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. 

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What Is a Glove Box in a Cleanroom?

What Is a Glove Box in a Cleanroom?

There are a lot of factors to consider when designing a cleanroom for your facility, from determining the size that will hold all of your equipment, to choosing the ISO classification that ensures the proper amount of cleanliness, and more. 

One of the final decisions you’ll have to make in regards to cleanroom design is what additional features and technologies your cleanroom may require — and cleanroom glove boxes are necessary, and most often required, in specific stringent applications. Below, we’ll explore more about what a cleanroom glove box is, what it’s used for, and under which circumstances you may need to incorporate one into your cleanroom’s design. 

What Is a Cleanroom Glove Box?

A cleanroom glove box is a sealed containment system that provides a controlled atmosphere for handling the contents within. In most cases, cleanroom glove boxes are manufactured with acrylic, static-dissipative PVC, and/or stainless steel, and they include one or more sets of gloves, allowing operators to work with objects while still upholding strict isolation protocols. 

Two Main Types of Glove Boxes

There are several different types of cleanroom glove boxes, but they all generally fall into two broad categories: “isolation” and “containment.” The difference between these two types is based on what you hope to protect, and which type of pressure is needed to protect it. 

  • Isolation glove boxes use positive pressure to isolate sensitive materials from the elements and contaminants in their surrounding environment.
  • Containment glove boxes use negative pressure to protect cleanroom operators from any hazardous materials or substances within the box. 

Glove Box Capabilities and Features

As far as capabilities and features go, glove boxes operate very similarly to your overall cleanroom. They’re typically referred to as your primary engineering control (PEC) and provide ISO 5 classification within the containment system. It’s then placed within the cleanroom, or the secondary engineering control (SEC) which has a lower ISO Classification. They provide an additional layer of isolation and protection — meeting slightly more stringent cleanliness requirements. 

For example, some of the most basic glove boxes capabilities and features include:

  • Exhaust/recirculation connections and control
  • Redundancy
  • HEPA/ULPA filtration
  • 2-4 glove ports (single or dual operator)
  • Air locking
  • Personnel & product protection
  • Differential pressure
  • Mobile or stationary

What Is a Cleanroom Glove Box Used For?

Glove boxes date all the way back to the 1940s, when they were used by the military to research radioactive materials. After that, they started gaining popularity in the medical field as a way to handle viruses and create various medications and vaccines. Today, cleanroom glove boxes’ controlled environments benefit a number of unique applications in a wide range of industries

Which Applications Need Glove Boxes in Their Cleanroom Design? 

The possibilities are truly endless here. You’ll likely see glove boxes in medical, laboratory, pharmaceutical, biological, chemical, and microelectronic cleanrooms most often, but they can also be incorporated into the cleanroom design for any other application that requires them. 

Get the Cleanroom Design Features You Need at Angstrom Technology

Does your cleanroom require a glove box, or some other additional feature or technology? We can help! With years of proven experience, our team at Angstrom Technology is able to design a cleanroom that meets all of your facility’s specifications. Talk to one of our design engineers to get started today.

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4 Key Considerations for Cleanroom Design

4 Key Considerations for Cleanroom Design

Installing a new cleanroom in your facility can be an exciting undertaking, but it also comes with a lot of decisions. From creating a design to coordinating the installation, you’ll want to ensure no part of the process goes unnoticed.

Not sure where to start? We can help! Here are a few simple, yet critical factors to consider when designing your cleanroom, so you can set yourself up for a smooth design and installation process and get the most out of your investment. 

4 Key Considerations for Effective Cleanroom Design

While there are many factors to consider when designing your cleanroom, these are the four that our experts at Angstrom Technology have deemed most important to a successful, rewarding project: 

1. Determine Your Project Budget Early

There’s nothing that derails a project quite like paying more than you wanted to. As with any other construction project, determining your budget early on can help you avoid financial stress or hardship later on. It’s important that you work with your cleanroom manufacturer to understand how much your cleanroom may cost based on your unique specifications. In most cases, the following five factors will have the most effect on cleanroom cost:

  • Size – The bigger, the more budget you’ll want to allocate. 
  • TypeHardWall, SoftWall, and RigidWall cleanrooms all have unique features and cost varying amounts. In most cases, you’ll spend more on a HardWall or RigidWall cleanroom than you will a SoftWall cleanroom.
  • Classification – The more stringent your ISO classification, the more fan filter units (FFUs) and equipment it will require, and the more it will cost you. 
  • Design complexity and additional features – If your cleanroom requires extra features like process piping, furniture, static control, or gowning rooms, it will need to accommodate specific design complexities that come at an additional cost. 

2. Consider a Modular Cleanroom for Greater Design Flexibility

Modular cleanrooms are cleanrooms that are constructed with prefabricated components. They perform just like traditionally built cleanrooms, but with labeled components that are precisely pre-cut and pre-finished, they’re faster and easier to install — and require less routine maintenance.

Another big advantage of modular cleanrooms is their unparalleled versatility. They’re built “backward compatible,” which means they can be minimized, expanded, or reconfigured to meet the changing needs of your facility’s operations. This feature makes modular cleanrooms extremely rewarding long-term investments. 

3. Choose the Right ISO Classification for Your Application

Your cleanroom’s ISO classification refers to the maximum acceptable number of particles (by size) in the air, per cubic meter. That said, in order to figure out which classification your application requires, you’ll want to have a good understanding of the particle size you need to filter out. 

Building a cleanroom for a pharmaceutical production line? You’ll likely need to meet more stringent classification standards and filter out even the smallest of particles. Manufacturing basic automotive parts? Your automotive cleanroom is probably better suited for a lower classification standard, but still one that’ll filter out large particles. 

Keep in mind, however, that the more stringent your classification is, the more your cleanroom costs will be. So while building a cleanroom with a higher classification than you actually need won’t do any harm production-wise, it usually doesn’t make financial sense. Find the sweet spot, and stick to the lowest possible cleanroom classification that still meets your application’s requirements. 

4. Understand Your Process Flow

The final consideration you should make while designing a cleanroom that works for you is your process flow. It’s important to understand how your personnel and products will go about entering the room, exiting the room, and everything in between. Establishing this operational protocol will help you decide where the best placements may be for certain work surfaces, equipment, and filtration units, in addition to understanding the space needed for access around these items. 

Perhaps the best way to do this is to create a conceptual drawing of your cleanroom design, insert your intended furniture and equipment, then draw arrows along the intended paths your personnel and products will take. Seeing these things drawn out visually can give you a better idea of how they’ll actually play out once the design is brought to life — and nailing down this operational flow can help accomplish so much in terms of meeting the requirements for optimal cleanroom performance. 

Trust Angstrom Technology to Help with Cleanroom Design

Planning the design for your new cleanroom or redesigning an existing one? Let the experts at Angstrom Technology help. Our design engineers can help you make the tough choices and ensure you receive a cleanroom that’s perfect for your application. Contact us today to learn more. 

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Modular Cleanroom FAQs

Modular Cleanroom FAQs

Need more details on modular cleanrooms? We’ve got you covered. Below, we’ve answered 10 of the most frequently asked questions we receive about modular cleanrooms here at Angstrom Technology. 

1. What Is a Modular Cleanroom?

A modular cleanroom is a cleanroom built of prefabricated components that are quickly and easily assembled to meet your specifications on-site. The prefabricated components are manufactured off-site, then delivered ready for installation, which allows for controlled conditions and improved quality and precision. 

Modular cleanrooms are able to meet any cleanliness and classification standards your application requires. They’re also easily reconfigured based on your facility’s changing needs.

2. Do I Need a Modular Cleanroom?

Modular cleanrooms are used in a variety of industries, for a variety of applications. If you need a space that is clean, safe, and virtually contaminant-free in order to successfully execute any of your processes, you’ll probably want to consider investing in one. It will keep your people, products, and property safe, so you can continue to run a profitable business. 

To provide some examples, here are a few of the industries that we commonly work with here at Angstrom Technology: aerospace & defense, agriculture, automotive, biotech, environmental testing, medical (hospital, medical device, research, marijuana), microbiology, pharmaceutical manufacturing, plastic injection molding, semiconductor. 

3. How Long Does a Modular Cleanroom Take to Design, Build, and Install?

Although the modular cleanroom design, build, and installation process can vary based on the size and complexity of your design, the process is usually very quick — especially when you compare it to that of traditionally built cleanrooms

Most often, framing, drywall, and painting are the worst trades in terms of efficiency. But with prefabricated modular construction systems, those are replaced with a high level of efficiency. In fact, prefabricated panels can result in a 25-75% schedule reduction compared to traditional construction.

At the start of the process, it may take a couple of weeks to consult with a designer about your application’s needs and create a design. After that, you’ll wait for a brief delivery period (6-8 weeks with Angstrom’s industry-setting standard). Once all components are delivered, your modular cleanroom can be installed in just a few weeks, depending on the size. 

4. How Much Does a Modular Cleanroom Cost?

The cost of a modular cleanroom is highly competitive to that of a traditionally constructed cleanroom — primarily due to the fast and simple design, build, and installation process. In addition, there’s a tremendous reduction in the costs of waste, unused materials, and lost items that are associated with traditional construction.

That said, modular cleanroom costs can vary tremendously from project to project. In most cases, the cost of a modular cleanroom is based on the following factors:

5. What Are the Benefits of Modular Cleanrooms?

Modular cleanrooms bring the same benefits as traditionally built cleanrooms — and more! In fact, when compared to their traditional counterparts, modular cleanrooms are generally:

  • Quicker and easier to install, ensuring that you’re able to resume regular operations in no time. 
  • More adaptable to your facility’s changing needs, as modular cleanrooms can be constructed and/or reconfigured to fit any space, even within an existing building. 
  • More affordable, due to prefabricated components and a speedy installation process. 

6. What Should I Expect From the Modular Cleanroom Installation Process?

As mentioned in Question #2 above, the modular cleanroom installation process is quick — and, if you’d like to, you can save on labor costs and do it yourself! At Angstrom Technology, we’ll send you a detailed list of installation instructions to follow. 

However, if you’re worried about the technical details, we’re also happy to complete the installation process for you. We employ an experienced team of modular cleanroom construction specialists who will install your room for you, leaving you with minimal disruption to your workdays. We’ll get things done and pay close attention to the details so you don’t have to. 

7. How Do I Know Which Type of Cleanroom I Need?

There are three common types of cleanrooms: HardWall, SoftWall, and RigidWall. The type you need depends on what you plan to use it for. 

  • HardWall cleanrooms are made of an aluminum frame and prefabricated solid panels. They suit most applications but are especially helpful for those with stringent cleanroom classification requirements. 
  • SoftWall cleanrooms are made of an aluminum frame and vinyl curtains around the perimeter. They’re capable of meeting most cleanroom classifications, but not the most stringent — especially when it comes to temperature and humidity control. 
  • RigidWall cleanrooms are made of an aluminum frame and clear, acrylic panels — giving them the durability and security of a HardWall cleanroom, plus the visibility of a SoftWall cleanroom. 

If you’re still unsure which type of cleanroom may best suit your application, it’s best to contact a cleanroom expert. They’ll listen to your needs and propose a solution that is sure to meet them. 

8. How Do I Know Which Cleanroom Classification I Need?

Your cleanroom is required to meet a certain ISO classification. ISO classification determines the degree of cleanliness, which is defined by the maximum amount of contamination allowed, by particle count and size. More stringent ISO classifications (i.e. Class 1-5) require higher filtration and air change rates. Less stringent ISO classifications (i.e. Class 6-9) are a little more lenient, working themselves all the way down to normal room air. 

For example, pharmaceutical cleanrooms require a stringent ISO classification because it’s a high priority to ensure products are kept safe so that, in turn, their consumers are kept safe. When even the smallest particle could affect the performance of a drug, there is no room for contamination or error. 

9. How Does Cleanroom Classification Affect Cost?

Generally, the more stringent your cleanroom classification, the more you’ll pay. This is because more stringent classifications require more filtration — and in order to achieve that, your cleanroom will need to accommodate more fan filter units and additional features like gowning rooms, air showers, etc.

10. Will My Modular Cleanroom Need Any Additional Features? 

Some modular cleanrooms just require the most basic components. However, modular cleanrooms that need to meet stringent classification requirements may require additional features and technologies to successfully avoid contamination. Things like airlocks, air showers, pass-through chambers, and gowning rooms are important considerations to keep sensitive applications free of harm. 

Have more questions about modular cleanrooms? Give the experts at Angstrom Technology a call! We’d be happy to walk through your specific needs and help to design, build, and install the best modular cleanroom for your facility.

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5 Biggest Threats to Medical Cleanrooms

5 Biggest Threats to Medical Cleanrooms

5 Biggest Threats to Medical Cleanrooms (and How to Prepare for Them)

In the medical industry, there’s no room for error. The slightest amount of contamination can not only result in reduced efficiency and missed development deadlines, but it can also put human lives at risk. 

Keeping your medical cleanroom airtight, fully controllable, and customized to meet your application’s ISO classification is essential in conducting safe, effective, and efficient operations. You can accomplish this by understanding and planning ahead for any risks your cleanroom may encounter. Below, we’ll outline five of the biggest threats to medical cleanrooms, as well as how you can prepare for them. 

5 Biggest Threats to Medical Cleanrooms

While some threats to medical cleanrooms are fairly common sense, others may take you by surprise. Either way, it’s important to take all into consideration throughout the design and installation processes. Here are five of the most common threats medical cleanrooms regularly face: 

1. Personnel Within the Medical Cleanrooms

Staff members are known to pose the greatest risk for cleanrooms — and medical cleanrooms are no exception. Improper or disregarded handwashing and gowning protocols can result in thousands of contaminant particles being introduced — from skin particles to hair strands, to perfumes and cosmetics. In fact, some cleanroom inspections have attributed personnel as the cause for 80% of identified particles. 

2. Medical Cleanroom Materials

Work samples and materials within medical cleanrooms can also pose a health threat to personnel. In many medical cleanroom applications, cleanroom operators work with microbiological substances that can cause serious harm if they aren’t contained and controlled properly and if operators aren’t wearing correct protective gear. From studying infectious diseases to dealing with bodily fluid samples, it’s important to be aware of potential biosecurity risks. 

3. Equipment in Your Medical Cleanroom

The machines and tools within your cleanroom pose varying levels of contamination risk. Machines often emit gas, lubricants, emissions, and other airborne particles while in use. Also, everyday tools like pens, beakers, trays — even cleaning items — can all introduce particles if not sanitized properly before use or handled appropriately during use. 

4. Dysfunctional Filtration Systems

If your medical cleanroom’s filtration system isn’t working properly, your cleanroom likely isn’t all that clean. Filtration systems — consisting of fans, pre-filters, and HEPA or ULPA filters — are responsible for treating contaminated air supplies and maintaining consistent air change rates in order to ensure good air quality. However, over time, their components can grow old and function at lower capacity, increasing the chance of higher particle counts and dead zones.

5. Static in Your Medical Cleanrooms

Static electricity in medical cleanrooms isn’t always a risk that comes first to mind — but it’s definitely one to take into account. Its “cling” effect increases the chance of attracting airborne particles to surfaces that need to remain sterile. Also, in applications involving medical device development, static can cause particles to be drawn in and permanently damage sensitive electronic components. 

How to Prepare Your Medical Cleanroom for Safe Operations

Fortunately, there are ways to prepare for and prevent each of the medical cleanroom threats listed. Although complete sterilization is virtually impossible, implementing the right tools, technologies, and procedures can help you reduce risk as much as possible. Here are a few preparation tips to consider during the design and installation processes:

Install and Maintain a Fully Functioning Filtration System

In order for your cleanroom to meet its ISO classification requirements, you need to install a quality filtration system. Make sure that your filtration system provides the required percentage of ceiling coverage and maintains consistent air exchange rates. 

And, once it’s designed and installed properly, make sure you stick to a regular filtration system inspection and maintenance schedule. Your pre-filters should be replaced at least six times per year, and your HEPA or ULPA filters should be replaced at least once every three years. If not maintained properly, your filtration system could fail and threaten control over your cleanroom environment. 

Apply the Right Type of Pressurization for Your Medical Cleanroom’s Application

Both positive and negative pressure cleanrooms have their place in the medical industry — it just depends on your specific application. Most medical cleanrooms operate with positive pressure, using HEPA filters and an external airflow pattern. However, some applications involving hazardous substances need negative pressure to prevent contaminants from escaping and causing harm to the surrounding environment. 

Include Pass Throughs in Your Medical Cleanroom Design

Pass-throughs are chambers for moving products in and out of your cleanroom. Adding one or more pass-throughs to your medical cleanroom can make transferring tools and materials quicker and more efficient. At the same time, pass-throughs reduce cleanroom traffic cross-contamination, helping to provide a less compromised work environment.

Adopt Thorough Cleanroom Cleaning Protocols

Medical cleanrooms require some of the most stringent ISO standards — and while your cleanroom may be designed with features and technologies to uphold that, you still need to do some cleaning as well. By establishing a daily, weekly, and as-needed set of cleaning tasks, you’ll ensure your cleanroom is operating at its maximum possible sterilization levels. 

While you’re cleaning, make sure to use specified cleaning products for medical cleanrooms like distilled water, neutral chemical solvents, and non-shedding cloths or wipes. How you clean is just as important as how frequently you clean. 

Implement Anti-Static Cleanroom Components

Controlling static isn’t always easy, but it is possible. There are many specialized products made for controlling static within a cleanroom, including anti-static flooring and wall panels. On top of this, a great way to control static is to adopt clothing and gowning guidelines that limit it. These could include anti-static garments, ESD cuffs, low-static shoes, or basic lab coats. 

No matter the specific environmental threats your facility and application may face, Angstrom Technology can design and install a medical cleanroom that controls and prevents them all. Contact our team to get started today. 

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