Maintaining a controlled environment is paramount in the highly regulated and data-driven pharmaceutical industry. Pharmaceutical cleanrooms help ensure product safety, efficacy, and compliance and control environmental variables that could adversely affect manufacturing processes and the quality of the final product. 

Keep reading to explore the importance of cleanrooms in the pharmaceutical sector and the key environmental variables they control to maintain optimal conditions for pharmaceutical manufacturing.

The Critical Role of Cleanrooms in Pharmaceutical Manufacturing

Cleanrooms establish controlled environments around critical processes where the concentration of airborne particles is specified and must be maintained at specific levels. These rooms are engineered to minimize ingress, product exposure, and operator exposure to aerosol contaminants. 

Contamination control is critical in pharmaceutical manufacturing due to the potential impact on product efficacy and patient safety. Even minute levels of contamination can lead to significant consequences, including product recalls, regulatory penalties, and harm to patients. 

Cleanrooms provide a controlled environment where factors such as air quality, temperature, and humidity are meticulously controlled to meet regulatory requirements and prevent contamination and cross-contamination between different stages of the manufacturing process.

5 Key Variables Controlled in Pharmaceutical Cleanrooms

By meticulously controlling environmental variables, cleanrooms ensure that pharmaceutical manufacturing processes are conducted under optimal conditions, minimizing the risk of contamination.

1. Temperature and Humidity Control 

Variations in temperature and humidity can affect the stability of pharmaceutical products. Controlled temperature ensures that chemical reactions occur under optimal conditions, while proper humidity levels prevent moisture-sensitive materials from degrading or becoming contaminated.

2. HEPA Filtered Air Supply

High-Efficiency Particulate Air (HEPA) and Ultra-Low Penetration Air (ULPA) filters remove 99.97% to 99.999% of particles as small as 0.3 microns from the air. These filters ensure that the air within the cleanroom is free from dust, bacteria, and other contaminants, thereby protecting the integrity of pharmaceutical products.

3. Air Pressure Differentials

Air pressure is maintained between cleanrooms and adjacent areas to prevent the ingress of contaminants. Positive pressure is used in cleanrooms to keep out unfiltered air, while negative pressure is utilized in containment areas to ensure hazardous substances do not escape. This careful air pressure management helps control contamination pathways and maintain a sterile environment.

4. Microbial Contamination Control

Cleanrooms are equipped with microbial monitoring systems, and surfaces are regularly cleaned and disinfected. Personnel entering the cleanroom follow strict protocols, including wearing sterilized garments, to minimize the introduction of microorganisms.

5. Lighting and Noise Considerations

Proper lighting ensures personnel can perform tasks accurately and efficiently without causing eye strain or errors. Cleanrooms are designed with lighting systems that provide adequate illumination. Noise control is also important to maintain a comfortable working environment and to prevent distractions that could lead to mistakes in sensitive manufacturing processes. 

The Impact of Environmental Variables on Pharmaceutical Processes

In pharmaceutical manufacturing, controlling environmental variables is crucial, as even minor deviations can lead to significant consequences.

Temperature and Humidity Affect Chemical Stability and Product Integrity

• Temperature and humidity are critical factors in maintaining the chemical stability and integrity of pharmaceutical products. 
• Fluctuations in temperature can accelerate chemical reactions, degrading active ingredients and reducing the medication’s efficacy. 
• High humidity levels can cause moisture-sensitive drugs to absorb water, resulting in changes to their physical state, such as dissolving, clumping, or becoming unstable. 
• Low humidity can lead to desiccation and changes in drug potency.

Particle Control Prevents Contamination

• Airborne particles, including dust, fibers, and microorganisms, pose a significant contamination risk in pharmaceutical manufacturing. These particles can originate from various sources, such as personnel, equipment, and the external environment.
• HEPA and ULPA filters in cleanrooms remove particles from the air, ensuring a contaminant-free environment.

Microbial Control Ensures Product Safety and Efficacy

• Microbial contamination is a critical concern in pharmaceutical manufacturing, as the presence of bacteria, fungi, or viruses can adulterate products making them unsafe for use. 
• Sterile materials and equipment adhere to rigorous cleaning and disinfection protocols and enforce strict hygiene practices for personnel.

Discover Angstrom’s Turnkey Cleanroom Solutions

Angstrom offers comprehensive turnkey cleanroom solutions tailored to the pharmaceutical industry’s unique needs. Our services encompass every aspect of cleanroom development, from facility programming and design to procurement,  installation, validation, and ongoing maintenance. 

We understand that each pharmaceutical manufacturing operation has distinct requirements. Our experienced consultants, engineers, and designers will work closely with you to develop tailored cleanroom solutions, whether accommodating unique workflows, integrating specialized equipment, or ensuring compatibility with existing facilities. 

At Angstrom, our turnkey solutions offer a seamless, end-to-end approach to cleanroom development:

• Design: Detailed planning and conceptualization to create a cleanroom that meets all technical and regulatory specifications.
• Installation: Expert construction services that adhere to the highest standards of quality and precision.
• Validation: Rigorous testing and validation procedures to ensure the cleanroom performs as expected and complies with industry standards.
• Maintenance: Ongoing maintenance and support services to keep the cleanroom operating at peak efficiency and compliance.

Partner with Angstrom for Expert Pharmaceutical Cleanroom Solutions

Contact Angstrom today for expert cleanroom solutions that enhance your pharmaceutical processes. Our team is dedicated to delivering custom-designed cleanrooms that meet the highest standards of quality and performance. Let us help you create the perfect cleanroom environment for your pharmaceutical operations.

CONTACT A LIFE SCIENCE CLEANROOM EXPERT

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.

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.

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. 

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.