10 Key Features of Certified ISO Cleanrooms

10 Key Features of Certified ISO Cleanrooms

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!

5 New Cleanroom Technology Trends

5 New Cleanroom Technology Trends

In the world of contamination control, cleanroom technology is constantly evolving. Here at Angstrom, we’re dedicated to staying at the forefront of these advancements, continuously updating our knowledge, and incorporating new technologies into our solutions.

This blog explores the latest advancements in cleanroom news, from automation to energy efficiency, and more. Keep reading to discover how these innovations refine contamination control and set new standards for excellence.

5 New Cleanroom Technology Trends

Let’s break down five of the latest technological advancements in cleanroom news. 

1. Automated Operations

Automation is transforming the landscape of cleanroom operations by introducing seamless processes and minimizing manual interventions. This technological advancement leverages robotics, intelligent controls, and other automated systems to optimize efficiency and enhance precision. 

Robotic arms are utilized for intricate handling of sensitive components, ensuring accuracy and minimizing contamination risks. Automated material handling systems streamline logistics, facilitating efficient movement of goods and reducing downtime.

The adoption of automation in cleanrooms brings numerous benefits. Increased efficiency is achieved through faster processes and reduced cycle times, enhancing productivity and cost-effectiveness. Automation also reduces human error, improving product quality. 

2. Data Monitoring Solutions

Real-time data monitoring is critical in cleanroom environments to maintain optimal conditions and promptly identify deviations. By monitoring key metrics in real-time, deviations can be addressed quickly, minimizing contamination risks and ensuring consistent product quality.

Advanced data monitoring technologies, such as sensors and IoT devices, are revolutionizing data collection in cleanrooms. Sensors accurately measure critical parameters like temperature, humidity, and particle levels. IoT devices enable data integration and analysis, facilitating predictive maintenance and continuous improvement initiatives.

3. Dehumidifiers and Desiccant Systems

Cleanrooms demand precise control over environmental conditions, including humidity levels, to maintain optimal operational efficiency and product quality. Excessive humidity can lead to moisture-related issues such as microbial growth, equipment corrosion, and compromised product integrity. Dehumidifiers are crucial to mitigate these risks by effectively regulating humidity levels within cleanrooms, ensuring a controlled and stable environment.

Modern dehumidifiers are designed with energy-conscious features, making them efficient and cost-effective solutions for cleanroom humidity control. These energy-efficient dehumidifiers utilize advanced technologies such as variable-speed compressors, smart humidity sensors, and programmable settings to optimize energy usage while maintaining precise humidity levels. 

At Angstrom, we crafted a state-of-the-art cleanroom with humidity control for Anaphite, a company that creates cathode powders to make Li-ion batteries. Anaphite’s main requirement for the project was achieving the target dewpoint, but they also stipulated they needed to quickly drive the dry room down to specification from a dormant state. Angstrom gave Anaphite the option of three different desiccant systems. After reviewing the performance and energy consumption, Anaphite chose the DT-LDP5 multi-rotor system as it provided an energy reduction of over 33% less when compared to the traditional single-rotor design.

4. Energy-Efficient Technologies

Sustainable practices and energy-efficient technologies are being embraced more than ever in cleanrooms to minimize environmental impact and reduce operational expenses. Examples of energy-efficient technologies in cleanrooms include LED lighting and advanced HVAC systems. 

LED lighting offers energy savings and a longer lifespan than traditional lighting solutions. HVAC systems with smart controls optimize energy usage, maintaining optimal conditions while reducing energy consumption.

5. Sustainable Practices

Cleanroom products increasingly incorporate renewable and plant-based materials, reducing reliance on non-renewable resources and minimizing environmental impact. These sustainable materials offer comparable performance while reducing carbon footprint and promoting a greener cleanroom ecosystem.

Many cleanroom equipment manufacturers are utilizing recycled plastics in their product designs. These plastics are sourced from post-consumer or post-industrial waste, reducing the demand for virgin plastics and diverting waste from landfills.

Cleanroom construction materials with low VOC emissions contribute to indoor air quality and environmental health. Choosing paints, adhesives, and sealants with low VOC content minimizes pollution and enhances occupant comfort in cleanroom facilities.

Partner with Angstrom for Cutting-Edge Cleanroom Solutions

Angstrom is a pioneer in cleanroom technology, consistently leading the way with innovative solutions. Whether you require advanced automation, precise data monitoring, energy-efficient designs, or sustainable practices, Angstrom is your trusted partner for all cleanroom needs. 

With our expertise and commitment to excellence, we ensure that your cleanroom operations meet the highest standards of quality, efficiency, and environmental responsibility. Partner with Angstrom today and experience the difference in contamination control and cleanroom technology.

 

What is the Difference Between a Controlled Environment and a Cleanroom?

What is the Difference Between a Controlled Environment and a Cleanroom?

The words cleanroom and controlled environment are often used interchangeably when talking about environment control in critical spaces. But what is a cleanroom? What is a controlled environment? There is a difference, and that difference is crucial. When it comes to controlled environments vs. cleanrooms, here’s what you need to know:

Controlled Environments vs. Cleanrooms

What Is a Controlled Environment?

A controlled environment, or critical environment, is an area that must have specific parameters controlled. The parameters include pressure, temperature, and segregation. Many laboratories are considered controlled environments, as they have controlled temperature and pressure and are separated from other operations, such as manufacturing or shipping. Unlike cleanrooms, controlled environments do not necessarily have to meet certain standards for particle contamination.

Common Applications for Controlled Environments:

  • Life science laboratories
  • Engineering laboratories
  • Laser labs
  • High-energy physics facilities
  • Hospitals
  • Cannabis grow rooms
  • Clean manufacturing
  • Food processing rooms
  • Pharmacies
  • Quality labs

What Is a Cleanroom?

A cleanroom is a type of controlled environment with much more stringent requirements. Cleanrooms require temperature and pressure control, as well as separation from the outside environment and other operations. 

All the requirements of cleanrooms are regulated and must meet designated standards. Cleanrooms are classified by the maximum acceptable number of particles (by size) in the air per cubic meter, and must be regularly tested to ensure compliance with that standard (see more about cleanroom classifications here). Compared to standard controlled environments, cleanrooms may require more energy, air, and advanced technology to maintain the cleanroom conditions.

Common Applications for Cleanrooms:

  • Semiconductor manufacturing
  • Pharmaceutical manufacturing
  • Research and development 
  • Laser and optics 
  • Electronics manufacturing 
  • Medical device manufacturing 
  • Precision industrial manufacturing 
  • Aerospace 
  • Mask manufacturing
  • 3D printing 
  • Nutraceutical cleanroom
  • Food processing/bottling

Do I Need a Cleanroom or a Controlled Environment? 

The answer to this question depends on two factors: your application and your industry. If packaging medical devices, you’ll need an ISO class 7 compliant cleanroom or higher. If you have a process control laboratory for a chrome plating company, you aren’t required to meet a specific ISO classification, but you need to control the environment. 

You may even have different needs within your facility; you may need a controlled environment for sensitive materials that don’t need to meet cleanroom standards but also require an ISO class 8 cleanroom for quality control testing.

When building and designing a cleanroom, contractors consider various factors to determine the necessary construction materials and regulating equipment. To ensure the facility is accurately equipped and meets standards, the contractor will consider the following: 

  • Required ISO class FDA regulations
  • Types and placement of HEPA or ULPA filters
  • Environmental conditions 
  • HVAC requirements
  • Spatial specifications
  • Construction materials
  • Air showers
  • Pass-thru units
  • Fire protection
  • Light and air supply
  • Electrical and plumbing requirements
  • Equipment hookups and special equipment

Partner with Angstrom Technology for Expert Guidance

Understanding the difference between controlled environments and cleanrooms is pivotal in determining the appropriate solution for your specific requirements and industry standards. 

With over 30 years of industry experience, we offer unparalleled expertise and a comprehensive portfolio to meet your cleanroom needs. From conceptualization to installation and ongoing support, our commitment to excellence ensures a seamless journey toward achieving your cleanroom objectives. 

Contact the Angstrom team today for all your cleanroom needs!

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How Can I Control Cleanroom Humidity?

How Can I Control Cleanroom Humidity?

Maintaining optimal humidity levels in your cleanroom is paramount to meeting regulatory standards and safeguarding the quality of your processes and products. 

In this blog, we’ll explore the importance of cleanroom humidity control and provide insights and strategies to ensure your cleanroom operates at peak efficiency.

Understanding Cleanroom Humidity

Cleanroom humidity plays a crucial role in various industries, from semiconductor manufacturing to pharmaceutical production. If the humidity is too high, bacterial growth can flourish, metal products or equipment can corrode, photolithographic degradation can occur, and condensation and water absorption can occur. This can cause issues for processes with moisture-sensitive products, like semiconductor manufacturers.

If the humidity is too low, static buildup and discharge can become an issue, possibly causing shorts for products in electronics cleanrooms. Plus, poorly controlled humidity can make working conditions uncomfortable for your employees. Therefore, it’s essential to strike the right balance to mitigate these risks effectively.

What Factors Impact Cleanroom Humidity?

Various factors influence cleanroom humidity levels, each critical in achieving optimal conditions.

Factors impacting cleanroom humidity include:

  • Temperature: Lower temperatures reduce relative humidity, while higher temperatures can increase it. Maintaining precise temperature control is vital for regulating humidity levels.
  • Airflow: Proper airflow distribution helps to prevent moisture buildup and ensures uniform humidity throughout the cleanroom.
  • External Environmental Conditions: Factors such as outdoor humidity, weather changes, and nearby sources of moisture can impact cleanroom humidity levels. Monitoring and adjusting for these external conditions are necessary for consistent humidity control.

3 Methods for Controlling Cleanroom Humidity Levels

So, what are some of the methods you can use to control humidity in your cleanroom? The experts at Angstrom Technology are here to answer that question.

1. Air Conditioning and Mechanical Refrigeration

Humidity is relative, meaning that the lower the temperature is, the lower the relative humidity is. So it only makes sense then that lowering a cleanroom’s temperature will decrease humidity. 

When using air conditioning systems to dehumidify a space, the system reduces the temperature of a surface within the condenser unit to a temperature below the dew point of the airstream in the cleanroom. That surface is then exposed to the airstream in the cleanroom and the water vapor in the airstream condenses, subsequently dehumidifying the space. The air must be re-heated to the desired room temperature and piped back into the cleanroom.

2. Desiccants

Desiccant systems draw air through a desiccant medium, which absorbs moisture. The dehumidified air is then routed to the cleanroom. Consumer-grade desiccant systems collect condensate in a receptacle that must be emptied. 

On the other hand, commercial systems exhaust humid air through the ductwork out of the building. Vented systems can dehumidify to lower relative humidity levels at lower temperatures.

These systems are not mutually exclusive. In fact, where temperature control is also important, they work best when used in conjunction. Using a desiccant system in addition to air conditioning can also help reduce the load on the HVAC system, saving energy, wear and tear on the HVAC system, and, of course, money.

3. An Integrated Approach

An integrated approach to humidity control combines air conditioning with desiccant systems to comprehensively regulate temperature and moisture levels within the cleanroom environment. By integrating these systems, businesses can effectively address both temperature and humidity concerns, ensuring optimal conditions for processes and product integrity. 

This approach not only enhances energy efficiency by optimizing the utilization of both systems but also extends the lifespan of the HVAC system by reducing its workload and minimizing wear and tear on components. Consequently, businesses can benefit from lower maintenance costs and prolonged equipment longevity. 

Moreover, the integrated approach optimizes cleanroom performance by maintaining precise and consistent control of humidity levels, safeguarding sensitive processes and products. This strategy offers operational flexibility by providing redundancy in humidity control mechanisms, minimizing downtime and disruptions in cleanroom operations. 

Angstrom Technology: Your Cleanroom Solution Partner

At Angstrom Technology, we specialize in state-of-the-art cleanrooms tailored to your specific needs. Our expertise ensures compliance with ISO classifications and international standards, guaranteeing cleanroom integrity and performance. By implementing advanced humidity control methods and partnering with us, you can ensure optimal cleanroom performance and regulatory compliance.

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Whether you’re embarking on a new cleanroom project or upgrading an existing facility, Angstrom Technology is your trusted partner. Contact us today to discuss your requirements and discover how we can elevate your cleanroom operations.

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What’s the Difference Between Horizontal vs. Vertical Laminar Flow Hoods?

What’s the Difference Between Horizontal vs. Vertical Laminar Flow Hoods?

Laminar flow hoods play a crucial role in minimizing contamination for sensitive products. In this blog, we’ll compare horizontal vs. vertical laminar flow hoods, providing insights into their configurations, pros, and cons. 

Whether you’re working with IV solutions, tissue culture, optics, or microelectronics, understanding these flow hoods is key to a contaminant-free workspace. Join us as we navigate the differences to help you make informed decisions for your cleanroom requirements.

Understanding Laminar Airflow and Its Crucial Role in Cleanrooms

Laminar airflow is air that constantly moves at the same speed in the same direction. In cleanrooms, a vertical laminar flow room is an enclosure where 100% of the ceiling provides filtered air downwards from the ceiling. Because of the 100% filter coverage, it creates an ultra-clean environment. But it’s much easier to achieve laminar flow in a smaller space, as equipment, personnel, and movement in a room cause turbulence that disturbs airflow.

A laminar flow hood is a device or enclosure commonly used as an ultra-clean workbench in laboratory applications. Filtered air sweeps particles in a uniform speed and direction from the hood’s most treated area (the filter) to its exit area.

Cleanroom airflow uniformity and laminar flow hoods are essential to ensuring that sensitive products placed under the hood are always upstream and, therefore, suffer little to no contamination. 

Horizontal vs. Vertical Laminar Flow Hoods

Flow hoods come in two configurations: horizontal and vertical. Both designs provide an effective sweeping action through the work zone and meet ISO Class 5 cleanliness standards. Your application and needs will help determine which is better for your facility.

laminar flow hood

Horizontal Laminar Flow Hoods

As their name indicates, horizontal laminar flow hoods direct air horizontally. Air is pushed through a HEPA or ULPA filter positioned on the back wall and moves forward across the work surface until it exits the enclosure.

By sweeping the air across the work surface and towards the operator, horizontal laminar flow hoods provide the highest protection from contaminating particles. No turbulence is caused by vertical air striking a perpendicular surface or the hands of the operator since they’re always further downstream than the materials they are working on.

However, the hood’s size, the filter’s positioning, and the airflow’s direction can also result in some negative consequences. Below you’ll find a helpful list of pros and cons for these types of hoods:

Pros

  • Low turbulence on the work surface due to air flowing parallel to the work surface
  • Easy to position products and materials close to the filter on the work surface
  • Little contamination from hands or gloves due to the operator being downstream from products and materials

Cons

  • Requires hood repositioning to gain rear access for filter changes and servicing
  • Objects can obstruct the flow and contaminate anything downstream
  • Operators could suffer from fume or powder contaminants blowing at them if they don’t use the sash correctly

Vertical Laminar Flow Hoods

In contrast, vertical laminar flow hoods take air from above the unit, push it through the HEPA or ULPA filter, and then direct it down onto the work surface, where it eventually disperses and exits the enclosure out of a front access area. They resemble the model of a laminar flow cleanroom with fan filter units on the ceiling, just on a much smaller scale.

Vertical laminar flow hoods are popular because of their size, layout, and operator safety. Since the filter is at the top of the unit rather than behind, these flow hoods require less floor space but can be taller to fit larger products and materials. Also, since the laminar air isn’t blowing toward the operator, they are less likely to suffer any contaminants.

Vertical laminar flow hoods are an excellent choice for many applications, including handling sterile, non-hazardous drug compounding in research labs, pharmacies, and microbiology. Here’s a quick overview of their pros and cons:

Pros

  • Require less floor space
  • Increased operator safety
  • Easy access to filter changes and servicing
  • Less cross-contamination of items on the work surface due to no parallel airflow
  • A taller system that can accommodate tall and large products and materials

Cons

  • May require overhead clearance for changing and servicing the filter
  • Increased work surface turbulence due to vertical air hitting a perpendicular surface
  • Products and materials could obstruct airflow when stacked

Which Laminar Flow Hood Is Right for Your Application?

Both horizontal and vertical laminar flow hoods can be utilized for many applications involving sensitive products and materials, including (but not limited to):

  • Injectable drugs
  • IV solutions
  • Tissue culture
  • Optics
  • Microelectronics

While both types of flow hoods are optimal for reducing contamination in a workspace, a few applications lend themselves more toward one or the other. Usually, the most important factors to consider include process location, clearance requirements, size of materials, work surface design, and operator safety.

That said, horizontal laminar flow hoods generally work best for applications that require minimal turbulence on the work surface and the highest level of object contamination control. If your application’s process is performed above the work surface, a vertical airflow configuration may be ideal; particles inside a vertical unit settle at the bottom of the work surface before exiting the enclosure. Vertical hoods are also a popular choice for any applications involving materials that could be especially large or dangerous to the operator.

Contact the Cleanroom Experts at Angstrom Technology

If your cleanroom requires laminar flow hoods, Angstrom Technology can design a cleanroom that will seamlessly meet your classification and industry requirements. Our experienced design engineers are ready to collaborate with you to create a tailored solution that ensures optimal performance and adherence to industry standards. Contact us today to initiate the conversation and enhance the efficiency of your cleanroom environment.