Cleaning Cleanrooms: How Often Should You Have Your cGMP Cleanroom Cleaned?

Cleaning Cleanrooms: How Often Should You Have Your cGMP Cleanroom Cleaned?

by | Aug 29, 2024 | Cleanrooms, Gowning, Helpful Tips

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. 

3. Establish Regular Cleanroom Cleaning Procedures

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! 

CONTACT A LIFE SCIENCE CLEANROOM EXPERT

Cleanroom Construction: Traditional vs. Modular Cleanrooms

Cleanroom Construction: Traditional vs. Modular Cleanrooms

by | Aug 1, 2024 | Cleanroom Design

When designing a new cleanroom, the first and most critical decision is whether it will be traditional or modular construction. Each option has benefits and limitations, and it can take time to determine which is best for your application. 

We can help. Here are the major differences between modular cleanrooms vs. traditional construction cleanrooms.

What Is a Traditional Cleanroom?

A traditional cleanroom is a highly controlled environment designed to minimize the presence of airborne particles, contaminants, and pollutants. These permanent installations are typically constructed with studs and drywall and integrated into the building’s architecture. They utilize advanced HVAC systems with HEPA or ULPA filters to maintain strict control over environmental factors such as temperature, humidity, and pressure. 

What Is a Modular Cleanroom?

A modular cleanroom is a flexible and scalable controlled environment that offers the same level of contamination control as traditional cleanrooms, plus the benefits of adaptability and cost-efficiency. Constructed using prefabricated panels and components, modular cleanrooms can be quickly assembled, disassembled, and modified to meet changing production needs or accommodate new processes.

Traditional Cleanroom Construction vs. Modular Cleanrooms

When deciding between traditional and modular cleanrooms, consider various factors such as flexibility, cost, installation, maintenance, and customization to determine which option best suits your specific needs.

Flexibility

For applications requiring flexibility, modular construction is your best bet. Traditional construction cleanrooms can’t be packed up and moved to another location. Nor is it as easy to expand as modular construction, where adjustments are minor, such as detaching a few panels and adding more to them. Instead, you have to renovate and knock out walls. 

Depending on your cleanroom use and classification, you could build a super-flexible Softwall cleanroom with impermanent curtain-like walls. You could also opt for a Rigidwall or Hardwall cleanroom with thicker, more substantial wall panels. All of these options are still flexible, modular cleanrooms.  

Cost

The cost of every cleanroom will vary depending on the size, application, special features, and construction type. Generally, modular cleanrooms are more expensive than traditionally built cleanrooms.

In addition to upfront costs, depreciation is something to consider when building a cleanroom. Modular cleanrooms qualify for accelerated depreciation, typically over seven years or less, whereas traditionally constructed rooms follow a 39-year depreciation schedule. This difference in depreciation timelines can impact financial planning and tax benefits for businesses.

Installation

While traditional cleanrooms can take months to build, modular construction is much simpler as the components are already manufactured. Instead of building walls from raw materials, with modular cleanrooms, the components simply need to be assembled to your specifications. Modular installation can take as little as a few days or weeks to complete, which is crucial to getting your operations up and running as soon as possible.

Additionally, while you’ll always need to hire pros for traditional construction, a modular cleanroom (typically smaller and less complicated cleanrooms) can often be assembled in-plant by your staff, with the instructions provided by the manufacturer. The manufacturer may even offer installation services at an additional cost or as part of a modular cleanroom design package.

Maintenance 

Traditional cleanroom maintenance can be quite demanding due to its permanent nature and the need for continuous compliance with stringent cleanliness standards. Regular and thorough cleaning, frequent filter replacements, and ongoing monitoring of environmental parameters are necessary to maintain the integrity of a traditional cleanroom. 

On the other hand, modular cleanrooms typically require less intensive maintenance. Their modular nature allows for easier access to components that need cleaning or replacement. Additionally, if a section of the cleanroom needs to be decontaminated or upgraded, it can be done without affecting the entire facility, reducing downtime and maintenance costs.

Customization

Due to their permanent construction and integration into the building’s architecture, traditional cleanrooms offer fewer customization options. Changes or upgrades often require significant construction work, which can be time-consuming and expensive. 

Modular cleanrooms offer a higher degree of customization with minimal disruption. They can be tailored to specific needs, whether adjusting the layout, adding new features, or upgrading to meet higher cleanroom classifications. The modular approach allows for quick modifications and scalability, enabling businesses to adapt their cleanroom environment to evolving requirements without significant overhauls.

Why Choose Angstrom Technology for Your Modular Cleanroom Needs?

If you’re designing a cleanroom, contact Angstrom Technology to discover how our state-of-the-art modular cleanroom designs can meet your unique requirements. Our expert team is dedicated to providing flexible, cost-effective, and customizable solutions that ensure your cleanroom operates at peak efficiency. 

Whether you need a quick installation, easy maintenance, or the ability to scale and adapt your cleanroom environment, Angstrom Technology has the expertise and innovative solutions to make it happen. Contact us today to learn how we can help you achieve a cleanroom that not only meets but exceeds your expectations.

What Is the Role of Dry Rooms in Lithium-Ion Battery Manufacturing?

What Is the Role of Dry Rooms in Lithium-Ion Battery Manufacturing?

by | Jul 31, 2024 | Dry Rooms

In today’s world, technological advancements are constantly being made. Therefore, the demand for lithium-ion batteries continues to surge, powering everything from smartphones to electric vehicles. 

Behind the scenes of these powerhouses lies a critical factor often overlooked: moisture. Controlling moisture levels is paramount when manufacturing lithium-ion batteries to ensure optimal performance and longevity.

That’s where dry rooms come in! Dry rooms are specialized environments meticulously engineered to maintain low humidity levels. In this blog, we dive into the role of dry rooms in lithium-ion battery manufacturing and how they uphold industry standards for quality and safety.

The Significance of Dry Rooms in Lithium-Ion Battery Production

Lithium-ion batteries are the backbone of modern portable electronics and electric vehicles. However, despite their remarkable capabilities, these power sources possess a sensitive nature that demands precision in their manufacturing processes. Even minute traces of moisture can wreak havoc on battery components, leading to compromised performance, reduced longevity, and potential safety hazards.

Given these vulnerabilities, the role of dry rooms in lithium-ion battery production cannot be overstated. By maintaining stringent control over humidity levels, dry rooms shield against moisture, safeguarding the integrity of battery components and ensuring consistent performance and reliability.

What Is Moisture’s Impact on Battery Components?

In lithium-ion battery manufacturing, moisture is detrimental. It’s capable of undermining the integrity and performance of crucial battery components. 

Here are some of the most common ways moisture impacts battery components: 

  • Electrolyte Degradation and Reduced Conductivity:
    • Electrolytes, vital for facilitating ion movement between electrodes, are susceptible to moisture-induced degradation.
    • Moisture triggers chemical reactions that degrade electrolyte integrity, diminishing its conductivity.
    • Reduced conductivity impedes efficient ion transfer, reducing battery performance and capacity.
  • Corrosion of Electrode Materials:
    • Electrodes, composed of materials like lithium cobalt oxide (LiCoO2) or lithium iron phosphate (LiFePO4), are prone to oxidation reactions when exposed to moisture.
    • Moisture-induced corrosion accelerates electrode surface degradation, compromising structural integrity and electrochemical activity.
    • Diminished electrode performance leads to decreased battery efficiency and shortened lifespan.
  • Implications for Battery Safety and Performance:
    • Moisture-induced corrosion undermines performance and raises safety concerns.
    • Structural damage caused by corrosion increases the risk of internal short circuits and thermal runaway events.
    • These events can cause battery fires or explosions, posing significant hazards to users and surrounding environments.

Lithium-Ion Battery Manufacturing Facilities Need Controlled Environments

Any manufacturing facility creating lithium-ion batteries needs a controlled environment or a dry room. As mentioned above, humidity control is key and can wreak havoc on battery performance. By meticulously regulating humidity levels, manufacturers can mitigate risks and uphold the reliability and longevity of their battery products.

Controlled environments also play a pivotal role in ensuring product consistency across manufacturing batches. Consistency is vital in the production of lithium-ion batteries to guarantee uniform quality and performance standards. Stable humidity levels within controlled environments provide the optimal conditions for reproducible manufacturing processes, minimizing variations in battery performance between production runs. 

Adherence to industry standards and regulations is fundamental in the lithium-ion battery manufacturing sector. These standards often mandate specific environmental conditions, including humidity levels, to ensure manufacturing quality and compliance. By maintaining controlled environments that meet or exceed these standards, manufacturers demonstrate their commitment to producing high-quality, safe, and reliable lithium-ion batteries. 

What are the Key Features of Dry Rooms?

Dry rooms are meticulously designed environments tailored to meet the stringent requirements of lithium-ion battery manufacturing. These specialized facilities incorporate a range of crucial features to control humidity levels and maintain optimal conditions for battery production. 

Let’s explore some of the essential features of dry rooms:

  • Temperature and Humidity Control:
    • Precise temperature and humidity control are fundamental in dry rooms to prevent moisture buildup and ensure stable manufacturing conditions.
    • Advanced HVAC (Heating, Ventilation, and Air Conditioning) systems regulate temperature and humidity levels within tight tolerances, typically kept within the range of 20-25°C and humidity levels below 1% relative humidity.
  • Air Filtration and Purification Systems:
    • High-efficiency air filtration and purification systems maintain clean and contaminant-free environments.
    • HEPA (High-Efficiency Particulate Air) filters and activated carbon filters are utilized to remove particulate matter, dust, and airborne contaminants, ensuring the integrity of battery components during production.
  • Importance of Sealed Environments and Airlock Systems:
    • Sealed environments are essential in dry rooms to prevent external moisture and maintain controlled humidity levels.
    • Airlock systems with double-door entryways facilitate controlled access to the dry room, minimizing the risk of moisture contamination from outside environments.

Angstrom Technology’s Dry Room Solutions for Lithium-Ion Battery Manufacturing

At Angstrom Technology, we specialize in designing and delivering efficient dry rooms tailored for lithium-ion battery manufacturing. With our expertise, we create stable, low dewpoint environments crucial for preserving battery integrity. Our solutions address humidity control, static, particulate matter, and out-gassing, meeting international standards and regulations while optimizing energy efficiency. 

One standout feature of our dry rooms is the industry-leading HVAC systems we offer. Known for their exceptional efficiency, capability, and life-long energy consumption, our mechanical systems surpass all other solutions available in the US. This superior performance sets us apart and is a key reason why clients choose Angstrom, recognizing the unmatched energy efficiency and reliability of our HVAC technology.

Achieving ISO classification, our dry rooms ensure quality and compliance. With over 100 cleanrooms delivered annually across America, the UK, and Europe, Angstrom Technology is your trusted partner for reliable cleanroom solutions in battery manufacturing.

Partner with Angstrom Technology for Industry-Leading Dry Room Solutions

Angstrom Technology stands as a beacon of innovation in lithium-ion battery manufacturing. Our commitment to providing cutting-edge solutions is unwavering, as we design and deliver top-of-the-line dry rooms tailored specifically for battery production. 

Whether you require a custom dry room solution or seek to optimize your cleanroom environment, our team of experts is dedicated to delivering tailored solutions that meet and exceed your expectations. Partner with Angstrom Technology for reliable, industry-leading cleanroom solutions that drive innovation and excellence in lithium-ion battery manufacturing.

Angstrom-Services-Maintenance-Offering-CTA-1
The Critical Role of Pharmaceutical Cleanrooms in Controlling Environmental Variables

The Critical Role of Pharmaceutical Cleanrooms in Controlling Environmental Variables

by | Jul 9, 2024 | Pharmaceutical Cleanrooms

Maintaining a controlled environment is paramount in the highly regulated and data-driven pharmaceutical industry. Pharmaceutical cleanrooms help ensure product safety, efficacy, and compliance and control environmental variables that could adversely affect manufacturing processes and the quality of the final product.
Keep reading to explore the importance of cleanrooms in the pharmaceutical sector and the key environmental variables they control to maintain optimal conditions for pharmaceutical manufacturing.

The Critical Role of Cleanrooms in Pharmaceutical Manufacturing

Cleanrooms establish controlled environments around critical processes where the concentration of airborne particles is specified and must be maintained at specific levels. These rooms are engineered to minimize ingress, product exposure, and operator exposure to aerosol contaminants.

Contamination control is critical in pharmaceutical manufacturing due to the potential impact on product efficacy and patient safety. Even minute levels of contamination can lead to significant consequences, including product recalls, regulatory penalties, and harm to patients.

Cleanrooms provide a controlled environment where factors such as air quality, temperature, and humidity are meticulously controlled to meet regulatory requirements and prevent contamination and cross-contamination between different stages of the manufacturing process.

5 Key Variables Controlled in Pharmaceutical Cleanrooms

By meticulously controlling environmental variables, cleanrooms ensure that pharmaceutical manufacturing processes are conducted under optimal conditions, minimizing the risk of contamination.

1. Temperature and Humidity Control

Variations in temperature and humidity can affect the stability of pharmaceutical products. Controlled temperature ensures that chemical reactions occur under optimal conditions, while proper humidity levels prevent moisture-sensitive materials from degrading or becoming contaminated.

2. HEPA Filtered Air Supply

High-Efficiency Particulate Air (HEPA) and Ultra-Low Penetration Air (ULPA) filters remove 99.97% to 99.999% of particles as small as 0.3 microns from the air. These filters ensure that the air within the cleanroom is free from dust, bacteria, and other contaminants, thereby protecting the integrity of pharmaceutical products.

3. Air Pressure Differentials

Air pressure is maintained between cleanrooms and adjacent areas to prevent the ingress of contaminants. Positive pressure is used in cleanrooms to keep out unfiltered air, while negative pressure is utilized in containment areas to ensure hazardous substances do not escape. This careful air pressure management helps control contamination pathways and maintain a sterile environment.

4. Microbial Contamination Control

Cleanrooms are equipped with microbial monitoring systems, and surfaces are regularly cleaned and disinfected. Personnel entering the cleanroom follow strict protocols, including wearing sterilized garments, to minimize the introduction of microorganisms.

5. Lighting and Noise Considerations

Proper lighting ensures personnel can perform tasks accurately and efficiently without causing eye strain or errors. Cleanrooms are designed with lighting systems that provide adequate illumination. Noise control is also important to maintain a comfortable working environment and to prevent distractions that could lead to mistakes in sensitive manufacturing processes.

The Impact of Environmental Variables on Pharmaceutical Processes

In pharmaceutical manufacturing, controlling environmental variables is crucial, as even minor deviations can lead to significant consequences.

Temperature and Humidity Affect Chemical Stability and Product Integrity

  • Temperature and humidity are critical factors in maintaining the chemical stability and integrity of pharmaceutical products.
  • Fluctuations in temperature can accelerate chemical reactions, degrading active ingredients and reducing the medication’s efficacy.
  • High humidity levels can cause moisture-sensitive drugs to absorb water, resulting in changes to their physical state, such as dissolving, clumping, or becoming unstable.
  • Low humidity can lead to desiccation and changes in drug potency.

Particle Control Prevents Contamination

  • Airborne particles, including dust, fibers, and microorganisms, pose a significant contamination risk in pharmaceutical manufacturing. These particles can originate from various sources, such as personnel, equipment, and the external environment.
  • HEPA and ULPA filters in cleanrooms remove particles from the air, ensuring a contaminant-free environment.

Microbial Control Ensures Product Safety and Efficacy

  • Microbial contamination is a critical concern in pharmaceutical manufacturing, as the presence of bacteria, fungi, or viruses can adulterate products making them unsafe for use.
  • Sterile materials and equipment adhere to rigorous cleaning and disinfection protocols and enforce strict hygiene practices for personnel.

Discover Angstrom’s Turnkey Cleanroom Solutions

Angstrom offers comprehensive turnkey cleanroom solutions tailored to the pharmaceutical industry’s unique needs. Our services encompass every aspect of cleanroom development, from facility programming and design to procurement, installation, validation, and ongoing maintenance.

We understand that each pharmaceutical manufacturing operation has distinct requirements. Our experienced consultants, engineers, and designers will work closely with you to develop tailored cleanroom solutions, whether accommodating unique workflows, integrating specialized equipment, or ensuring compatibility with existing facilities.

At Angstrom, our turnkey solutions offer a seamless, end-to-end approach to cleanroom development:

  • Design: Detailed planning and conceptualization to create a cleanroom that meets all technical and regulatory specifications.
  • Installation: Expert construction services that adhere to the highest standards of quality and precision.
  • Validation: Rigorous testing and validation procedures to ensure the cleanroom performs as expected and complies with industry standards.
  • Maintenance: Ongoing maintenance and support services to keep the cleanroom operating at peak efficiency and compliance.

Partner with Angstrom for Expert Pharmaceutical Cleanroom Solutions

Contact Angstrom today for expert cleanroom solutions that enhance your pharmaceutical processes. Our team is dedicated to delivering custom-designed cleanrooms that meet the highest standards of quality and performance. Let us help you create the perfect cleanroom environment for your pharmaceutical operations.

CONTACT A LIFE SCIENCE CLEANROOM EXPERT

5 Reasons Why You Should Hire A Professional for Cleanroom Services and Maintenance

5 Reasons Why You Should Hire A Professional for Cleanroom Services and Maintenance

by | Jun 4, 2024 | Cleanroom Supplies, Cleanrooms

Choosing professional cleanroom services and maintenance is crucial for ensuring the optimal performance of your cleanroom. While it may seem cost-effective to handle maintenance in-house or opt for a DIY approach, the complexities of cleanroom operation make professional services the most reliable and cost-efficient choice.

There are many reasons to leave cleanroom maintenance and repairs to the pros. Let’s get into them!

5 Reasons to Hire a Professional for Cleanroom Services and Maintenance

1. Professional Cleanroom Companies Have Crucial Expertise

A cleanroom company specializing in cleanroom design and maintenance will have years of experience to ensure that all necessary maintenance is performed on schedule and that any issues are identified and addressed promptly. The company that designed and installed your cleanroom will know all the ins and outs of the facility, therefore, they’ll be able to perform all necessary maintenance activities quickly and efficiently.

2. Cleanroom Maintenance Is More Than Just Equipment Testing

Maintaining your cleanroom takes more than just equipment testing (which is already a lot). Cleanroom maintenance also includes ensuring that the space is set up correctly for the tasks and activities performed there and that all necessary supplies are always on hand. A cleanroom maintenance provider can ensure you have all the required testing supplies and provide project-specific equipment and storage to meet your application and classification requirements.

3. Cleanroom Maintenance Is Too Important to Get Wrong

If you don’t properly maintain your cleanroom, you’ll encounter many issues. This could be failing to meet your desired ISO classification because of particulate contamination, equipment issues, old filters in need of replacement, or other problems. If you fail to meet your classification requirements, you can find yourself in legal trouble or lose important clients.

4. Companies Have Compliance and Certification Expertise

Professional cleanroom service providers bring invaluable expertise when navigating the complex landscape of compliance and certification. They are familiar with the stringent standards required by various regulatory agencies, such as the FDA, EPA, and OSHA. This expertise ensures that your cleanroom not only meets current industry standards but is also prepared for routine audits and inspections. 

5. Tailored Solutions and Upgrades are Available

Professional cleanroom servicers offer customized solutions and technological upgrades that enhance your cleanroom’s functionality and efficiency. Whether adapting your cleanroom to new processes, expanding its capacity, or integrating the latest technology, a specialized provider can assess and modify it to fit evolving needs. This adaptability is crucial for staying competitive in industries that are rapidly advancing. 

Angstrom-Services-Maintenance-Offering-CTA-1

Cleanroom Maintenance and Repair Services From Angstrom

At Angstrom, we specialize in ensuring your cleanroom facilities operate at peak efficiency and compliance. Our expertise in cleanroom maintenance and repair is backed by over three decades of industry leadership, making us a trusted partner in supporting various industries.

Keep Your Cleanroom Operating at Peak Performance With Our Comprehensive Service Offerings:

  • Repairs and Maintenance: Whether replacing HEPA units and air filters, repairing walls and doors, or upgrading cleanroom lighting, Angstrom’s expert team is equipped to handle all aspects of cleanroom repair and maintenance. We also provide specialized services such as challenge port installation, vinyl curtain installation, and pass-thru troubleshooting and replacement.
  • Preventative Maintenance Assessments: Our Preventive Maintenance Program is designed to address potential issues before they escalate. This program includes regular cleanroom assessments to help minimize downtime and extend the lifespan of your cleanroom facilities. Clients of this program benefit from priority services for emergency maintenance and repairs and preferential pricing on our services.
  • Cleanroom Enhancements: To keep your facilities updated with the latest standards, we offer enhancements such as HEPA control system upgrades, temperature and humidity specification adjustments, and modifications to meet specific ISO and GMP requirements. 
  • Tailored Solutions for Every Need: Angstrom’s services are customized to meet the unique needs of each cleanroom facility. From biopharma cleanroom validation to comprehensive contamination control, our services are designed to ensure compliance with international industry standards. 
  • Flexible Scheduling and Meticulous Planning: To accommodate our clients, we offer flexible scheduling options, including weekend and after-hours services, to minimize disruption to your operations. 
  • Comprehensive Support: We provide end-to-end support, ensuring that every aspect of your cleanroom operation is covered. From planning and repairs to documentation and reporting, our team delivers a seamless service experience.
  • Global Reach, Local Service: With operations across the globe, Angstrom offers tailored cleanroom solutions that meet the specific needs of clients in various sectors, including pharmaceuticals, electronics, and more.

Keep Your Investment in Tip-Top Shape with Angstrom’s Cleanroom Services

Your cleanroom is a significant investment. To maintain its integrity and functionality, professional maintenance and repair services are crucial. At Angstrom, we redefine excellence in cleanroom solutions, from initial design to ongoing maintenance. Our commitment to innovation, quality, and customer-centricity sets us apart in the industry.

Contact our team of experts today to learn more about our comprehensive services. Let us help you keep your cleanroom in pristine condition, maximizing your investment and supporting your continued success.