Medical Cleanroom Gowning Procedure

Medical Cleanroom Gowning Procedure

In many medical cleanroom applications, the slightest risk of contamination could have disastrous consequences for the development or testing of products. For this reason, garments are used to protect employees and processes. The purpose of the cleanroom gowning procedure is to limit particles that get in or on garments before entering the cleanroom. Once you have a cleanroom gowning procedure laid organized, make sure it is clearly communicated to all employees and posted in a visible location within the gowning room itself.

Having a procedure for donning protective equipment is crucial for the safety of your operations, although the gowning process itself as well as the cleanroom supplies and garments used will vary depending on your cleanroom’s application and the classification requirements for your cleanroom. Let’s walk through an example of a cleanroom gowning procedure that can be used for many medical cleanrooms.

Medical Cleanroom Gowning Procedure

A comprehensive cleanroom gowning procedure involves three stages, which are translated into distinct areas within the gowning room. Each must be kept separate in order to limit contamination. The three areas used in the cleanroom gowning procedure are:

  • The Pre-Changing zone: for the removal of items not worn under garments 
  • The Changing zone: for donning and storing garments and cleanroom supplies
  • The Entrance zone: to conduct final checks before entering the cleanroom

Before beginning the cleanroom gowning procedure, employees must have recently showered, be wearing clean clothing and hair covers, and be as personally clean as possible.

Pre-Change Zone

The pre-change zone is the preliminary step of the cleanroom gowning procedure, where the majority of particles are removed prior to entering the cleanroom. In this zone, a sticky mat is used to clean the soles of the employee’s shoes. The employee must also remove clothing that won’t be worn in the cleanroom under the garment and store items safely where they can’t shed particles or contaminate clean garments.

In the pre-change zone, there will be a place for employees to scrub hands for a minimum of thirty seconds. Afterwards, they can apply a disinfectant and sterile moisturizer before moving onto the changing zone.

Changing Zone

Employees enter the changing zone by passing over a bench or into a separate room. In this area, they will don gloves, put on a facemask, select garments, and put on any necessary headgear and garments without touching the floor or other items in the room. While changing, the employee should take care to touch as little of the garments as possible. Specific gloves can be worn for this process if necessary to ensure no particles are carried onto the garments themselves.

With the proper attire donned, the employee will tuck their sleeves into their gloves and put on boots or shoe covers carefully so that they don’t touch the “dirty” area where they previously tread. 

Entrance Zone

The entrance zone is the final area of the gowning room, and the final stage of the cleanroom gowning procedure. It will have a full-length mirror and a place where employees can wash their hands to disinfect them one more time before entering the cleanroom. 

In the mirror, the employee should do a thorough visual check that the garment is worn properly and tucked in the necessary places — around sleeves and gloves, into boots, etc. — and that any headgear is secured and clean. The gloves should also be checked, and replaced if torn or contaminated before reaching the entrance zone. Once the check is complete, the employee may enter the cleanroom.

The cleanroom gowning procedure may seem extensive or complicated, but it is vital to limit the potential level of contamination entering the cleanroom. However, implementing a solid procedure is only part of this task. The cleanroom gowning procedure depends on a thoughtfully designed gowning room in order to be effective. 

Medical Cleanroom Design: Gowning Rooms

The medical cleanroom design should facilitate a proper gowning procedure by including the necessary space for gowning rooms and the three zones within them, including the pre-changing zone, the changing zone, and the entrance zone. Each area should be equipped with the furniture and cleanroom supplies employees will need as they move through the cleanroom gowning procedure. These supplies include benches and cabinets for changing areas and storage of both clean garments and dirty ones — which must be kept in separate and secure areas.

The structure of the gowning room must also facilitate the cleanroom gowning procedure. Cleanroom doors and pass-throughs must allow contamination-free entrance and exit areas for both employees and supplies.

Finally, the cleanroom systems — including HVAC, HEPA filtration, and airflow — must work together to change the air effectively and prepare the employee for entrance into the cleanroom environment. In some sensitive applications, a dedicated HVAC system and fan/filter units may be necessary to capture particles during the cleanroom gowning procedure to keep them from entering your medical cleanroom.

Is your gowning room prepped to allow for maximum efficiency and minimum contamination? Angstrom Technology designs, builds, and installs secure and controlled cleanroom gowning rooms. We can help make sure your space is helping you reach your stringent classification requirements and eliminating contaminants wherever possible. For more information, give us a call or reach out online.

Automotive Cleanroom Design Tips: Cleanroom Doors and Pass-Throughs

Automotive Cleanroom Design Tips: Cleanroom Doors and Pass-Throughs

Your cleanroom doors are the most vulnerable part of the cleanroom. As the most likely place for particles and contamination to enter your controlled cleanroom environment, it’s important to choose cleanroom doors that are secure, reliable, and contaminant-free. There are many factors to consider when choosing cleanroom doors for your facility. The first consideration you’ll need to make is the type of cleanroom doors that will best serve your automotive cleanroom’s needs.

 

Types of Cleanroom Doors

Cleanroom doors typically come in two main varieties: swinging, sliding, and high-speed roll-up doors. Let’s take a look at the difference between them and the advantages they can offer your automotive cleanroom application.

 

Swinging Cleanroom Doors

Swinging cleanroom doors are attached to hinges on one side of the cleanroom door frame. They swing out of the cleanroom, or in, or both. These doors are designed to close flush with the rest of the wall panel with an airtight seal. They can be installed at different heights and widths as your application demands.

A disadvantage of swinging cleanroom doors is they take up space in your cleanroom, as there needs to be room for the door to swing. Also, the movement of the door can sometimes create turbulent air within the cleanroom. In some applications this could disrupt the airflow pattern and spell trouble for contamination-sensitive processes.

 

Sliding Cleanroom Doors

Sliding doors are attached on tracks at the top and bottom of the threshold. The tracks can be built seamlessly into the floor and ceiling panels so no particles can get inside. A major advantage of sliding cleanroom doors is that they don’t take up as much space as swinging doors. They slide into wall panels or fit along the wall with a slim profile, saving valuable floor space for your operations.

Sliding doors can also be programmed to open and close automatically, which improves efficiency in high traffic areas. The automatic option saves your employees from having to touch handles to operate the door, which works well in applications where employees need to carry materials or move between rooms hands-free. Be aware that sliding cleanroom doors usually require electronic access to open and close. If there’s a power failure, you’ll need to have a back up system in place to operate the door.

 

High-Speed Roll-Up Doors

High-speed roll-up doors are an increasingly popular option for cleanrooms in many industries. When in operation, the fabric “curtain” rolls up and is conveniently stored in a space-efficient head assembly at the ceiling, saving valuable wall space compared to other types of cleanroom doors. These doors are able to maintain a high-quality seal so as to retain clean air within the cleanroom and keep out contaminating particles. They can be made using non-porous, non-particle-shedding, and antimicrobial materials to withstand your cleanroom cleaning protocol and protect the controlled environment.

High-speed roll-up cleanroom doors can be built to a custom height and width to accommodate non-standard equipment and products. The new generation of roll-up doors can be operated at speeds as high as 100 in/s, so you can open and close the door with minimum disruption to cleanroom activities.

 

Cleanroom Pass-Throughs

Cleanroom pass-throughs are cabinets installed in the walls of your automotive cleanroom for the transfer of objects in and out of the cleanroom environment. Pass-throughs have swinging doors attached at both ends where items can be placed or removed.

When properly installed and sealed, cleanroom pass-throughs can improve productivity and safety, and reduce the need for traffic to enter and exit through cleanroom doors which preserves the cleanroom environment. This also lowers your operating costs, as you’re not wasting the energy to filter and regulate the air lost when opening and closing a door, versus the smaller volume of a cleanroom pass-through.

 

Choosing Cleanroom Doors Pass-Throughs

When designing your automotive cleanroom, it’s important to choose the right cleanroom doors and pass-throughs that will offer the best performance for your application.

Your automotive cleanroom doors and pass-throughs…

  • Must be airtight and flush with the walls. An airtight seal prevents particles from settling in the hinges, around the edges or any part of the door or pass-through itself. This helps to minimize the transference of unfiltered air and reduce the risk of contamination in your automotive cleanroom.
  • Must be easily integrated with your modular wall panels. Should also be able to accommodate the people, equipment, and products moving in and out of the cleanroom, but not too large that you waste extra energy by releasing filtered and regulated air out of the cleanroom unnecessarily.
  • Must be sturdy and impact-resistant. The ideal cleanroom doors will be strong enough to withstand consistent use, yet light enough to be easily operated. They should not be damaged easily if a piece of equipment or employee bumps into them.
  • Must be able to withstand cleaning. Your cleanroom doors should be made of a material that won’t corrode or shed particles into your controlled environment when cleaned.
  • Must be antistatic. Cleanroom doors should not allow the buildup of static electricity which could cause damage to your processes or people, or attract contaminating particles.
  • Must be able to lock. Having cleanroom doors with a secure locking mechanism is necessary to maintain a closed environment to protect interior operations, as well as to secure the room when it’s not in use. The locking mechanism must be able to function if electricity is interrupted — you don’t want to risk not being able to close the room, or worse, trapping personnel inside if there’s an unexpected outage.

 

At Angstrom Technology, we design our cleanroom doors to protect you and your products, while allowing easy passage in and out of the cleanroom. To learn more about the best door options for your cleanroom, reach out to us.

Cleanroom Construction in your Existing Structure

Cleanroom Construction in your Existing Structure

The ability to construct a cleanroom in any space is a major advantage of the modular cleanroom building process. Retrofit cleanrooms can still reach a wide variety of ISO cleanroom classifications. With a modular cleanroom retrofit in your existing structure, you have the ability to adapt your existing structure to save space and materials.  Let’s take a look at where you can build a cleanroom in your existing space, and what that process looks like.

Where Can You Construct a Cleanroom?

Cleanroom construction can happen in a variety of spaces, depending on the application and its requirements. The type of cleanroom for each space may differ, as well as the capabilities each may have. Let’s take a look at three examples.

Cleanroom construction can happen in a variety of spaces, depending on the application and its requirements. The type of cleanroom for each space may differ, as well as the capabilities each may have. Let’s take a look at three examples. 

Cleanroom Construction in a Large Industrial Space

If you’d like to construct a cleanroom in a large space, you have many options when it comes to the square footage and layout of your cleanroom. Although you have plenty of space and flexibility, it’s important to only build the cleanroom as large as it needs to be. This will not only save you money on materials during cleanroom construction, but will also cut down energy usage and utilities expenses once the cleanroom is in operation. 

In a large space, you can suspend modular cleanroom panels from a strong ceiling grid or build a freestanding cleanroom. Your cleanroom can also be built to include existing walls, utilize light from existing windows, and even connect to the utilities of the building — as long as they meet your cleanroom classification requirements. In a large space, any type of modular cleanroom will do, so you can choose between a HardWall, SoftWall, or RigidWall cleanroom — whatever will be best for your application.

Cleanroom Construction in Small Spaces

Although large spaces offer plenty of room to spread out, don’t discount smaller spaces for cleanroom construction. Using a more flexible modular cleanroom type — such as SoftWall cleanrooms — can be just as effective in a tighter space. SoftWall modular cleanroom panels can be arranged into more condensed layouts than their HardWall or RigidWall counterparts, while still able to cater to a wide variety of cleanroom classifications (ISO Classes 4-8). 

With high customization options and project versatility, SoftWall cleanrooms are ideal for applications that need to be set up in small spaces. Additionally, their minimalist and lightweight design means they can be set up quickly, easily reconfigured or taken down and stored, and moved virtually anywhere you need a cleanroom.

Office Space to Cleanroom Conversion

When looking for space to put a new cleanroom, unused office space presents a great opportunity. Cleanroom construction can use many elements of the existing structure in the new cleanroom design. Depending on your cleanroom’s requirements, you may be able to make use of an existing ceiling grid, walls, and windows, or even connect with the building’s HVAC system. However, if your cleanroom has stringent requirements it may need a dedicated cleanroom HVAC.  

To convert the office space into a cleanroom, modular furring panels are attached to the walls of the space, creating a flush, non particle-shedding structure. Office space conversions can even be outfitted with the capabilities of HardWall cleanrooms — offering a high level control over environmental conditions within the space. The retrofit cleanroom design might also include antistatic flooring, a grid lighting system, and an airflow pattern that works with the customized space. 

Retrofit Cleanroom Construction Process

The process of retrofit cleanroom construction in every space will look a bit different, as it’s highly customized to each application. It involves four main steps, of which the first two are the most critical. Those include assessment, design, construction, and installation.

Cleanroom Assessment

Cleanroom construction in an existing structure relies more on the planning stages to make sure your space can support the cleanroom you need, before any work begins. A cleanroom expert must first assess the space to determine it will accommodate the necessary equipment, furniture, and personnel. They’ll also examine the quality of the room’s air to determine filtration needs, and look at what systems can be adapted or replaced. 

If the HVAC system in the current building can be utilized, it may need to be upgraded to meet your classification requirements. Or, if it’s not powerful enough to achieve the desired level of control, it will need to be replaced with a more efficient system.

Cleanroom Design

When planning for cleanroom construction in an existing structure, there are many components that must be carefully considered in the retrofit cleanroom design. When designing your retrofit cleanroom layout, the cleanroom designer will need to factor in the space they have to work with, and how it influences the design of other systems in the cleanroom space — particularly the airflow pattern. 

A cleanroom design expert uses computational fluid dynamics to map out the airflow pattern for your application and layout. They’ll also decide where furniture and equipment will be installed, and the wiring and insulation needed in each modular panel.

Cleanroom Construction

With design complete, it’s time to move on to cleanroom construction. With modular cleanrooms, the modular panels are built out to meet the specification of the design and the classification standards of the cleanroom. They are pre-wired and pre-insulated so they can be quickly assembled and installed in the existing building once they arrive.

Cleanroom Installation

Finally, the cleanroom is ready to be installed in your existing structure. Having spent more time planning and designing the cleanroom to work in your space, the installation process will be straightforward — simply a matter of putting the pieces together where they belong:  Modular panels will be attached to existing walls, set up freestanding, or suspended. Lighting systems will be integrated and the cleanroom HVAC system connected. HEPA filters will be installed and checked, so they can start cleaning the air as soon as possible.

Cleanroom construction in an existing structure requires extra care and attention. Due to the critical nature of the cleanroom, it’s recommended to have a team of experts install the cleanroom into your space to ensure a flawless end product. Cleanroom experts dedicate their livelihoods to providing this service, so you get the right cleanroom for your application and your space every time.

Wondering if you can build a cleanroom in your space? Give Angstrom Technology a call! Our professional cleanroom designers can assess your site and design a cleanroom that will work perfectly in your space. To get started, give us a call or reach out to us online today.

 

Understanding Aerospace & Defense Cleanroom Classifications

Understanding Aerospace & Defense Cleanroom Classifications

Aerospace & Defense cleanroom classifications regulate a 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. Aerospace and defense cleanrooms are typically regulated by the classification standards of two major organizations: The International Standards Organization (ISO) and the American Society for Testing and Materials (ASTM).

ISO Cleanroom Classifications for Aerospace and Defense Cleanrooms

The International Standards Organization developed the set of standards by which all cleanroom industries and applications must follow. ISO 14644-1 outlines the requirements for all cleanroom environments.

ISO 14644-1

ISO 14644-1 describes cleanroom cleanliness levels in terms of Classes 1-9, where Class 9 is equivalent to the cleanliness of 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 aerospace and defense cleanrooms fall within ISO Classes 7-8, although some sensitive applications, such as the development of microchips or sensors may be governed by stricter classifications.

Understanding ISO Aerospace Cleanroom Classifications

ISO 14644-1 outlines cleanliness standards for aerospace and defense cleanrooms by determining the allowed contamination levels in each ISO class 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. 
  • Air Change Rate: The air change rate at is how quickly air is removed, filtered, and replaced within your cleanroom. 
  • Ceiling Coverage: Ceiling coverage refers to the percentage of ceiling coverage for HEPA filter/fan units, or FFUs. 

Understanding the way these elements affect the cleanliness of your facility is the key to designing a successful cleanroom.

ASTM Standards for Aerospace & Defense Cleanrooms

American Society for Testing and Materials (ASTM) has also developed a set of International Standards, which test the cleanroom’s ability to limit contamination through the restriction of allowed particles in the cleanroom environment. They also deal with the more technical aspects of aerospace and defense applications, including the cleanroom’s ability to control mechanical, thermal, chemical, and electrical properties within the controlled environment.

Aerospace cleanrooms must comply with ASTM relevant to their application and use of materials. This could include regulation for the handling and disposal of combustible fuels, static control systems, and even processes for parts manufacturing. More extreme standards apply for highly sensitive applications, where airborne particle concentrations must be strictly controlled such as in the development of spacecraft hardware, fine electronics, or optical devices.

Blending Aerospace Cleanroom Classification Standards

Some aerospace and defense cleanrooms must be able to comply with different classifications for the different tasks or projects, or different stages within the same project, such as from manufacturing to assembly to packaging. 

Aerospace and defense cleanrooms need to be able to adapt to the circumstances of your work, and have everything necessary to evolve with project requirements and keep products and workers safe. This includes highly specific control over environmental factors and filtration needs, monitoring equipment to maintain strict particle count and temperature ranges, and proper solutions for supporting or storing equipment to effectively utilize the facility’s space.

Aerospace and Defense Cleanroom Design

Aerospace and defense cleanrooms require active filtration and complete control over temperature and humidity, as well as other environmental factors. The cleanroom design should address the three main areas of concern to reach strict aerospace cleanroom classifications:

  • Particle count: Aerospace 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: While less stringent aerospace and defense applications may only require an air change rate of 5-48, defense cleanrooms with strict air quality standards may require hundreds of air changes per hour. In these cases, it’s expressed as air velocity, because air is constantly moving as it’s filtered out and replaced.
  • Ceiling coverage: The more stringent your aerospace 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 are necessary to complete more air changes.

Modular Cleanroom Design for Aerospace and Defense Cleanrooms

Modular cleanrooms are ideal for the aerospace and defense industries — particularly applications with changing requirements as they can meet the needs of customized spaces, including those with oversized equipment and products. The two main types of cleanrooms used for aerospace and defense applications are HardWall cleanrooms and RigidWall cleanrooms.

  • HardWall cleanrooms are the most common type of cleanroom used in aerospace and defense applications, as they offer a high level of control over environmental factors, so they can easily reach with the strictest aerospace cleanroom classifications. 
  • RigidWall cleanrooms can also provide a suitable environment for aerospace and defense applications and can reach a variety of aerospace cleanroom classifications. They consist of clear panels that can easily be reconfigured as you need to make changes to the layout of your cleanroom, and offer many customization options.

Aerospace and defense cleanroom design should also include a powerful HVAC system as well as cleanroom lighting that integrates seamlessly with modular panels and facilitates proper airflow velocity. Additional features and cleanroom supplies can be added to customize the cleanroom to specific applications. Some of these additions might include air showers, a fire suppression system, laminar flow systems, and industry-specific equipment and furniture.

Aerospace cleanroom classification requirements can be complicated and difficult to reach without the right cleanroom design. When it comes to aerospace cleanroom design, you can trust Angstrom Technology to design, build, and install the best cleanroom for your unique application and classification. To get started, reach out to our professional design team today.