How Can Custom Cleanroom Designs Adapt to My Industry’s Requirements?

How Can Custom Cleanroom Designs Adapt to My Industry’s Requirements?

In today’s world, cleanliness isn’t just a virtue – it’s a necessity. Here at Angstrom Technology, we’re experts in tailoring cleanrooms to meet the unique needs of various industrial applications. From automotive to life sciences and beyond, we’ll explore how custom cleanroom designs can be implemented to meet industry requirements and keep businesses thriving. 

Discover the Vital Role of Cleanroom Designs

Cleanrooms are controlled environments engineered to minimize contamination from particles, microorganisms, and other impurities by precisely regulating air quality, temperature, humidity, and pressure. Achieving this level of control requires meticulous design, construction, and ongoing maintenance. 

Cleanrooms are implemented in a wide array of industries, ranging from pharmaceuticals to aerospace. In some fields, the tiniest of particles or microbes can lead to product defects or health hazards, so cleanrooms have become an invaluable tool.

The need for custom cleanroom designs tailored to industry-specific requirements cannot be overstated. Each sector presents unique challenges, including stringent cleanliness standards and specific regulations. Therefore, a one-size-fits-all approach does not suffice when it comes to cleanrooms. 

Attempting to apply a uniform design to vastly different industries risks compromising the quality and safety of products and can result in regulatory non-compliance. Custom cleanroom designs address these challenges head-on by adapting to the precise needs of each industry. 

To learn more about specific cleanroom classifications and standards, check out our helpful Classifications & Standards page. 

Cleanroom Designs Across Popular Industries:

At Angstrom Technology, we offer dynamic and flexible cleanroom designs, ensuring that your environment aligns seamlessly with the objectives and standards of your industry. We utilize custom designs so you can achieve the highest level of cleanliness, precision, and product integrity. 

Below, we will showcase some of the most popular sectors we work with when creating custom modular cleanrooms. Don’t your field? No worries! We work with many companies that differ from what’s listed below. Email or call our team and discover what we can do for you. 

Pharmaceuticals

The pharmaceutical industry relies heavily on cleanrooms for drug manufacturing and research. Sterile environments are paramount to ensure product safety and regulatory compliance.

pharmaceutical cleanroom projectPharmaceutical cleanrooms must adhere to stringent regulations. The industry requires cleanliness down to the molecular level to ensure drug purity and patient safety.

Angstrom Technology Custom Cleanroom Solutions for the Pharmaceutical Industry:

The pharmaceutical industry is subject to heavy government regulation, and pharmaceutical cleanrooms must meet stringent cGMP standards and requirements. You can be assured that Angstrom Technology designs, constructs, and installs the highest-quality pharmaceutical cleanrooms in the business. 

Automotive

In the automotive sector, cleanrooms are indispensable for manufacturing sensitive components. Precision is the name of the game, as even a speck of dust can impact the performance of critical parts.

automotive projectAutomotive cleanrooms must accommodate a variety of components, from delicate electronic systems to robust engine parts. Each type of component presents its unique contamination challenges.

Angstrom Technology Custom Cleanroom Solutions for the Automotive Industry:

Angstrom Technology designs, builds, and installs top-of-the-line cleanrooms to meet the needs of the automotive industry. Our automotive cleanrooms can meet any classification requirements and are ideally suited for automotive innovation, component manufacturing, and quality testing applications.

Aerospace

Aerospace companies utilize cleanrooms for the production of aircraft components. The slightest impurity could compromise the structural integrity of these parts and have massive effects on production.

aerospace projectAerospace cleanrooms must always meet the regulated levels of the industry. The challenge is maintaining cleanliness while dealing with large and complex parts, as even a tiny defect could have catastrophic consequences.

Angstrom Technology Custom Cleanroom Solutions for the Aerospace Industry:

When it comes to the rigorous cleanroom classifications of the aerospace industry, Angstrom Technology creates the best modular cleanrooms available. All of our cleanroom builds comply with US building and safety codes and are complete with the fixtures and systems you need to use right away. 

Cell and Gene Therapy

A one-size-fits-all approach to cleanrooms drastically falls short when dealing with the intricacies of cell and gene therapy. These revolutionary therapies involve manipulating and administering living cells and genetic materials, making the need for pristine, contamination-free environments paramount. 

Cell and gene therapy have their own distinct set of requirements, including the need for ultra-sterile conditions to ensure patient safety and therapy effectiveness. Custom cleanrooms are designed to tailor to this innovative field’s stringent standards and specialized needs, thereby playing a crucial role in advancing life-saving treatments and ensuring regulatory compliance.

Angstrom Technology Custom Cleanroom Solutions for the Cell and Gene Therapy Industry:

Cell and gene therapies require complex production processes requiring cellular engineering, genetic engineering, growth, and purification. All these operations must be carried out in a controlled environment to ensure safe, reliable, and repeatable results. You can be sure that our cleanrooms meet all the necessary ISO classification requirements. 

Life Sciences

Life sciences is a multifaceted field encompassing many applications, from biotechnology and medical device manufacturing to research and development in genetics and microbiology. Cleanrooms play a pivotal role in maintaining the integrity and innovation of this industry.

biopharma cleanroomCustom cleanrooms provide tailored solutions to cater to the unique needs of each life sciences subsector. They ensure that the environment is precisely aligned with the industry’s specific cleanliness, safety, and operational standards, thereby facilitating groundbreaking research, the production of life-saving therapies, and the advancement of knowledge in the life sciences field.

Angstrom Technology Custom Cleanroom Solutions for the Life Sciences Industry:

The Angstrom Technology Life Sciences Division (ATLSD) has quickly emerged as a leader in cutting-edge products and services for cleanrooms, dry rooms, and cold rooms. We’re dedicated to pushing the boundaries of what’s achievable in the industry, focusing on how integrated teams can provide the best project approach for compliance and success.

Partner with Angstrom Technology for Your Industry-Specific Cleanroom Needs

If you’re seeking tailored cleanroom solutions for your industry, Angstrom Technology is ready to be your dedicated partner in crafting contamination-free environments. Our proven expertise in custom cleanroom designs spans various sectors, ensuring compliance, precision, and product integrity. 

Don’t compromise when it comes to the cleanliness and safety of your operations. Reach out to Angstrom Technology today and discover how we can help you meet your industry-specific cleanroom needs!

Angstrom Technology Completes Azzur Cleanrooms on Demand™ Raleigh facility

Angstrom Technology Completes Azzur Cleanrooms on Demand™ Raleigh facility

Azzur Group appointed Angstrom Technology to build its latest Cleanrooms on Demand™ (COD) Raleigh facility in Morrisville, NC. Azzur Cleanrooms on Demand™ offers a hybrid early-phase manufacturing model. Early-phase manufacturers face specific challenges when starting up and scaling out. COD can remove barriers, such as the need for clinical manufacturing capability and lengthy facility design-build timeframes. Morrisville is minutes from the celebrated Research Triangle area of North Carolina, making it a prime location for this new state-of-the-art facility.

The 24,000 square foot Cleanrooms on Demand™ Raleigh facility features 24 independent cleanroom suites each with a Material Airlock (MAL), Personnel Airlock (PAL), Cleanroom and Exit PAL.  Shared entry and exit corridors provide easy access to and from each cleanroom via the locker room and changing area near one end of the cleanroom.  On the opposite end of the cleanroom, material airlocks provide a path for large equipment to enter the suites via the GMP warehouse.  All cleanroom suites are controlled and monitored by advanced systems which are tied into the building management system.

Azzur Morrisville cleanroom render

Cleanrooms on Demand™ locations

Azzur Cleanrooms on Demand™ Raleigh is the first COD facility Angstrom has completed for the Azzur Group and the 4th in the Azzur COD group. In June, Angstrom attended its grand opening ceremony.

Azzur Group plans to open additional Cleanrooms on Demand facilities in locations across the U.S. over the next two years. Our global structure allows us to project manage builds in multiple locations. Consequently, Angstrom Technology is also under construction on Azzur COD facilities in Devens, MA, and Alameda, California.

At Angstrom Technology, we have the capability to deliver exceptional cleanroom installations. Working with us across multiple facilities provides consistency in cleanroom design, specification, monitoring, and validation. This approach generates efficiencies and drives value. Equally important, it instills confidence in the performance and reliability of your controlled environments.

SPEAK WITH THE EXPERTS AT ANGSTROM TECHNOLOGY

Angstrom Technology partners with the world’s leading contamination control brands so we can design, build, and install high-spec, turnkey cleanrooms to meet your critical requirements across the US and around the globe. 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

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

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?

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

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.