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September 22, 2023

Revamp Your Mixing Room: USP 797 Edition

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Revamp Your Mixing Room: USP 797 Edition


Are you ready to give your compounding area a much-needed makeover? The countdown to the November 1st, 2023 deadline has officially started, and it's time to ensure your compounding area is up to par. I'm sure you're making your checklist and getting prepared because November 2023 is right around the corner. Here’s a brief overview of what you need to know!

Room Layout Matters

When it comes to creating the perfect compounding area, your room layout should fall under one of two categories: AECA (Allergenic Extracts Compounding Area) or PEC (Primary Engineering Control).

  1. AECA (Allergenic Extracts Compounding Area): This is a designated space with a visible perimeter that is suitable for extract mixing.
  2. PEC (Primary Engineering Control): Under USP 797 section 21, if you don't have an AECA, you'll need a PEC, also known as an ISO class 5 ventilation hood.

Key Considerations for Your Compounding Area

Regardless of whether you choose an AECA or PEC, here are some important considerations for your compounding area:

  • Steer Clear of Unsealed Openings: Ensure there are no unsealed windows or doors that open to the outside.
  • Dedicated Compounding Zone: Compounding time is sacred; no multitasking allowed! Limit traffic and other activities in the area during compounding, restricting access to authorized personnel only.
  • Location Matters: Place your compounding area away from restrooms, food preparation areas, and other sources that could negatively affect air quality.
  • Spacing: Maintain a distance of at least one meter from the sink.
  • Temperature and Humidity Control: Keep your compounding area temperature and humidity controlled for optimal conditions.

Stay Tech-Savvy

Don't worry; you can still use the ModuleMD system to streamline your mixing process. With minimal clicks, you can access all your extract orders from one screen and print labels for enhanced safety, accuracy, and efficiency. Consider dedicated devices like a laptop and label printer with sanitary protections, such as disposable poly laptop covers.

Special Design Features for AECA Rooms

If you opt for an AECA-style room, here are some special design features to consider:

  • Visible Perimeter: Define the AECA with a visible perimeter.
  • Clean and Smooth Surfaces: Ensure that all surfaces, including walls, floors, fixtures, shelving, counters, and cabinets, are free of cracks, non-porous, and easy to clean.
  • Minimize Dust Collection: Reduce overhangs that can collect dust, and make sure they are easily cleanable.
  • Proper Lighting: Design your AECA for ample, well-controlled lighting to create a well-lit working environment.
  • Modernize Your Space: If your compounding area still has that shag carpet from the '70s, it's time to ditch it for a modern, easy-to-clean upgrade.

Consider a PEC

If the thought of a complete demolition for an AECA seems daunting, consider a simpler DIY with a PEC-style room. One simple update that can transform your space is installing an ISO class 5 hood vent in a dedicated area, potentially saving you from a demolition disaster.

Remember, not all hood vents are created equal; your hood must be an ISO class 5 and certified initially and every 6 months.

Whether you're leaning towards an AECA or PEC-style room, the clock is ticking to tackle this project. Just like many ModuleMD clients, you can be ready for the November 1st deadline. With careful planning and attention to detail, you can properly transform your compounding space and meet the new USP 797 specifications.

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