That’s where medical packaging cleanrooms come in. Below, we’ll discuss these spaces in further detail, giving information about what they are, what requirements they have, and what projects Angstrom Technology has been working on lately. 

What Is a Medical Packaging Cleanroom?

As its name suggests, a medical packaging cleanroom is a controlled, filtered space dedicated to the packaging of sensitive medical materials and products. However, this is a pretty broad term given the number of medical materials and products available. 

As we’ve covered in our previous blog, there are three main types of medical cleanrooms: those for medical research, those for medical devices, and those for pharmaceuticals. Therefore, medical packaging cleanrooms are usually built to accommodate medical device packaging, pharmaceutical packaging, or both. 

What Requirements Does a Medical Packaging Cleanroom Need to Meet?

Depending on the specific type of medical product that needs packaging, one medical packaging cleanroom may have different requirements than the next. But there are still some things they all have in common. Below are a few common considerations for medical packaging cleanroom requirements:

Size

In many cases, medical packaging applications involve large pieces of equipment like packaging lines and conveyor belts. Therefore, medical packaging cleanrooms tend to be relatively larger than cleanrooms in other industries, in terms of both floor space and height. 

ISO Classification

Medical packaging cleanrooms require a good level of filtration and cleanliness, but they usually don’t need to meet the most stringent ISO standards. Since they’re mainly focused on the packaging of the product, rather than the actual production or testing of it, they’ll usually fall into ISO Class 7 or 8 range. 

Additional Design Features

When it comes to medical packaging cleanrooms, the additional design features and technologies needed vary from company to company and application to application. However, most include gowning rooms, a material airlock, and at least one area for parts storage. 

Angstrom Technology’s Recent Medical Packaging Cleanroom Projects

At Angstrom Technology, we’ve completed a number of cleanroom projects within the medical industry — but recently we’ve been excited to share some of our unique medical packaging projects! Completed within the past couple of years, these projects have ensured consistently controlled operations for our clients and have even resulted in some long-term relationships and additional projects. 

Medical Packaging Cleanroom 

In 2021, Angstrom completed a huge, 32,000 square foot cleanroom project for a medical packaging company in West Michigan — in just four months! The cleanroom is now able to fit numerous large pieces of medical packaging equipment, as well as the large number of workers needed to operate them. It also features the following specifications and technologies: 

• ISO Class 8
• Seamless Construction
• 24’ Suspended Walkable Ceilings
• High-Speed Roll-Up Doors
• Automated HEPA Controls & Pressure Sensors Linked to BMS through BACnet

To view featured videos and photos from this project, visit our Medical Packaging Cleanroom Project page. 

Pharmaceutical Packaging Cleanroom 

Back in 2019, Angstrom worked with Praxis, a Michigan-based, contract packaging company, to design, build, and install a 2,120 square foot cleanroom for their OTC and prescription pharmaceutical packaging applications. This project brought a unique challenge to our team because the cleanroom needed to be designed and installed around a large piece of existing equipment in the facility — and on a tight timeline. 

But by employing two expert crews to handle the job, Angstrom was able to deliver a quality cleanroom solution on time, eventually resulting in Praxis becoming a long-term customer and requesting two more identical pharmaceutical cleanroom projects. Specific cleanroom features and technologies are listed below: 

• ISO Class 8
• Gowning Room and Parts Storage Room (both ISO Class 8 as well)
• 14’ Internal Ceiling Height
• Epoxy Floor

To discover more details about this project, read our case study that was featured on Cleanroom Technology’s website. To view featured videos and photos from this project, visit our Pharmaceutical Packaging Cleanroom Project page. 

Hoping to install a medical packaging cleanroom in your facility? Contact Angstrom Technology! Our engineers have nailed down processes for design, building, and installation that are both efficient and effective. We’re excited to take on any challenges your cleanroom project may present. And, with an extensive portfolio of successful projects, we’ve proven our ability to achieve quality, consistent results. 

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.

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. 

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.

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.