Understanding Biological Safety Levels

Understanding Biological Safety Levels

In any cleanroom application, safety is top priority — for the benefit of both operators and end consumers. In order to ensure the safety of all, various industry authorities have created guidelines for cleanliness and protection.  When it comes to applications that require working with potentially hazardous biological microorganisms, the Centers for Disease Control and Prevention (CDC) have established the leading regulations: biological safety levels (BSLs). Let’s explore more about what BSLs are, and how they may be applied in your cleanroom. 

What Are Biological Safety Levels? 

BSLs are sets of biocontainment precautions required to isolate potentially hazardous biological microorganisms in enclosed, controlled environments. They’re intended to ensure operator safety by outlining recommendations for safe operating procedures and atmospheric controls. BSL protocols are used everyday in a number of industries and applications, from medical, to microbiology, to environmental testing. 

The Four Biological Safety Levels

The CDC has proposed four BSLs, each of which is associated with a varying degree of danger, and a set of appropriate operational protocols. These levels range from Biosafety Level 1 (least hazardous) to Biosafety Level 4 (most hazardous). Below, we’ll explain the basics of BSL 1, 2, 3, and 4. 

BSL-1

BSL-1 requires a basic level of protection against agents that aren’t known to cause disease in healthy, non-immunocompromised humans. This could include non-pathogenic and non-infectious bacteria like E.coli. Usually, there are doors that separate a BSL-1 lab from the rest of the facility, but within those doors, operators can do open-bench work with just the most standard regulations in place: personal protective equipment (PPE), hand washing, and decontamination of work surfaces after use. 

BSL-2

BSL-2 requires a level of protection appropriate for handling moderate-risk agents, known to cause varying degrees of disease in humans. This could include the microbial organisms like Staphylococcus aureus or Salmonella. A BSL-2 cleanroom is restricted from the rest of the facility behind self-closing doors, and features various biological safety cabinets (BSCs) to perform procedures safely in. Operators are required to wear additional PPE, including a face shield, and follow each of the standard cleanliness regulations as in BSL-1. 

BSL-3

BSL-3 requires protection against “exotic” airborne microbial agents that are known to sometimes cause fatal reactions in humans post-ingestion. An example of one of these agents is Mycobacterium tuberculosis. Because of the potentially deadly nature of these microbes, BSL-3 cleanrooms require even more enhanced protection protocols, including:

  • The lab must be restricted behind two sets of doors.
  • Operators must be immunized and wear PPE, plus respirators. 
  • All work must be performed in a BSC. 
  • Filtered room air must be exhausted appropriately. 

BSL-4

BSL-4 requires the maximum amount of preventative measures and protection. It’s recommended in labs that handle agents that have a high risk of airborne transmission and are frequently fatal for humans. Often, this includes microbial agents that we don’t yet have a treatment for, such as Ebolavirus. BSL-4 necessitates that operator and environmental protection is at its highest level, meaning the following protocols are in place:

  • The lab is located in a completely separate building. 
  • Operators must wear PPE, including a full-body, positive-pressure cleanroom suit. 
  • Operators must shower after exiting the lab. 
  • All work must be performed in a Class III BSC. 
  • All material must be decontaminated before exiting the lab. 

Biological Safety Levels vs. ISO Classifications: What’s the Difference?

While BSLs and ISO classifications are both withheld in cleanroom environments, there isn’t much correlation between them because they deal with different issues: protection of operators from biological exposure vs. protection of sensitive product materials from contaminant exposure. That being said, BSLs work in tandem with ISO classifications, with most requiring ISO Class 7 cleanrooms with separate gowning and degowning rooms. It’s best to have a conversation with your cleanroom manufacturer to get a sense of how to accommodate both needs and keep your operators, products, and environment safe all at once.  Maintaining a controlled, biosafe environment is critical for many environmental and medical cleanroom applications. If you need a cleanroom that’s designed to meet specific design or cleanliness requirements, contact Angstrom Technology. Our team of experts is happy to help you build the solution you’re looking for. 

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Medical Cleanroom Terminology: What Are Hoods?

Medical Cleanroom Terminology: What Are Hoods?

Many cleanrooms require the implementation of additional features in order to perform their specific application safely and efficiently. One of the most common additions is a cleanroom hood. Below, we’ll outline the basics of what a cleanroom hood is, what it’s used for, and how it can be maintained for maximum efficiency and durability. 

What Are Cleanroom Hoods?

Cleanroom hoods (also called laminar flow hoods) are enclosures designed to guide filtered air in a uniform speed and direction, all in an effort to prevent contaminant particles from building up on the work surface, and to protect the product and operator. They can come in the form of workstations, work benches, and cabinets. 

Cleanroom hoods work in a circulatory process, pushing treated air from the fan filter unit to flow across the work surface until it reaches the enclosure’s exit area where it’s treated and circulated again. This ensures that any sensitive materials placed on the hood’s work surface are always upstream and suffer little to no contamination. 

Types of Cleanroom Hoods

There are two types of laminar flow hoods: horizontal and vertical. As their names suggest, each of them either blows air horizontally or vertically in relation to the hood’s work surface, and there’s some debate in the industry over which method is best. 

Horizontal laminar flow hoods direct air horizontally, or parallel across the work surface. This system helps reduce the amount of turbulence (random air movement) drastically, offering sensitive materials maximum protection from contaminants. 

Vertical laminar flow hoods direct air vertically, or perpendicular to the hood’s work surface. They resemble the design and operation of a laminar flow cleanroom, where air is treated through a fan filter at the top of the enclosure, then pushed downwards — just on a much smaller scale. The vertical flow of air is especially good at preventing any harmful particles from being blown at the operator. 

Cleanroom Hood Components

No matter if they’re horizontal or vertical flow, all cleanroom hoods have the same basic components. If you’re planning on using a hood for your cleanroom application, it’s important to be comfortable with each of the parts and their functions. 

  • Sash – Located on the face of the hood, this is a transparent panel that shields internal materials from the outside environment, while also providing some protection to the outside environment and operator. 
  • Airfoil – Usually located at the bottom front of the hood, this is a vent that allows room air to enter the hood enclosure. It helps prevent vapors from escaping and air imbalances in the workspace. 
  • Baffle – Usually located on the hood’s ceiling, this is an adjustable partition that affects air force and direction within the enclosure. It works to ensure laminarity (uniformity) by controlling pressure in airflow. 
  • Fan filter unit – This is the component that’s primarily responsible for the hood’s clean environment by filtering particles and maintaining consistent air change rates. For horizontal laminar flow hoods, this is located at the back of the enclosure. For vertical laminar flow hoods, this is located on top of the enclosure. 
  • Plenum – This is the space underneath the work surface or behind the hood walls that balances and distributes air. Air usually enters the plenum from the airfoils and is pushed to the air filter before re-entering the enclosure. 
  • Duct – This is an exhaust passage that’s used to transport contaminated air out of the hood’s clean environment — either into another room or outside of the building completely. 
  • Gauges – These are meters that continuously monitor the hood’s air velocity, particle count, and air pressure. 
  • Work surface – This is the main space where sensitive materials are placed and processes are carried out within the hood. Depending on which type of hood you have, this could be in front of (horizontal flow hood) or underneath (vertical flow hood) the hood’s fan filter unit. 

Which Cleanroom Applications Require Hoods?

Any process involving highly sensitive materials that can’t be contaminated may be carried out within a cleanroom hood. This includes a number of applications within a number of industries, including (but not limited to): 

How to Clean and Maintain Cleanroom Hoods

Cleaning and maintaining your cleanroom hood is paramount in ensuring its effectiveness for years to come. Typically, certification of the hood is required annually or semi-annually, depending on your industry’s standards. In terms of cleaning, there are three levels of cleanliness that you can achieve: 

  • Sanitized – Removing visible dirt and contaminants on the surface, reducing the amount of germs and chances of infection, illness, and/or contamination. 
  • Disinfected – Eliminating virus, bacteria, and fungi from the work surface with a cleaning agent. 
  • Sterilized – Completely eliminating any microorganisms and contaminants from the work surface, usually by means of chemicals, heat, and/or pressure. 

 

Angstrom Technology’s modular cleanrooms can be customized to meet the needs of your application. If your application requires special equipment like cleanroom hoods, get in touch with our team of design engineers. We’ll help explain the process and design a controlled space that accommodates all of your requests. 

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How Much Does a Plastics Industry Cleanroom Cost?

How Much Does a Plastics Industry Cleanroom Cost?

In the plastics industry, quality is critical. No matter which industrial application you’re manufacturing for, a controlled cleanroom environment is critical for the efficient production of safe, durable, reliable plastic products. But with all that emphasis on quality and cleanliness, you may be left wondering, how much is all of this going to cost me? 

In this article, we’ll explore the answer to that question. After we discuss what a plastics industry cleanroom consists of, we can discover how much one may cost you, depending on your unique specifications. 

What Is a Plastics Industry Cleanroom?

Plastics industry cleanrooms are used for researching, developing, and assembling plastic components in a controlled, clean environment. Plastic products can be used for a number of industrial applications, so their cleanrooms vary in stringency based on that. For example, if your plastic components are used to make medical devices, you’ll need much more cleanliness regulation than another facility that uses plastic components to make furniture. 

Regardless of the application, there is still some amount of regulation for each of them. This helps ensure the quality of end products and the safety of operators throughout various methods of plastic manufacturing, including:

  • Injection molding – Melted plastic is injected into a set mold, fills the shape, and cools to permanent form. 
  • Extrusion molding – Melted plastic is pushed through a die, then cools in the desired shape. 
  • Rotational molding – Plastic powder is placed into a mold, then rotated until the plastic creates an outer layer with a hollow interior. 
  • Blow molding – Air pressure is used to shape melted plastic around a pre-shaped hollow plastic piece, which creates a cavity where the plastic has expanded around it. 

Changes in temperature, humidity, pressure, or static during any of these processes can result in product defects and failures — potentially wasting your facility’s time and money or putting end consumers at risk of harm. A plastics industry cleanroom mitigates that risk by controlling all the environmental factors you need, to the amount you need them. 

How Much Does a Plastics Industry Cleanroom Cost? 

All that being said, it’s apparent that a plastics industry cleanroom could look like a lot of different things — and the same goes for the cost of that cleanroom. Because of this variation, it can be difficult to get a sense of what your cleanroom may cost before you outline your specific needs to an expert manufacturer. However, there are some key considerations that you can look at to give you a general guideline:

ISO Classification

Plastics industry cleanrooms are regulated by standards created by the International Standards Organization (ISO) — specifically by the ISO 146441-1 standard, which provides the particle count, air change rate, and ceiling coverage requirements for all cleanroom environments. ISO 146441-1 is split into nine separate classes, with 1 being the most filtered air, and 9 being equivalent to regular room air. Most plastics industry cleanrooms require an ISO Class of 7 or 8, but some applications that are more sensitive to contamination may bump requirements up to Class 5 or 6. 

How does this relate to the cost of your cleanroom? The general rule is, the more stringent your cleanroom is, the more equipment it usually requires, and the more it will cost you. 

Type

Another factor that determines your cleanroom cost is your choice between these three types of cleanrooms, which is heavily based on which ISO requirements you need to meet: 

  • SoftWall – Meets ISO Class 5-8 requirements, and is completely versatile and customizable to fit whatever space is needed. 
  • HardWall – Offers the highest level of control over the environment, and can uphold even the most stringent ISO Class 1 requirements. 
  • RigidWall – Meets ISO Class 5-8 requirements, and features a modern, transparent panel design. 

 

In most cases, SoftWall cleanrooms are the most affordable cleanroom option, and you’ll pay extra for the additional structure, control, or design benefits of HardWall and RigidWall types. 

Size

As you can probably imagine, size is the most easily understood factor to account for in terms of cleanroom cost. Simply put, the bigger your cleanroom is, the more expensive it will be. Cleanroom manufacturers usually account for the biggest piece of equipment (in terms of both width and height) that will be stored in it to determine your ideal sizing. 

Design Complexity and Additional Features

The least expensive cleanrooms have basic layouts and no additional features or technologies. However, for many plastics industry applications, this just isn’t feasible. From added equipment, process piping, furniture, static control, access controls, and even attached gowning rooms, your cleanroom will likely need to accommodate specific design complexities that come at an additional cost. 

Get the Most Out of Your Cleanroom at Angstrom Technology

All this being said, it’s important to get the cleanroom you need in order to manufacture, test, assemble, or package products safely and effectively. Budget is an important consideration in the design process, but you need to be sure to make a budget that accommodates all your needs — otherwise, you’ll end up wasting on a space that doesn’t work for you. 

Trying to save on the costs of your cleanroom? Contact one of our experts at Angstrom Technology! Our team of experts will create custom designs to your exact specifications — both for your cleanroom classification and your budget. 

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Understanding the Value of Modular Cleanrooms

Understanding the Value of Modular Cleanrooms

At Angstrom Technology, we like to take a step back every once in a while, taking the time to acknowledge and appreciate the impact of our work in various industries. It helps us put our work into perspective, and it motivates us to deliver excellence each and every day.

As we’ve reflected throughout the past years, we’ve always been astonished at how much innovation happens within modular cleanrooms. These quickly built, easily modified, heavily treated chambers truly make groundbreaking work possible. As a resource that helps scientists, and engineers test, manufacture, and package products safely, cleanrooms bring tremendous value not only to the workforce, but to society as a whole. 

In this article, we’ll explore some amazing ways that various industries have used modular cleanroom technology to trailblaze a path of innovation.

The Value Modular Cleanrooms Bring to Various Industrial Applications

Modular cleanrooms have proven themselves to be beneficial for a number of applications, in a number of industries. Some of history’s most important inventions required cleanrooms’ quality control, and some of the future’s best and brightest innovations are being tested in them today. Below, let’s discuss some common industries that use cleanrooms, and what important things they’re using them for. 

Aerospace

Aerospace cleanrooms are crucial for the development of aircraft and spacecraft hardware, fine electronics, engine components, and more. In order to manufacture, assemble, and test those components, the aerospace industry needs a high level of control over the cleanroom environment — usually meeting an ISO Class 7 requirement, at minimum.

Each day, aerospace engineers are working hard to develop technologies that help us continue our journey of exploring the unknown. Modular cleanrooms give them the space they need to do that revolutionary work. 

Semiconductor

Semiconductor cleanrooms prevent particles from contaminating certain parts of nanotechnology — like semiconductors and microchips — that allow us to operate phones and computers more safely and efficiently. When even the smallest bit of contamination can lead to serious product issues and failures, a stringent modular cleanroom environment of ISO Class 5 or lower is necessary. 

Our world is reliant on constant technological innovations in order to stay connected, do business, and maintain a quality lifestyle. Modular cleanrooms will always provide a space to make those technological advances happen.

University Labs and Research Facilities

University labs and research facilities encompass a variety of applications, from medical research, to forensic science, to hazardous chemicals. Additionally, the university setting requires that spaces are able to be reassigned and restructured as student, research, and funding needs change throughout the years. Therefore, the versatility of quickly built, easily modified modular cleanrooms is extremely valuable here. 

Universities host some of the most advanced, highly recognized research facilities. Students and faculty are working with state-of-the-art technology to solve some of their industry’s most perplexing problems. A modular cleanroom can provide a controlled environment to foster that learning, no matter what the specific application may be. 

Military 

In regards to the military, weapons manufacturing is a critical component in upholding national security and protecting American citizens. Due to the deadly nature of the products and volatile compounds used in this industry, a controlled cleanroom environment is crucial in maintaining the safety of information, products, and personnel. 

Weapons manufacturing is, and always will be, dangerous. However, it plays a key role in protecting our nation’s infrastructure from devastating threats. Modular cleanrooms can help lessen the risk and bolster the production. 

Angstrom Technology can design a modular cleanroom to meet all your requirements and design considerations. If you’re interested in designing and installing one for your facility, speak with one of our design engineers to get started.

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How to Set Up a Semiconductor Manufacturing Cleanroom

How to Set Up a Semiconductor Manufacturing Cleanroom

Semiconductors are made with a glassy, pure silicon material which is cut into very thin wafers, and they’re responsible for the performance of circuitry in computerized devices. They’re extremely sensitive materials, so without a sterile cleanroom to manufacture them in, you’re risking contamination that could lead to various production issues and product failures. 

All that being said, if your facility manufactures computerized devices of any type, size, or application, it’s likely that you’ll need to install a semiconductor cleanroom. Let’s take a look at what components go into setting one up. 

Where to Start: Understanding the Requirements of a Semiconductor Cleanroom

Even the slightest bit of contamination or settling of particulate produce can ruin semiconductor production and performance, sometimes leading to disastrous consequences. Therefore, it’s important to understand the strict cleanliness standards that semiconductor cleanrooms must abide by. 

Semiconductor Cleanroom Classifications

Semiconductor cleanrooms have some of the most stringent ISO standards. They usually need to comply with ISO 14644-1 Class 5 or lower, which means the maximum amount of particles allowed per cubic meter is 3,520 particles that are 0.5 µm or smaller. They also need to comply with ISO 14644-2, which requires a minimum requirement for quality control and a monitoring plan to consistently ensure these standards and parameters are met.

Semiconductor cleanrooms may also have industry-specific requirements depending on their application, such as unique NASA standards for aerospace applications. In those instances, the industry-specific requirements work in tandem with ISO requirements to build a controlled environment that produces consistently safe and quality products.

Potential Issues Associated with Semiconductor Cleanrooms

When working in a semiconductor cleanroom, operators face a number of challenges regarding detailed processes and contamination control. In fact, human workers are often the main source of contamination during the semiconductor manufacturing process. They can create unwanted electrostatic discharge (ESD) that can compromise the sensitive electronic circuits in the material. 

However, there are a variety of other factors that can disrupt the cleanroom’s sterility, including:

  • Power glitches
  • Pressure malfunctions
  • Broken fans
  • Dropped equipment, tools, and parts
  • Outgassing
  • Static
  • Particulate matter

 

Yes, that’s a lot to keep in mind! But semiconductors are so fragile that even the tiniest speck of dust can ruin them. Luckily, a reliable, controlled cleanroom environment can do most of the work for you. When installed properly, your semiconductor cleanroom can maintain the level of environmental control you need to optimize productivity and profitability. 

Setting Up Your Semiconductor Cleanroom

Now that you understand the cleanliness requirements of your semiconductor cleanroom, it’s time to start setting it up. Below, we’ve outlined four considerations you’ll want to keep in mind during the design process. 

1. Start with Airflow

Air flow is one of the most important components in a semiconductor cleanroom, as it determines how particles travel and prevents them from building up on equipment. The most popular type of airflow in cleanrooms is unidirectional or laminar airflow, which involves air blown at a constant speed, in a straight, unimpeded path. The air is pushed through a filter at the top of the cleanroom, directed down to the floor, then flows through holes in the flooring where it is retreated and recirculated before entering into the cleanroom again. 

2. Consider Furniture and Machinery Placement

It’s also a good idea to map out where your large furniture and machinery will be placed in order to build the most efficient, sterile cleanroom. One of the best design recommendations for a semiconductor cleanroom is to place furniture and machinery along the outer walls. This helps decrease the chance of those large objects obstructing the main airflow. 

Many cleanrooms are also designed with wire racks and shelves instead of regular tables or shelving. This eliminates a portion of the flat surfaces that particles may build up on. 

3. Implement Anti-static Protection

In order to prevent electrostatic discharge (ESD), your semiconductor cleanroom needs to take preventative measures against static. Aside from maintaining a consistently sterilized, pressurized environment, this can also include the implementation of various ESD-free products, including protective clothing, flooring, workstations, tools, and wipes. 

4. Plan for Daily Operations

Your semiconductor cleanroom will be used daily in order to keep production moving. Therefore, it’s important to ensure that all the daily operations are accommodated for. You should know things like how your operators will enter the cleanroom via access control systems, ESD testing, gowning rooms, airlock rooms, air showers, etc. This information can help you set up a design and layout that works around those necessities. 

Not sure where to start when setting up your semiconductor cleanroom? Let the experts at Angstrom Technology help. Our design experts can help you make the tough choices, and ensure you get the cleanroom that’s perfect for your application.

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