What are Biotech Cleanrooms?

What are Biotech Cleanrooms?

Biotech cleanrooms are used in a wide range of industries to meet unique needs and project requirements. They can be utilized in a variety of ways, but have to meet strict standards of quality and control. Let’s talk about biotechnology and cleanrooms used to perform its complex applications.

What Are Biotech Cleanrooms?

Biotechnology applies the principles of biology to improve life through the use of plants, animals, and the natural world to enhance food sources, the environment, and human health. Biotech cleanrooms make the study of biotechnology possible by maintaining extremely controlled spaces that allow the science to be the only variable. 

Biotech cleanrooms must often meet stringent cleanroom classifications while also complying with industry-specific regulations for product quality and processes. To better understand the demands and requirements for biotech cleanrooms, let’s explore a few common biotechnology applications.

Biotech Cleanroom Applications

Biotechnology reaches across many fields and industries, but has particularly important applications in medical, agricultural, and environmental fields.

Medical Biotechnology

Many medical cleanrooms can also be biotech cleanrooms, as the two fields often intersect. Medical applications for biotechnology include forensics and diagnostics, vaccinations, and medicinal therapy production and testing. Cleanrooms used to conduct important research such as cancer studies and therapy development, gene therapy, stem cell research, and many other critical applications in health care, all require the extreme control of biotech cleanrooms to mitigate contamination risks for the purpose of study and safety of patients.

Animal and Plant Agricultural Biotechnology

The study of biological processes, especially related to food and food products, are another major application of biotechnology. Agricultural applications of biotech cleanrooms are widespread, and also include the development and testing of agricultural products for non food uses, such as biodegradable materials, biofuel, vegetable oils, etc.

Environmental Biotechnology

Biotechnology is an important field for studying our environment and how human actions affect its quality. Biotech cleanrooms are used to study biological samples, test products for environmental safety, and conduct environmental monitoring and cleaning. 

Biotech Cleanroom Classifications

Because of the delicacy of each of these applications, strict standards must be in place to maintain the cleanest possible environment to conduct tests, develop new treatments, or discover new compounds.

Most biotech cleanrooms must comply with the ISO 14644-1 cleanroom classifications of Class 5 or less. (As the Classes 9-1 descend, the cleanroom must be more and more “clean”, with ISO Class 1 being the strictest standard with the cleanest possible environment.) 

ISO Class 5 is considered to be an extremely stringent classification standard. Most cleanrooms fall in ISO Classes 7 or 8, which require moderate control over particle count and size. They must routinely change the air to cleanse it for particulate matter and regulate other environmental factors like temperature and humidity. ISO Class 5 must do all these things to a higher degree. They only allow a maximum of 3,520 particles 5 µm or larger, and must change the air so many times per hour, the constant flow is described as the air velocity of 40-80 feet per minute. 

Biotech cleanroom classifications exist to hold facilities to a minimum standard of cleanliness to ensure products and processes can exist within the cleanroom with an acceptable level of risk for contamination. Even biotech cleanrooms that meet their classification requirements must be properly outfitted to operate safely, effectively, and efficiently. The difference between an inefficient biotech cleanroom and a high performance biotech cleanroom is an exceptional cleanroom design.

Biotech Cleanroom Design

To achieve the high level of control needed in a biotech cleanroom, the cleanroom design must be flawless, and be outfitted with everything the applications will need to conduct its work without interruption or risk of contamination. The special features of cleanroom design work together to make this possible, including the type of cleanroom and its unique systems, such as filtration, HVAC, and more.

Biotech Cleanroom Type

Biotech cleanrooms require a cleanroom type that is able to achieve the highest level of control, which is why most are HardWall Cleanrooms. HardWall cleanrooms are able to reach all ISO cleanroom classifications — and can even match the demands of Class 1. Biotech HardWall cleanrooms feature seamless wall panels, flooring, and ceiling grid to prevent particles from settling. All components of the cleanroom build are made using non corrosive and non particle-shedding materials, that can withstand thorough cleaning to keep them contaminant-free at all times.

Biotech Cleanroom Systems

The systems within a biotech cleanroom support its everyday functions. They are responsible for keeping the environment clean, controlled, and consistent, and make sure the facility always reaches its stringent cleanroom classifications. A few of these systems include cleanroom filtration, cleanroom HVAC, and cleanroom pressurization.

  • Cleanroom filtration: Filtration in a biotech cleanroom produces a high level of air quality control using multi-stage HEPA filtration and a laminar air flow pattern.
  • Cleanroom HVAC: Biotech cleanrooms often require a powerful cleanroom HVAC system to supply the cleanroom with temperature and humidity-controlled air.
  • Cleanroom pressurization: Some biotech cleanrooms may require pressurization to isolate dangerous substances or fumes, or to protect sensitive processes. Positive pressure cleanrooms and negative pressure cleanrooms have many uses as biotech cleanrooms across a diverse range of industries, from medical research cleanrooms to manufacturing cleanrooms for devices and food products.

Biotech cleanrooms play a very important role in many applications across various industries. To be successful and meet stringent classification requirements, they require a top-of-the-line cleanroom design.

Think a biotech cleanroom is right for your application? Get in touch with Angstrom Technology! We can design, build, and install a biotech cleanroom that complies with your classification requirements and keeps your products and staff protected.

Cleanroom Cleaning Solutions for the Automotive Industry

Cleanroom Cleaning Solutions for the Automotive Industry

As new generations of vehicles get more complex and advanced, new standards for cleanliness must be reached in the manufacturing, assembly, testing, and development of automotive parts and processes. Keeping automotive cleanrooms clean is more than a quality issue — it’s also a safety issue, an environmental issue, and an economical issue.

Let’s take a look at some of the problem areas to assess in your automotive cleanroom with regards to cleanroom cleaning protocols, and a few solutions you can employ in your facility today.

Cleanroom Cleaning Solutions in Automotive Cleanrooms

When it comes to cleanroom cleaning in your automotive cleanroom, take a look at the areas that require the most attention: the surfaces in your cleanroom, the air that fills it, and the equipment and products it contains.

Automotive Cleanroom Surfaces

Surfaces within your cleanroom include the walls, floors, cleanroom tables and furnitures. In automotive cleanrooms, oil or grease spills could not only threaten the quality of your cleanroom but could also create slippery surfaces and a hazardous work environment. Your facility is responsible for maintaining clean surfaces in order to reach your cleanroom classifications, but also to provide a safe area for employees to conduct work, and protect your products from contamination.

Solution: The solution for keeping surfaces within your automotive cleanroom clean is to maintain clean floors by following a schedule with daily sweeping and mopping, and sticking to weekly thorough cleaning and sterilization of all surfaces. Your cleanroom cleaning protocol should be clearly understood by all employees, posted in a visible location in the cleanroom, and regularly reviewed with quality checks.

Automotive Cleanroom Air

In automotive cleanrooms, air quality issues can threaten your products as well as your personnel. If you work in an environment with exhaust and other fumes, proper air quality management is crucial.

Also, modern automotive cleanrooms are responsible for developing and testing parts that are smaller with a larger, more efficient output, more advanced computers and sensors, and other innovations in automotive technology. As parts become smaller and more complex, even the tiniest particles can prove a significant threat to cleanroom operations.

Keeping air quality standards to a strict level is essential for a clean environment. Particle count and size filtration requirements will change depending on the parts your facility handles whether it’s power steering, brakes, or electrical components. While these standards may be provided in your cleanroom classification, you may also need to reach air quality standards for your specific industry or application. 

Solution: To keep your cleanroom air as clean as possible, it’s important to make sure your cleanroom filtration system is working properly to comply with classification standards. Check and replace pre filters as necessary and make sure HEPA filters are effectively reaching particle count and size requirements.

Automotive Cleanroom Equipment & Products

The equipment and products your cleanroom supports must also be regularly cleaned in order to achieve control over the cleanroom environment. Some amount of contamination is unavoidable, as all parts and equipment have holes, crevices, and edges that can’t always be completely cleaned. The goal of cleanroom cleaning is to minimize contamination to an acceptable level where the product quality and consumer safety are not at risk.

Solution: Inspect equipment regularly, and have employees use correct protective equipment to limit contact with equipment and parts. Fortunately, modern cleaning systems are available to clean equipment and the parts you fabricate to remove any residue, debris, and bacteria.

Prioritize Automotive Cleanroom Cleaning

Regular and thorough cleanroom cleaning is the best solution to minimize contamination risks, promote employee safety, and guarantee product quality within your automotive cleanroom. Establish a cleanroom cleaning protocol that fits the needs and cleanliness level of your facility. Make sure all necessary employees are trained in how to properly clean the cleanroom without reintroducing contaminants. Then enforce a cleaning schedule that allows you to easily meet your cleanroom classification requirements.

Cleanroom Design and Cleanroom Cleaning

Your cleanroom design should be able to support a consistently controlled environment and your cleaning protocol, which is why cleanroom design and cleanroom cleaning go hand-in-hand.

All wall and floor surfaces, furniture, lighting, and other cleanroom components should be able to support the chemicals and processes you use to clean your cleanroom. They should be made of materials that are non corrosive and non particle-shedding. The cleanroom should also have plenty of available storage to stow

cleaning supplies and equipment. This will help to limit contamination from entering and exiting the facility each time it needs to be cleaned. 

Finally, the cleanroom should be designed to maintain cleanliness on its own, through proper filtration and a carefully mapped airflow pattern, with surfaces that limit contamination or particle buildup. A properly designed cleanroom will still require cleaning, but the risk of contamination will be significantly reduced.

Have everything you need to keep your automotive cleanroom clean? Angstrom Technology can help! We can help you design a cleanroom that helps your facility stay clean, so you’ll never have to worry about meeting your classification requirements. Give us a call to learn more.

What to Know About Plastics Industry Cleanroom Classifications

What to Know About Plastics Industry Cleanroom Classifications

Cleanroom classifications for the plastics industry regulate the cleanroom’s cleanliness and operating procedures. When designing a cleanroom for the plastics industry, the cleanroom classification plays a large role in determining which elements are included, how they are laid out, and how they make the cleanroom cleaner. Let’s take a look at the plastics industry cleanroom classifications and how the standards affect plastics industry cleanroom design.

Cleanroom Classifications for Plastics Industry Cleanrooms

Plastics industry cleanrooms are regulated by the classification standards set out by the International Standards Organization (ISO).

ISO Cleanroom Classifications

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, including plastics industry cleanrooms. ISO 14644-1 standards are separated into Classes 1-9, where Class 9 is room air and Class 1 is the cleanest possible environment. 

Most plastics manufacturing cleanrooms fall under the requirements of ISO Classes 7 or 8. Some plastics manufacturing applications that are especially sensitive to contamination or involve more complex assembly may require a more stringent cleanroom classification, such as ISO Class 5 or 6. As the cleanroom environments for each class get more clean, they must meet increasingly stringent requirements for particle count, air change rates, and ceiling coverage.

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. For most plastics industry cleanrooms complying with ISO Class 7 or 8, this would mean they cannot exceed a count of 352,000 to 3,520,000 particles that are .05μ or greater in size.

Air Change Rate

The air change rate  is how quickly air is removed, filtered, and replaced within the cleanroom. In a Class 7 plastics industry cleanroom, for example, the required minimum number of air changes per hour is between 60-90. For a Class 5 cleanroom, this goes up to 400+ air changes, at which point it is better expressed as an air velocity of 40-80 ft/min.

Ceiling Coverage 

Ceiling coverage refers to the percentage of the cleanroom ceiling dedicated HEPA filter/fan units, or FFUs. Most cleanrooms in Classes 7 and 8 require about 15% of ceiling coverage for filtration, which helps them reach stringent particle count and air change rate requirements.

Cleanroom Design for Plastics Industry Cleanrooms

Cleanroom classifications determine if the cleanroom is establishing control over the cleanroom environment. Cleanroom design is what enables the cleanroom to reach stringent standards. 

Every component within a properly designed cleanroom should work together to achieve more control over environmental factors, support equipment and personnel, and facilitate processes within the cleanroom. For plastics industry cleanrooms, this boils down to three main factors: the type of cleanroom, the cleanroom filtration system, and the cleanroom HVAC. 

Plastics Industry Cleanroom Type

To meet the cleanroom classification requirements of a plastics industry cleanroom, three types can be used. These cleanrooms can be designed to be free-standing or integrate with an existing structure, including walls, windows, HVAC and ventilation equipment. 

  • HardWall cleanrooms allow the highest level of control over environmental factors and can conform to even the most stringent cleanroom classifications of ISO Class 1.
  • RigidWall cleanrooms are also an option for most plastics industry cleanrooms requiring a classification of ISO Class 5-8, and feature a minimalist, clear panel design.
  • SoftWall cleanrooms can fit in almost any space and are fully customizable.They can accommodate cleanroom classification standards ISO Class 4-8. 

The best fit for each application will depend on its specific classification requirements and industry standards, but HardWall cleanrooms,  RigidWall cleanrooms, and SoftWall cleanrooms, are all durable and high-quality, and capable of supporting plastics industry projects.

Plastics Industry Cleanroom Filtration

Cleanroom filtration is usually built into the ceiling using FFUs, which change the air within the cleanroom at a regular rate, replacing it with clean, filtered air. The filtration system of a plastics industry cleanroom will work in tandem with the cleanroom HVAC to provide temperature and humidity controlled air, delivered in a powerful, thorough, and consistent airflow pattern. 

Plastics Industry Cleanroom HVAC

The plastic industry cleanroom HVAC regulates temperature and humidity levels within the cleanroom environment, to not only to keep your employees comfortable, but also to keep machines functioning at optimal levels and protect sensitive products and processes within the cleanroom. Fluctuations in temperature and humidity can be detrimental to productivity, so a reliable HVAC system is a must in any cleanroom design.

Other features, such as cleanroom lighting, cleanroom furniture, and industry-specific equipment, must also be considered in the cleanroom design in order to meet cleanroom classification requirements and fit within a cohesive workspace. 

Plastics industry cleanrooms should be designed to reflect the unique and evolving operations they support. The cleanroom design should comply with classification standards and incorporate all the extra features each project needs to keep productivity and efficiency up, while minimizing or eliminating safety and contamination risks.

Considering a cleanroom but not sure where to start? Let Angstrom Technology help! Our professional team can design, build, and install the best cleanroom for your application and classification requirements. Whether you’re starting from scratch or adapting an existing cleanroom, we can help you make it a success.

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.