What Is a GMP Cleanroom?

GMP stands for Good Manufacturing Practices, which are quality management standards most commonly used by medical and pharmaceutical manufacturers. Among other things, they help to ensure a controlled cleanroom environment that reduces the risk of microbiological, particulate, and pyrogen contamination during the preparation and sterilization of medicines or medical devices. In the United States, GMP standards are established and enforced by the Food & Drug Administration (FDA). 

Therefore, a GMP cleanroom is a cleanroom that has been assessed and confirmed to comply with applicable GMP standards. 

It’s important to mention cGMP here as well. If you’ve done any research regarding GMP standards, you might have seen “cGMP standards” pop up and wondered if they’re the same. They’re similar, but not quite the same. Note the differences here: 

• GMP focuses on how your cleanroom is designed, built, and operates in a way that results in safe and effective products. 
• cGMP focuses on how you use technologies and systems that are up-to-date and comply with GMP standards. 

5 Industries That Require GMP Cleanrooms & Why

Now let’s take a closer look at a few industries that require GMP-compliant cleanrooms. While these aren’t the only industries or applications that need GMP cleanrooms, they’re some of the most common that we work with here at Angstrom Technology. 

1. Pharmaceutical

Pharmaceutical cleanrooms are designed to house any application that involves medicines or supplements. This includes tasks like research, testing, compounding, packaging, and more. 

The pharmaceutical industry calls for GMP cleanrooms in order to protect patient safety and ensure accurate, effective, and repeatable results. Without adherence to GMP standards, pharmaceutical cleanrooms could produce medicines that are ineffective, or even worse, harmful to human health. 

In addition to GMP standards, some pharmaceutical cleanrooms that deal with compounding must also comply with another set of quality management standards: USP standards. Learn more about USP standards here. 

Curious to see what a finished, GMP-compliant pharmaceutical cleanroom project looks like? Check out this one completed by our team at Angstrom Technology!

2. Radiopharmaceutical

Radiopharmaceuticals are a subcategory of pharmaceuticals that contain radioactive isotopes. In the past, they’ve been widely used as diagnostic agents to detect a range of health issues. Recently, they’re gaining recognition as a viable form of treatment for serious diseases like cancer. 

Although they sound similar to traditional pharmaceutical cleanrooms, radiopharmaceutical cleanrooms require specific design considerations. This is because exposure to radioactive isotopes within the drugs can harm the health of cleanroom operators. Therefore, there are two reasons radiopharmaceutical cleanrooms must comply with GMP standards: to ensure accurate, effective, and repeatable results, and to ensure cleanroom operator safety. 

Radiopharmaceutical cleanrooms must also comply with USP standards, specifically USP General Chapter 825. Explore USP General Chapter 825 guidelines here. 

To see an example of a GMP-compliant radiopharmaceutical cleanroom completed by Angstrom Technology, click here. 

3. Cell & Gene Therapy

Cell and gene therapy are two forms of regenerative medicine. In cell therapy, live and intact cells are injected into a patient to treat or cure the disease. In gene therapy, altered genetic material is injected into a patient to change how a single protein (or group of proteins) is produced by a cell, ultimately treating or curing the disease. 

That said, cell and gene therapy cleanrooms house some extremely sensitive processes, such as cellular and genetic engineering, growth, and purification. GMP compliance is necessary in order to ensure product efficacy and patient safety. 

Explore a GMP-compliant cell and gene therapy cleanroom project, completed by our partners at Connect 2 Cleanrooms, here. 

4. Medical Device Manufacturing

Medical device cleanrooms are designed to house applications in which medical devices like injectables, surgical supplies, and imaging equipment are manufactured. Many people understand that consumables like medicine must be regulated, but what they don’t realize is that the devices used to help consume them must also be regulated. They come in contact with tissues and membranes, and can therefore affect patient health. 

In order to protect patient health and safety, GMP compliance is required for any medical device cleanroom. 

Angstrom Technology recently completed this GMP-compliant medical device manufacturing cleanroom project. Check it out!

5. Food & Beverage

Last but not least, any cleanroom involving food or beverage products requires GMP compliance. This could include activities like testing, manufacturing, packaging, or more. 

Since food and beverage products are consumed, their production processes must be regulated by GMP standards to ensure consumer safety. 

Start Your GMP Cleanroom Project With Angstrom Technology

GMP cleanrooms are built to ensure that health, medicinal, and food products are consistently safe for consumption. If your cleanroom application is required to meet GMP standards, contact our experts at Angstrom Technology. We’d be happy to design a cleanroom that meets applicable requirements and help you navigate the GMP qualification and validation processes.

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.

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. 

Radiopharmaceutical Cleanroom Design?

USP standards are developed by the United States Pharmacopeia (USP) to protect patient and worker safety while developing, packaging, distributing and consuming medicines and dietary supplements. Therefore, they must be adhered to in many cleanroom applications involving radio pharmaceutical development or manufacturing. 

Some of the most common USP standards in the cleanroom industry are USP 797 and USP 800 — but in this article, we’ll be discussing a more specialized one: USP 825.

What Is USP 825?

USP General Chapter 825 is the USP standard that provides the minimum requirements for preparing, compounding, dispensing, and repackaging both sterile and nonsterile radiopharmaceutical drugs. It describes facilities and engineering controls, personnel training and qualifications, and procedural requirements for processing radiopharmaceuticals in various clinical settings. All of these requirements work together to ensure that workers are protected while handling these hazardous drugs and that patients are protected while consuming them. 

Who Needs to Follow USP 825?

If you’re working with radiopharmaceutical development or manufacturing, you likely need to follow USP 825. That includes a variety of healthcare personnel and environments, including:

Personnel

• Authorized nuclear pharmacists (ANPs)
• Authorized user (AU) physicians
• Individuals in training and under supervision, like students, technicians, and trainees

Environments

• State-licensed nuclear pharmacies
• Federal-licensed nuclear pharmacies
• Nuclear medicine departments in hospitals and other specialized healthcare clinics

There are some exceptions, however. USP 825 doesn’t apply to the following processes and environments: 

• Manufacturing approved radiopharmaceuticals in FDA-registered manufacturing establishments
• Manufacturing radiopharmaceuticals as investigational agents

Why Was USP 825 Developed?

Radiopharmaceutical drugs have been around for over 70 years, but their development is really starting to take off and lead to big changes in the industry. Due to their radioactive nature, radiopharmaceuticals need to be managed and manufactured differently than traditional medicines.

USP 825 permits three environments for sterile radiopharmaceutical handling: segregated radiopharmaceutical processing areas, ambient hot air labs, and cleanroom suites. The appropriate environment depends on the particular radiopharmaceutical processing task at hand. 

In a radiopharmaceutical cleanroom environment, control is needed to ensure the safety and effectiveness of the drugs, as well as to protect the lives of workers who are handling them.

The unique characteristics of radiopharmaceutical drugs and cleanrooms make complying with the longstanding USP 797 and 800 standards a difficult, unproductive, and sometimes unsafe task. This is why nuclear medicine professionals have called for a move beyond USP 797 and 800 and the creation of a new radiopharmaceutical-specific standard, USP 825. This way, more specific policies and requirements could be established to protect the safety and repeatability of radiopharmaceutical processes.

However, it’s important to note that USP 825 has not yet been implemented due to a series of appeals during the publication process. Therefore, it’s currently used as a guideline for radiopharmaceutical cleanroom design, not a requirement. 

A Few Specific USP 825 Cleanroom Requirements

So what exactly makes USP 825 different from USP 797 and 800? It reflects the unique characteristics of radioactive drugs, emphasizes the importance of following radiation safety protocols, and provides information on how to balance the short lifespan of radiopharmaceutical drugs for clinical use and the importance of proper aseptic handling practices. It also offers guidance on how to place absorption pads in hoods, how to handle sharp utensils during compounding, and how to position radiation-measuring devices in hoods during compounding. 

To break it down more, USP 825 discusses safe practices involving:

• Radiation safety (time, distance, shielding, contamination control)
• Personnel qualification, training, and technique
• Hand hygiene & garbing
• Regular sanitation & cleanliness protocol

Build Your USP 825 Cleanroom With Angstrom Technology

Planning to install a radiopharmaceutical cleanroom in your facility? At Angstrom Technology, we can help design and install one that meets your specifications and complies with industry standards. To get started, contact our team online. 

In the cleanroom industry, there are many different quality standards that both manufacturers and facilities managers must be aware of and comply with. We’ve already discussed ISO standards and Federal 209E standards, even USP standards — but one we haven’t discussed much is GMP standards. 

Let’s explore what GMP standards are, what they entail, who needs to comply with them, and more. 

What Are GMP Standards for Cleanrooms?

GMP stands for Good Manufacturing Practices, which is a quality management system used mainly by medical and pharmaceutical manufacturers to ensure a controlled cleanroom environment. In the United States, GMP standards are established and enforced by the Food & Drug Administration (FDA), but in other countries they’re controlled by different regulatory bodies. 

Although it’s important to be aware of minor differences across the globe, the main goal of GMP standards remains the same: to minimize the risks of microbiological, particulate, and pyrogen contamination during preparation and sterilization of medicines or medical devices. This helps ensure that products are of consistent high quality, are appropriate for their intended use, and meet the requirements of product specifications. 

In order to ensure this level of control, GMP standards address cleanroom issues like: 

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

How Do GMP Standards Differ from Other Cleanroom Quality Standards?

GMP standards are different from other cleanroom quality standards, but none of them are mutually exclusive. Some cleanrooms need to meet multiple sets of standards in order to be fully controlled and compliant. 

For the sake of brevity, we won’t discuss every type of cleanroom quality standard. Instead, we’ll focus mainly on how GMP standards are different from ISO standards since they’re the most common. 

The biggest difference between GMP standards and ISO standards is that GMP standards are mainly used in medical applications. ISO standards, on the other hand, are commonly used in a diverse range of industries, from medical to automotive, plastic injection molding, and more. 

Another difference between these two standard sets is that ISO standards distinguish nine “classes,” while GMP standards distinguish four “grades.” Here’s an overview of the four GMP grades:

• Grade A – A zone for high-risk operations that need the highest level of environmental control. It’s equivalent to ISO Class 5, both at rest and in operation. 
• Grade B – A zone for aseptic preparation, filling, and compounding. It’s equivalent to ISO Class 5 at rest and ISO Class 7 in operation. 
• Grade C – A clean area for less critical stages in the manufacturing process. It’s equivalent to ISO Class 7 at rest and ISO Class 8 in operation. 
• Grade D – Another clean area for less critical stages in the manufacturing process. It’s equivalent to ISO Class 8, both at rest and in operation. 

If you’d like a more detailed description of GMP/ISO equivalents, check out these cleanroom classification comparison tables from our partners at Connect 2 Cleanrooms (C2C). 

Which Cleanrooms Need to Comply With GMP Standards?

As mentioned above, GMP standards are mostly used in medical and pharmaceutical cleanrooms. Any application that involves producing, filling, compounding, or packaging sterile medicinal products needs to comply with GMP standards. This could include cleanroom industries and applications like:

• Cell and gene therapy
• Medical device manufacturing
• Pharmaceutical manufacturing
• Radiopharmaceutical manufacturing

If you’re unsure if your cleanroom must comply with GMP standards, it’s best to consult with a cleanroom design and installation professional. They’ll be able to tell you which quality standards your space must be designed to accommodate. 

An Overview of the GMP Cleanroom Qualification & Validation Process

Qualification and validation are critical components of GMP standards. These protocols help provide documented evidence that your cleanroom meets a high level of control, is compliant with all applicable standards, and will consistently yield high-quality products. GMP guidance calls for the following four stages of qualification and validation: 

• Design Qualification (DQ), which verifies that your cleanroom design can meet all regulatory and process requirements. 
• Installation Qualification (IQ), which verifies that your cleanroom is consistent with specified designs after installation. 
• Operational Qualification (OQ), which verifies that your cleanroom equipment achieves specified operational requirements. 
• Performance/Process Qualification (PQ), which verifies that your cleanroom equipment performs well together, in a cohesively controlled, repeatable state. 

At first glance, this may seem like a lot of qualification stages to go through — and it can be! GMP qualification and validation requires a significant amount of effort, but it must be done before you can begin operations. If you’re looking to streamline the process, a reputable and experienced cleanroom manufacturer can support you. 

 GMP Cleanroom Example: RoslinCT

Want to see a GMP cleanroom project in action? Recently, our partners at C2C completed a GMP-compliant cleanroom suite for cell and gene therapy client RoslinCT. 

The cleanroom suite consisted of 33 different rooms, the breakdown being:

• 3 Grade B cleanrooms
• 2 Grade C cleanrooms
• 15 corridors, lobbies, and changing areas (Grades B, C, D)
• Sample and packing area
• Cryostorage and vaporized hydrogen peroxide (VHP) staging area
• Training laboratory
• Waste room, warehouse, and plant room
• Stairwells, foyers, and bathrooms
• Offices and conference rooms

The large facility obtained full GMP qualification and now operates according to both US and EU GMP standards — ensuring consistent, high-quality results in the rapidly growing, life-saving field of cell and gene therapy.

If you’d like to learn more about this GMP cleanroom project, you can find the full project description here. 

Build Your GMP Cleanroom With Angstrom Technology

Have questions about GMP standards and how they relate to your cleanroom design? Get in touch with our team at Angstrom Technology. As cleanroom design and installation experts, we’re happy to guide you through the GMP qualification and validation process and to ensure your cleanroom is built for safe, controlled operations.

Cleanroom classifications and standards are an important part of cleanroom design and development. They regulate many cleanroom aspects, including levels of air cleanliness, air exchange rates, workflow, pressure, and more. 

While we usually discuss ISO standards, there are plenty of other cleanroom standards that help us design and build highly effective and controlled environments that are specific to an industry — one of them being USP standards. Let’s discuss what USP standards are and how to know if your cleanroom must comply with them. 

What Are USP Standards?

The United States Pharmacopeia (USP) is an independent, scientific nonprofit organization that establishes and enforces quality standards for pharmaceutical products. USP standards help protect patient and worker safety while developing, packaging, distributing, and consuming medicines and dietary supplements. They’re often used to inform decisions made by the United States Food and Drug Administration (FDA), and they’re an important set of standards to keep in mind when it comes to designing, installing, and operating cleanrooms. 

USP Standards vs. ISO Standards

USP and ISO are both types of cleanroom quality standards, but they’re not the same. 

USP standards are most commonly used for pharmaceutical applications and must be followed along with ISO classification standards. Alternatively, ISO standards are much less specific and are followed by a broad range of industries and applications, including pharmaceuticals. 

You may think of this in the same way that you think about squares and rectangles. All squares are rectangles, but only some rectangles are squares. Similarly, all cleanrooms follow an ISO standard, but only some need to adhere to both ISO and USP standards. 

Who Needs to Follow USP Standards for Cleanrooms? 

So, how do you know if you need to follow USP standards while designing, installing, or operating your cleanroom? Simply put, if you’re working with pharmaceutical development or manufacturing, you need to follow USP standards. 

Common USP Standards for Cleanrooms

A USP-compliant cleanroom needs to follow all the requirements set by its applicable standard. In pharmaceutical compounding cleanroom applications, USP 797 and USP 800 are the two most common.

While both of these USP standards call for stringent cleanliness requirements, they do have different goals and design specifications. Let’s take a closer look at them below. 

USP General Chapter 797 — Sterile, Non-Hazardous Pharmaceutical Compounding Preparation

USP 797 outlines the procedures and requirements for pharmaceutical cleanroom applications that involve compounding sterile products (CSPs). These products are non-hazardous to humans and the surrounding environment, some examples being: 

• Syringes
• Injections
• IV medications
• Eye-drops

Compliance with this standard’s requirements is critical — otherwise, pharmaceuticals could be mishandled and cause harm, even death, in patients due to contamination, strength variation, poor-quality ingredients, and more. 

As you can likely determine, the most important safety precaution here is ensuring that the pharmaceutical products aren’t altered by external factors like contaminants and operators. For this reason, USP 797 cleanrooms require ISO 7 Classification, required temperature and humidity specifications, and continuous differential positive pressure to minimize airflow from an area with lower air quality classification to an area of higher air quality classification. They also have other requirements relating to:

• Unidirectional airflow using a primary engineering control (PEC) certified to meet ISO Class 5 or better
• Workstation and door placement to facilitate better control
• Operator technique
• Garbing & donning
• Proper hand hygiene
• Regular sanitation & cleanliness protocol

USP General Chapter 800 — Sterile, Hazardous Drug Handling in Healthcare Settings

USP 800 outlines the procedures and requirements for pharmaceutical cleanroom applications that involve hazardous drugs. These products can threaten patients, personnel working in this environment, and the environment. A drug is considered hazardous if it exhibits one or more of the following characteristics in humans or animals: 

• Carcinogenicity 
• Teratogenicity or developmental toxicity
• Organ toxicity
• Reproductive toxicity
• Genotoxicity
• Structure and toxicity profiles of new drugs that mimic existing hazardous drugs

There are two types of hazardous drugs found in healthcare settings: antineoplastic drugs, which are used to treat cancer, and non-antineoplastic drugs, which are used to treat various other conditions but can pose serious reproductive risks for men and women if they are not managed safely. 

Compliance with USP 800 requirements is critical in order to mitigate risk to cleanroom operators as they work with hazardous substances and promote patient safety. Therefore, USP 800 cleanrooms require an ISO 7 Gowning Room with positive pressure, an ISO 7 Cleanroom with negative pressure between 0.01-0.03 inches of water column relative to all adjacent spaces. They also have other requirements relating to: 

• Receipt of material
• Safe storage with secure access & detailed product labeling
• Primary Engineering Control (PEC) certified to meet ISO 5 Class or better with external ventilation 
• Proper hand hygiene with emergency safety precautions
• Workstation and door placement to eliminate cross contamination
• Garbing & donning
• Regular sanitation & cleanliness protocol

Building a pharmaceutical cleanroom that needs to meet USP 797 or 800 standards? Contact Angstrom Technology. Our cleanroom design experts have experience working on many pharmaceutical and radiopharmaceutical cleanroom projects, and we’re happy to help you build yours in a way that supports your specific needs.