If you're thinking of integrating compounding services into your pharmacy, are new to compounding or are a seasoned professional who’s looking to expand, it's important to know regulatory standards are changing the compounding environment. Modular cleanrooms are a great way to implement or expand existing cleanrooms and address the ever-evolving compounding pharmacy regulations and standards.

Advantages of choosing a modular compounding cleanroom include:

• Lower costs

• Greater customization & flexibility

• Can be built adjacent to existing walls within pharmacy lab

• Shorter build time

• Easier to clean and maintain pressure

• Reduces risk of insanitary conditions related to appropriate materials of construction

• Less “down” time

• Easier to supply air and exhaust air if required

• Fewer disruptions for pharmacy & customers

What is a modular cleanroom?

Generally speaking, a modular cleanroom provides a dedicated space for compounding medicines within an enclosed environment. Its purpose is to help prevent compounded medications from potential contaminants and protect compounders from potentially harmful chemicals (hazardous materials) when appropriate controls are included in the design of the room. As such, a compounding cleanroom requires a well-sealed area using non-porous, powder coated materials that won’t harbor chemicals or microbes.

Modular cleanrooms are built using prefabricated materials. Given the increased regulatory focus on maintaining sanitary conditions in cleanroom environments, materials used in prefabricated constructions must be able to sustain routine exposure to harsh cleaning, sanitizing, decontaminating, or sporicidal solutions, which can easily degrade walls, doors, ceilings, and floors when they are not made from suitable materials.

Careful consideration should also be given to the cleanroom’s design, which directly impacts staff efficiency and efficacy of meeting cleaning standards. For example, walls, floors and ceilings designed with rounded or coved corners are much easier to clean than those with angular corners. Ceilings designed with a T-grid system with removable vinyl coated panels are easily sanitized and help safeguard against hidden microbes and other potential contaminants.

The type of compounding performed by your pharmacy will determine the types and levels of controls needed in the cleanroom:

• A cleanroom used to compound non-sterile preparations (CNSP, USP 795) require the fewest controls;

• A cleanroom used for CNSP using hazardous materials (USP 795 + USP 800) increases controls;

• A cleanroom used to compound sterile preparations (CSP, USP 797) adds significant controls;

• A cleanroom used for CSP using hazardous materials (USP 797 + USP 800) need maximum controls.

Additional Considerations

On November 1, 2022, the United States Pharmacopeia (USP) published revisions to General Chapter 795, Pharmaceutical Compounding — Nonsterile Preparations (CNSPs), will be official and possibly enforceable in your state on November 1, 2023. The date also triggers potential enforcement of USP 800, which addresses CNSPs and CSPs using hazardous drugs.

USP 795 revisions define minimum schedules for cleaning and sanitizing nonsterile compounding area surfaces. Cleaning and sanitizing procedures also changed in Chapter 797 revisions, including environmental monitoring and cleaning processes for specific categories of compounded sterile preparations. The FDA also focuses on the quality of the compounding environment for both CNSPs and CSPs in their guidance, Insanitary Conditions at Compounding Facilities .

Cleanroom Providers

Given regulatory oversight and complexities, it’s vital to partner with an experienced and reputable cleanroom provider with:

• Knowledge of regulatory & compounding industry standards

• Recommendations to improve pharmacy workflow & minimize patient inconvenience

• Experience in modular compound cleanroom installation for type(s) of compounding

• Guidance and support throughout the build process

  1. Immediate notification of delays in cleanroom construction materials or build time

  2. Previous customer experience (i.e., testimonials, peer organizations, peer collaboration)

  3. Foremen and installation crews familiar with all wall-system components & trained from A to Z to install modular compounding cleanrooms

Initial Steps

• Decide type(s) of compounding service(s) your pharmacy will offer (including lab expansion)

• Become familiar with USP Minimum Standards

  1. USP 795 sets minimum standards for non-sterile compounded preparations

  2. USP 797 sets minimum standards for sterile compounded preparations

  3. USP 800 sets minimum standards for compounding preparations with hazardous materials

• Contact your state board of pharmacy to learn state board requirements

• Become familiar with FDA guidance

Helpful Resources

PCCA partnered with ISO 9001 certified Nicos to deliver seamless cleanroom design with expert support that exceed USP minimum standards. Learn more here.

Look for our forthcoming four-part Blog series on USP 795, 797 and 800 Revisions & Impacts, scheduled to begin February 13.

For those looking for USP implementation training, we partnered with the Alliance for Pharmacy Compounding (APC) to provide courses on quality, compliance and regulatory requirements.

PCCA offers additional resources to our members, including eLearning Compounding Training and multiple online webinars and training sessions . Members with Clinical Services may also contact our Clinical Services team for help with formulas and other compounding concerns.

Related Blog Posts: 

What to Consider in Building a Modular Cleanroom
Recommendations For Navigating USP 800
Important Considerations for Cleanroom Design