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.Â
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.Â
5 Important Cleanroom Supplies You Should Always HaveÂ
Below is a list of five essential cleanroom supplies you should always have on hand and what makes them so important.Â
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.Â
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.
Visit our website or call us at 888-768-6900 for all your cleanroom needs!
After investing in a top-of-the-line cleanroom, keeping it in pristine condition is crucial, especially when adhering to cGMP compliance.Â
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.Â
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.Â
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.Â
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.Â
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.Â
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.Â
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.Â
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 document provides an extensive, detailed look at cGMP standards and regulations.Â
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.Â
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:Â
High ISO class cleanrooms (ISO levels 5-7) often require sterilizing disinfectants before use, further protecting the cleanroom from contaminants.Â
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.Â
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.Â
Note: For a detailed list of cGMP-approved products for cleaning cleanrooms, visit the FDA website here.Â
5. Properly Train Staff on cGMP Cleaning Procedures & MaintenanceÂ
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.Â
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.Â
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.Â
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.Â
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!Â
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.Â
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.Â
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.Â
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.Â
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.Â
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.
Controlled environments are critical to the success and reliability of various high-stakes manufacturing processes. Dry rooms have stringent control of humidity levels, making them essential in many modern production and research fields.
But why exactly are dry rooms so important, and why is their demand growing across industries? The answer lies in the sensitive nature of the products and processes that require such meticulous environmental control—where even a slight deviation in humidity can lead to costly defects or failures.
If you’re looking to deepen your understanding of dry rooms, their features, and their applications, you’re in the right place.Â
What Is a Dry Room?
A dry room is defined by its ability to control and reduce atmospheric moisture to levels that far exceed the capabilities of standard environmental control systems. This is achieved through the use of advanced dehumidification technologies that ensure the air remains dry and stable. Typically, a dry room maintains humidity levels below 1% Relative Humidity (RH), though this can vary based on specific industry requirements.
Moisture can lead to oxidation, contamination, and other forms of degradation in environments where electronic components or other critical items are manufactured. For instance, in the production of lithium-ion batteries, excess moisture can cause unwanted chemical reactions that compromise the batteries’ integrity and safety.Â
5 Key Features of Dry Rooms
Dry rooms are equipped with a range of structural and technological features to ensure that the room meets the stringent requirements necessary for controlling humidity at very low levels. Here’s a closer look at some of these key features:
1. Dehumidifiers:
The most critical component of a dry room is the dehumidification system. These systems are highly specialized and capable of reducing and maintaining humidity to levels as low as 1% RH or even lower. Industrial-grade dehumidifiers used in dry rooms operate on the principle of adsorption or refrigeration and are often customized based on specific needs.
2. Airlocks:
Most dry rooms are fitted with airlocks. These airlocks act as buffer zones between the dry room and other parts of the facility. Personnel and materials must pass through these airlocks, where air is carefully controlled to minimize humidity entering the controlled environment.
3. Specialized HVAC Systems:
Apart from standard heating, ventilation, and air conditioning functions, HVAC systems in dry rooms are equipped with additional features to handle extreme dehumidification. These include enhanced filtration systems to remove particulates and contaminants and precision control mechanisms to maintain consistent temperature and humidity levels.
4. Sealed Environment:
Dry rooms are constructed to be as airtight as possible to prevent external air from compromising the controlled environment. This includes the use of vapor barriers and specialized sealants around doors, windows, and other potential air ingress points.
5. Monitoring and Control Systems:
Sensors are strategically placed throughout the room to monitor real-time conditions like temperature and humidity. These sensors are linked to a central control system that automatically adjusts the room’s environment based on predefined parameters, ensuring constant conditions are maintained.
Essential Dry Room Requirements
For a dry room to function effectively, it must meet specific construction and operational requirements. Here are some examples of dry room requirements:Â
Materials: The construction materials for walls, floors, and ceilings must be selected for their low moisture permeability and resistance to environmental conditions.
Maintenance: Regular maintenance of dehumidifiers, HVAC systems, and other critical components is essential to prevent failures that could introduce moisture into the room.
Personnel Protocols: Workers entering a dry room need to undergo specific procedures, such as wearing moisture-absorbing garments and passing through air showers, to minimize the amount of humidity they carry into the environment.
Industries and Applications of Dry Rooms
Dry rooms are pivotal in industries where even minor humidity can compromise product quality, safety, or efficacy. Here’s how they are utilized in various sectors:
Electronics Manufacturing:
Semiconductor Fabrication: Semiconductors are extremely sensitive to moisture because even trace amounts can lead to oxidation of the silicon wafers. Dry rooms ensure these components are manufactured and assembled in a moisture-free environment.
Assembly of Sensitive Electronics: Components such as OLED panels and precision sensors require assembly in dry rooms to prevent malfunction or degradation caused by moisture.
Battery Production:
Lithium-Ion Batteries: The production of lithium-ion batteries is one of the most critical applications for dry rooms. Exposure to humidity during manufacturing can cause unwanted chemical reactions, leading to reduced battery efficiency and potential safety issues.Â
Battery Testing and Packaging: Batteries must be tested and packaged in low-humidity environments to ensure they meet safety and performance standards without degradation.
Aerospace and Defense:
Material Storage and Handling: Aerospace components often include materials that are highly sensitive to moisture, such as composite materials and adhesives. Dry rooms are used to store and handle these materials to prevent moisture absorption that can compromise structural integrity.
Equipment Manufacturing: Many aerospace devices, including satellites and sensors, must be assembled in ultra-low humidity environments to ensure they function reliably in the harsh conditions of space.
Food and Beverage:
Powdered Products: Foods sold in powdered form, like milk powder and coffee, often require dry rooms during the packaging process to prevent clumping and microbial growth induced by moisture.
Dry Rooms vs. Cleanrooms: What’s the Difference?Â
Both dry rooms and cleanrooms are controlled environments designed to minimize specific environmental variables that otherwise compromise the quality or functionality of sensitive products.Â
Despite their similar purpose, they serve distinctly different functions and are designed with varying priorities in mind:
Humidity vs. Particulate Control | The primary focus of a dry room is to control humidity levels. Cleanrooms primarily focus on minimizing particulate contamination in the environment. They are classified based on the number and size of particles permitted per volume of air.
Implications for Design | The design of a dry room involves selecting materials and constructing barriers that prevent any form of moisture ingress, including specialized dehumidification systems and sealed constructions. In cleanrooms, the design focuses on smooth, cleanable surfaces, laminar air flow, and sophisticated air filtration systems that remove contaminants from the air.Â
Use and Applications | Dry rooms are essential in industries where even minimal moisture can cause significant product degradation, such as in lithium-ion battery manufacturing. Cleanrooms are indispensable in the production of semiconductors and any other environment where the presence of microscopic particles can result in defective products.
Partner with Angstrom for Expert Dry Room Solutions
Whether you’re venturing into the electronic or battery production sectors or any other industry where moisture control is crucial, partnering with Angstrom can assure you that your dry room environment is optimized for your specific needs.Â
Our team of experts is not only skilled in the latest dry room technologies but also brings a deep understanding of regulatory standards and practical applications to each project. Reach out to discuss how we can enhance your manufacturing processes through state-of-the-art dry room solutions.
Your Answers to Frequently Asked Questions About Cleanroom Classifications
Cleanroom classification can be one of the most confusing parts of designing and building your cleanroom – but it’s also usually the most important aspect. Every type of cleanroom requires a different classification depending on your industry and purpose.Â
So, if you’re new to the world of cleanrooms and have questions regarding classifications, we’re here to help. Here are answers to some of the most common cleanroom classification questions we receive.
10 Cleanroom Classifications FAQs
If you’ve got cleanroom questions, you’re in the right place. We’ll explore what type of cleanroom classification you need, inspection requirements, design needs, and more!Â
1. What cleanroom classification do I need?
Your required cleanroom classifications and standards will depend on your industry. The requirements will vary depending on what size particles need to be filtered, the sources of contamination present, and the recommended air change rate.Â
If your industry is government-regulated, you can check applicable regulations for the required classification. If there is no government-mandated or industry default classification, you’ll need to determine the appropriate classification based on your application, and we can help with that.
The ISO classification system has eight classes and defines the level of cleanliness based on the concentration of airborne particles. Here’s a breakdown of the eight ISO classes from least controlled (ISO Class 8) to most controlled (ISO Class 1):
ISO Class 8: This class allows the highest concentration of airborne particles. The maximum allowable particle count is 3,520,000 particles per cubic meter of air (0.5 micrometers and larger in size).
ISO Class 7: The maximum allowable particle count is 352,000 particles per cubic meter of air (0.5 micrometers and larger).Â
ISO Class 6: The maximum allowable particle count is 35,200 particles per cubic meter of air (0.5 micrometers and larger).
ISO Class 5: The maximum allowable particle count is 3,520 particles per cubic meter of air (0.5 micrometers and larger).
ISO Class 4: The maximum allowable particle count is 352 particles per cubic meter of air (0.5 micrometers and larger).Â
ISO Class 3: The maximum allowable particle count is 35 particles per cubic meter of air (0.5 micrometers and larger).
ISO Class 2: The maximum allowable particle count is 7 particles per cubic meter of air (0.5 micrometers and larger).Â
ISO Class 1: The most stringent of all, ISO Class 1 cleanrooms allow only one particle per cubic meter of air (0.5 micrometers and larger).
4. How often do I need to test my cleanroom to see if it’s meeting classification requirements?
ISO classifications require that air pressure difference and flow be tested every 12 months. Particle count tests must be performed every 12 months for ISO Class 6 and above and every six months for ISO Class 5 and below.Â
There are also tests recommended for all classes every 24 months: installed filter leakage, containment filter leakage, recovery, and airflow visualization. These tests are regulated by ISO document 14644-2 Cleanroom Testing and Compliance.
5. How often do I need to have my cleanroom inspected?
How often you need your cleanroom inspected depends on your classification. The more stringent classifications will require inspection more often. Inspection may coincide with compliance testing, which may occur every six or 12 months, depending upon the cleanroom classification.
6. How does cleanroom classification affect my budget?
The more stringent the classification, the greater the cost of the cleanroom. Strict classifications require more air, energy, advanced technology, and equipment. For a more detailed breakdown of the costs, see How Does Cleanroom Classification Affect Your Cleanroom Budget?
7. Can I redesign my cleanroom if my required classifications change?
Yes, of course! Every company is bound to evolve, and our cleanrooms can change right along with them. All Angstrom cleanrooms are modular, meaning they can be expanded or decreased in size, components can be added or removed, and any other design changes can be made.
8. Can I replace a major cleanroom component if need be?
Yes, the Angstrom team would be happy to help you with that. We offer all necessary cleanroom components and can help you replace them quickly and easily.
9. Do I need a permit to build a cleanroom?Â
In most cases, small cleanrooms built within a plant or any pre-existing structure usually do not require a permit. However, verifying this with your local building codes department is crucial before construction.Â
Larger cleanrooms might require a permit under specific circumstances. Our team of seasoned cleanroom professionals can offer guidance on whether a permit is required and assist you in liaising with local building code officials.
10. Are hardwall cleanrooms or softwall cleanrooms more clean?
Both hardwall and softwall cleanrooms can be built to meet the same air-change-per-hour standards. However, hardwall cleanrooms typically offer a more complete barrier to particle intrusion and better control over atmospheric temperature and humidity.Â
Softwall cleanrooms generally have a perimeter air gap to maintain very little positive pressure and no negative pressure differentials. Hardwall cleanrooms can hold a significant positive pressure, which prevents particulate intrusion.
Expert Cleanroom Services From Angstrom
At Angstrom, we aim to redefine excellence in cleanroom solutions, setting the industry standard for innovation, quality, and customer-centricity. If you have more questions about your cleanroom classifications or just cleanrooms in general, we’d love to chat! Request a quote today for all your cleanroom needs.Â
ISO-certified cleanrooms are the backbone of industries where precision, quality, and contamination control are paramount. These highly controlled environments play a crucial role in sectors ranging from pharmaceuticals to forensic science, battery manufacturing, and more.Â
At Angstrom, we understand the critical importance of ISO certification in cleanrooms. Let’s explore the essential features that every ISO cleanroom must have to ensure products and operations meet the designated quality standards.Â
10 Key Features of Every Certified ISO Cleanroom
Incorporating these ten features into every cleanroom ensures compliance with ISO cleanroom standards and a top-of-the-line controlled environment.
1. Documentation & Compliance
Detailed documentation is the cornerstone of every ISO-certified cleanroom. It outlines specific procedures, maintenance logs, and audit records, all of which are crucial for ensuring compliance with ISO cleanroom standards.Â
Meticulous documentation not only facilitates traceability but also plays a vital role in quality assurance, guaranteeing that every aspect of the cleanroom meets the stringent requirements set forth by ISO.
2. Environmental Monitoring Systems
Real-time monitoring systems help maintain the pristine conditions of ISO-certified cleanrooms. These systems continuously track temperature, humidity levels, and particle counts, providing valuable data for optimizing environmental parameters. Control systems integrated with monitoring enable swift responses to deviations, ensuring the cleanroom environment remains at its peak performance.
3. Quality Cleanroom Design and Construction
The design and construction of an ISO-certified cleanroom require in-depth attention to detail. Seamless wall and ceiling surfaces are essential to minimize particle generation, while proper sealing and high-quality construction materials prevent external contamination.
4. Air Filtration and Quality Control
HEPA filters are vital for ISO cleanrooms. They remove airborne particles to maintain exceptional air quality in the controlled environment. Regular maintenance and timely filter replacements are imperative for optimal performance and ensure the cleanroom’s air remains contaminant-free.
5. Personnel Protection and Hygiene
Personnel working in cleanrooms must adhere to strict protection and hygiene protocols. Cleanroom garments such as gowns, gloves, and shoe covers are required to act as barriers against personnel contamination.Â
Proper training on hygiene practices is equally crucial, emphasizing the importance of maintaining cleanliness standards to uphold the integrity of the cleanroom environment.
6. Contamination-Resistant Equipment and Furniture
Contamination-resistant equipment and furniture are non-negotiable in cleanroom environments. For example, stainless steel surfaces are preferred for cleanroom furniture, ensuring minimal particle shedding and easy cleaning.
7. Controlled Access and Entry Protocols
Access control, including airlocks and entry protocols, is implemented in cleanrooms to minimize contamination risks. Personnel training is pivotal to ensure strict adherence to entry and exit procedures, reducing the likelihood of introducing contaminants into the cleanroom environment.
8. Cleaning and Maintenance Practices
Effective cleaning and maintenance practices are essential for preserving the cleanliness of ISO-certified cleanrooms. Routine cleaning schedules, appropriate cleaning materials, and techniques tailored for contamination control are key for upholding the cleanroom’s sterile conditions.
9. Emergency Response and Contingency Planning
Detailed emergency response plans are critical components of certified cleanrooms. These plans should outline contingency measures to address potential risks such as power outages, equipment failures, or other emergencies. By having proactive contingency plans in place, cleanroom facilities can mitigate contamination risks effectively.
10. Training and Certification Programs
Regular training programs for cleanroom personnel are required to maintain protocols for hygiene practices, gowning procedures, and contamination prevention. Certification programs ensure strict adherence to cleanroom standards, boosting the overall effectiveness of ISO-certified cleanrooms in meeting industry requirements.
Partner with Angstrom for Industry-Leading Cleanroom Solutions
At Angstrom, we specialize in crafting cleanrooms tailored to every industry’s unique needs. Whether you’re in pharmaceuticals, electronics manufacturing, or any other sector requiring stringent cleanliness standards, our cleanroom turnkey services ensure that your facility meets and exceeds ISO requirements.Â
Contact Angstrom today to discover how our expertise can elevate your cleanroom operations and drive excellence in your industry!
