Global Cleanroom Expertise: Capabilities

Global Cleanroom Expertise: Capabilities

by | May 19, 2023 | Cleanroom Standards, Pharmaceutical Cleanrooms

As you may already know, the Angstrom Technology Group of market leading cleanroom companies in the US, UK, and Europe has capabilities to provide multinational services to our global clients. But what does this mean for our customers?

The stringent control of process variables is a global requirement for pharmaceutical, electronics, and biotech industries worldwide. Our cleanrooms support top-tier multinational organizations to increase quality at sites across the world.

 

EXPANDED PRODUCT RANGE

Through in-house expertize and collaborations with specialist industry-partners, we can deliver facilities with precise requirements, such as battery dry rooms or cell and gene therapy suites.

 

CONSISTENT QUALITY

When it comes to global operations, maintaining consistent quality standards is crucial. Angstrom Technology understands this well and no matter where you are in the world, we can deliver compliance to the applicable regulations. This commitment to quality gives you the reassurance that partnering with Angstrom Technology will result in reliable and high-performing solutions for your business.

 

FASTER RESPONSE TIMES

In a fast-paced business environment, time is of the essence. Angstrom Technology’s global network of partners enable us to reduce shipping and installation times significantly. This streamlined approach translates into improved operational efficiency for your business, giving you a competitive edge.

 

LOCALIZED SUPPORT CAPABILITIES

By having a network of support teams strategically located across different regions, Angstrom Technology ensures that you receive personalized attention and timely assistance. This localized approach strengthens our commitment to customer satisfaction and builds long-lasting partnerships.

 

COMPETITIVE PRICING

Angstrom Technology’s global capabilities enable them to optimize their supply chain and take advantage of economies of scale. This optimized approach allows them to offer competitive pricing without compromising on quality. By partnering with Angstrom Technology, you can access cost-effective contamination control.

 

ACCESS TO GLOBAL EXPERTIZE

With a multi-disciplined, in-house team of cleanroom experts, we have expansive industry experience, with applied knowledge and skills across the globe, such as our global regulatory governance team.

 

GLOBAL CLEANROOM PROJECTS

 

Capabilities - Global cleanroom customers

 

SPEAK WITH THE EXPERTS AT ANGSTROM TECHNOLOGY

If your facility needs a new cleanroom, Angstrom Technology can design, build, and install one that meets your specifications. Using proven design strategies and quality build systems, you can trust that your work and employees will always be protected.

Request a cleanroom quote today, or contact our team for more information.

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Global Cleanroom Expertise: Regulatory Governance Team

Global Cleanroom Expertise: Regulatory Governance Team

by | May 5, 2023 | Cleanroom Standards, Pharmaceutical Cleanrooms

The regulatory landscape for cleanrooms can be complex. On top of managing the requirements of the ISO 14644 suite of standards, you may also need to comply with cGMP (Good Manufacturing Practice) guidelines and those of industry regulatory bodies. But the experts at Angstrom Technology are committed to supporting you through successful audits. All cleanroom projects with a requirement for cGMP compliance have oversight from our dedicated regulatory governance team. 

With over 40 year’s combined experience in cGMP and pharmaceutical industries, this level of in-house expertise sets us apart from other cleanroom companies. In this blog — the first in our Global Cleanroom Expertise series — we explain how we can support your regulatory compliance.  

 

Meet the Regulatory Governance Team

Global Compliance and Quality Assurance Manager

Global Compliance Lead

Joan Benson - Global Compliance and Quality Assurance ManagerSimon Rice - Global Compliance Lead
Joan has 30 years previous experience in Cell and Gene Therapy, Academia, Pharmaceutical Industry, Contract Clinical Research and Hospital Aseptic facilities. She was front facing regulatory inspections in MHRA, FDA, HTA and HFEA for 20 years.Simon has 8 years previous experience in the production of radiopharmaceuticals within a fully accredited GMP facility manufacturing sterile pharmaceuticals. This gives him a unique understanding on the implications of GMP.

 

Regulatory compliance services

Our cleanroom systems can be qualified to cGMP, and the required ISO classification. Not only that, but they can also meet any applicable international engineering and building standards and regulations. Our skilled and multi-faceted team can provide the following key services to support your compliance: 

  • Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) 
  • Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT) 
  • Validation 
  • Audits of facilities and Quality Management Systems 
  • Gap analysis 
  • Mock regulatory inspections 
  • Bespoke validation studies 

 

Regulatory governance successes

Our team has led high-profile global cleanroom projects to regulatory compliance. There are just a few of their recent successes. 

  • Led cleanroom validation (DQ, IQ, OQ, PQ, FAT, SAT and a wrap-around validation package covering EMS, VHP systems and cryostorage) for a 33-room Cell and Gene Therapy Manufacturing Facility. 
  • Led cleanroom validation (DQ, IQ, OQ, PQ, and all commissioning data) for a 6,500 Cleanroom Facility in their 11,000 square feet Single-Use Bioprocessing Technologies Manufacturing Facility. 
  • Supported numerous clients on the delivery of their projects with regulatory support on all aspects including design, validation, and commissioning 
  • Led cGMP qualification packages for current clients with GMP facilities 
  • Gap analysis for leading clinical research units 

 

Ready to start your cGMP cleanroom project? Contact us

We are committed to supporting you through successful audits and inspections, now and in the years to come. To learn more about our cGMP cleanroom design-build services, request a quote or contact us. 

 

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Your Guide to Radiopharmaceutical Cleanroom Design

Your Guide to Radiopharmaceutical Cleanroom Design

by | Mar 14, 2022 | Pharmaceutical Cleanrooms

Used to diagnose and treat life-threatening diseases, radiopharmaceuticals make up a relatively new sector in the field of medicine. And, due to their radioactive nature, they need to be managed and manufactured a bit differently than traditional pharmaceuticals. This is why it’s critical (and required by public health standards and laws) that radiopharmaceutical drug production is done in a highly controlled cleanroom that’s equipped to store, prepare, fill, and pack radioactive materials safely. 

Below, we’ve created a guide to radiopharmaceutical cleanroom design — giving you an inside look at all the design considerations that go into creating one of these controlled, cutting-edge spaces. 

6 Key Radiopharmaceutical Cleanroom Design Components

Of course, all radiopharmaceutical cleanroom designs are a bit different. It depends on a variety of factors, such as the particular application happening within them, the space in which they’re built, etc. However, many of them have the same basic components and design considerations. We’ve listed six fairly common ones below:

1. Radiopharmaceutical Cleanroom Classification

The main component of any cleanroom is its ISO classification, and radiopharmaceutical cleanrooms are no different. In most cases, radiopharmaceutical cleanrooms are required to meet ISO Class 7-8 standards. However, they may also have designated areas or chambers that must meet even more stringent standards, like ISO Class 6 or higher. 

2. Radiopharmaceutical Cleanroom Type

In order to meet high levels of cleanliness and environmental control, radiopharmaceutical cleanrooms are most often built as HardWall structures. This type of cleanroom has the most control over contamination, temperature, humidity, pressure, and static. 

3. Radiopharmaceutical Cleanroom Size

Cleanroom size can greatly vary from one radiopharmaceutical cleanroom project to another. But in terms of effective radiopharmaceutical cleanroom design, the most important thing to consider is allowing enough space for all necessary equipment, as well as personnel and product flow. 

Radiopharmaceutical cleanrooms generally host multiple pieces of equipment, the most common being hot cells. Hot cells are shielded containment and operating chambers that protect cleanroom personnel from radioactive substances within the medicines. 

They’re usually around 4 feet wide and 12 feet tall, so allocating space for a few of them can be challenging — especially when you also need to accommodate space for efficient workflow surrounding them. That’s where a radiopharmaceutical cleanroom designer’s expertise really comes in handy. 

4. Radiopharmaceutical Cleanroom Pressure

Radiopharmaceutical cleanroom design can also get a bit complicated when it comes to pressurization and confirming there is a cascading effect; where the most stringent or highest classification cleanroom should have the highest positive pressure. When a facility has multiple cleanroom areas (which is typical in radiopharmaceutical applications), it’s critical to design pressure and air to flow a certain way so that particles and contaminants are unable to enter the most controlled space in the facility. 

In addition, radiopharmaceutical cleanrooms typically have fume hoods that are operating at ISO 5 and need to be exhausted to the exterior or out of the cleanroom suite.

5. Radiopharmaceutical Cleanroom Temperature & Humidity

In radiopharmaceutical cleanrooms, temperature and humidity are both important factors to keep under strict control and monitoring. Radiopharmaceuticals cannot be kept under extreme temperatures or humidity levels, otherwise they will become less effective, run the risk of microbial growth, or be unsafe for human consumption. Therefore, environmental control and monitoring systems are built into many radiopharmaceutical cleanrooms’ designs. 

6. Additional Equipment & Technologies for Radiopharmaceutical Cleanrooms

Finally, radiopharmaceutical cleanroom operations call for a variety of unique pieces of equipment and technology. These devices could include (but aren’t limited to) some of the following:

  • 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
  • Gowning rooms

Hoping to design and install a radiopharmaceutical cleanroom in your facility? Let us know! At Angstrom Technology, our team can help you build a modular cleanroom that’s perfect for your project needs. To get started working with us, contact us online. 

Interested in learning more about one of our latest radiopharmaceutical cleanroom projects at Angstrom? Check out our Advanced Radiopharmaceuticals Cleanroom Project page or our recent case study. 

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What Are Radiopharmaceuticals?

What Are Radiopharmaceuticals?

by | Feb 21, 2022 | Pharmaceutical Cleanrooms

Here at Angstrom Technology, our experts have recently put the finishing touches on another exciting project: a radiopharmaceuticals cleanroom! 

Not sure what a radiopharmaceuticals cleanroom is, or what it entails? We’ll walk through the details below. 

What Are Radiopharmaceuticals?

Radiopharmaceuticals are a group of pharmaceutical drugs that contain radioactive isotopes. In most cases, they’re used as diagnostic agents that help doctors detect a variety of medical problems. After a patient is given a small amount of a radiopharmaceutical drug, it either passes through or is absorbed by the intended organ. Then, once the radioactivity is detected, special imaging equipment is used to take pictures that allow the doctor to study how the organ is functioning. 

In addition to that very cool application, radiopharmaceuticals are also gaining recognition and popularity as a viable form of therapy or treatment for certain types of cancer, among other life-threatening diseases. In those cases, the radiopharmaceutical drug is absorbed in the cancerous area and works to destroy any affected tissue. 

That said, radiopharmaceuticals (especially those used for therapeutic and treatment purposes) make up a relatively new sector within the medical and pharmaceutical industries. The number of radiopharmaceuticals in clinical use continues to grow rapidly, allowing the medical community to better understand different diseases, as well as the best treatments for them. 

Key Considerations for Radiopharmaceuticals Cleanrooms

Just like any other pharmaceutical or medical cleanroom project, radiopharmaceuticals cleanrooms require the same basic considerations to get started: 

  • Budget
  • Size
  • Type
  • ISO classification

However, they also present a unique challenge. In traditional pharmaceutical applications, the main purpose of a cleanroom is to protect drugs from any contaminants that could reduce their safety or effectiveness. While that’s still important in radiopharmaceutical applications, there’s another huge component to consider: the safety of cleanroom operators and facilities. 

Radiopharmaceutical drug production requires a highly controlled environment that’s properly equipped to store, prepare, fill, and pack radioactive materials safely. This often means implementing a number of specialized machines and technologies, including (but not limited to) access control systems, isolators, fume hoods, and hot cells. 

The bottom line is that, after everything is designed, constructed, and installed, all components should work together to ensure the safety of both the drugs being handled and the people handling them. 

Angstrom Technology’s Latest Radiopharmaceuticals Cleanroom Project

Our recent radiopharmaceuticals cleanroom project, completed in October 2021, was for an advanced radiopharmaceuticals research and development company with a focus on cancer treatment. Based in Grand Rapids, Michigan, this cleanroom totaled 3,200 square feet and held 17 internal rooms for various operations. Below are more details on the project: 

  • Cleanroom type: HardWall
  • ISO classification: ISO 7 & ISO 8
  • Internal ceiling height: 10’
  • Additional design features and technologies: extensive door and access control system, isolators, hot cells

To view the project video and featured images, visit our Advanced Radiopharmaceuticals Cleanroom Project page. 

If you’re interested in learning more about the unique cleanroom projects we’ve completed here at Angstrom Technology, check out our Projects page. Or, if you’re ready to get started on your own cleanroom project, get in touch with our team. We’re happy to guide you through our proven design, building, and installation processes, ensuring you a final result that accommodates the needs of your facility and application. 

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New Trends in Cleanroom Design

New Trends in Cleanroom Design

by | Feb 26, 2018 | Cleanroom Design, Cleanrooms, Manufacturing Cleanrooms, Medical Laboratory Cleanrooms, Pharmaceutical Cleanrooms, Uncategorized

Now that the holidays are over and the new year has begun, you might finally be getting around to implementing a new cleanroom in your facility. If you’re designing a new cleanroom or updating your current one, here are the latest trends in cleanroom design that you should consider as you design your cleanroom space.

 

Sustainability

Sustainability is an important consideration for all of us, including corporations. Because cleanrooms use so much energy to maintain the desired environmental conditions, engaging in sustainable practices when possible is crucial. Not only do these sustainability efforts support the natural environment, they are also energy efficient, which can help you save on energy costs. Using energy efficient equipment and energy efficient LED lighting can aid in sustainability efforts, as can a modular cleanroom. Modular cleanrooms can be altered and right-sized as the needs of your company change, while reusing the modular components, and require less material than traditional construction. Additionally, modular cleanrooms can make use of the currently existing HVAC and ventilation systems in your space, rather than requiring separate systems.

 

Transparency

Now, more than ever, we’re aware of the value of transparency from leaders and companies. When it comes to your cleanroom, the primary concern will always be the integrity of the controlled environment within, and it may also be important to maintain privacy for the safety of intellectual property, but cleanrooms can benefit from some openness and visibility. Using transparent partitions in the place of opaque walls can provide some benefits, the biggest of which being that lab processes can be observed, whether by compliance regulators or supervisors within your organization, without disturbing cleanroom processes or the environment within.

 

Flexibility

Many organizations are resisting the use of specific dedicated spaces for certain tasks or operations, instead opting for more shared spaces and flexibility in order to reduce costs and under-utilized space. This means incorporating fixtures and furniture, such as lab benches and workstations, into your cleanroom that can accommodate a variety of tasks or processes, as well as modular cleanrooms that can be easily expanded, contracted, or reconfigured to maximize use of space.

 

As you’re working on your cleanroom design or redesign, consider the needs of your company and your cleanroom, as well as how the cleanroom can continue to meet those needs over time, with organizational and regulatory changes. Incorporating sustainability, transparency, and flexibility into your cleanroom design can make your cleanroom efficient and future-proof, not matter the changes to come.

Looking to design a new cleanroom? Get in touch with the cleanroom experts at Angstrom Technology.

Benefits of Cleanroom Pass-Through Chambers

by | Jul 28, 2017 | Cleanroom Design, Cleanrooms, Manufacturing Cleanrooms, Medical Laboratory Cleanrooms, Pharmaceutical Cleanrooms

Pass-through chambers are a commonly used cleanroom term, and they’re also an ideal addition to just about any cleanroom. They’re easy to install, they don’t draw much out of your budget, and they hold tons of benefits for the operation of your cleanroom. While there are all types of pass-through chambers, from basic transaction windows to industrial roll-up door pass-throughs, most cleanroom pass-throughs fall into the dual-door category. Because the removal of contaminants is any cleanroom’s top priority, most cleanroom pass-through chambers have two doors, one on the outside and one on the inside of the cleanroom. Those cleanrooms that must meet higher standards often install pass-throughs with additional features like an air shower or fire resistance, but the general construction and operation is the same.

What are the benefits of cleanroom pass-through chambers?

  • They allow your employees to transfer materials in and out of your cleanroom without contamination.
  • They make it easy for employees to pass materials into the cleanroom without having to gown. This also cuts down on the number of employees in your cleanroom at any one time.
  • They come in a variety of sizes and materials, ensuring you get the pass-through that meets the needs of your employees. Stainless steel options are corrosion-free, which extends the life of your pass-through, and helps keep your cleanroom clean.
  • Double door designs ensure cross contamination doesn’t happen. And heavy duty sealing lock features keep contaminants out of the chamber when it’s not in use.
  • Most pass-through chambers are customizable, allowing you to choose the option that best fits the needs of your cleanroom. Whether you need a fire safe option, one that’s chemical resistant, or a pass-through chamber that includes a blower with HEPA filtered air, you can choose the chamber that best suits your cleanroom needs, ensuring you benefit from a pass-through chamber, regardless of your cleanroom classification.

How do cleanroom pass-through chambers increase productivity?

The single greatest benefit of a cleanroom pass-through chamber is its ability to speed up your processes and increase employee productivity. Pass-through chambers eliminate the need for employees to properly gown to enter a cleanroom environment just to hand off a necessary item or sample. As you likely know, the gowning process can be time-consuming, and additionally, the more employees you have in a cleanroom, the greater the chance for contamination. When employees can simply place materials in the pass-through chamber, you save a great deal of time on both sides of the cleanroom. Best of all, pass-through chambers are easily installed, whether you have an existing cleanroom or you’ve just commissioned a new one.

Who uses pass-through chambers?

The benefits of pass-through chambers are clear. They boost productivity without sacrificing cleanliness. So, which cleanroom industries use pass-through chambers, and how?

Research Facilities

Because research facilities often study new and unpredictable chemicals and substances, they need pass-through chambers for safety more than for convenience. Because some chemicals can easily become volatile and cause fires, fire safe pass-throughs are commonly used in this application. These pass-through chambers can withstand fire exposure for up to 90 minutes, and their sturdy construction maintains frame shape that protects research labs from destruction. While these labs also often make use of air shower pass-throughs to decontaminate materials before they’re introduced to the lab, fire safe pass-throughs are the most common.

Medical and Pharmaceutical cleanrooms

Decontamination is the first priority of both medical and pharmaceutical cleanrooms. Because hospital laboratories often deal with highly contagious substances, it’s paramount that the environment remains sterile. In the same vein, pharmaceutical cleanrooms have to ensure there is absolutely no contamination in the manufacturing process that could alter their product. In both cases, these cleanrooms require pass-through chambers that keep samples, specimens, and other materials sterile as they’re brought into the cleanroom. These industries typically make use of a standard two door pass-through chamber that keeps outside contaminants from entering the cleanroom and ensures the materials remain sterile as they’re waiting to be brought in.

Electronic and technology manufacturing cleanrooms

Manufacturing facilities that put together the complex inner workings of technological devices like computers and smartphones require very strict cleanroom environments that filter out even the smallest particles of dust and other contaminants. Just one tiny particle settling on a single piece in the manufacturing environment could render a future hard drive useless. Many electronic and technology manufacturing cleanrooms opt for highly monitored pass-through windows in order to maintain the sterility necessary to produce quality electronic products while maintaining a high level of productivity.

 

Pass-through chambers are a highly useful component of any cleanroom. They help you ensure that you keep your processes moving, while maintaining the high standard of cleanliness within your cleanroom. If you’re installing a new cleanroom, or even if you’re considering adding a pass-through chamber to your existing cleanroom, be sure to give the experts at Angstrom Technology a call! We’ve been manufacturing top-of-the-line cleanrooms for years and would be more than happy to help you find the pass-through best for your operation. Call our office at 888-768-6900 or contact us online today!