USP <797>
Sterile Preparations for Pharmaceutical Compounding
Overview
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“Describes conditions and best practices to prevent critical harm to patients, which can be attributed to contaminated or improperly compounded sterile preparations (CSPs).”
The outlined standards apply to all persons who prepare CSPs. This also includes the areas in which CSPs are prepared which may include: pharmacies, treatment clinics, hospitals, healthcare institutions, etc.)
Cleaning & Disinfecting Pharmacy Controlled Environments
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The preparation of CSPs is to be complemented with equally maintained sterility and a minimized introduction of particulate matter.”
“Environmental contact is one of the core sources of microbial contamination of CSPs.” While USP Chapter <797> provides best practices and minimum safety standards, Clean Air Essentials, offer the highest standard of cleaning and disinfecting products for compounding personnel preparing CSPs, who can be confident in knowing they are maintaining sterility and cleanliness to the compounding area.
Some of the sterile compounding duties include:
- Antiseptic Hand Cleansing and Disinfecting of Non-sterile compounding services Maintain sterility of CSPs in ISO Class 5
- Selection of appropriate protective garb
- Maintain sterility of CSPs in ISO Class 5
- Identify, weigh, and measuring of ingredients
It is important to recognize the contamination categories for CSPs, notably for their 3 levels of risk (low, medium and high) which can vary from harmful to life-threatening. While it is the responsibility of compounding personnel to be aware of the potential risks to the integrity of CSPs. It is also important to note that they are also responsible for the application of quality assurance practices, cleaning products and usage frequency. Proper product selection is important and should be done carefully.
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Clean Air Essentials Guide for Cleaning and Disinfecting
Primary Engineering Controls (PEC):
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- Page 15 of the USP <797> indicates that “Cleaning and disinfecting surfaces in the LAFWs, BSCs, CAIs, and CACIs are the most critical practices before the preparation of CSPs.
- Consequently, such surfaces shall be cleaned and disinfected frequently, including at the beginning of each work shift, before each batch preparation is started, every 30 minutes during continuous compounding periods of individual CSPs, when there are spills, and when surface contamination is known or suspected from procedural breaches.”
Apply the P-E-C Cleaning Method:
Minimum Cleaning Frequency: |
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Anteroom and the Buffer Room:
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Isolators:
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Minimum Cleaning Frequency: |
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Ceilings and Walls:
- Page 16 of the USP <797> indicates that “In the buffer or clean area, ante-area, and segregated compounding area, walls, ceilings, and shelving shall be cleaned and disinfected monthly.”
Cleaning Method: Eyes Up, Eyes Down (Top to Bottom)
Minimum Cleaning Frequency: |
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Floors:
- Page 15 of the USP <797> dictates that “Floors in the buffer or clean area, ante-area, and segregated compounding area are cleaned by mopping with a cleaning and disinfecting agent once daily at a time when no aseptic operations are in progress.”
It is essential to be mindful of the following:
- Cleaning Materials Our sterile wipes or wiper rolls are recommended for cleaning.
- *Note: Cleaning tools should be treated as single-use only.
- Floor Cleaning Disinfectants: “When the surface to be disinfected has heavy soiling, a cleaning step is recommended prior to the application of the disinfectant.”
- Storage: Cleaning supplies used should be dedicated to that area, exclusively and not used in combination (i.e.) buffer or clean, ante and compounding areas.
- *Note: Removal of supplies from areas should be for proper disposal purposes, only.
Cleaning Method: “Far Out”
Minimum Cleaning Frequency: |
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