How Does Humidity Control Ensure Excellence in Medical Device Manufacturing?

How Does Humidity Control Ensure Excellence in Medical Device Manufacturing?

Maintaining a controlled environment is critical when manufacturing medical devices. Cleanrooms play a pivotal role in creating this environment, protecting delicate components from harmful contaminants and environmental factors that could compromise the quality of the devices being produced.

At Angstrom, we understand the unique challenges of manufacturing medical devices and specialize in designing cleanroom solutions that address those challenges head-on. 

One key factor in achieving excellence in this field is humidity control. By maintaining precise humidity levels, cleanrooms preserve the integrity of medical devices and ensure that manufacturers meet the industry’s stringent quality and regulatory requirements. 

Let’s explore the importance of humidity control in medical device manufacturing and how cleanroom solutions can help ensure manufacturing excellence.

The Crucial Role of Humidity Control in Cleanrooms for Medical Device Manufacturing 

Humidity control is essential in maintaining the quality and safety of medical devices. Proper humidity levels help ensure materials and parts function as expected, preventing damage or degradation.

Why Humidity Control Matters:

In the medical device industry, even minor deviations in humidity can lead to significant consequences. Maintaining optimal humidity levels ensures that devices are reliable, durable, and safe, helping manufacturers avoid costly recalls while ensuring patient safety.

Key Risks of Improper Humidity Control:

  • Corrosion: Excess moisture can corrode metallic parts, compromising the device’s structure.
  • Microbial Growth: High humidity fosters microbial growth, leading to contamination risks.
  • Compromised Adhesive Properties: Improper humidity can weaken adhesives, resulting in defective devices.

Benefits of Precise Humidity Control:

  • Optimal Conditions for Materials: Precise control minimizes defects, ensuring materials remain stable and functional throughout production.
  • Reduced Risk of Defects: Consistent humidity prevents reactions that could compromise device integrity, reducing the likelihood of defects.
  • Improved Regulatory Compliance: Devices produced in humidity-controlled environments are more likely to pass stringent testing, minimizing the risk of recalls or failures.

3 Major Reasons Why Cleanrooms Are Essential for Medical Device Manufacturing

While humidity control is crucial, there are other significant reasons why cleanrooms are indispensable in medical device manufacturing. Cleanrooms provide an environment where contamination is minimized, ensuring the highest level of product quality and safety.

1. Contamination Control

Medical devices are susceptible to contaminants such as dust, microbes, and particulates. Cleanrooms maintain a controlled environment, preventing these elements from compromising device safety and functionality. Using advanced filtration and airflow systems in cleanrooms minimizes the risk of contamination during production, safeguarding device integrity.

2. Protection from Environmental Factors

External environmental factors like temperature, airflow, and particulate matter can significantly affect medical device manufacturing. Cleanrooms create a stable environment where sensitive components are protected from fluctuations that could cause material degradation, affecting the longevity and reliability of the device.

3. Regulatory Compliance

Medical device manufacturers must meet stringent regulatory standards, such as those set by the FDA and ISO. Cleanrooms help manufacturers comply with these regulations by controlling critical environmental factors like particle count, air quality, and cleanliness. Maintaining these standards is essential to avoid production delays, costly recalls, and compliance issues.

How Angstrom’s Medical Device Cleanroom Solutions Optimize Manufacturing

Here at Angstrom, we’re proud to be a leader in providing cleanroom solutions that meet the rigorous demands of medical device manufacturing. Our cleanrooms are designed to create optimal production environments that ensure compliance with industry standards while protecting product quality.

Custom Medical Device Cleanrooms for Manufacturers:

  • HardWall Cleanrooms: Offering maximum control over static, pressure, contamination, and humidity, hardwall cleanrooms are ideal for environments requiring strict compliance with ISO 14644 standards, such as medical equipment. 
  • Modular Designs: We offer modular cleanrooms that can integrate with your existing structure or be entirely free-standing, depending on your facility’s needs.

Key Benefits of Angstrom’s Cleanrooms:

  • Contamination Prevention: Designed to meet ISO standards, our cleanrooms help protect against particulate contamination, safeguarding the integrity of your products.
  • Regulatory Compliance: Our cleanrooms meet stringent FDA and ISO standards, ensuring that your facility remains compliant and minimizes the risk of recalls or regulatory issues.
  • Real-time Environmental Monitoring: Angstrom’s cleanrooms have advanced monitoring systems to track vital environmental factors like humidity and particulate levels, helping maintain a consistent, controlled environment.
  • Regulatory Assurance: Our monitoring systems ensure that all environmental conditions meet regulatory requirements, allowing you to focus on production while maintaining compliance.
  • Business Success: With optimized cleanroom environments, we help businesses increase efficiency, reduce production downtime, and improve overall output quality, ultimately contributing to long-term success and growth.

Do You Want to Optimize Medical Device Manufacturing with Angstrom?

Maintaining precise environmental control, especially humidity, is essential for ensuring medical devices’ integrity, safety, and compliance during production. Angstrom Technology’s cleanroom solutions are designed to meet the unique needs of medical device manufacturers, providing a controlled environment that guarantees high-quality production and meets industry standards.

If you want to optimize your medical device manufacturing process, Angstrom is here to help. Contact us today to request a quote and learn how our cleanroom solutions can enhance your manufacturing outcomes and drive your business success.

All About Medical Packaging Cleanrooms

All About Medical Packaging Cleanrooms

There are a lot of steps that go into the safe research, testing, and production of medical products — but the process doesn’t stop there! Once medical products are tested and manufactured, they need to be packaged and distributed safely as well. 

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. 

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How to Achieve Aseptic Conditions in Medical Cleanrooms

How to Achieve Aseptic Conditions in Medical Cleanrooms

The ability to achieve aseptic conditions is invaluable in many medical cleanrooms and other healthcare applications. Let’s talk about what aseptic conditions are — and are not — as well and look at what you need to design an aseptic cleanroom.

What are Aseptic Conditions?

Aseptic conditions refers to the objective of a facility to limit microorganisms through design, material choices, and sterilization in order to protect sensitive work, products, or people in a space. Aseptic cleanrooms take every precaution to prevent microorganisms from entering and settling in controlled environments where they could threaten health and safety.

It’s important to note that aseptic does not mean the same thing as sterile. An aseptic environment differs from a sterile environment in that it is not just only that a space that has been sterilized, but one that has been specifically designed to maintain sterility as much as possible. 

Medical Cleanroom Applications that Require Aseptic Conditions

The purpose of aseptic cleanrooms is to prevent biological contaminants from threatening work or causing disease. Through choosing aseptic materials and specific design features, cleanrooms capable of achieving aseptic conditions can make important work safe from microorganisms such as bacteria, allergens, fungi, and pathogens. These types of cleanrooms provide a contaminant-free environment that is easier to keep clean. 

Any medical cleanroom that is threatened by the presence of microorganisms can benefit from establishing aseptic conditions, but there are many that require them in order for procedures to be safe and effective, such as:

  • Pharmaceutical cleanrooms
  • Medical device cleanrooms
  • Medical research cleanrooms
  • Hospital settings such as surgery procedure rooms

Many of these applications require additional steps to be taken for the prevention of microorganisms in their industry-specific standards. With the goal of complete asepsis, the design and construction of facilities used for the purposes listed aids in optimizing facility cleanliness and control. 

How to Achieve Aseptic Conditions in a Medical Cleanroom

Aseptic conditions are first established through the cleanroom design features, then maintained through proper training of employees to maintain sterile conditions through gowning, cleaning, and proper removal of waste.

Let’s take a look at the design features of medical cleanrooms that can work to create and maintain aseptic conditions, and how proper training and procedures can be used to optimize them.

Aseptic Cleanroom Design Features

A well-designed cleanroom that can prevent contaminants from entering the controlled environment is invaluable to achieving aseptic conditions. All components used in the cleanroom design must:

  • not contribute to contamination themselves through shedding particles or outgassing
  • be easy to clean and able withstand thorough cleaning procedures and solution

Here are the cleanroom design features that can help medical cleanrooms achieve aseptic conditions.

  • Cleanroom Walls: Medical cleanrooms design should promote coved corners wherever possible, to prevent microorganisms or contaminating particles from settling where they are difficult to be removed. All wall panels should be sealed to prevent any particles leaking into the controlled space. Positive air pressurization can help prevent entering contaminants.
  • Ceiling Grid: Sturdy, reinforced steel ceiling grids provide the necessary support for medical cleanroom systems including fan filter units, lighting, and ceiling panels, while being easy to wipe down to maintain aseptic conditions.
  • Cleanroom Filtration: Fan filter units (FFUs) are essential to achieve the required cleanliness levels proscribed by the ISO and industry-specific standards for medical cleanrooms. Room-side replaceable FFUs are ideal because they can be serviced easily, reducing effort and cost for maintenance.
  • Doors, Windows, and Pass-Throughs: Any access points, including cleanroom windows, doors, and pass-throughs, should be flush-mounted to form a complete seal when closed and prevent ledges or lips where particles could settle or be difficult to clean.
  • Special Features and Technology: Other special features, such as ultraviolet-C technology, which neutralizes bacteria and pathogens in the air, either in the ducting system or in the cleanroom itself, can be used to support filtration and establish aseptic conditions.

When choosing components for your medical cleanroom design, the best materials that will be safe to use in aseptic environments are stainless steel and plastic — either FRP or U-PVC. 

Maintaining Aseptic Cleanrooms

With every part of the cleanroom design working to establish aseptic conditions, it’s up to personnel to maintain them. This can be done through comprehensive training, adequate protective clothing, and set procedures for gowning, cleaning, and waste removal. 

Also, it’s vital to keep the cleanroom in optimal condition to ensure all systems and components are an effective defense against microorganisms and potential contaminants. Replace filters according to a regular schedule and inspect the facility regularly to check for signs of damage or deterioration. This will ensure that the cleanroom is always working hard to provide a safe environment for workers and work to continue, and that you’re always reaching your cleanroom classification.

Need help achieving aseptic conditions in your cleanroom? At Angstrom Technology we have the expertise and the tools to design the cleanroom that best fits your application and your budget. Reach out to our team today for a free custom quote.

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.