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.
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.
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.
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.
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.
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.
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:
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.
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?
Both dry rooms and cleanrooms are controlled environments designed to minimize specific environmental variables that otherwise compromise the quality or functionality of sensitive products.
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.
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.
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.
WHITEPAPER: DRY ROOM DESIGN GUIDE FOR LITHIUM BATTERY MANUFACTURING
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.
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!
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.
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).
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).
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).
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.
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?
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.
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.
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.
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.
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.
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.
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.
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.
Contact Angstrom today to discover how our expertise can elevate your cleanroom operations and drive excellence in your industry!
