Free Resource for Sterile Compounding Pharmacies

Sterile compounding environments require a structured approach to cleaning and disinfectant rotation to maintain microbial control and support compliance with USP <797>.

USP <797> requires:

• Routine disinfection of critical surfaces
• Daily cleaning of cleanroom environments
• Periodic use of a sporicidal agent to control bacterial spores

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A Simple, Defensible Cleaning Framework

1. Routine disinfection during compounding
2. Daily surface cleaning of the cleanroom
3. Periodic sporicidal control

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1. Routine Disinfection (ISO 5)

Purpose

Rapid reduction of microbial contamination during active compounding.

Use Frequency

Throughout the compounding day.

Recommended Products

• Sterile 70% Isopropyl Alcohol (IPA) – sprays or wipes

Common Uses

ISO 5 Primary Engineering Controls (PECs):

• Before compounding
• Between batches
• At least every 30 minutes during compounding

Other Surfaces:

• Small equipment
• Materials entering the hood

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2. Daily Surface Cleaning (ISO 7 / 8)

Purpose

Broad-spectrum microbial control throughout the cleanroom.

Use Frequency

Daily.

Recommended Products

• TexQ® Sterile Quat Disinfectant (TX650)
• Hydrogen peroxide–based disinfectants (e.g., Peroxigen® ST)

Common Uses

• Work tables
• Carts and staging areas
• Pass-through chambers
• Floors and general cleanroom surfaces

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3. Sporicidal Control (Required Step)

Purpose

Control of bacterial spores not eliminated by routine disinfectants.

Use Frequency

Defined by the facility SOP (commonly monthly).

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Primary Option (One-Step Sporicidal)

• PeridoxRTU
  • Fast-acting sporicidal disinfectant
  • Available sterile for ISO 5 use
  • Widely used in compounding cleanrooms

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Alternative Option (Two-Step Process)

• Avert Sporicidal Disinfectant Cleaner
• Follow with sterile IPA wipe-down

Why use this approach?

Some pharmacies prefer to avoid peroxide/peracetic acid–based sporicidals due to odor, residue, or surface compatibility concerns.

Avert provides true sporicidal efficacy using a different chemistry (bleach-based), and when followed with a sterile IPA wipe, offers a practical and widely used alternative approach.

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Common Sporicidal Applications

• ISO 5 surfaces (PECs)
• Walls and ceilings
• Pass-through chambers
• Difficult-to-clean areas

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Optional: Enhanced Disinfection Step

For facilities looking to reduce reliance on harsher sporicidals:

• SporGon® (high-level disinfectant)
• Peroxigen® ST (sterile hydrogen peroxide)

These can be used between sporicidal events to:

• Increase overall microbial control
• Reduce residue and surface impact
• Improve day-to-day usability

(Note: These products are not positioned as primary sporicidal agents.)

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Why Disinfectant Rotation Matters

Sporicidal disinfectants are essential for controlling bacterial spores, but they are typically not used for routine daily cleaning due to:

• Cost
• Material compatibility
• Workflow impact

A structured rotation allows pharmacies to:

• Maintain strong microbial control
• Align with USP <797> expectations
• Reduce overuse of harsh chemistries
• Improve staff usability and consistency

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Need Help Evaluating Your Current Setup?

Every pharmacy operates a little differently depending on workflow, facility design, and compounding volume.

If you’d like a second set of eyes on your cleaning rotation or disinfectant selection, we’re always happy to help.

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Beaker Bunker

Supporting 503A compounding pharmacies with:

• Cleanroom disinfectants
• Sterile alcohol wipes
• Environmental monitoring products
• PPE and gowning supplies
• Sterile compounding consumables

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Additional Guides Available

We also offer simple guides for:

• USP <795> non-sterile compounding
• USP <800> hazardous drug handling

If you’d like copies, just let us know.