When building a cleanroom, you need more than a cut-and-run vendor. You need a partner you can trust. One who understands the stakes, solves problems before they happen, and stands by their work long after the project is complete.
At Angstrom Technology, we don’t take that responsibility lightly.
We understand that your cleanroom is crucial to your operations, compliance, and reputation. That’s why we’ve spent decades refining our cleanroom design and build solutions, as well as how we show up for our clients.
What You Can Expect from Angstrom Technology as Your Cleanroom Partner
Regardless of your industry, timeline, or cleanroom classification, these six commitments form the foundation of every partnership we establish.
1. Turnkey Cleanroom Solutions—Designed, Built, and Delivered Seamlessly
From your first consultation through installation and beyond, Angstrom Technology delivers complete, turnkey cleanroom solutions—streamlining every phase of your project with precision and care.
Our team manages the entire cleanroom design and build process, including:
Design & Engineering
Compliance
Procurement & Project Management
Construction & Installation
HVAC, Electrical, and Plumbing Integration
Validation & Commissioning
Ongoing service, Maintenance, Upgrades, and Expansions
Instead of juggling multiple vendors or navigating communication gaps between disciplines, you’ll work with one dedicated cleanroom partner who owns the entire process. We coordinate closely with your internal stakeholders, general contractors, and specialized trades to ensure every detail is handled accurately, efficiently, and to spec.
Whether you’re launching a new facility or adapting an existing space, our cleanroom solutions are tailored to your timeline, regulatory requirements, and performance goals—delivered on time and built to last.
2. The Right Cleanroom Products, Every Time—No Manufacturer Lock-In
Angstrom Technology isn’t a cleanroom manufacturer—we’re a cleanroom partner. That means we’re not locked into a single product line or rigid catalog. Instead, we design each cleanroom using the materials, systems, and equipment that make the most sense for your project.
Whether it’s optimizing for cost, lead time, compliance, or long-term performance, we tailor every solution to meet your specific goals. And if something changes during the build—like an unexpected delay or a better product becoming available—we can pivot quickly to keep things moving.
This flexibility gives you more than just options. It gives you confidence that you’re getting the right solution, not just the standard one.
With Angstrom, you get smarter sourcing, more responsive service, and a space that’s built around you, not what’s easiest for us.
3. 30+ Years of Cleanroom Expertise—Applied to Your Success
With roots dating back to 1989, Angstrom Technology has been a trusted cleanroom partner for industries where precision, compliance, and control are critical. We’ve designed, engineered, and built cleanrooms for nearly every application—from pharmaceutical labs and medical device cleanrooms to aerospace, semiconductors, and battery manufacturing.
Over three decades, we’ve completed hundreds of cleanroom projects across a wide range of sectors, regulatory environments, and facility types. That deep, hands-on experience allows us to anticipate challenges before they occur, and apply time-tested strategies to solve them quickly, confidently, and with your success in mind.
Our cleanroom experts bring a refined, proven approach to every project. When obstacles emerge—and they will—we’re ready with practical, effective solutions built on decades of lessons learned.
Want to see what that expertise looks like in action? Explore a few of our featured cleanroom builds:
4. Uncompromising Quality. Total Regulatory Compliance.
In critical environments, precision isn’t optional—it’s essential. From air changes per hour to surface materials and airflow patterns, every element must meet exacting standards. And the proof must be in the documentation.
At Angstrom Technology, we approach every cleanroom project with a zero-compromise mindset. Whether your facility needs to meet ISO 14644 classifications, USP 797/800 guidelines, or FDA and cGMP requirements, we build cleanroom solutions that perform, pass inspection, and stand the test of time.
Our team monitors the latest code changes and regulatory shifts to ensure your cleanroom is audit-ready from day one. We oversee every phase—from design through validation—to eliminate risks like code violations, spec mismatches, or costly rework.
With Angstrom as your cleanroom partner, you get more than a compliant space. You get peace of mind, knowing it’s done right the first time.
5. We Anticipate Cleanroom Challenges—So You Don’t Have To
Every cleanroom project involves complex coordination, exacting specifications, and no margin for error. At Angstrom Technology, we don’t wait for problems to appear—we work to prevent them before they impact your timeline or budget.
Our seasoned project managers take a forward-thinking approach to every detail. From identifying design inconsistencies early to aligning subcontractors and suppliers ahead of schedule, we anticipate challenges and neutralize them before they slow you down.
Whether you’re navigating regulatory approvals, accommodating evolving needs, or managing multiple stakeholders, we stay ahead of the curve so you can stay focused on your goals.
And throughout the process, you’ll work with a dedicated cleanroom partner who knows your project inside and out. No handoffs. No confusion. Just clear communication and expert support—every step of the way.
6. Your Long-Term Cleanroom Partner—Here When You Need Us
At Angstrom Technology, our commitment doesn’t end when construction wraps—it evolves. We’re your cleanroom partner for the long haul, supporting your facility through every stage of its lifecycle.
From routine service to urgent repairs, we offer a full suite of post-project solutions that keep your cleanroom performing at its best—safely, efficiently, and in full compliance. Our expert team is ready to assist with:
Routine maintenance & inspections
Recertification & compliance updates
Emergency repairs
Cleanroom upgrades & expansions
We tailor service packages to your facility’s needs, compliance requirements, and operational priorities. And because we know your space inside and out, we can respond quickly and effectively, minimizing downtime and stress.
Our relationship doesn’t end when the cleanroom build is complete. In fact, that’s often just the beginning.
When you choose Angstrom, you’re not just building a cleanroom. You’re building a lasting partnership—one that protects your investment for years to come.
When you partner with Angstrom Technology, you’re not just checking boxes on a cleanroom project—you’re gaining a team that shows up with integrity, experience, and your success in mind.
Whether you’re just starting to plan your cleanroom or need long-term support for an existing facility, we’re here to help every step of the way.
Let’s talk about how we can support your cleanroom goals today.
The CHIPS and Science Act represents a groundbreaking moment for the U.S. semiconductor industry. Signed into law in 2022, this legislation allocates billions of dollars to maintain America’s leadership in advanced technologies. For businesses in the semiconductor sector, it’s more than just funding—it’s a once-in-a-generation opportunity to innovate, expand, and position facilities for long-term success.
Do you know how the CHIPS Act impacts semiconductor manufacturing facilities that utilize cleanrooms?
Here’s how you can leverage this opportunity to support your operations. Whether you plan to upgrade an existing facility or build a new cleanroom from the ground up, the time to act is now.
What is the CHIPS and Science Act?
The CHIPS and Science Act was introduced in 2022 to address gaps in the U.S. semiconductor manufacturing ecosystem. The demand for semiconductors was skyrocketing, and global supply chain vulnerabilities were being exposed. As a solution, the Act provides $52.7 billion in federal funding to bolster domestic semiconductor research, development, and production. This initiative is part of a broader strategy to strengthen the nation’s technological infrastructure, support innovation, and ensure long-term economic competitiveness.
What does the CHIPS Act provide:
$39 billion for manufacturing incentives: This includes funding for facility construction, cleanroom upgrades, and equipment purchases to expand domestic manufacturing capabilities.
Tax credits for capital expenses: A 25% investment tax credit reduces the financial burden of establishing or upgrading semiconductor manufacturing facilities.
Guardrails for equitable growth: This will ensure funding is used responsibly, prioritizing projects that create jobs, foster innovation, and exclude facilities in countries of concern.
With its comprehensive funding and strategic initiatives, the CHIPS and Science Act is more than just legislation—it’s a catalyst for transformation, providing semiconductor manufacturers with the tools needed to lead the industry into the future.
How the CHIPS Act Creates Opportunities for Semiconductor Facilities
The CHIPS and Science Act creates long-term opportunities for semiconductor facilities to thrive in a competitive and evolving industry.
What financial incentives does the CHIPS Act provide?
Tax Credits for Capital Expenses: Facilities can claim a 25% investment tax credit for expenses related to cleanroom construction, advanced equipment, and facility upgrades.
Grants and Subsidies: The Act provides $39 billion in manufacturing incentives, including direct grants and subsidies, making it easier for companies to expand their production capabilities and build state-of-the-art facilities.
Does the CHIPS Act promote workforce development?
Investments in STEM Education: Funding is directed toward educational programs at all levels, from K-12 initiatives to advanced degree programs, ensuring a pipeline of talent for semiconductor manufacturing and research roles.
Creation of Skilled Jobs: The Act supports the creation of tens of thousands of well-paying jobs in construction and ongoing facility operations.
How is the CHIPS Act a catalyst for regional economic development?
Innovation Hubs Across the U.S.: The Act spurs the development of high-tech innovation hubs that create economic opportunities in underserved regions. It encourages partnerships between local governments, educational institutions, and private businesses.
Boosting Local Economies: Facility upgrades and new construction projects generate significant local economic activity and benefit small businesses by creating job opportunities beyond the semiconductor industry.
How to Leverage the CHIPS Act Funding to Future-Proof Your Cleanroom Facility
The CHIPS and Science Act allows semiconductor manufacturers to enhance their cleanroom facilities and stay ahead in the industry.
1. Identify Areas for Improvement in Cleanroom Capabilities
Take stock of your facility and identify areas that would benefit from improvement and funding:
Evaluate whether your existing cleanrooms meet current production demands and ISO standards.
Pinpoint areas where automation or advanced materials could enhance efficiency and output.
2. Apply for Funding and Tax Incentives to Upgrade or Expand Facilities
The CHIPS Act provides substantial financial support for cleanroom enhancements to reduce the upfront costs of facility improvements:
Apply for grants or subsidies aimed at modernizing semiconductor manufacturing facilities.
Leverage the 25% investment tax credit to offset costs associated with new cleanroom construction, equipment purchases, or major renovations.
3. Collaborate with Experienced Partners Like Angstrom for Cleanroom Design and Installation
Building or upgrading a cleanroom requires specialized expertise. Collaborate with experts to minimize risks and ensure your cleanroom meets or exceeds standards:
Work with a trusted partner like Angstrom to design and install cleanrooms that meet the rigorous demands of semiconductor manufacturing.
Ensure compliance with ISO standards and industry-specific requirements.
Benefit from customized solutions tailored to your facility’s unique needs.
4. Invest in Advanced Technologies to Maintain Competitiveness
The semiconductor industry evolves rapidly, making technological innovation a necessity. Staying ahead of technological trends ensures your facility remains competitive in the global market:
Upgrade your cleanroom with cutting-edge technologies, such as automated monitoring systems, energy-efficient HVAC systems, and modular cleanroom designs.
Incorporate advanced materials and processes that improve yield rates and reduce contamination risks.
5. Align Facility Upgrades with Long-Term Production Goals
When planning improvements, think beyond immediate needs. Take a strategic approach to facility upgrades to make sure your cleanroom remains a valuable asset for years to come:
Consider how your facility upgrades can support the production of next-generation semiconductors.
Ensure scalability so your cleanroom can accommodate increased production capacity as demand grows.
Align investments with your organization’s long-term vision for innovation and market leadership.
Angstrom Is Here to Help You Leverage the CHIPS Act for Cleanroom Success
The CHIPS and Science Act is a transformative opportunity to strengthen your cleanroom facility. You can enhance your production capabilities and secure your place as a leader in the global market.
With billions of dollars allocated to revitalizing domestic manufacturing, now is the time to act. Upgrade your cleanroom facilities to meet the demands of advanced semiconductor production. Leverage CHIPS Act funding, tax incentives, and grants to future-proof your operations and contribute to the resurgence of American manufacturing.
Ready to take the next step?
Contact Angstrom today to learn how our expert team can help you design and build state-of-the-art cleanroom facilities. Let’s turn opportunity into reality—together.
Cleanrooms are designed to prevent contamination and protect sensitive products. But even with the best practices and equipment in place, cleanrooms are not immune to wear and tear.
Routine maintenance addresses minor issues before they escalate, but problems can still arise unexpectedly. These issues can compromise the cleanroom’s integrity and hinder productivity without intervention.
5 Signs You Need Cleanroom Cleaning, Services, or Repair
Here are five key signs that indicate it may be time to schedule a cleanroom service or repair to keep your operations running smoothly.
1. Unusual Odors or Chemical Smells
Unpleasant odors or chemical smells in a cleanroom can indicate that the filtration system is not neutralizing or removing harmful substances. When these systems fail, it can result in the buildup of airborne contaminants or chemical byproducts that affect air quality. If left unaddressed, this can contaminate sensitive products and compromise safety and compliance.
It is crucial to address unusual odors promptly to prevent contamination from spreading and to avoid further damage to the cleanroom’s systems.
2. Visible Contamination or Dust Accumulation
Dust, particles, and other foreign substances can be detrimental to cleanroom operations. If you notice contamination or dust accumulation, it can be a clear sign that the air filtration system is malfunctioning. Contamination can lead to defective products, delays, or even product recalls, especially in industries like pharmaceuticals and biotechnology.
Monitor and clean cleanroom surfaces regularly to prevent the buildup of contaminants. If visible contamination becomes an issue, it may indicate a problem with the filtration system, and immediate attention is required.
3. Damaged or Malfunctioning Equipment
HVAC units, particle counters, and filtration systems regulate airflow, monitor particulate levels, and ensure air quality, which is crucial for meeting cleanliness standards and preventing contamination.
For example, a malfunctioning HVAC unit can lead to improper temperature or humidity, or a faulty particle counter might fail to detect airborne contaminants. Even minor issues with these systems can impact the cleanroom’s performance and lead to a non-compliant environment.
It’s essential to inspect and maintain cleanroom equipment regularly to prevent malfunctions. If you notice any irregularities, address the issue immediately to avoid compromising the environment.
If you notice that your cleanroom’s temperature or airflow is inconsistent, you must address the issue promptly to avoid any detrimental effects on production and to ensure compliance.
5. Increased Downtime or Decreased Productivity
When cleanroom equipment malfunctions or the controlled environment is compromised in any way, production delays, reduced output, and potentially a halt in operations can occur. If a cleanroom consistently experiences breakdowns, inefficiencies, or compliance issues, it may indicate an underlying system problem that requires professional assessment.
Addressing these issues early on with professional evaluation and service can help avoid long-term downtime and improve overall productivity.
Stay Up to Standards With Angstrom’s Cleanroom Repair Services
Angstrom offers comprehensive cleanroom services to keep your cleanroom in optimal condition. By being proactive, you can avoid unplanned downtime, maintain compliance, and extend the lifespan of your cleanroom systems.
At Angstrom, we’re proud to offer an array of cleanroom services, including:
Comprehensive Repair Solutions
Whether it’s equipment repairs, environmental control adjustments, or system checks, our team ensures your cleanroom’s components are functioning as they should. We’ll restore the controlled environment to its original state, ensuring everything meets the necessary standards.
Preventative Maintenance
Avoid breakdowns and costly repairs with Angstrom’s ongoing maintenance services. Regular inspections and preventative measures identify potential issues before they become major problems, minimizing downtime and extending the life of your equipment.
Emergency Support
We’re ready to provide fast, reliable support for urgent repairs. Our team is equipped to handle emergencies so you can return to normal operations as soon as possible.
Get Your Cleanroom Back on Track with Angstrom’s Expert Services
If you’ve noticed any signs mentioned in this blog or want to ensure your cleanroom is running at its best, don’t hesitate to contact Angstrom. Our team of experts is ready to assist with everything from routine maintenance to emergency repairs so you stay compliant and productive.
Contact us today to schedule a service or repair and keep your cleanroom performing at its highest level.
If your company already has a cleanroom or is in the process of getting one, you likely understand the crucial role it plays in your operations. However, have you considered the type of cleanroom that best suits your needs?
There are two main types of cleanrooms: a traditionally constructed space and a modular cleanroom.
Modular cleanrooms have numerous benefits compared to traditional construction – let’s dive in further.
The 5 Main Benefits of Modular Cleanroom Systems
If your company is seeking a cleanroom with top-tier flexibility, efficiency, and effectiveness, modular cleanrooms are probably the best option. We’re here to tell you all about them.
1. Modular Cleanrooms Are Free-Standing
Free-standing, modular cleanrooms can be built without extensive construction or renovation (not to mention the costs and disruption those processes entail). Whether the best location is in the middle of a large open production floor or tucked back in a corner, these controlled environments can go anywhere. You don’t need to build walls or change existing ones, and electricity and plumbing are already engineered into the cleanroom as part of the modular design.
2. Modular Cleanrooms Can Be Built Within a Shorter Timeframe
Building cleanrooms from a pre-designed kit with all the building materials included and the design already complete is faster and much more efficient than starting from scratch. With modular cleanrooms, the design is finalized, the materials are pre-selected, and the construction process is simplified. This streamlined approach allows for quicker installation, reducing downtime and helping you get up and running faster.
3. Modular Cleanrooms Are Easier To Modify or Expand
Should your company’s cleanroom needs ever change, modifying a modular cleanroom is much easier than renovating or remodeling a traditionally constructed space. Modular cleanroom walls can be easily moved to accommodate a new cleanroom layout and expanded by adding additional wall pieces. You don’t need to start fresh with all new materials every time your cleanroom needs change – saving you money and avoiding downtime.
4. Modular Cleanrooms Can Be Built From a Range of Materials
Another key advantage of modular cleanrooms is the flexibility to choose from a wide range of materials that best meet your operational requirements. Whether you need high-grade stainless steel, aluminum, or another type of specialized panel, you can select materials that offer the durability, chemical resistance, or contamination control required for your specific environment. This customization ensures your cleanroom will withstand your industry’s demands, whether you’re in pharmaceuticals, biotech, or manufacturing.
5. Modular Cleanrooms Require Minimal Maintenance
Modular cleanrooms are designed for convenience and efficiency, requiring far less maintenance than traditionally constructed spaces. Their modular design allows individual panels to be easily disassembled and reassembled, making repairs or replacements simple without needing extensive reconstruction. Traditional cleanrooms may require more invasive and costly maintenance – modular cleanrooms offer a straightforward solution that minimizes downtime and keeps operations running smoothly.
Ready to Transform Your Cleanroom Space?
Here at Angstrom, we’re proud to be a leader in the modular cleanroom industry. We offer top-of-the-line, tailored solutions for projects of any size and classification. Whether you need a compact cleanroom or a large-scale controlled environment, we can design and build a modular system that meets your precise specifications.
Contact Angstrom today for expert guidance on your modular cleanroom needs and take the next step toward creating a flexible, efficient, and reliable cleanroom for your business.
Are cleanrooms a critical part of your business? If so, you know that they can be finicky at times. You have to maintain exact standards, and when your cleanroom is down, so is your company.
So, what can you do to ensure that your cleanroom always functions according to its required standards?
Though it might sound obvious, keeping it well stocked with necessary cleanroom supplies is the best way to keep your cleanroom performing to standard.
5 Important Cleanroom Supplies You Should Always Have
Below is a list of five essential cleanroom supplies you should always have on hand and what makes them so important.
1. Replacement Filters
Filters are what keep the air in a cleanroom clean. Without filters, your cleanroom has little hope of performing to standard. So, it’s good to always have backup filters on hand, both HEPA, ULPA, and pre-filters. But how many should you have?
Pre-filters: Depending on the standards your cleanroom has to meet, you probably change your pre-filters once every few months. Every time you change them, you should ensure you have enough replacements to last at least one more change. Otherwise, you risk putting your operation behind.
HEPA/ULPA: For HEPA or ULPA filters, it’s a good idea to keep one or two replacements on hand in case a situation arises where a filter needs to be changed unexpectedly. Having replacements ready ensures you’re prepared for any emergency.
2. Gowning Materials
If you regularly order cleanroom supplies, you know that you go through boxes of gowning materials in no time. Hoods, bunny suits, booties, and cleanroom gloves are crucial to your everyday operations. It’s important that your company develop some sort of system so that you never run out of these essential cleanroom supplies.
For example, have employees alert the person in charge of ordering cleanroom supplies whenever you have less than two weeks’ worth of a certain gowning material. Whether it’s gloves or cleanroom suits, a good rule of thumb is that when you open the last box of cleanroom supplies, you order another shipment.
3. Cleanroom Cleaners
While this might sound like common sense, it’s surprising how quickly you can run out of cleanroom cleaning supplies. Maybe you’ve experienced that feeling of dread when an employee reports and says that there aren’t any more bottles of cleaner. There’s nothing worse than frantically trying to find the right cleaner and then making sure it gets shipped overnight so your cleanroom can continue functioning at standard for the next business day.
Similar to gowning materials, it’s a good idea to have a system in place to prevent this sort of situation. Make sure you always have at least one full bottle of disinfectant or cleaner.
4. Cleanroom Wipes
Cleanroom wipes are specifically designed to clean surfaces within the cleanroom without introducing additional contaminants. They’re often made from lint-free materials and are pre-saturated with a cleaning solution safe for use in controlled environments. They’re used to wipe down surfaces, equipment, and even personnel as needed to maintain cleanliness. Their ability to clean without leaving residue makes them indispensable for maintaining the strict hygiene standards required in cleanrooms.
It’s best to monitor your usage and set up automatic reorders based on your average consumption rate. We also suggest storing an emergency supply of wipes to prevent unexpected running out.
5. Sticky Mats
Sticky mats are your first line of defense against contamination. They’re placed at the entrance to trap dirt, dust, and other contaminants from shoes or equipment wheels before they enter the controlled environment. Regularly replacing sticky mats is crucial, as they significantly reduce the risk of particles entering your cleanroom, which can otherwise lead to costly downtime and compromised products.
We recommend keeping an inventory log of your sticky mats and setting a schedule for regular replacements. Consider ordering in bulk to ensure you always have an ample supply.
Trust Angstrom for Expert Cleanroom Design and Supplies
If you need cleanroom supplies or are considering the design of a new facility, trust the experts at Angstrom. We specialize in designing cleanrooms that meet your exact specifications and standards and offer a full range of replacement cleanroom supplies to keep your operations running smoothly.
After investing in a top-of-the-line cleanroom, keeping it in pristine condition is crucial, especially when adhering to cGMP compliance.
When properly cared for, a cGMP cleanroom will function at peak performance, ensuring that all processes meet strict regulatory standards. However, failure to adhere to cGMP cleaning standards can lead to contamination, jeopardizing product quality and resulting in costly regulatory issues that can disrupt daily operations.
Here’s a rundown of the best cleaning cleanroom procedures and practices for your cGMP-compliant cleanroom.
What Are cGMP Requirements for Cleanroom Cleaning?
cGMP, or Current Good Manufacturing Practices, are regulations enforced by the FDA to ensure that products are consistently produced and controlled according to quality standards. These regulations are particularly crucial in pharmaceuticals, biotechnology, and medical device manufacturing, where product safety and efficacy are paramount.
Classifications of cGMP Cleanrooms
cGMP cleanrooms are classified based on their ISO standards, which define the cleanliness level required for different types of manufacturing environments. The most common classifications include:
ISO 5 (Class 100): These cleanrooms have the strictest cleanliness requirements, allowing only 3,520 particles (0.5 microns or larger) per cubic foot of air. They are often used in critical processes such as aseptic filling and sterile drug manufacturing.
ISO 6 (Class 1,000): Allows for 35,200 particles per cubic foot and is typically used in processes like vial filling or assembly of sterile devices.
ISO 7 (Class 10,000): Permits 352,000 particles per cubic foot and is commonly found in less critical manufacturing processes, such as packaging or certain laboratory environments.
The classification of your cleanroom dictates the stringency of the cleaning protocols. For example, an ISO 5 cleanroom requires more frequent and thorough cleaning than an ISO 7 cleanroom due to the higher sensitivity to particulate contamination.
6 Effective Cleanroom Cleaning Strategies For cGMP Requirements
1. Follow Industry-Specific Standards
Cleanrooms vary widely in use, and cGMP cleanrooms have unique requirements and standards they must adhere to depending on the industry. For example, cGMP cleanrooms in pharmaceuticals must adhere to extremely stringent standards to prevent contamination that could compromise the safety and efficacy of drugs.
Depending on your industry, your cGMP cleanroom will have a specific layout, ISO rating, and cleanliness standard. Therefore, its cleaning schedule and procedure will also differ.
Cleanrooms with higher ISO ratings, like ISO 5, for example, must be kept at much higher sanitation levels to reduce the chance of interference from minute particles and contaminants.
Cleanrooms with lower class ratings, such as ISO 7, may be less threatened by certain contaminants or smaller particle sizes, but they still require regular cleaning to maintain standards and efficiency.
2. Follow Contamination Prevention Protocols
In a perfect world, zero contaminants would enter your cleanroom environment. While this is virtually impossible, the best way to keep your cGMP cleanroom clean is to follow strict contamination prevention protocols designed to meet cGMP requirements. These protocols include:
Proper Gowning Procedures: All personnel must adhere to cGMP-specific gowning protocols. This includes wearing sterile, non-powdered gloves, sterile gowns, masks, and other protective gear.
Sterilization and Equipment Usage: All tools and equipment used in a cGMP cleanroom must be sterilized according to cGMP standards, including ensuring that all cleaning tools, garments, and materials are appropriately sanitized before use to prevent contamination.
Strict Entry Procedures: Entry protocols may involve multiple stages of decontamination, such as air showers, sticky mats, and separate gowning areas, ensuring that personnel and materials are free of contaminants before entering.
Importance of Training Staff in cGMP Practices: To minimize risks, staff members should be trained in cGMP contamination prevention practices.
Keeping your workspace clean requires diligent adherence to daily and weekly cleaning schedules. Depending on the strictness of your class standard, you may need to add more rigorous objectives or increase the frequency of these tasks.
Whatever your facility requires, it’s essential to create and follow a cleaning schedule that clearly defines all assignments, making them easy to understand and follow. Here are the general cleaning protocols recommended for broad cleanroom needs:
Daily Cleanroom Cleaning:
Before a shift begins, use a damp mop on floors and vacuum to dry.
Vacuum all walls using a HEPA filter vacuum.
Wash and wipe all windows and pass-throughs dry.
Wipe down all work areas at the end of every shift. This should occur more frequently in cleanrooms with higher standards.
Put away products and supplies between shifts to prevent further contamination.
Weekly Cleanroom Cleaning:
Mop floors with a cleanroom-specific detergent, distilled water, and a HEPA filter vacuum.
Wipe walls with a damp sponge and distilled water, then vacuum dry.
As Needed:
Remove any residue or deposits on ceilings by washing with detergent and distilled water.
Using a damp sponge, wipe off all light lenses.
Change sticky mats as soon as you notice wear.
Note: This FDA webpage provides a detailed look at cGMP standards and regulations.
4. Use cGMP-Approved Products Approved for Cleaning Cleanrooms
Cleaning products that are improperly sterilized or unsuitable for cleanroom use can cause contamination, particularly in cGMP cleanrooms where maintaining strict standards is critical.
Using only cleaning products that are cGMP-approved, non-reactive, and specifically designed for cleanroom environments is essential. This includes using deionized and distilled water for mopping and wiping surfaces and cleanroom-specified cleaning agents that meet cGMP standards. All chemicals and solvents for cleaning must be neutral, non-ionic, and non-foaming to avoid buildup on surfaces over time, which could compromise the cleanliness of the environment.
Cleanroom Cleaning Tips:
High ISO class cleanrooms (ISO levels 5-7) often require sterilizing disinfectants before use, further protecting the cleanroom from contaminants.
Never use scrubs or rags that could shed or corrode surfaces. Instead, only use woven polyester specified for cleanroom use.
Follow a mopping protocol that efficiently cleans floors without spreading dirty water over cleaned areas. Employ a mopping system that separates dirty and clean water and won’t scratch or contaminate the floor or walls.
Bringing all needed materials—such as brooms, mops, and cleaning agents—into the cleanroom before cleaning is good practice. This way, once the process is complete, you only need to exit once, reducing the possibility of contamination.
Note: For a detailed list of cGMP-approved products for cleaning cleanrooms, visit the FDA website here.
5. Properly Train Staff on cGMP Cleaning Procedures & Maintenance
All staff members and janitorial personnel must be rigorously trained in cGMP cleaning protocols to ensure compliance and maintain the cleanroom’s class standards. This includes comprehensive education on gowning procedures, environmental sterilization practices, general equipment maintenance, and more.
Staff should be equipped to handle spills or other incidents that could lead to contamination. Tools and cleaning supplies should be easily accessible but not stored in a way that could lead to cross-contamination. To support this, having guides and cleaning checklists posted visibly in the room can help staff consistently follow cGMP protocols and maintain a sanitary environment
6. Conduct Regular Inspections and Monitoring for cGMP Compliance
Even if you’re doing everything right and following the proper cleanroom procedures, it’s crucial to conduct regular inspections and environmental monitoring to ensure ongoing cGMP compliance. Regular checkups help verify that your cleanroom consistently meets cGMP standards, preventing potential lapses that could lead to contamination or non-compliance.
Cleanroom Inspection & Monitoring Tips:
Air samplers or settle plates can be used to test for organisms and measure particles per cubic foot, ensuring that the cleanroom environment remains within the required cleanliness levels.
Regular checkups of your HVAC system play a vital role in maintaining cGMP compliance. The HVAC system controls temperature, humidity, and air filtration, all of which are critical factors in ensuring the cleanroom environment remains stable and free from contaminants. A properly functioning HVAC system will maintain a steady temperature and humidity level, consistently changing air to meet your ISO specifications, which is essential for preserving the cleanliness and integrity of the cleanroom.
Utilize cleanroom experts to inspect, monitor, and repair your cleanroom. At Angstrom, our tailored maintenance and repair services ensure your cleanroom continues to meet the highest industry standards. When the unexpected occurs, our team is ready to assist wherever needed.
Count On Expert Cleanroom Maintenance Solutions from Angstrom Technology
If you’re cleaning your cleanroom and still not getting the desired results, it might be time for specialized maintenance. To ensure your cleanroom remains compliant with cGMP standards, it’s crucial to consult with experts like our expert team at Angstrom.
Whether you need help troubleshooting specific issues or want to enhance your cleaning protocols, our expertise can ensure your cleanroom always functions to the best of its ability. Contact us today to learn more!
