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. 

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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!

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Cascading Cleanroom Pressure: Explained

Cascading Cleanroom Pressure: Explained

You probably already know how important proper air filtration is in meeting your cleanroom’s ISO requirements. But what you may not realize is how important some other environmental factors are as well. Things like temperature, humidity, static, and pressure all need to be controlled in order to ensure a clean, hazard-free space for your sensitive operations. 

In this article, let’s take a closer look at airflow design and pressure — specifically cascading pressure. We’ll discuss what it is, why it matters, and when it’s needed. 

An Overview of Cleanroom Airflow Design & Pressure

If you have a baseline knowledge of cleanrooms, you may already know about airflow design and the two most common types of cleanroom pressure: positive pressure and negative pressure. If you don’t, we’ll break these concepts down for you: 

  • Positive pressure means the air pressure inside your cleanroom is greater than the pressure outside of it. Achieved by pumping filtered supply air into your cleanroom, this helps prevent harmful particles from entering and disturbing sensitive applications. The general rule of thumb here is that more supply air is coming into the cleanroom than is being exhausted out of it.  
  • Negative pressure means the air pressure inside your cleanroom is lower or less positive than the pressure outside of it. This prevents harmful particles from escaping or exiting to other critical spaces and damaging external environments. The general rule of thumb here is that more air is being exhausted out of the cleanroom than is being supplied and coming into it. You may think of it like a vacuum working to remove hazardous particles.   

Find more details on the difference between positive and negative cleanroom pressure here

What Is Cascading Pressure in a Cleanroom?

Most facilities and cleanroom suites require a specific airflow design, specifically known as cascading pressure. Cascading pressure means the most stringent cleanroom zone has the highest level of pressure, and the least stringent cleanroom zone has the lowest level of pressure. This is to ensure the flow of contamination is from clean to less-clean. In other words, there are pressure differentials in each of the zones within a cleanroom suite, based on how strict their cleanliness requirements are. 

Why Is Cascading Pressure Needed in a Cleanroom? 

Proper airflow design and pressurization is essential for facilities with cleanroom suites, or cleanrooms that have multiple rooms and/or zones within them, to control contamination. Typically, the tasks that are carried out within these zones require different levels of cleanliness and environmental control. Therefore, cascading pressure is needed to ensure air flows in a way that prevents particles from entering the cleaner zone, or most controlled space, in the suite. 

That said, airflow design is an important consideration for you to make before your cleanroom and associated technologies are installed. Talk with your cleanroom manufacturer to figure out the most effective, safe process flow for your applications and how best to monitor the airflow within the cleanroom. They’ll work with you to determine which zones should accommodate certain tasks, and how pressure should flow throughout them to best protect personnel and material processes. 

How to Monitor Cleanroom Airflow and Pressure in Between Zones

So you’ve designed your cleanroom suite to accommodate optimal airflow and pressure — but your work isn’t over yet. In order to ensure consistently controlled operations, you need to regularly measure and monitor airflow and pressure levels. 

Luckily, there are a few tools and technologies that make this process an easy one, including: 

  • Differential pressure gauges, which measure and visualize the difference between two pressure points within your cleanroom suite. 
    • Magnehelic or analog gauges, which have a needle pointer or dial that senses the differential in air pressure and responds to the change in pressure between the adjacent spaces. The pressure reading is displayed. 
    • Digital pressure gauge, which senses the differential in air pressure and responds to the change in pressure between the adjacent spaces, and is then converted to an electronic signal, shown using a digital display.
  • Distributed sensor modules (DSMs), which are network-accessible modules used to monitor room differential pressure, and in some cases temperature and humidity as well. The output of the sensor is an analog signal that can be fed to a console or interface card for monitoring and control. One great benefit of these modules is that they can be connected to your building management system (BMS), so measuring and monitoring cleanroom airflow and pressure is in one cohesive system where all the readings are in one place.

Need Help With Your Next Cleanroom Project? Contact Us

If you have questions related to pressure or any other cleanroom-related topic, don’t hesitate to contact us at Angstrom Technology. Our team is full of skilled, friendly experts who are happy to provide the answers you need. And as an industry leader in cleanroom design and installation, we’re able to tackle whatever specifications your cleanroom project may require. 

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ULPA vs. HEPA Filters for Cell & Gene Therapy Cleanrooms

ULPA vs. HEPA Filters for Cell & Gene Therapy Cleanrooms

In the past couple of years, cell and gene therapies have been recognized as viable forms of treatment for life-threatening conditions, leaving many healthcare professionals excited about putting more effort into researching, developing, and distributing them. But in order to do so, they need a highly controlled environment — otherwise their results aren’t guaranteed to be safe, effective, or repeatable. 

The cleanroom component that plays the most integral role in a space’s cleanliness and performance is its filtration system, which consists of either ULPA or HEPA filters. Let’s discuss the differences between these two types of filters, so you have a better idea of which one may be best suited for your cell and gene therapy cleanroom. 

ULPA vs. HEPA Filters: What’s the Difference?

ULPA and HEPA filters both do great work catching tiny, airborne particles like bacteria, pollutants, and dust. They’re manufactured with similar technologies, but feature some differences in their filtration efficiency, airflow capacity, price, and lifespan. 

ULPA Filters

ULPA filter stands for Ultra-Low Particulate Air filter (ULPA). These filters are highly efficient and capable of meeting even the most stringent cleanliness requirements. Below are some of their standard specifications (which may or may not vary, depending on the exact size or brand of system you choose):  

  • Filtration efficiency: 99.999% efficient at removing particles 0.12μm or larger 
  • Airflow capacity: 20-50% lower than HEPA filters, due to denser filter
  • Price: generally more expensive than HEPA filters, due to higher filtration efficiency
  • Lifespan: estimated 5-8 years, depending on the surrounding environment

HEPA Filters

HEPA filter stands for High-Efficiency Particulate Air (HEPA). These filters are the most commonly used in cleanroom applications due to their quality filtration, cost-effectiveness, and longevity. Below are some of their standard specifications (which may or may not vary, depending on the exact size or brand of system you choose):  

  • Filtration efficiency: 99.999% efficient at removing particles 0.3μm or larger 
  • Airflow capacity: 20-50% higher than ULPA filters, due to less dense filter
  • Price: generally more affordable than ULPA filters, due to lower filtration efficiency
  • Lifespan: estimated 7-10 years, depending on the surrounding environment

Filtration Considerations for Cell & Gene Therapy Cleanrooms

Cell and gene therapies are practices that require a high level of control. In order to fulfill their purpose and work effectively to treat life-threatening diseases, there can be no disruption in their production process — which is why they’re usually concerned about removing smaller airborne particles between .1, .3, and .5 microns. Other cleanroom applications with less stringent requirements are typically only concerned about .5, 1, and 5 microns. This is the most important factor in determining which type of filter is best for cell and gene therapy cleanrooms. 

This also implies that most cell and gene therapy cleanrooms must meet stringent ISO standards, which are usually between ISO Class 5-7, but can be higher or lower depending on the application. For ISO 5, this means that they must have at least 240 air changes per hour, 35-70% ceiling coverage, 40-80 feet per minute of air velocity, and no more than 10,200 particles 0.3μm or larger in a cubic meter. The requirements are a little looser for ISO 7, which requires at least 60 air changes per hour, 15-20% ceiling coverage, 10-15 feet per minute of air velocity, and no more than 1,020,000 particles 0.3μm or larger in a cubic meter.

ULPA vs. HEPA Filters for Cell & Gene Therapy Cleanrooms

So, which type of filter is right for your cell and gene therapy cleanroom? ULPA or HEPA? 

It depends on what specific tasks you’re hoping to accomplish within your cleanroom. Currently, in the world of cell and gene therapy, there are four main types of therapies:

  • Cell therapy
  • Gene-modified therapy
  • Gene therapy
  • Tissue-engineered products

Each of these therapies require a number of different sub-processes, which all require a different level of control. It’s best to determine which ISO standard your cleanroom needs to meet first and what size airborne particulates can be detrimental to your process, then choose your type of filter based on that.

But from a broad perspective, ULPA filters are generally recommended for cell and gene therapy processes, since they offer more stringent control over smaller airborne particles. HEPA filters can offer enough control for some cell and gene therapy applications, but aren’t the most commonly recommended. 

Cell and gene therapy are two fairly new, but steadily growing practices in the medical field. If you’re hoping to install a cell and gene therapy cleanroom in your facility, it’s important that you get the details right — and for that, you can trust Angstrom Technology. Our experts have experience designing, building, and servicing cell and gene therapy cleanrooms (check out our latest project!) across the globe, and we’d be happy to create a solution that meets your specific needs. Contact us online to get started. 

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SoftWall Cleanroom Features

SoftWall Cleanroom Features

There are three common types of cleanrooms: HardWall, SoftWall, and RigidWall. The differences behind each of them lie in their materials, construction, layout, level of environmental control, and more. While all of them are great cleanroom options, one may be better suited for your cleanroom application and classification than the others. 

In this article, let’s take a closer look at SoftWall cleanrooms. 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 SoftWall Cleanrooms?

SoftWall cleanrooms are the most cost effective type of cleanroom. Known for their affordability and versatility, they’re minimalist, easy to install cleanrooms that can meet a variety of ISO standards. Because of these characteristics, they make great cleanroom options for industries and applications that have minimal space within their facility, are under a quick time frame to get the project completed, and don’t require strict environmental requirements such as: plastics manufacturing, automotive, and some medical cleanroom applications. 

SoftWall Cleanroom Features

Depending on the specific application, every SoftWall cleanroom is designed and built differently. However, they all have some of the same basic features, which are listed in the three sections below: 

SoftWall Cleanroom Materials

In the most basic sense, SoftWall cleanrooms consist of an extruded aluminum ceiling system, legs, and clear curtains around the perimeter. Additional specifications include:

  • Ceiling System – A SoftWall cleanroom’s ceiling system consists of a detailed network full of extruded aluminum framework, fan filter units (FFUs), lights, and cleanroom ceiling tiles. 
  • Framing – SoftWall cleanroom framing is made of a durable, extruded aluminum, which is finished with white powder baked enamel or clear anodized. 
  • Curtains – SoftWall cleanroom curtains are made of 40, 60, or 80 mil acrylic, PVC, polycarbonate, anti-static PVC, or polysim. They’re typically clear curtains, but depending on your application you may require light wavelength control and UV absorption. Curtains are mechanically fastened to the structure in an extruded track around the perimeter of the room.
  • Entrances – SoftWall cleanrooms are compatible with strip curtain entrances, which can either be stationary or on a sliding track. 

SoftWall Cleanroom Sizes

SoftWall cleanrooms are available in standard sizes that come in 2’ x 4’ increments. However, many cleanroom manufacturers will allow you to request a custom size if needed. 

SoftWall Cleanroom Standards

SoftWall cleanrooms are able to meet most ISO standards. However, they don’t provide as much environmental control as their HardWall and RigidWall counterparts. 

Benefits of SoftWall Cleanrooms

So, what exactly makes SoftWall cleanrooms such a popular choice? Here are some of the most common reasons why our customers at Angstrom Technology enjoy them: 

Unmatched Affordability

Due to their simple, minimal design, SoftWall cleanrooms are typically the most affordable type of cleanroom. However, it’s important to remember that if your application requires the high level of control that only HardWall or RigidWall cleanrooms can provide, you’re better off making that higher upfront investment than trying to pinch pennies and purchase an ineffective solution. 

Extreme Reconfigurability

Also due to their simple, versatile design, SoftWall cleanrooms are more portable. They’re easy to move and modify, and they’re even able to fit into tight spaces other cleanroom types won’t because of their small footprint. This extreme reconfigurability results in their ability to provide a long-lasting investment. 

Exceptional Versatility

Although SoftWall cleanrooms all have the same basic features, they can be built to meet your specifications. Whatever filtration systems, specialized equipment, or workspaces you need, they’re all able to be installed and accommodated in a SoftWall cleanroom. 

Quick & Easy Installation

With minimal required materials and a relatively simple design, SoftWall cleanrooms can typically be installed within just a few days. Of course, this timeline depends on your project’s size and scope — but, overall, they’re the quickest type of modular cleanroom to build and install. 

The combination of low-cost and high versatility makes SoftWall cleanrooms an appealing option for any growing business. Think a SoftWall cleanroom might be right for your application? Angstrom Technology can help! Our team has extensive experience designing, installing, and servicing all types of cleanrooms, and we’re ready to aid in the development of yours. To get started, give us a call or contact us online today.

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