and install the solutions that will make your cleanroom cleaner.

Medical Cleanroom Design Tips: Cleanroom Windows

Medical Cleanroom Design Tips: Cleanroom Windows

When it comes to medical cleanroom design, you are constrained by the cleanroom classification you must meet. That said, every medical cleanroom has its own unique application and processes that require an accommodating design. One common design feature of a medical cleanroom is cleanroom windows. Can your medical cleanroom have windows? And if so, what types of windows are available that provide the design you’re looking for, while meeting your specific classifications? 

Here’s what you need to know about medical cleanroom windows, from why you might install them to the different types of cleanroom windows that can suit medical cleanliness requirements. 

 

Why Install Windows in Your Medical Cleanroom?

 

Medical cleanrooms, especially those used for pharmaceutical and hospital applications, must meet some of the most stringent cleanroom classifications. It might feel that windows would only detract from the standards you’re trying to meet, but in reality, true cleanroom windows can provide the cleanliness and security you need, with a few additional benefits you may not have considered. Here are just a few reasons to install windows in your medical cleanroom:

    • Morale. A little natural light can go a long way to boost team morale. Sitting in a windowless room all day can affect your staff’s mood, and studies have shown that workers who sit by a window are more productive than those who don’t have access to natural light.
    • Lighting. Cleanroom windows can let in a significant amount of natural light. Not only does this make it easier for your team to complete their processes, but it also can help you save on electricity costs, and minimize the number of cleanroom-specific lighting fixtures you need to install. 
    • Supervision. For applications that must adhere to specific protocol, like pharmaceutical cleanrooms, windows provide the transparency your facility needs. Supervisors can easily monitor production from outside the cleanroom. This helps maintain your cleanroom classification, and minimizes the number of people within the space, without sacrificing the quality and procedure of your process. 

 

Medical Cleanroom Window Styles

 

The benefits of cleanroom windows are clear — they can help increase productivity, reduce lighting costs, and ensure proper supervision without compromising your controlled environment. Any quality cleanroom window will feature a glaze or finish that works to make the window easy to clean, sealed, and contaminant free. Glazing options for cleanroom windows include:

  • Tempered glass
  • Tinted glass
  • Static dissipative
  • Lexan™
  • Laser glass
  • Acrylic
  • Double glazing
  • Film covered glass
  • Acrylic
  • UV

A quality cleanroom supplier can provide the cleanroom window with appropriate glazing for your application and cleanroom standard. While the type of window glaze is important for any medical cleanroom, the window style you choose is a bigger consideration to make. 

If you’re considering installing windows in your medical cleanroom, here’s a look at a few of the styles most suited to your applications. 

Flush or Double Flush Cleanroom Windows

 

Flush cleanroom windows are the best option for nearly any medical cleanroom application. As the name suggests, these windows are installed flush with your cleanroom wall, eliminating any frame or sill where dust, debris, or particle might collect. 

Flush cleanroom windows are available as double flush windows, which means they’re installed directly into the wall, usually with two panes, each of which is flat with its side of the wall. Regular flush cleanroom windows can also be installed flat on the clean side of the cleanroom, with a ledge on the “dirty” side of the cleanroom. 

Beveled Cleanroom Window

 

Beveled cleanroom windows are an affordable alternative to the double flush window. The window itself is flat to the wall but features a beveled sill that eliminates any corners that dust, particles, or micro-organisms could sit on. Since a beveled cleanroom window requires just one pane of glass, it’s more cost-effective than the double-flush window while achieving a similar look and functionality.  

Floor-To-Ceiling Cleanroom Window Panels

 

The final window option available to medical cleanrooms is floor-to-ceiling cleanroom window panels. Depending on your classification, you can opt for a fully windowed cleanroom like Angstrom Technology’s RigidWall cleanrooms. Our RigidWall product offers crystal clear paneling throughout the cleanroom. This is ideal for pharmaceutical and medical applications where transparency and supervision are essential. It also offers a clean aesthetic that allows in plenty of light for your staff. 

If you’re not sure about a completely transparent cleanroom, it’s also possible to integrate just a few window wall panels to let in light, without compromising the design or standard of your cleanroom. These clear panels can meet a variety of cleanrooms classifications. Since each panel is one complete piece of glass or fiberglass, they eliminate the potential for leaks around window seals.  

Installing Cleanroom Windows for Your Medical Application

 

Cleanroom windows are an excellent addition to any medical or pharmaceutical cleanroom. They provide additional light and the transparency and supervision many medical processes require. If you’re working to integrate windows into your existing cleanroom, or if you’re designing a new cleanroom and are hoping to incorporate cleanroom windows, it’s always best to work with a cleanroom expert. 

Cleanroom windows provide a range of benefits, but proper installation is key to ensuring you get the light you need while maintaining your cleanroom’s classification. Look for a cleanroom expert with experience in medical and pharmaceutical cleanrooms, and try to find a provider that will work to help you design and install the ideal cleanroom for your unique application. 

Windows make for a more attractive cleanroom that’s easy for your investors to see and appreciate. If you’re looking to design, build, or reconfigure a cleanroom with windows, whether you’re in the pharmaceutical or medical industry, let us know. We design and install custom cleanrooms that are built to your exact specifications, from the HVAC system and classification down to the windows. Give Angstrom Technology a call at 888-768-6900 or contact us online for more information today.

3 Types of Medical Cleanrooms

3 Types of Medical Cleanrooms

Medical cleanrooms are vital for the work of finding medical solutions, developing vaccines and treatments through pharmacological products, and manufacturing life-saving medical devices, among other important applications. Three main types of medical cleanrooms are medical research cleanrooms, medical device cleanrooms, and pharmaceutical cleanrooms. The cleanroom design for each type will differ depending on the goals of the facility and its cleanroom classification requirements. 

Let’s take a closer look at these three types of medical cleanrooms, and how they differ in their applications, classifications, and cleanroom design. 

 

Medical Research Cleanrooms

 

Medical research cleanrooms are used in the pursuit of medical understanding, research and experimentation, and the development of treatments. Medical research cleanrooms are often required to be biosafe, and have extra safeguards in place to protect employees and their important work from potential biosecurity risks.  

The cleanroom environment must be highly sterile. Medical research cleanrooms usually fall within ISO 14644-1 Class 5-7. The rigorousness of the standard is dictated by the risk level of contaminants to cleanroom operations and safety. For example, for research involving blood or stem cells, an ISO Class 5 cleanroom environment is likely necessary. This means the cleanroom must have a powerful filtration system in place, with allowed particle count of fewer than 3,520 particles half a micron or larger. 

Medical research applications working with infectious or toxic fumes or substances often require negative pressure cleanrooms. This added safeguard keeps contaminants from inside the cleanroom from escaping where they could cause harm to those outside the cleanroom environment. 

Whether for the uses of cancer research, the study of infectious diseases and viruses, or the pursuit of potent and effective vaccinations, medical research cleanrooms are fully equipped with all the specialized equipment, safe storage, and ergonomic furniture researchers need to do their jobs comfortably and effectively. Medical research cleanrooms are usually designed with HardWalls. HardWall cleanrooms can meet even the most stringent classifications these types of medical cleanrooms may require, and are highly modifiable to any application’s unique needs. 

 

Medical Device Cleanrooms

 

Medical devices are specialized products used to diagnose, treat, and cure patients. Unlike pharmaceutical products, medical devices are not metabolized. Instead, they can be used internally and externally as a tool by medical professionals, or even implanted for a long-term solution. Because they come into contact with tissues and membranes, medical devices must be contaminant-free or able to be thoroughly sanitized to prevent the possibility of infection or other risks. For this reason, the production, assembly, and packaging of medical devices requires a controlled cleanroom environment, validated and monitored by stringent requirements and quality control. 

The different stages of medical device production, assembly, and packaging have different cleanliness requirements, and often fall under separate classifications. For example, most medical device manufacturing cleanrooms must comply with ISO Class 5-8 standards. 

More specifically, medical device cleanrooms manufacturing non-critical and semi-critical devices fall in the ISO Class 7-8 range, while devices with critical disinfection levels (like surgical equipment and implanted devices) require the cleanest environments and must comply with ISO Class 5 or greater. Essentially, the stringency of requirements increases as device part sizes become smaller and more intricate.

Medical device packaging cleanrooms, while still very closely monitored to prevent contamination, generally operate within ISO Class 7-8 standards. 

The best cleanroom type for medical device manufacturing and packaging is a HardWall cleanroom. This cleanroom type is able to comply with strict classification requirements and maintain a stable, contaminant-free environment throughout all stages of device production. 

 

Pharmaceutical Cleanrooms

 

Pharmaceutical cleanrooms are used to develop chemical treatments and cures to improve health and save lives. In the development and testing of pharmaceuticals, even the slightest contamination could have serious consequences on medical study results or treatment efficiency, and could even lead to life-threatening consequences. Because of this, the pharmaceutical industry is subject to heavy regulation.

Pharmaceutical cleanrooms often require varying levels of cleanliness depending on the type of substances, chemicals, and procedures involved in their operation. The minimum standard for pharmaceutical cleanrooms is generally ISO 7 with progressing needs of ISO 5 or more, which requires 240-600 air changes per hour and 35-70 percent ceiling coverage to maintain an environment of 100,000 0.1μm particles per cubic meter.

Pharmaceutical cleanrooms are also governed by additional regulations by US Pharmacopeia, or USP Standards. Pharmaceutical compounding spaces follow USP Standards 797 for sterile non-hazardous compounds, or the stricter USP 800 for sterile hazardous compounds. USP standards prescribe layout options according to the optimal airflow patterns, cleanroom organization, operator techniques, and sanitation levels of each standard. 

Due to the high level of control needed in a pharmaceutical cleanroom, HardWall cleanrooms are the obvious solution. Able to maintain strict environmental standards and eliminate error caused by temperature, humidity, or contamination, HardWall cleanrooms offer a reliable structure to any medical cleanroom design. 

These three types of medical cleanrooms are vital and valuable investments to businesses pursuing research or creating and preparing compounds and devices to improve health and save lives. Important work in the healthcare industry merits a high-performing medical cleanroom to keep projects and employees protected. 

From pharmaceutical development to medical device manufacturing and packaging, Angstrom Technology designs, builds, and installs medical cleanrooms for any classification standard. If you’re ready to start designing your new cleanroom, get in touch with Angstrom Technology’s professional team today.