If you need a space to compound medications but don’t have the room or budget for a traditional cleanroom suite, a segregated compounding area may be a viable alternative.
A proper segregated compounding area design can offer you a cost-effective way to achieve compliance without investing in a complete ISO-classified cleanroom suite. More healthcare facilities have started using SCAs for smaller compounding operations when they can’t justify the time or cost of a cleanroom.
This helpful guide unpacks the question “What is a segregated compounding area?” so you can determine whether this solution may be appropriate for your operations.
What Is an SCA?
A segregated compounding area (SCA) is an unclassified space that contains an ISO Class 5 primary engineering control (PEC) dedicated to sterile compounding. An SCA doesn’t require ISO 7 or ISO 8 room classifications, which makes it different from a traditional cleanroom suite.
USP General Chapter <797> allows SCAs only for Category 1 CSPs, which have shorter beyond-use dates because they receive less environmental protection than preparations made inside a cleanroom suite.
Here are the defining characteristics of an SCA:
An unclassified room with no ISO room-classification requirement
An ISO Class 5 PEC that provides critical airflow protection
A clearly designated compounding perimeter that extends at least one meter around the PEC or occupies a separate dedicated room
Support for Category 1 CPSs with beyond-use dates of up to 12 hours at room temperature or 24 hours under refrigeration
Use these characteristics to determine whether a segregated compounding area can adequately support your production processes or whether you need to invest in a complete cleanroom suite.
SCA vs. Cleanroom Suite
Both a segregated compound area and a cleanroom suite are built for sterile compounding, but an SCA is subject to additional limitations. It features the following key characteristics:
Is an unclassified room
Used for Category 1 CSPs only
Minimal environmental monitoring
Lower construction costs
Simpler maintenance requirements
On the other hand, a cleanroom suite for compounding is characterized by the following elements:
Features an ISO 7 buffer room
Suitable for Category 1 and Category 2 CSPs
Extensive environmental monitoring
Higher construction costs
More comprehensive maintenance requirements
All of the foundational elements of an SCA vary from those of a cleanroom. For example, a cleanroom HVAC system is built to different specifications than a segregated compounding area.
An SCA may be a good solution if your pharmacy:
Prepares a small volume of sterile products
Faces space limitations
Needs an affordable path toward USP <797> compliance
Doesn’t require longer beyond-use dates
If your pharmacy has a higher production volume or is expanding its services, then investing in a pharmacy cleanroom is a wiser long-term decision.
USP <797> Requirements
A segregated compounding area USP <797> space must meet the following requirements:
Location: Must be an adequate distance from high-traffic areas, doors, and construction zones
Surfaces: Must be smooth, impervious, and non-shedding
Temperature and Humidity: Must be kept to ≤ 68 °F, with humidity of ≤ 60%
Handwashing Sink: Must be ≥ one meter from PEC
While USP <797> contains many other guidelines for SCAs, these are among the most critical, as they directly affect the quality and risk of contamination in daily operations.
Design and Common Mistakes
When designing a USP <797> segregated compounding area, it’s vital to consider all essential components that could impact the integrity of your workspace. This includes the FFU fan filter, sensors, and the HVAC system itself. Here are some other design considerations to account for:
A clearly marked perimeter
Supply storage outside the SCA
Adequate isolation from potential contaminants
Common mistakes when designing and implementing a segregated compounding area include:
Installing the SCA in a high-traffic location
Placing the handwashing sink too close to the PEC
Crowding the work area with excess supplies
Creating layouts that limit cleaning access
Ignoring airflow patterns around the PC
By planning properly and working with an experienced designer, you can prevent many of these issues before construction begins.
When to Upgrade
An SCA can work well for many pharmacies, but you’ll need a more functional space as your business grows. Consider upgrading to a cleanroom suite if any of the following are true:
Your sterile compounding volume is on the rise
Your pharmacy needs to prepare Category 2 CSPs
Hazardous drug compounding is a part of your daily operations
You want greater regulatory flexibility during inspections
A full cleanroom suite will give you greater control over the compounding environment and support a wider range of sterile compounding activities. In this way, having a larger, more capable space will enable you to expand your operations and capitalize on growth opportunities.
Invest in a Containment Segregated Compounding Area
Whether you need a new segregated compounding area or a complete cleanroom suite, the success of your project hinges on choosing the right design partner. CleanAir Solutions designs, retrofits, and upgrades pharmacy compounding environments that align with current USP <797> standards.
We offer pharmacy cleanrooms and other custom solutions for clients in heavily regulated industries, and our experts help clients with everything from design to parts selection and installation. With our assistance, you can meet the cleanroom and segregated compounding area requirements that apply to your operation.
Contact us for a free consultation on design, compliance, and upgrade planning.
FAQs
What Is the Main Difference Between an SCA and a Cleanroom Suite?
An SCA uses an unclassified room with an ISO Class 5 PEC and supports only Category 1 CSPs. By contrast, a cleanroom suite includes ISO-classified rooms that support both Category 1 and Category 2 sterile compounding while providing greater environmental control.
Can I Prepare Category 2 CSPs in an SCA?
No. Category 2 CSPs must be prepared in an ISO 5 PEC that’s classified as a cleanroom suite. You can only use SCAs for Category 1 compounded sterile preparations, according to USP <797>.
What Surfaces Are Required for an SCA Under USP <797>?
USP <797> requires smooth, impervious, non-shedding surfaces that allow for easy, thorough cleaning and disinfecting. All surfaces, including workspaces, ceilings, floors, and walls, should promote contamination control.
How Often Must I Perform Air Sampling?
USP <797> requires environmental monitoring for the ISO Class 5 PEC according to the standard’s prescribed schedule. You must engage in routine air sampling, surface sampling, and certification to sustain compliance.
Consult the latest USP <797> requirements and your accrediting organization for the specific testing frequencies that apply to your facility.