MEDICAL CLEANROOMS

MEDICAL CLEANROOMS

Angstrom Technology develops controlled modular cleanroom environments for a number of industries and applications, including medical cleanrooms. Modular cleanrooms are growing in demand for medical applications because they can comply with the rigid standards of medical cleanrooms, yet are adaptable enough to accommodate whatever you need to do your work. 

In medical industries, there’s no room for error. Even a slight risk of contamination could prove disastrous to efficiency and development goals, or put lives on the line. We design our medical cleanrooms to be airtight, fully controllable, and customized to your unique project needs and cleanroom classification. At Angstrom Technology, we design and build medical cleanrooms to eliminate risk wherever possible, so you have a cleanroom you can trust, built specifically and uniquely for your application.

What is a Medical Cleanroom?

Medical cleanrooms are controlled spaces that enable the safe production of treatments and cures, secure the results of medical studies, and create an environment where medical devices can be properly sanitized and packaged before use. These cleanrooms are vital and valuable investments to businesses pursuing medical research or creating and preparing compounds and devices to improve health and save lives. 

Angstrom Technology designs, constructs, and installs the highest quality medical cleanrooms to meet any classification standards and requirements. We offer modular cleanrooms that can be free-standing, modular units or that make use of your existing wall and structure. Not only do we build and set up high-quality, high performing cleanrooms, we also service these cleanrooms to ensure that they consistently meet our clients’ standards.

Types of Medical Cleanrooms

Medical cleanrooms are used for finding medical solutions, developing vaccines and treatments through pharmacological products, and manufacturing life-saving medical devices, among other important applications. These cleanrooms require a variety of standards, equipment, and materials depending on the goals of the facility and its cleanroom classification requirements. 

The three main medical cleanroom types we create are used for medical research, pharmaceuticals, and medical devices.

Medical Research Cleanrooms

Angstrom Technology designs modular cleanrooms that can meet even the stringent requirements of medical research cleanrooms used in the pursuit of medical understanding, research and experimentation, and the development of treatments. Medical cleanrooms can be built with biosafe materials and systems to protect employees and their important work from potential biosecurity risks.  

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 to handle the ever-changing needs of a skilled research team and specialized equipment within a highly sterile environment.

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 staggering effects 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 government regulation, and pharmaceutical cleanrooms must meet the stringent standards of US Pharmacopeia as well as rigorous ISO requirements. 

Pharmaceutical cleanrooms often require varying levels of cleanliness depending on the type of substances, chemicals, and procedures involved in their operation. USP standards (commonly 795, 797, and 800) prescribe layout options according to the optimal airflow patterns, cleanroom organization, operator techniques, and sanitation levels of each standard.

Medical Device Cleanrooms

Medical devices are products used in healthcare to diagnose, treat, and cure that are not metabolized by the patient like a pharmaceutical product. 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. 

Medical devices fall under three different classes based on the level of risk involved with their use and the potential danger from contamination. They range from non-critical to semi-critical to critical, with the protocols for disinfection increasing as the risks rise. 

  • Class I: Non-critical and semi-critical disinfection required. This class of devices come into contact with skin, like stethoscopes, medical tape, or bandages; or mucous membranes like endoscopes or dental tools. They present a relatively low risk to the patient but must also be regulated with proper disinfection.
  • Class II: Semi-critical and critical, with rigorous disinfection protocols. This class includes devices like coronary catheters that are a greater risk if the product were to fail or be contaminated.
  • Class III: Critical level of disinfection required. This class includes surgical equipment and devices like valves and pacemakers that contact sterile tissues during procedure. These devices function to support life in procedures with a high potential of risk, and allow no room for error or possible 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. Angstrom Technology designs the best medical cleanrooms available to meet your cleanroom classification standard and accommodate your application’s specific needs.

All Angstrom Technology structures are built using durable and safe materials, and meet all US building and safety regulations.

Medical Cleanroom Structure

Medical cleanrooms require intentional design to create the ideal layout and structure for each application. Modular cleanroom panels can be modified, reconfigured, expanded, condensed, or even relocated as your project needs change. HardWall or RigidWall panels are recommended for use with medical cleanrooms, as they can meet any classification standards and industry-specific requirements.

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HARDWALL CLEANROOMS

Angstrom Technology HardWall cleanrooms allow a high level of control over pressure, static, humidity, and of course, contamination; they can conform to even the highest cleanroom classifications required in medical research, pharmaceutical applications, and medical device manufacturing.

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RIGIDWALL CLEANROOMS

Our RigidWall cleanrooms are also an option for medical cleanroom requiring a classification of up to ISO Class 5, while providing similar flexibility as our HardWall cleanrooms and offering visibility floor to ceiling. Using a durable and heavy-duty frame, RigidWall modular cleanroom panels can be made using clear acrylic, static dissipative PVC, or polycarbonate.

With either of these wall types, we can construct a free-standing cleanroom or incorporate your existing walls, structures, and HVAC. Our modular cleanroom panels come prewired for efficiency, so installation is quick and straightforward. However, if you’d rather not assemble it yourself, our professional team can set it up for you.

Segmented Medical Cleanrooms

Medical cleanrooms can have different cleanliness requirements for different stages of research or development, different products, or separate procedures within the same cleanroom. To meet these varying classifications, a cleanroom can be designed in segments, so each part operates at a different level. This strategy is more efficient than designing the entire cleanroom to run at the strictest cleanliness standard, which can increase costs exponentially. 

Modular cleanroom panels make segmenting possible and easy to incorporate into cleanroom design. If you think you might benefit from segmenting your cleanroom, talk to a cleanroom design expert to help you coordinate your cleanroom layout, and arrange the systems and airflow pattern to match your needs

Medical Cleanroom Systems and Supplies

To best meet the specific needs of your medical cleanroom, Angstrom Technology has a variety of options when it comes to pressurization, filtration, and circulation. We can also help you outfit your space with equipment and furniture such as cleanroom cabinets, tables and chairs, waste disposal, gowning cleanroom supplies, and anti-static and ergonomic accessories.

Medical Cleanroom Pressurization 

Both positive and negative pressure cleanrooms have their places in the medical industry. Most cleanrooms, including medical device cleanrooms, operate with positive pressure, using an external airflow pattern and HEPA filters. Some medical cleanrooms, such as medical research applications or pharmaceutical cleanrooms that work with hazardous substances, use negative pressure to prevent contaminants, viruses, or dangerous particulates from escaping the controlled environment.

Medical Cleanroom Air Filtration

In medical cleanrooms, maintaining optimal air filtration and high air change rates is paramount. We design medical cleanrooms to include multi-stage air filtration systems and make use of prefilters, HEPA filters, and ULPA filters where necessary.

Medical Cleanroom Air Circulation

Our medical cleanroom design includes laminar airflow systems with either a dedicated HVAC or airflow integration with your building’s existing HVAC systems. For other airflow system options, talk with our cleanroom design experts.

Additional Medical Cleanroom Supplies

Angstrom Technology also provides other cleanroom supplies such as cleanroom lighting, including standard and flow through modules; static control systems and ESD-safe materials and cleanroom furniture; cleanroom storage solutions, including a variety of options for cleanroom cabinets or shelving, garment storage, and solutions for the containment and disposal of waste; and other workspace elements such as tables, countertops, ergonomic chairs and anti-fatigue mats.

Medical Cleanroom Classifications

Medical cleanrooms have some of the most stringent cleanroom classifications of any cleanroom type. They require, at minimum, ample room for all equipment and materials as well as space for personnel to move freely; systems in place to limit cross contamination or mix ups of substances, samples, or products; aseptic equipment and supporting furniture; and the space and all surfaces to be easy to disinfect. 

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 cleanroom classifications for each medical cleanroom type.

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. 

Current good manufacturing practices (CGMP) apply to pharmaceutical cleanrooms and require validation of any facility that produces quality products. CGMP evaluates pharmaceutical cleanrooms in four areas: facility, equipment, standards, and training.

Medical Device Cleanrooms

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 5-8 standards. 

More specifically, medical cleanrooms working with Class I and II medical devices fall in the ISO Class 7-8 range, while Class III requires the most control and must comply with the most stringent requirements of ISO Class 5 or greater. The stringency of requirements increases as device part sizes become smaller and more intricate.

Medical devices that fall under Class II and Class III distinctions require a quality management system, as designated under the unique ISO 13485:2016 classification system, with which all medical device cleanrooms must comply. 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 device packaging cleanrooms, while still very closely monitored to prevent contamination, especially through the potentially damaging effects of static electricity, generally operate within ISO Class 7-8 standards.

Medical Cleanroom Services

Angstrom Technology’s cleanroom experts provide the best modular cleanrooms on the market in all phases of creation, development, and installation. From the initial design to construction, to adaptation and reconfiguration, to routine maintenance and cleaning, Angstrom Technology makes high-performance medical cleanrooms so you can focus on research, development, and testing.

Medical Cleanroom Design and Build

When it comes to cleanroom design, rely on the experts at Angstrom Technology. Based on your specifications and unique application, we can design the ideal cleanroom for you. Our team can build versatile layout options that will encourage productivity and accessibility. 

With a layout in place, we can use computational fluid dynamics to create a digital model of your cleanroom space to find the best airflow pattern for your cleanroom, reducing the strain on your cleanroom’s HVAC system and changing the air more effectively. 

Angstrom Technology can assist in construction of your cleanroom, adaptation of your cleanroom site, even retrofit the cleanroom build to existing infrastructure. Our modular cleanrooms are pre-manufactured so when they arrive at your site, they can be assembled quickly and efficiently. 

We’ll provide straightforward instructions so you can set up your cleanroom yourself, or have our crew install it for you. We can also install industry-specific equipment so your cleanroom is up and running as soon as possible.

Medical Cleanroom Services

Angstrom Technology’s cleanroom experts provide the best modular cleanrooms on the market in all phases of creation, development, and installation. From the initial design to construction, to adaptation and reconfiguration, to routine maintenance and cleaning, Angstrom Technology makes high-performance medical cleanrooms so you can focus on research, development, and testing.

Medical Cleanroom Design and Build

When it comes to cleanroom design, rely on the experts at Angstrom Technology. Based on your specifications and unique application, we can design the ideal cleanroom for you. Our team can build versatile layout options that will encourage productivity and accessibility. 

With a layout in place, we can use computational fluid dynamics to create a digital model of your cleanroom space to find the best airflow pattern for your cleanroom, reducing the strain on your cleanroom’s HVAC system and changing the air more effectively. 

Angstrom Technology can assist in construction of your cleanroom, adaptation of your cleanroom site, even retrofit the cleanroom build to existing infrastructure. Our modular cleanrooms are pre-manufactured so when they arrive at your site, they can be assembled quickly and efficiently. 

We’ll provide straightforward instructions so you can set up your cleanroom yourself, or have our crew install it for you. We can also install industry-specific equipment so your cleanroom is up and running as soon as possible.

Reconfigure and Repurpose

If you need to upgrade, downsize, or reconfigure your existing cleanroom, Angstrom Technology can help you adapt your cleanroom to fit your revised needs and cleanroom standards. Using modular panels, a cleanroom can be expanded or condensed to accommodate new equipment, additional personnel, or a new layout. Our cleanroom experts can help create an intuitive and efficient cleanroom layout, upgrade your cleanroom HVAC system, and design an airflow pattern that works with your new space. 

Maintain and Clean

Medical cleanrooms require consistent evaluation to make sure they meet class standards, and that all systems perform efficiently and operate safely. In addition to routine maintenance, cleanrooms should also receive regular cleaning to reduce contaminant generation and prevent the transfer of contaminants inside the cleanroom.

If you want to make sure your space is always up to your cleanroom classification standards, Angstrom Technology can add you to our regular maintenance schedule for cleanroom HVAC service, filter replacement, deep cleaning, and more.

To discover more about Angstrom Technology’s cleanroom offerings, as well as our cleanroom design, maintenance, and installation services, reach out online or give us a call to speak with our team about your cleanroom needs.

If you need to upgrade, downsize, or reconfigure your existing cleanroom, Angstrom Technology can help you adapt your cleanroom to fit your revised needs and cleanroom standards. Using modular panels, a cleanroom can be expanded or condensed to accommodate new equipment, additional personnel, or a new layout. Our cleanroom experts can help create an intuitive and efficient cleanroom layout, upgrade your cleanroom HVAC system, and design an airflow pattern that works with your new space. 

Maintain and Clean

Medical cleanrooms require consistent evaluation to make sure they meet class standards, and that all systems perform efficiently and operate safely. In addition to routine maintenance, cleanrooms should also receive regular cleaning to reduce contaminant generation and prevent the transfer of contaminants inside the cleanroom.

If you want to make sure your space is always up to your cleanroom classification standards, Angstrom Technology can add you to our regular maintenance schedule for cleanroom HVAC service, filter replacement, deep cleaning, and more.

To discover more about Angstrom Technology’s cleanroom offerings, as well as our cleanroom design, maintenance, and installation services, reach out online or give us a call to speak with our team about your cleanroom needs.

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