How Does Cleanroom Size Affect Process Flow?

How Does Cleanroom Size Affect Process Flow?

Designing and installing a large cleanroom is a lot different than designing and installing a small one — but how exactly? Let’s take a look at some cleanroom design considerations you should make at the start of a large project so that you end up with a finished space that optimizes process flow. 

7 Considerations for Designing Large Cleanrooms

Designing a large cleanroom is no small feat, as there are many factors to consider. It’s important to carefully plan everything out during the design process, so that building and installation go as smoothly as possible, and so you don’t waste any time or money fixing mistakes. 

With the right knowledge, tools, and support, designing a large, complex cleanroom is more than possible. Here are seven key considerations you’ll want to make before starting. 

1. Project Timeline

Simply put, if you have a large cleanroom project, every part of the design, build, and installation process will take more time. While it’s difficult to estimate timelines without knowing the specific size and design complexity of your cleanroom, you can expect them to be similar to these ranges for larger cleanroom projects: 

  • Design: 1-6 months
  • Fabrication/Production: 4-12 weeks
  • Installation: 2-16 weeks

2. Cleanroom Resources & Materials

More complex cleanroom projects generally call for more resources and materials, which could include any of the following: 

  • Structural components
  • Process piping
  • Machines/equipment
  • Furniture
  • Filters
  • Casework
  • Control systems (access doors, environmental, generators, UPS systems, etc.)
  • And more!

All of these materials and equipment require the introduction of various vendors, suppliers, and trade partners, which we’ll touch on a bit more below. But this brings up the fact that more resources doesn’t just mean equipment and materials — it also means bringing in more labor resources, or workers to coordinate with. 

3. Cleanroom Cost

Additional time and resources often come with additional costs. Of course, cleanroom cost is dependent on more factors than just size. But if all those other factors remained the same, a bigger cleanroom would likely cost more than a smaller one. This is an important consideration to take into account during the cleanroom design process, so you can be sure to stick to any budgetary constraints you have. 

4. Project Trade Partners

As we briefly mentioned above, bigger, more complex cleanroom projects often require you to work alongside more vendors, suppliers, and trade partners. People like electricians, facilities managers, contractors, HVAC specialists, and plumbers can all be pulled in to manage their parts of the process. 

Working with this many trade partners requires constant, effective communication and collaboration between all parties. Otherwise, there can be detrimental setbacks or holes in design — extending your project timeline further than you originally hoped. 

If you’re worried about managing all these different professional relationships, make sure you hire a reputable, experienced cleanroom manufacturer. They’re likely to have existing relationships with high-quality trade partners, which can help ensure a smooth design, build, and installation process. 

5. Type of Cleanroom

There are three types of cleanrooms: HardWall, SoftWall, and RigidWall. While the type you need heavily depends on your cleanroom requirements and ISO classification, HardWall cleanrooms do typically lend themselves to larger, more complex projects. The robust wall system allows for greater versatility and design customization. And, if you wish to expand your cleanroom even more in the future, HardWall cleanrooms are set up best to make these accommodations. 

6. Cleanroom Filtration

The amount of filtration your cleanroom needs is mostly dependent on its application and ISO classification — not so much its size. However, it’s still important to maintain the required ceiling coverage and furniture placement for optimal air movement. 

To be more specific, you need to put careful thought into where your filters will be placed in the cleanroom ceiling grid, and what types of work surfaces, furniture, and equipment will be directly below them. That way, when you have unidirectional airflow, the air can move straight down and suffer minimal disturbance — helping to maintain a uniform pattern for peak cleanliness and control. 

7. Cleanroom Airflow & Pressure

Large cleanrooms frequently include multiple different cleanroom rooms or zones. In each of these zones, different operations can be performed, which most often require different levels of cleanliness and control. 

That said, most large cleanroom projects require special attention to cascading pressure patterns. This is when the most stringent cleanroom zone has the highest level of pressure, and the least stringent cleanroom zone has the lowest level of pressure — all of which work to ensure the flow of contamination is from most clean to least clean. 

Have a Large Cleanroom Project? We Can Help!

Big cleanrooms come with big responsibilities. If you need help designing and installing one that meets your facility’s unique needs while complying with industry standards, contact us at Angstrom Technology. Our experts have the skills and experience needed to tackle any cleanroom project — no matter what design challenges it may present.

cleanroom-classification-quiz-cta
What Is USP 825, and How Does It Affect Radiopharmaceutical Cleanroom Design?

What Is USP 825, and How Does It Affect Radiopharmaceutical Cleanroom Design?

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

cleanroom-classification-quiz-cta
What Are GMP Standards for Cleanrooms?

What Are GMP Standards for Cleanrooms?

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:

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 is a critical component 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-classification-quiz-cta
What to Know About USP Standards

What to Know About USP Standards

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. 

cleanroom-classification-quiz-cta
HardWall Cleanroom Features

HardWall Cleanroom Features

If you’re trying to figure out which type of cleanroom is right for you, you have three choices: SoftWall, HardWall, and RigidWall. They’re all great choices, but there’s probably one that will work better for you than others — and we’re here to help you narrow that decision down. 

We’ve already talked about SoftWall cleanroom features (check that blog out if you haven’t yet!). Now, let’s move on to HardWall cleanroom features. We’ll discuss what they are, what special features and capabilities they provide, and what benefits they could bring to your cleanroom application. 

What Are HardWall Cleanrooms?

HardWall cleanrooms are built with prefabricated solid panels and provide the highest level of environmental control. Known for meeting stringent cleanliness requirements and maintaining peak performance for years, they’re durable, adaptable, solid-walled cleanrooms that can comply with any ISO standard or classification

Due to these characteristics, HardWall cleanrooms are great choices for industries and applications that require strict control over contamination, temperature, humidity, static, pressure, sound, fire protection, and more. At Angstrom Technology, we’ve worked on an extensive list of HardWall cleanroom projects in industries involving semiconductors, pharmaceuticals, aerospace, cell and gene therapies, and more. 

HardWall Cleanroom Features

Depending on each specific application, every HardWall cleanroom is custom designed and constructed based on customer needs. However, they all have some of the same basic features, which are discussed in the following three sections. 

HardWall Cleanroom Materials

The most prominent material within HardWall cleanrooms is their panelized wall systems. We’ll describe those, as well as some other necessary materials, below:

  • Wall Panels – HardWall cleanroom wall panels fit within the framework and are prefabricated and non-progressive — meaning they’re designed for easy removal without disturbing adjacent panels and for minimizing contamination possibilities. They’re composed of a panel core (gypsum laminated to a polystyrene core or aluminum honeycomb), and finished with a stainless steel, fiberglass reinforced plastic (FRP), uPVC, painted aluminum, or smooth vinyl finish.
  • Roof Deck – The roof deck is secured to the perimeter wall panels and spans over the HardWall cleanroom, creating a standalone, modular cleanroom structure. The deck supports the ceiling system and all its components, but can also be designed to meet load bearing requirements. It’s composed of a 20-22 gauge ribbed steel deck.
  • Ceiling System – HardWall cleanroom ceiling systems can be a robust T-grid ceiling system or a panelized walkable ceiling, both of which hold the cleanroom’s fan filter units (FFUs) and lights. 
  • Framework – The framework is the modular wall support system that provides a HardWall cleanroom’s structural integrity. The framing components are made of a durable, extruded aluminum and stainless steel, which has a powder-coated or clear-anodized finish. 
  • Entrances – HardWall cleanrooms are compatible with various types of entrances, such as swing doors, overhead roll up doors, automatic or manual sliding doors, and more. 

HardWall Cleanroom Sizes

HardWall cleanrooms are available in any size and configuration. While standard prefabricated panels are 4’ wide nominally and come in 8’, 9’, or 10’ heights, many cleanroom manufacturers allow you to choose the cleanroom size that fits your process the best.

HardWall Cleanroom Standards

Due to their high level of environmental control, HardWall cleanrooms can meet any ISO standard. They’re naturally suited for ISO Classes 5-8, but with additional equipment and technologies, they’re capable of meeting even stricter requirements. 

Benefits of HardWall Cleanrooms

Out of all three types of cleanrooms, HardWall cleanrooms are generally the most popular. Below are some of the most common reasons our customers at Angstrom Technology have chosen HardWall cleanrooms for their facilities: 

Great Environmental Control

With HardWall cleanrooms, environmental control doesn’t stop at preventing particle contamination. Instead, you’ll enjoy various other forms of strict control — from temperature and humidity, to static and pressure, to sound and fire protection. This high level of control enables your cleanroom to meet whatever ISO standard is required for your application. 

Easy Modification & Expansion Capabilities 

HardWall cleanrooms are constructed with a prefabricated, modular construction design, which allows for multiple configurations and the ability to modify and expand spaces quickly and easily. You’ll be able to reconfigure to meet changing cleanroom needs, expand as your company grows, and upgrade with new technologies as they become available. This makes a HardWall cleanroom a sound, long-lasting investment for your facility. 

Unmatched Durability

With reliable wall panel composition, robust ceiling systems, and dependable structural framework, HardWall cleanrooms are highly recognized for their outstanding durability and longevity. Their systems are made to have structural integrity and be self-supporting, so they will not sag. In addition, because of their specific non-porous finishes, the systems will not warp, rust, or corrode, so you’ll be able to enjoy long-lasting performance — even if your space is reconfigured multiple times to accommodate your facility’s needs. 

Simple Maintenance

HardWall cleanrooms are one of the easier types of cleanrooms to maintain. Their non-porous surfaces and specific finishes on modular components make routine cleaning and testing a breeze. That way, you can spend less time and energy worrying about maintaining the space, and more time and energy actually using it to drive production and profit. 

Interested in installing a HardWall cleanroom in your facility, or have questions about which type of cleanroom is right for your application? Contact Angstrom Technology. Our experts have experience designing, installing, and maintaining all types of cleanrooms, for various industries — and we’d be happy to get started on one for you!

cleanroom-classification-quiz-cta