Pharmaceutical Cleanroom Maintenance Tips

Pharmaceutical Cleanroom Maintenance Tips

If you work in the pharmaceutical industry, you know that even the slightest bit of contamination could drastically disrupt your production line and affect the safety of consumers. Because of this, it’s not only important to perform operations within a cleanroom, but it’s also important to keep that cleanroom well-maintained. 

You should think of your cleanroom just like any other piece of equipment. It needs a little tuning up here and there to keep it running as it’s intended. Let’s take a closer look into what regular maintenance looks like for pharmaceutical cleanrooms. 

Looking for examples of our work with pharmaceutical cleanrooms at Angstrom Technology? Check out this case study on a pharmaceutical cleanroom we designed and installed for our client, Praxis. 

Pharmaceutical Cleanroom Maintenance Tips

When it comes to pharmaceutical cleanrooms, there’s one main category of contaminants that could disrupt your operations: process- or human-related contaminants, such as dirt, skin, hair, clothing fibers, etc.

In order to combat these contaminants, most facilities have their own unique method and schedule for cleanroom maintenance. But if you’re new to the cleanroom world and you’re wondering where to start, the following sections outline some of the most basic cleanroom maintenance tips to keep in mind. 

Day-to-Day Cleanroom Maintenance

The most tried-and-true method of keeping your cleanroom in good operating condition is to diligently adhere to daily cleaning tasks. You’ll want to do the following at least once per shift: 

  • Wet mop floors with an ISO-recommended mop, cleaning solution, and deionized water
  • Change sticky mats (if applicable)
  • Wipe walls with an ISO-recommended mop and cleaning solution
  • Wipe furniture, tables, and work surfaces with ISO-recommended wipes and cleaning solution
  • Clean pass-through chambers and other additional features with ISO-recommended wipes and cleaning solution (if applicable)
  • Remove trash, soiled garments/PPE, and waste

Something to keep in mind — while accomplishing each of these tasks, it’s best to think of your cleanroom divided into four sections: ceilings, walls, surfaces, and floors. Then, clean each area following that particular order, from the highest point of your room (ceilings) to the lowest point (floors). This helps to reduce the risk of transferring contaminants from one area to another or counterproductively dirtying a workspace you’ve just cleaned. 

Filter Maintenance

Your filtration system is responsible for filtering the air that is constantly circulated in and out of your cleanroom. Since they’re usually operating on a 24/7 basis, these filters need to be serviced and changed with some sort of frequency. There are two main components of your filters that require regular servicing: 

  • Pre-filters are the outermost filters and, in most cases, are located in the return air grilles. They are easily accessed from within the cleanroom, and should be checked on a quarterly basis to see if they need to be replaced. By changing out the pre-filters with some sort of frequency you will extend the life of your HEPA/ULPA filter.
  • HEPA/ULPA filters do the heavy lifting in the filtration process and therefore are more of an investment — in terms of both labor and finances. ULPA filters remove 99.9995% of particles 0.12 microns or larger. HEPA filters remove 99.99% of particles 0.3 microns or larger. These filters typically sit inside the fan filter housing which is installed in the ceiling grid. But with proper pre-filter maintenance and replacements, HEPA/ULPA filters can last up to 8-10 years, depending on the cleanliness of the surrounding facility. 

Additional Equipment Maintenance

From glove boxes to pill packaging conveyor systems, whatever equipment your cleanroom holds should be serviced according to manufacturer recommendations. Any malfunctioning machines could release contaminants or gases that pose a threat to the sensitive materials you’re handling. Always make sure your equipment is working normally before starting daily operations. Equipment typically requires bi-annual or annual servicing, calibration, and certification.

Cleanroom Maintenance Reporting

Our final cleanroom maintenance tip is to keep a thorough, detailed record of all your cleanroom maintenance efforts. We recommend setting up cleanroom maintenance protocols, documenting and outlining the following:

  • The person responsible for each maintenance task
  • A schedule for accomplishing each maintenance task
  • Contamination levels before and after cleaning and/or maintenance
  • Any “good-to-know” items or maintenance tasks that require follow-up

 

By using these protocols, you’ll help to ensure that your team sticks to all required maintenance, that your facility remains compliant with all ISO classification standards, and that your business remains profitable. 

If your company doesn’t have the capacity and/or resources to stick to regular cleanroom maintenance, don’t worry! There are plenty of resources out there for contracting maintenance and cleanroom cleaning work. Check with your cleanroom manufacturer to see if they have their own maintenance services, or if they can refer you to someone they trust. 

Looking for someone to service your cleanroom and get it back into top shape? Give Angstrom Technology a call! As experienced cleanroom experts, we’re happy to talk through your needs and find the right solutions. 

cleanroom-classification-quiz-cta
Understanding the Value of Modular Cleanrooms

Understanding the Value of Modular Cleanrooms

At Angstrom Technology, we like to take a step back every once in a while, taking the time to acknowledge and appreciate the impact of our work in various industries. It helps us put our work into perspective, and it motivates us to deliver excellence each and every day.

As we’ve reflected throughout the past years, we’ve always been astonished at how much innovation happens within modular cleanrooms. These quickly built, easily modified, heavily treated chambers truly make groundbreaking work possible. As a resource that helps scientists, and engineers test, manufacture, and package products safely, cleanrooms bring tremendous value not only to the workforce, but to society as a whole. 

In this article, we’ll explore some amazing ways that various industries have used modular cleanroom technology to trailblaze a path of innovation.

The Value Modular Cleanrooms Bring to Various Industrial Applications

Modular cleanrooms have proven themselves to be beneficial for a number of applications, in a number of industries. Some of history’s most important inventions required cleanrooms’ quality control, and some of the future’s best and brightest innovations are being tested in them today. Below, let’s discuss some common industries that use cleanrooms, and what important things they’re using them for. 

Aerospace

Aerospace cleanrooms are crucial for the development of aircraft and spacecraft hardware, fine electronics, engine components, and more. In order to manufacture, assemble, and test those components, the aerospace industry needs a high level of control over the cleanroom environment — usually meeting an ISO Class 7 requirement, at minimum.

Each day, aerospace engineers are working hard to develop technologies that help us continue our journey of exploring the unknown. Modular cleanrooms give them the space they need to do that revolutionary work. 

Semiconductor

Semiconductor cleanrooms prevent particles from contaminating certain parts of nanotechnology — like semiconductors and microchips — that allow us to operate phones and computers more safely and efficiently. When even the smallest bit of contamination can lead to serious product issues and failures, a stringent modular cleanroom environment of ISO Class 5 or lower is necessary. 

Our world is reliant on constant technological innovations in order to stay connected, do business, and maintain a quality lifestyle. Modular cleanrooms will always provide a space to make those technological advances happen.

University Labs and Research Facilities

University labs and research facilities encompass a variety of applications, from medical research, to forensic science, to hazardous chemicals. Additionally, the university setting requires that spaces are able to be reassigned and restructured as student, research, and funding needs change throughout the years. Therefore, the versatility of quickly built, easily modified modular cleanrooms is extremely valuable here. 

Universities host some of the most advanced, highly recognized research facilities. Students and faculty are working with state-of-the-art technology to solve some of their industry’s most perplexing problems. A modular cleanroom can provide a controlled environment to foster that learning, no matter what the specific application may be. 

Military 

In regards to the military, weapons manufacturing is a critical component in upholding national security and protecting American citizens. Due to the deadly nature of the products and volatile compounds used in this industry, a controlled cleanroom environment is crucial in maintaining the safety of information, products, and personnel. 

Weapons manufacturing is, and always will be, dangerous. However, it plays a key role in protecting our nation’s infrastructure from devastating threats. Modular cleanrooms can help lessen the risk and bolster the production. 

Angstrom Technology can design a modular cleanroom to meet all your requirements and design considerations. If you’re interested in designing and installing one for your facility, speak with one of our design engineers to get started.

cleanroom-classification-quiz-cta
Understanding Cleanroom Costs by Type

Understanding Cleanroom Costs by Type

If your facility needs a controlled space for one or more of its operations, you may be looking into purchasing a cleanroom. However, while doing your research, you may find yourself stuck on which type of cleanroom is the best investment for you: SoftWall, HardWall, or RigidWall?

Each of these cleanroom types has different characteristics and advantages, which naturally means that each of them are sold at different price points. In this article, we’ll explore the relative costs of these types of cleanrooms, as well as the value that each can bring to your facility. 

SoftWall Cleanrooms – $

Generally, SoftWall cleanrooms are the most affordable cleanroom option. The low price point reflects their simple design and minimal use of materials. 

However, just because SoftWall cleanrooms are the most affordable doesn’t mean that they lack quality. Their lightweight, powder-baked enamel framework and clear vinyl sheeting offers simple installation, maintenance, and customization to best fit the needs of your facility. Also capable of meeting cleanroom classification standards for ISO Class 4-8 and Federal 209E Class 10-100,000, SoftWall cleanrooms work great for many applications. 

SoftWall cleanrooms are ideal for facilities that need to meet some classification and standards requirements, but don’t quite need to meet the highest standards or a tight temperature and humidity specification. As an affordable option that’s easy to assemble, maintain, and reconfigure, they can bring great value to large applications and custom cleanroom applications. 

HardWall Cleanrooms – $$$

HardWall cleanrooms are usually the most expensive type of cleanroom, for good reason. Their higher price tags are accompanied by superior cleanroom performance, capable of meeting even the most stringent cleanliness standards. 

HardWall cleanrooms are made from solid materials like stainless steel, vinyl, plastic laminate, aluminum, and fiberglass-reinforced plastic. These solid materials make them an extremely secure, treated, and durable solution for facilities that need an ultra-controlled environment. 

With the ability to meet ISO Class 1-8 and Federal 209E Class 1-100,000 standards, HardWall cleanrooms are worth the investment if your facility’s applications require an extensive amount of control over factors like contamination, humidity, temperature, static, and pressure. No other type of cleanroom will provide that level of protection. 

RigidWall Cleanrooms – $$$

RigidWall cleanrooms tend to fall in a similar price range as HardWall cleanrooms. They’re somewhat of a hybrid between the two types of cleanrooms previously mentioned. They have the same structural system as a SoftWall cleanroom, but instead of curtains, they use an extruded aluminum extrusion in conjunction with a 1/4 inch acrylic panel.

RigidWall cleanrooms can offer extreme versatility for a variety of applications. While they don’t offer quite as much stringency as a HardWall cleanroom, they do offer a good bit of control and provide a good show piece for potential customers. They offer contamination security to fit ISO Class 5-8 requirements and Federal 209E Class 100-100,000 requirements. 

If your facility is looking for a cleanroom with good control, but also requires a certain level of aesthetics, a RigidWall cleanroom is a worthy investment for you. It’s a versatile solution with a structural system that can be adapted to fit the needs of your facility, and an environmental control factor that keeps your materials and operators safe — giving you some of the best of both worlds. 

No matter what type of cleanroom you need, Angstrom Technology can help you design and install it to meet your classification and budget requirements. We’re experts in working with clients to find the solutions that best suit their facilities and applications. Reach out to our team to get started today.

cleanroom-classification-quiz-cta
4 Questions to Ask Before Starting Automotive Cleanroom Construction

4 Questions to Ask Before Starting Automotive Cleanroom Construction

There’s a lot of planning involved in automotive cleanroom construction. From layout design to operational components, you need to figure out what you need and how to implement it before you start building.

Many experienced cleanroom designers and engineers have streamlined this process. However, it’s important to be certain that you’ve got all the details in line so you can get production started without any hiccups. From the experts at Angstrom Technology, here’s a checklist of four questions to ask yourself before starting your automotive cleanroom construction project.

1. What Processes Will Be Housed Within My Cleanroom?

Within an automotive cleanroom, there are various applications that ensure automotive parts are produced, cleaned, and packaged safely. Some of these applications include.

  • Research and development
  • Component manufacturing
  • Assembly
  • Testing
  • Packaging

Each of these applications include different manufacturing processes, which also call for differences in humidity, temperature, pressure, and particle contamination. These differences can change the type, design, and level of cleanliness of the cleanroom you choose to construct.

Other process-related elements that could alter your cleanroom plan include: how many personnel access it, how often they access it, and what protective gear they wear when they access it.

2. What Are My Automotive Cleanroom’s ISO Class Requirements?

Automotive cleanrooms are controlled environments where air and surface particle contamination is limited. They’re grouped into various cleanliness classification groups created by the International Standards Organization (ISO). Based on the allowed size and number of particles, rate of air change, and percentage of ceiling coverage with fan filter units, cleanrooms are placed into an ISO Class.

ISO Classes are ranked 1-9, with Class 1 having the most stringent regulations and Class 9 having the most lenient regulations. Most automotive cleanrooms fall into ISO Classes 5-8, but this could vary depending on your application’s specific cleanliness and worker safety requirements. By determining which ISO Class you need, you can make a more informed choice of which type of cleanroom will give you the best results.

3. How Much Space Do I Need for My Automotive Cleanroom?

Your cleanroom will only work if it provides the allotment of space necessary for your application. While some cleanrooms are relatively small in size, automotive cleanrooms occasionally require larger equipment clearances. You’ll want to plan for that ahead of time.

It’s also valuable to keep in mind that cleanrooms are built for long-term use. This means that they’re able to grow and adapt based on your facility’s changing needs. You can add to them, reconfigure them, and relocate them as you need, as long as your changes comply with U.S. building and safety codes. With that in mind, it’s best to plan and design for the space you need now, and have peace of mind knowing you can always expand down the road.

4. What Type of Air Pressure Does My Cleanroom Need?

Cleanroom air pressure is divided into two categories: positive and negative air pressure. Basically, the type of air pressure determines what is being protected by installing a cleanroom.

Positive air pressure is achieved by pumping clean, filtered air into your cleanroom. This makes the air pressure inside your cleanroom greater than the pressure outside of it. It’s meant to protect whatever is inside the cleanroom from being contaminated by the surrounding environment.

Negative air pressure is achieved by filtering air out of the room. This makes the pressure inside your cleanroom lower than the pressure outside it. It’s meant to keep possible contamination from escaping the cleanroom.

Some automotive applications like electronic manufacturing require positive air pressure to ensure products are clean and safe for us. On the other hand, some automotive manufacturing applications, like applying special paints and part coatings, can be harmful to human health. In these situations, you may prefer negative air pressure to ensure those VOCs and harmful chemicals aren’t released into the rest of the facility.

Have more questions about designing and constructing a cleanroom for your automotive application? Give the experts at Angstrom Technology a call or contact us online! We’d be happy to walk through your specific requirements and help you get the best cleanroom installed in your space.

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.

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.