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. 

What to Expect When Assembling Your Pre-Fabricated Modular Cleanroom

What to Expect When Assembling Your Pre-Fabricated Modular Cleanroom

Modular cleanrooms are the most convenient way to build a custom cleanroom for your facility. Panels are pre-fabricated according to your specific cleanroom design, and arrive with everything you need to get your cleanroom up and running as soon as possible. Modular cleanroom panels offer many benefits to the cleanroom building process, such as: 

  • Designed with a cleanroom expert to meet your cleanroom classification
  • Custom-built to your application and project requirements
  • Pre-wired and pre-insulated panels are ready to use
  • Can easily be reconfigured if your project needs change
  • Easy to assemble for a quick turnaround time

When your prefabricated modular cleanroom panels arrive, they’ll come with detailed directions to guide you through the setup. If the process of ordering, shipping, and assembling a modular cleanroom seems daunting, let’s break down what you can expect throughout this process. 

What to Expect When Assembling a Modular Cleanroom

Modular cleanrooms are much more convenient than building a cleanroom on-site, but you may not know what to expect when it arrives. Let’s talk about what happens when you order your custom modular cleanroom and what’s needed when it comes time to assemble it onsite.

Ordering Your Modular Cleanroom

When you order your modular cleanroom, a cleanroom design expert will go over the details of  your specific project with you to make sure it contains everything you need to make your  new cleanroom a success. The designing process could take a few weeks, depending on the intricacies of your cleanroom design, the type of cleanroom you order, and your cleanroom classification and specific industry requirements.  Once design is complete, the panels will be fabricated to your exact specifications.

Once the panels are ready to ship, they will be packaged and transported with the utmost care. All modular cleanroom panels are made of the highest quality materials — strong enough to withstand the conditions of your work, yet flexible enough to be set up and reconfigured with ease if your project needs change.

Cleanroom design experts handle all the arrangements, so you won’t have to worry about controlling contamination risks in the shipping of your cleanroom panels. 

Professional Cleanroom Assembly Assistance

If you want to skip the DIY setup, you can have cleanroom professionals complete the installation for you. A cleanroom installation team can assemble your custom modular cleanroom with minimum disruption to your facility’s operations and with maximum efficiency to get your new cleanroom up and running as soon as possible. Quality cleanroom construction is very important to the initial and future functionality of a cleanroom.   A professional install team can make sure all the technical details are carried out according to your cleanroom design so that it complies with your classification requirements and industry standards.

How Long Does Modular Cleanroom Assembly Take?

The entire design-to-installation process will depend on the complexity of your unique cleanroom. Do you have special features, storage, furniture, lighting, or systems to include in the design? Does your cleanroom fall under a stringent cleanroom classification? More complex cleanrooms will require more time to make sure every detail is just right when the modular panels arrive on your site.

Once the cleanroom has arrived, the assembly time can also vary by cleanroom type. SoftWall cleanrooms are known for being easy to assemble, disassemble and reconfigure. SoftWall modular cleanroom assembly generally only takes a few hours. HardWall and RigidWall cleanroom assembly is more involved, but can still be completed in just a few days. 

Once your modular cleanroom is set up, it’s only a matter of keeping it in optimal condition. Routine maintenance will serve to keep all systems running at peak efficiency so your operations can continue to move along smoothly.

Whether you prefer to assemble your modular cleanroom yourself, or would like a team of professionals to install it for you, Angstrom Technology is here to design, build, and deliver the best cleanroom available. To learn more about the process and get started with your cleanroom installation, get in touch with us today.

Plastic Industry Cleanroom Design Tips: How to Choose Cleanroom Tables

Plastic Industry Cleanroom Design Tips: How to Choose Cleanroom Tables

When it comes to choosing the right cleanroom furniture for your plastics industry application, you have many options. Cleanroom tables come in a large selection of shapes, sizes, and materials, but not every table is a good fit for your cleanroom. Understanding the difference between common types of cleanroom tables could help you find the best option for your plastics industry cleanroom.

Cleanroom Tables, Workbenches, and Workstations

Cleanroom tables are just one type of surface you can use in your cleanroom. Other similar cleanroom furniture includes workbenches and workstations. What’s the difference? Tables, workbenches, and workstations are often used interchangeably, and the furniture itself could be used to serve a variety of purposes within your cleanroom design, but they do have small differences which could make one a better choice for you.

Workbenches are typically made to withstand a greater weight capacity. Built with sturdy, powder-coated steel frames, these surfaces are great for applications involving manual labor, such as in manufacturing and assembly.

Cleanroom tables are often used for lighter purposes, though not always. Cleanroom tables are versatile pieces of furniture, and can be used to hold equipment, serve as a desk, or a work space for conducting detailed tasks.

Workstations are typically for focused work, assembly of small parts, or as standing desks. They can also be used to support equipment like microscopes or vision systems for quality control. Workstations often have adjustable height options, so the user can decide what’s most comfortable for them.

Types of Cleanroom Tables

Cleanroom tables are made of sturdy materials that won’t shed particles or contribute to contamination of the controlled environment. The most common types of cleanroom tables are laminated, stainless steel and perforated.

Laminated Cleanroom Tables

Laminated cleanroom tables are coated with an epoxy resin or polypropylene to create a non porous, chemical-resistant surface that’s easy to clean and sterilize. These cleanroom tables are great for cleanrooms in ISO Class 5 or greater. Many laminate tables can be made conductive or electrostatic dissipative if the application demands anti-static properties.

Stainless Steel Cleanroom Tables

Stainless steel tables are a popular choice for cleanroom tables because they are easy to clean and sterilize, and are corrosion-resistant and non particle-shedding. These tables will work with any cleanroom classification standard, even the stringent requirements of ISO Class 3.

Perforated Cleanroom Tables

Perforated cleanroom tables are typically made of stainless steel, and offer all the same benefits, but have the added advantage of laser-cut holes across the table’s surface. This allows air to pass through the table without interrupting the cleanroom’s laminar flow or creating turbulence. Perforated cleanroom tables have powder-coated steel bases for great load bearing capacity.

Choosing the Right Cleanroom Table

To choose the best cleanroom tables for your application, you should also consider how you’ll use the furniture, and any other features that would make your work easier. These might include:

  • Size: Consider how you’ll use your cleanroom tables: for working on larger tasks, or small, focused work. Keep in mind that larger tables also take up more space in your cleanroom.
  • Height: Cleanroom tables with an adjustable height feature are ergonomic for employees and can be adaptable to a variety of uses.
  • Storage: Some cleanroom tables have built-in storage in the form of drawers or shelves.
  • Weight-Bearing Capacity: Consider what types of projects your cleanroom is involved in, or the weight of equipment cleanroom tables will be required to support.
  • Anti-Static: Some plastics industry cleanrooms require conductive laminate or electrostatic dissipative materials for cleanroom furniture.
  • Material: Your cleanroom classification will dictate which materials are acceptable within your cleanroom, but it should be a material that won’t corrode, shed particles, or be sensitive to chemicals used for cleaning.

Although there are many options to consider when choosing cleanroom tables, this gives you a great opportunity to find the ideal furniture for your application. If you’re still not sure which table will suit your needs best, talk to the cleanroom design experts at Angstrom Technology. With your industry requirements and cleanroom classification in mind, we can help guide you toward the best tables for your cleanroom design.

Aerospace Cleanroom Design Tips: Finding the Right Lighting

Aerospace Cleanroom Design Tips: Finding the Right Lighting

Lighting is a critical part of cleanroom design. This system allows employees to properly view what they’re working on, improves the efficiency of your cleanroom operations, and can even help identify contaminants to help keep your cleanroom clean. Which cleanroom lighting is best for your application? Let’s explore your options to help you decide.

How to Choose Cleanroom Lighting

You’ll want to choose cleanroom lighting that is as illuminating as it is simple to maintain and clean. Additionally, consider the way your lights are mounted and how they work with your overall cleanroom design to help you reach your cleanroom classification. The cleanroom lighting you choose must be highly efficient and contaminant-free. The fixtures and any mounting mechanisms must be able to be cleaned effectively and ensure no contaminants can enter the cleanroom.

LED Cleanroom Lighting

LED lighting is known to be more durable and longer-lasting, require less maintenance, and use less energy than incandescent lighting. Plus, LEDs are extremely bright, which is a useful quality for aerospace cleanrooms where a lot of illumination is needed.

Cleanroom Lighting: Useful Measurements to Know

When choosing cleanroom lighting, you’ll need to understand how lights differ by comparing their measurements. Here are a few useful measurements to know:

Watts: measures how much energy is required to power the light

Foot-candles: measure the distance light reaches, by square feet

Lux: measure the intensity of light produced, as interpreted by the human eye

Lumens: measure light output

Depending on the use of light in your cleanroom, you will use these measurements differently. For example, if work in your aerospace cleanroom is task oriented and needs light to focus on small parts, you’ll require brighter, more intense lighting that allows significant illumination of the work area without causing employees to strain their eyes. Conversely, work over a broader area that isn’t detail-focused will need to prioritize area coverage, but not necessarily intensity.

Mounting Cleanroom Lighting

How lighting is mounted is another important part of choosing the right fixtures for your cleanroom. When comparing lighting systems, consider how much space the lighting system will occupy on the ceiling, a factor that is especially important when ceiling space must also be shared with filtration and fan units.

The way your cleanroom lighting is mounted will also determine how you access it to perform service such as replacing bulbs, fixing wiring, or cleaning the fixtures. Lighting can be mounted so that it is accessible from inside the cleanroom, but keep in mind this means all servicing of lights will interfere with cleanroom processes. Lights can also be installed from above. The advantage of this is that accessing lights does not mean as much of an interruption for the room below, and keeps contaminants from entering from the lighting space. However, this option requires more space above the ceiling for access.

Types of Cleanroom Lighting

Each aerospace cleanroom will have specific lighting needs and varying amounts of available ceiling space. Because of this, there are many different types of cleanroom lights to choose from. Here are a few common types of cleanroom lighting:

Flat Panels 

Flat panels are mounted flush with the ceiling. They provide a lot of light and are easy to clean. Because of their wide panel design, this cleanroom lighting type requires more ceiling space compared to other options, which makes it less than ideal for cleanrooms with stringent filtration requirements.

Teardrop Lighting

More stringent cleanroom classifications prioritize ceiling space for fan units and filters. Lighting, therefore, is a secondary concern and must work around the filtration system. 

Teardrop lighting extends below the ceiling to allow for precious ceiling space to be used for filtration. The teardrop shape allows an uninterrupted flow of air around the lighting without creating turbulence. The disadvantage of teardrop lighting is that it takes up valuable headspace within the cleanroom environment.

LED Lighting Grid

Batten lighting, or lighting strips, are linear LED lighting which is integrated with the ceiling grid system. This allows adequate space for fan/filter units around filters. Wiring for the lights is also built into the grid system so it provides consistent light throughout space without taking up a lot of room on the ceiling.

Recessed Lighting 

Recessed lighting units sit in the ceiling on a gasket to create an airtight seal. While they leave plenty of headroom, recessed lighting requires extreme care when servicing to ensure no contaminants are trapped when light is accessed. In cleanrooms with extremely stringent requirements, recessed lights and filtration can be combined in singular units for ultimate space-saving capabilities.

Expert Cleanroom Design and Lighting Help

An expert cleanroom designer will make choosing cleanroom lighting easier. They can work with you and your specific application to determine which types of lighting and mounting options will best complement your design needs. An cleanroom expert can:

  • Help decide which lighting can be used to perform different tasks in your cleanroom — specific to your application and workers’ needs.
  • Help design lighting to fit around other features of your cleanroom design, including filtration and mounted equipment.
  • Allocate control panels where they are accessible and convenient for staff.
  • Choose energy-efficient lighting fixtures that will maximize productivity while minimizing operational costs.

Cleanroom lighting is an essential part of your cleanroom design and should work with all the other elements to make a high functioning cleanroom for your application. If you’re still unsure which lighting option is best for you, talk to a cleanroom design expert about your concerns and specific project requirements.

Need a little help designing your cleanroom? Call the experts at Angstrom Technology. From lighting to flooring, we can help you make the best choices for your budget and your application. 

Safe and Effective Cleanroom Cleaning Solutions for the Medical Industry

Safe and Effective Cleanroom Cleaning Solutions for the Medical Industry

Although your cleanroom design is meant to limit the introduction of contaminants into your cleanroom through high-performing HEPA and/or ULPA filters, cleanroom garments and gowning protocols, and airflow patterns, it still needs regular cleaning with proper solvents and methods to maintain its cleanroom classification.

What makes this process successful? The right tools. Working in sensitive environments like medical cleanrooms, it’s vital to use the right cleaning solutions — ones that are powerful enough to sterilize surfaces and kill microorganisms, but gentle enough to not introduce harsh chemicals or contaminants into the controlled environment.

Medical Cleanroom Cleaning vs. Disinfecting

When it comes to cleanroom cleaning, there are two levels of cleaning which translate to steps in the process: cleaning vs. disinfecting. Understanding the difference between them is crucial — particularly in medical cleanrooms, where high levels of cleanliness are necessary to maintain the cleanroom classification.

Cleaning refers to the removal of dirt, grime, or buildup. This stage uses a mild detergent or soap, followed by a rinse to loosen debris and remove surface particles. 

Disinfection serves the purpose of killing microorganisms that weren’t removed during cleaning. Disinfection is a crucial step in the cleanroom cleaning process, as it sterilizes surfaces to prepare them for work to resume.

Using cleaning agents with disinfectants in tandem will ensure an all-over clean for your controlled environment. Make sure the detergents and disinfectants you choose are compatible, so as to not inhibit active ingredients or cause an unfavorable reaction.

Medical Cleanroom Cleaning Solutions

Let’s break down how to choose detergents and disinfectants that are safe to use for your medical cleanroom.

Choosing a Detergent

Detergents used in medical cleanrooms must be effective at breaking down dirt, but not harmful to cause corrosion or particle shedding from surfaces. A simple mild soap with sterile water is often effective for loosening debris. Be sure to follow up with a rinse to remove all particles and prevent buildup.

Choosing a Disinfectant 

Disinfectants come in oxidizing and non oxidizing. Oxidizing disinfectants, such as hydrogen peroxide and peracetic acid, are designed to kill a wide variety of microorganisms and are powerful agents. However, they can be harmful to the user and have a greater chance of being reactive with other chemicals, so use oxidizing disinfectants with caution.

Non oxidizing disinfectants, which are typically alcohols or ammonium compounds, target specific antagonists and can be effective when used with a cleaning strategy aimed at the contaminants and microorganisms by which your application is threatened. 

You can also rotate the disinfectants you use to combat contaminants more effectively, but don’t combine a non oxidizing disinfectant with an oxidizing disinfectant. Be sure to research any combination of chemicals thoroughly, as some can cause reactions, toxic fumes, or substances that are not only dangerous for your cleanroom, but also hazardous to the user.

Medical Cleanroom Cleaning Protocols

When cleaning your medical cleanroom, you should have a clear protocol for what needs cleaning, what you’ll use to clean it, and in what order things will be cleaned. Clutter and loose debris should be gathered first, in a top-down approach, so that any dust or particles will move toward uncleaned areas and not risk contaminating what’s already been cleaned. Once loose dirt has been collected, apply your detergent or soap using a clean mop head. Follow up with a thorough rinse to remove any soap residue. 

With cleaning complete, you can then apply disinfectant to kill microorganisms not removed during cleaning. Some disinfectants require rinsing to remove residues, typically using sterile water or an isopropyl alcohol and water solution. Allow the proper drying time before rinsing to ensure the disinfectant has done its job.

Your cleanroom design should include adequate storage for all cleanroom cleaning supplies, detergents, and disinfectants. Ideally, cleaning products should be stored somewhere in the cleanroom so you won’t risk contamination by transporting things in and out of the space each time you need to clean. Storage should be secure and contaminant-free. Always dispose of used cleaning materials and waste responsibly.

Cleanroom Cleaning Tips:

  • Use different mop heads for different parts of the room, i.e. a different tool for the floor than you use on the ceiling and walls.
  • Follow a proper mopping pattern. A proper mopping protocol will ensure that all areas are properly cleaned and disinfected without missing “dirty” sections or drawing contaminants into previously cleaned parts of the surface.
  • Make sure to save mopping for last. Remove waste, clean surfaces, and organize equipment prior to mopping so you won’t track over a cleaned area. Mop from the farthest area from the door backwards so the entire room has been completed and you can safely exit without contaminating the cleaned space.

Are You Cleaning Your Cleanroom Often Enough?

If you’re wondering “how often should my cleanroom be cleaned?” — the answer is probably more often than you think. Every day there will be some level of cleaning required, with special attention paid to heavy use areas like floors and surfaces. Some tasks, like replacing filters and other routine maintenance can be performed at regular intervals throughout the year. Like any well-oiled machine, your cleanroom needs some work to keep it running smoothly and effectively. Paying attention to a regular cleaning schedule, using the right tools and solutions, will make your cleanroom that much more effective.

Cleaning your medical cleanroom will remove any contaminants before they can build up, preventing cross contamination and significantly reducing the risk of chemical interference. Regular cleaning also helps to make sure all systems run effectively, and extends the life of expensive filters. At its most basic function, cleaning resets the space for the next day’s work.

Have a list of cleanroom cleaning products but nowhere to put them? At Angstrom Technology, we design medical cleanrooms of all shapes and sizes, and can include all the sterile storage space you need for detergents, disinfectants, mops and more. Our cleanroom designs are comprehensive, and can reach any cleanroom classification requirements. If you need a cleanroom that works for you, give Angstrom Technology a call.