What Do the GMP Qualification & Validation Processes Look Like?

What Do the GMP Qualification & Validation Processes Look Like?

by | Jun 27, 2022 | Cleanroom Standards

In order to deem a cleanroom “GMP compliant,” it needs to meet various qualification and validation requirements. For facilities that are new to GMP standards and regulations, these processes can be a bit complicated — but we’re here to help clear things up.

Let’s discuss what the GMP qualification and validation processes entail below.

An Overview of the GMP Qualification & Validation Process

The GMP qualification and validation processes are designed to ensure all components of your cleanroom’s design, installation, operations, and performance are optimized for safe, high-quality, repeatable results. They’re critical steps in protecting the safety of both consumers and cleanroom operators. 

In order to understand the processes in more detail, it’s important to break down the difference between them.

GMP Qualification & Validation: What’s the Difference?

While GMP qualification and GMP validation may sound like the same thing, they’re not. GMP qualification generally comes first, then validation follows soon after. 

GMP Qualification

GMP qualification is the act of proving and documenting that equipment and supplementary systems are installed correctly, operate correctly, and comply with specified requirements. Qualification generally follows these four steps: 

  1. Design Qualification (DQ), which determines if your cleanroom design can meet all regulatory and process requirements. 
  2. Installation Qualification (IQ), which determines if your cleanroom is consistent with specified designs after installation is complete. 
  3. Operational Qualification (OQ), which determines if your cleanroom equipment achieves specified operational requirements. 
  4. Performance/Process Qualification (PQ), which determines if your cleanroom equipment performs well together in a controlled and repeatable manner. 

Here’s where things can get a little tricky. These qualification steps are the first part of validation. However, the steps alone aren’t the only part of validation. There’s a little more to it, which we’ll talk about below. 

GMP Validation

GMP validation is the act of documenting objective evidence that offers a high level of assurance that a specific cleanroom process will consistently deliver products that meet predetermined specifications. It follows these four steps: 

  1. Performance/Process Validation, which is step #4 of the qualification process above.
  2. Cleaning Validation, which ensures that equipment is cleaned regularly and in accordance with specified regulations. 
  3. Method Validation, which ensures that the analytical procedure for a specific task is suitable for intended purposes. 
  4. Computer System Validation, which ensures that any cleanroom software applications meet their intended purposes. 

Side Note: What About cGMP Qualification & Validation?

It’s important to note the difference between GMP and cGMP here. You may have seen “cGMP” during your research and wondered if it’s the same as GMP. It’s similar, but it’s not quite the same. 

GMP requires you to ensure your cleanroom is designed, built, and operable in a way that creates safe and effective products, whereas cGMP requires you to use technologies and systems that are modern and comply with GMP standards. Therefore, while the qualification and validation process for these two systems are similar and can be streamlined together, they are a little different. 

How Long Do the GMP Qualification & Validation Processes Usually Take?

The timeline for GMP qualification and validation can vary greatly depending on the scope of your cleanroom project. It’s usually an extensive amount of work, though, so it’s important to plan accordingly in terms of both the time and resources you’ll need. 

GMP qualification and validation happen in stages, often in accordance with the stages you design and build your cleanroom. Therefore, you can expect the entire process to take somewhere between a couple of months to a year, depending on the duration and complexity of your project. 

Who Is Responsible for Obtaining GMP Qualification & Validation?

You, the facility manager or owner of the cleanroom, are responsible for obtaining GMP qualification and validation for your new cleanroom. 

However, there are plenty of resources available to help you get there — one being a reputable cleanroom manufacturer with GMP experience. While they can’t usually carry out the GMP qualification and validation process for you, they can help you understand it, navigate it, and design, build, and install a cleanroom that meets necessary requirements. 

Design & Build Your GMP Cleanroom With Angstrom Technology

GMP qualification and validation can get confusing, especially if you’re new to the processes. If you’re looking for some help, reach out to our team at Angstrom Technology. We’ll be your guide to designing and installing a cleanroom that’s safe, efficient, and compliant with industry standards.

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Why Do I Need a Cleanroom for Plastic Injection Molding?

Why Do I Need a Cleanroom for Plastic Injection Molding?

by | Jun 20, 2022 | Plastics Industry Cleanroom

Plastic is used for various tools and applications in everyday life. But where do those plastic components come from, and how are they made? Plastic injection molding!

Plastic injection molding is the primary method of manufacturing for most plastic tools, packaging, components, appliances, and more. As most professionals in the industry know, plastic injection molding is a complex process that must be conducted in a controlled environment like a cleanroom. Let’s dive deeper into why. 

What Is Plastic Injection Molding? 

Plastic injection molding is a process used to manufacture a variety of plastic parts and devices. It involves placing molten plastic into a metal mold, then allowing it to cool until a solid structure is formed. It is used for a variety of industrial applications, including (but not limited to): 

  • Medical devices
  • Pharmaceutical packaging
  • Food and beverage packaging
  • Aerospace parts
  • Automotive parts
  • Parts used for the research and development of new products

So why does plastic injection molding need to be done within a cleanroom environment? 

Why Does It Require a Cleanroom?

Well, there are many sensitive applications where contamination can be detrimental to a finished plastic product’s safety and performance. For applications like aerospace and automotive part manufacturing, contamination during the injection molding process could decrease the level of performance. And for applications involving medical devices, food, or other consumables, contamination during the injection molding process could put human lives at risk. 

Therefore, it’s necessary to have a cleanroom that’s designed to reduce the risk of contamination while operators and equipment create these plastic components. Doing so not only ensures great product performance and consumer safety, but also protects you from having to start over and manufacture replacement products — effectively saving you from losses in efficiency and profitability. 

Unique Challenges for Plastic Injection Molding Cleanrooms

The plastic injection molding sector faces a unique set of challenges when it comes to cleanroom design and operations. These challenges are mostly due to the nature of the process and the specific types of equipment used during it. Here are a few of those challenges you’ll want to consider when planning your own injection molding cleanroom:

  • Minimizing contamination from cleanroom personnel
  • Minimizing contamination from cleanroom equipment
  • Accommodating large pieces of injection molding cleanroom equipment, such as mold cranes and mold presses
  • Allowing direct access for overhead mold cranes to enter the cleanroom through ceiling access panels
  • Allowing mold cranes to be grounded outside of the cleanroom at all times (if possible)

How to Design a Safe & Effective Plastic Injection Molding Cleanroom

So how can you design a plastic injection molding cleanroom that operates efficiently and meets all of the criteria above? Here are some tips from our experts:

  • ISO Classification — Most plastic injection molding cleanrooms are ISO Class 7 or 8. However, this can vary depending on your specific application. 
  • Type of Cleanroom — All three types of cleanrooms can be used for plastic injection molding. It’s best to ask your cleanroom manufacturer which is most suitable for your specific application. 
  • Cleanroom Size — There isn’t a minimum or maximum size requirement that your plastic injection molding cleanrooms need to meet. Just make sure it’s big enough to house the large furniture and machinery you’ll be using. Remember, choosing modular construction is a smart idea if you anticipate expanding in the future. 
  • Cleanroom Pressure — Your plastic injection molding cleanroom should operate under positive pressure in order to prevent harmful particles from entering and disturbing your process.
  • Special Equipment — Plastic injection molding cleanrooms house a few unique types of equipment, most importantly mold cranes. In most cases, you will need to consider a ceiling hatch to allow your mold crane, which is a potentially high source of contamination, to be kept outside of your cleanroom. That way, only part of the machine enters your cleanroom for tool/mold changing purposes. Another important decision to make is choosing electric machines instead of hydraulic machines, which can also reduce the amount of contamination that enters the space. 

For an example of what a plastic injection molding cleanroom may look like, check out one of our latest projects here. 

Work With the Plastic Injection Molding Cleanroom Experts at Angstrom Technology

In order for injection molding applications to be safe, effective, and repeatable, cleanrooms are necessary. If you’re looking to design a plastic injection molding cleanroom of your own, contact our team at Angstrom Technology. We’ll listen to your facility’s specific needs, then provide a turnkey cleanroom solution that meets each one of them.

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Radiopharmaceutical Cleanroom FAQs

Radiopharmaceutical Cleanroom FAQs

by | Jun 14, 2022 | Helpful Tips

 Interested in learning about the radiopharmaceutical industry and radiopharmaceutical cleanrooms? As an experienced radiopharmaceutical cleanroom manufacturer, we’re here to answer any questions you have about the design or installation of these innovative spaces. 

To get you started, we’ve listed 10 of our most frequently asked questions about radiopharmaceutical cleanrooms, along with their answers, below. 

1. What Are Radiopharmaceuticals?

Radiopharmaceuticals are a group of pharmaceutical drugs that contain radioactive isotopes. In the past, they’ve mainly been used as diagnostic agents that help doctors identify a number of medical problems. 

However, they’ve recently gained recognition for being viable forms of treatment for life-threatening conditions like cancer. For those cases, the radiopharmaceutical drug is absorbed into the cancerous area, then destroys any affected tissue. Many patients have found radiopharmaceuticals to be a less-invasive, less-painful alternative to other chemotherapy and radiation techniques. 

2. What Risks Are Associated With Handling Radiopharmaceuticals?

In traditional pharmaceutical applications, the main goal is to protect sensitive products from being harmed by contaminants. However, in radiopharmaceutical applications, there are two goals: to protect the products and to protect the people handling them. 

Why? Radiopharmaceuticals contain radioactive isotopes, which can be harmful to human health after lengthy or frequent exposures. Too much radiation exposure has been known to cause the following health conditions: skin burns, acute radiation syndrome, cancer, cardiovascular disease, reproductive issues, and more. 

3. What Is a Radiopharmaceutical Cleanroom?

As the name suggests, a radiopharmaceutical cleanroom is a controlled cleanroom environment in which radiopharmaceuticals are tested, produced, packaged, or distributed. Radiopharmaceutical cleanrooms are not the same as traditional pharmaceutical cleanrooms, as they have unique control, cleanliness, and process requirements in order to ensure patient and operator safety. They also house different types of cleanroom furniture and equipment. 

All this said, it’s important to be aware of any unique design considerations radiopharmaceutical cleanrooms require.

4. What ISO Classification Do Radiopharmaceutical Cleanrooms Require?

In most cases, radiopharmaceutical cleanrooms are required to meet ISO Class 7-8 standards. However, they may also feature some designated areas or chambers that meet even more stringent standards, such as ISO Class 6 or above. 

5. What Other Quality Standards Do Radiopharmaceutical Cleanrooms Need to Meet?

ISO standards aren’t the only quality standards that radiopharmaceutical cleanrooms need to meet. In most cases, they also need to meet GMP standards and USP standards. 

GMP stands for Good Manufacturing Practice, which is a quality management system enforced by the US Food and Drug Administration and used mainly by medical and pharmaceutical manufacturers. The main goal of these standards is to minimize the risks of microbiological, particulate, and pyrogen contamination during the preparation and sterilization of medicines or medical devices. 

USP stands for United States Pharmacopeia, which is “an independent, scientific nonprofit organization focused on building trust in the safe supply of safe, quality medicines.” USP is not a government entity, but works alongside government agencies and regulatory authorities around the world to safeguard the global supply of medicines and other consumable products. Their standards are legally recognized in the United States and are used in over 140 countries.

The main goals of these standards are to protect patient and worker safety while developing, packaging, distributing, and consuming medicines and dietary supplements. The USP standard that’s most pertinent to radiopharmaceutical applications is USP 825, which you can read more about in our previous blog post. 

6. What Types of Equipment Do Radiopharmaceutical Cleanrooms Require?

Radiopharmaceutical cleanrooms require various types of equipment, some of which are completely different from those found in traditional pharmaceutical cleanrooms. A few common types of radiopharmaceutical equipment include:

  • Hot cells
  • Isolators
  • Elaborate casework
  • Fume hoods
  • Environmental control and monitoring systems (which can be connected to the building management system, or BMS)
  • Biosafety cabinets
  • Sterile work tables and surfaces
  • Cyclotron storage 

7. What Type of Cleanroom Is Best for Radiopharmaceutical Applications? 

Radiopharmaceutical cleanrooms require a high level of environmental control in order for drugs to be safe and effective for patient use. Therefore, HardWall cleanrooms are generally the best option, as they can accommodate that high level of control against contamination, temperature, humidity, and more. 

8. How Big Do Radiopharmaceutical Cleanrooms Need to Be?

Your radiopharmaceutical cleanroom can be any size your facility needs. However, when determining cleanroom size, it’s important to consider all the specialized furniture and equipment it needs to house. Things like hot cells and isolators aren’t small, so make sure your cleanroom can accommodate the amount that you need. 

Another important consideration is that with modular cleanroom design, you always have room and opportunity for growth. If your facility chooses to expand in the future, modular design allows for quick and simple reconfigurations and additions — but that process is only quick and simple if it’s planned for ahead of time. 

For almost all cleanroom projects, we recommend that facilities plan for this growth during the initial design phase. Considering what expansion will look like or could potentially be is an important step in eliminating additional costs or unwanted downtime within the cleanroom. 

9. What Type of Pressure Do Radiopharmaceutical Cleanrooms Require?

More often than not, radiopharmaceutical cleanrooms are actually radiopharmaceutical cleanroom suites, which contain multiple different controlled rooms or zones. Within these cleanroom suites, cascading pressure is typically required. 

Cascading pressure means the most stringent cleanroom zone has the highest level of pressure, and the least stringent cleanroom zone has the lowest level of pressure. This helps ensure that contamination and particles will not flow into the most critical or cleanest zone.

10. What Radiopharmaceutical Cleanroom Projects Has Angstrom Technology Completed?

In October 2021, Angstrom Technology completed a radiopharmaceutical cleanroom suite project for Michigan State University’s College of Human Medicine and Bold Advanced Medical Future (BAMF) Health. 

BAMF Health is a key innovator in the global radiopharmaceuticals and theranostics industry. With a focus on AI-based precision medicine, molecular imaging, and theranostics, they’re working to create a cutting-edge technology that results in the most efficient, effective, and non-invasive therapeutics for life-threatening conditions like cancer, Alzheimer’s, Parkinson’s, cardiac disease, and more. 

The cleanroom facility is based in Grand Rapids, MI, and totals 3,200 square feet. Here are some of the details:

  • 17 internal rooms, sectioned into three main areas: Commercial Operations, Therapeutic Infusion, and Research and Development
  • HardWall cleanroom
  • ISO 7 & 8
  • 10’ internal ceiling height
  • Environmental control and monitoring systems in each room, all connected to the BMS
  • 18 hot cells

To learn more about this project, visit our Advanced Radiopharmaceuticals Cleanroom page.

Design & Build Your Radiopharmaceutical Cleanroom With the Experts at Angstrom Technology

With the recent development of advanced radiopharmaceutical treatments and therapies, radiopharmaceutical cleanrooms are on the rise. If you’re hoping to build one of your own, contact our team at Angstrom Technology. We can help answer your questions, guide you through the process, and install a cleanroom that meets your facility’s specifications. 

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GMP Cleanroom Requirements for Safe and Effective Workflow

GMP Cleanroom Requirements for Safe and Effective Workflow

by | Jun 8, 2022 | Cleanroom Standards

One of the key aspects that sets GMP cleanroom standards apart from other cleanroom standards is that they account for more than just airborne particle control and filtration. In fact, one of the most important aspects of GMP qualification and validation is ensuring safe, efficient, and effective workflow. 

Let’s discuss what that means, and what GMP workflow requirements include below. 

What Is a GMP Cleanroom? 

A GMP cleanroom is one that complies with Good Manufacturing Practice (GMP) standards. GMP is a quality management system used predominantly by medical and pharmaceutical manufacturers to ensure a controlled cleanroom environment for operations. 

The main goal of GMP standards is to minimize the risks of microbiological, particulate, and pyrogen contamination during the preparation and sterilization of medicines or medical devices. Any application that involves producing, filling, compounding, or packaging sterile medicinal products must comply with GMP standards in order to ensure a high level of product safety and consistency. To achieve this level of control, safety, and repeatability, GMP standards address a wide range of cleanroom issues, including:

  • Equipment verification
  • Personnel qualification
  • Process validation
  • Workflow
  • Sanitation and cleanliness
  • Record keeping and documentation

For this article, we’re focusing on just one of the GMP cleanroom issues listed above: workflow. 

What Are GMP Cleanroom Requirements for Workflow?

In medical and pharmaceutical cleanrooms, operations must be efficient, but also highly controlled. GMP standards can help you design and operate a cleanroom that meets both of those needs, as they outline guidelines for safe and effective workflow. 

To start, there are two main categories of cleanroom workflow to understand: material flow and personnel flow. 

Material Flow for GMP Cleanrooms

Material flow is the method and route in which various materials move throughout a cleanroom. From product testing and development all the way to product packaging, GMP standards require that there needs to be a plan in place for materials to be moved safely and efficiently. This helps to protect sensitive materials from outside contaminants and to protect operators while handling potentially hazardous substances. 

When designing a route for materials to move throughout your cleanroom, make sure you consider the following: 

  • Where and how will materials be processed? What level of environmental control does this require?
  • What are the guidelines for cleanroom operators when handling materials?
  • How will materials be transported? What equipment may you need?
  • How and where will materials be tested? What level of environmental control does this require?
  • Does your cleanroom require any material pass-through chambers to ensure the safe handling and transportation of materials? 
  • Where and how will materials be stored when not in use?

Personnel Flow for GMP Cleanrooms 

Personnel flow is the method and route in which cleanroom operators move through a cleanroom and perform tasks. If you have previous cleanroom experience, you may already know that one of the biggest threats to medical cleanrooms is contaminants from personnel — but a comprehensive, well-designed personnel flow plan can help reduce this risk. Personnel flow takes into account the introduction of contaminants from personnel, the prevention of cross-contamination, the protection of personnel from potentially harmful substances, and the efficiency of personnel. 

When designing a route for personnel to move throughout your cleanroom, make sure you consider the following: 

  • Which cleanroom tasks are the most sensitive, and which ones are the least sensitive? Based on that, in what order should cleanroom operators’ tasks be completed?
  • Where and how will operators put their gowns and garments on/off?
  • What type of non-shedding fabrics will be used for operator gowns and garments? How will these gowns and garments be stored?
  • How long will operator gowns and garments be used before disinfection or disposal? 
  • How will operators be trained?
  • How often should operators wash their hands?
  • When and how will cleanroom surfaces be sanitized? 
  • How do all of these considerations fit within a single, streamlined route through your cleanroom? 

Overall, the main priority in designing a safe and effective personnel flow is having one route in the cleanroom and one route out of it. Here’s an example: 

A cleanroom operator stages materials in a pass-through chamber. Then, they move to a gowning room to outfit themselves in appropriate gowns and garbs and enter the cleanroom. From there, they retrieve the materials at the other side of the pass-through chamber within the cleanroom. They perform their task at the necessary cleanroom station, then place the materials in a safe, controlled storage container. They then exit the cleanroom through the gowning room and remove their gowns and garbs into a designated bin. 

Why Are GMP Cleanroom Workflow Requirements Important? 

Mainly, GMP cleanroom workflow requirements are important in protecting the safety, efficacy, and repeatability of products. They also go to great lengths to protect the safety of those handling the products, which could be harmful to human health. 

However, another important factor in GMP cleanroom workflow is designing a logical route that improves efficiency and productivity. This can help cleanroom facilities reduce downtime and labor costs, while maximizing cost-effectiveness and profitability. 

How to Meet GMP Cleanroom Requirements for Workflow

So, how can you get your cleanroom to meet GMP workflow requirements? Depending on the scope, industry, and details of your cleanroom, the process can greatly vary. However, there are two main steps that remain the same. 

  • Step 1 — Work With a GMP Cleanroom Provider. Do your research and find a reputable cleanroom provider that works with leading manufacturers and has experience designing and installing GMP cleanrooms. They’ll help you create a design that both meets the needs of your facility and is compliant with applicable regulations. 
  • Step 2 — Obtain Necessary GMP Qualification and Validation. The GMP qualification and validation process has four stages: Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance/Process Qualification (PQ). All of these stages require you to meet different criteria that ensure your cleanroom is GMP compliant and meets workflow requirements. 

Get Safe & Effective GMP Cleanroom Solutions From Angstrom Technology

If you plan to install a GMP cleanroom, you need to ensure it meets established workflow requirements. This process can get a little complicated, so if you need help, contact our cleanroom experts at Angstrom Technology. We have extensive experience building GMP cleanrooms, and we’re happy to help you with yours. 

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5 Types of Equipment Used in Cell & Gene Therapy Cleanrooms

5 Types of Equipment Used in Cell & Gene Therapy Cleanrooms

by | May 31, 2022 | Cleanrooms

Cell and gene therapies are both forms of regenerative medicine. Cell therapy involves transferring live, intact cells into a patient to lessen or cure a disease. The cells may be from the patient (autologous) or from a donor (allogeneic). Gene therapy involves transferring genetic material into a patient to change how a single protein or group of proteins is produced by the cell. 

These are relatively new treatment options, but many healthcare professionals are optimistic about the safer, more targeted, less invasive way to treat serious illnesses. 

All that said, the various processes that go into developing cell and gene therapies require a controlled cleanroom environment. Tasks like cellular engineering and genetic engineering, growth, and purification all require stringent cleanliness standards, so that their results can be safe, effective, and repeatable. 

Something that can jeopardize that environmental control? The various types of equipment housed within the space. Below, we’ll talk about cell and gene therapy cleanroom equipment, what risks it can pose, and what steps you can take to mitigate those risks. 

Risks Associated with Cell & Gene Therapy Cleanroom Equipment

While designing a cell and gene therapy cleanroom, it’s important to consider the pieces of equipment that are required for your operations and how they may affect the surrounding cleanroom environment. Many pieces of cell and gene therapy equipment can emit heat and contaminants, which presents a bit of a challenge during the design process. Depending on the risk they carry, you may need to determine if this equipment should be located in a classified or external support area, or if other accommodations need to be made to ensure a high level of safety and control. 

Here are a few of the main risks associated with cell and gene therapy cleanroom equipment, along with considerations you should take to mitigate them: 

  • Equipment material – Equipment should be manufactured using non-shedding materials that can withstand sanitation and decontamination practices, which could include exposure to vaporized hydrogen peroxide (VHP) and other biocides. Materials should also have low electrostatic properties in order to reduce particle adherence. 
  • Equipment surface – All equipment surfaces should be smooth, with no joints, cracks, or crevices for contaminants to accumulate. Also, surfaces that come into contact with products and consumables should be non-absorbent and non-reactive. 
  • Particle emission – Oddly enough, the equipment used to safely carry out cleanroom operations can be a contributor to particle emission as well. For these types of equipment, you may need to either find an external storage area, conduct additional sanitation procedures, or boost your filtration efforts. 
  • Heat gain – Many pieces of cell and gene therapy cleanroom equipment can increase the temperature in cleanrooms, which means you may need to include additional cooling systems and account for the heat loads in the design. Also, when writing a user requirement specification (URS), you should include details for what equipment will be located in which area so that heat load calculations can be made easily. 
  • Weight – For larger pieces of cell and gene therapy cleanroom equipment, weight needs to be considered. Make sure you have tables, workstations, and benches that meet the necessary load-bearing capacity to safely store and operate equipment. 

One final consideration you may make for cell and gene therapy cleanrooms is that they should be configured in closed-loop systems whenever possible. A closed-loop system is designed and operated in a way that doesn’t expose products to the surrounding room environment. This helps to ensure a further layer of protection against any of the equipment risks listed above. 

5 Types of Equipment Used in Cell & Gene Therapy Cleanrooms

So what are these pieces of equipment? Well, while there are many different types of cleanroom equipment, there are a few that are most commonly used in cell and gene therapy applications. Here are just five of them, along with associated environmental hazards to be aware of. 

1. Biosafety Cabinets

Biosafety cabinets are enclosed workspaces that use laminar airflow to filter out fumes and contaminants. They help to protect cleanroom personnel and the surrounding environment from hazardous substances. There are three different biosafety cabinet classes that offer varying amounts of protection: 

  • Class I – Provides protection for personnel and the surrounding environment, but not the product itself. 
  • Class II – Provides protection for personnel, the surrounding environment, and the product itself. 
  • Class III – Provides the highest level of protection for personnel, the surrounding environment, and the product itself. 

Although biosafety cabinets can provide great protection, they can also pose a few risks. When planning to install one in your cleanroom, it’s important to consider the following:

  • Equipment surface
  • Could a closed system be used?

2. Incubators

An incubator is a device that provides the optimal environment for growing and maintaining microbiological cultures and cell cultures. They regulate internal temperature, humidity, and carbon dioxide levels so that even the most sensitive of cultures are able to thrive — which is a critical part of the treatment process. 

The following environmental risks are associated with incubators:

  • Equipment material
  • Particle emission
  • Heat gain
  • Gas lines within cleanroom

3. Refrigerators

Refrigerators are used to store various cell and gene cultures in cold temperatures. These cultures and products need to be housed in continuously refrigerated conditions in order to be fully safe and effective upon reinjection. 

However, refrigerators pose the following environmental risks for cleanrooms: 

  • Equipment material
  • Heat gain

4. Freezers

Similar to refrigerators, freezers are used to store various cell and gene cultures in cold temperatures. They’re most often used when samples need to be stored for extended periods. It’s important that these freezers remain at their required temperature because dropping too low or rising too high could compromise the cultures’ viability. 

Freezers pose the same environmental risks for cleanrooms as refrigerators: 

  • Equipment material
  • Heat gain

5. Centrifuges

A centrifuge is a machine used to separate the various components of a fluid. In cell and gene therapy applications, it’s typically used to isolate strains of cells or DNA. Centrifuges are typically large in size and heavy in weight, often requiring a heavy-duty bench to sit upon. 

If you’re planning to install a centrifuge in your cell and gene therapy cleanroom, you should be aware of these potential hazards:

  • Equipment material
  • Heat gain
  • Weight

Planning to install a cell and gene therapy in your facility? Angstrom Technology can help. We’ll ensure your cleanroom is outfitted with the right equipment and technologies — and it’s capable of mitigating any risks that come with them. To get started working with us, contact us today. 

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