What does USP 797 guidelines include?

The objective of the USP <797> Standard is to describe conditions and practices to prevent harm, including death, to patients resulting from a contaminated or improperly made compounded sterile preparations (CSPs).

How do you clean an IV room?

Remove items from areas to be cleaned, and clean surfaces by removing loose material and residue from spills; e.g., remove water-soluble residues with sterile water (for injection or irrigation) using low shedding wipes then wipe with a residue-free disinfecting agent such as sterile 70% IPA, and allow to dry before …

How do I clean my cleanroom?

Cleanroom Cleaning Procedure:

  1. Before shift begins, use a damp mop on floors and vacuum to dry.
  2. Vacuum all walls using a HEPA filter vacuum.
  3. Wash and wipe dry all windows and pass-throughs.
  4. At the end of every shift, wipe down all work areas.
  5. Put away products and supplies between shifts to prevent further contamination.

What surfaces in a clean room must be cleaned daily?

Inside surfaces of PECs used for non-hazardous compounding must be cleaned daily with germicidal detergent: Daily cleaning of all the surfaces inside of the PECs as well as easily cleanable horizontal surfaces and floors of the buffer and anterooms must be performed using a germicidal disinfectant.

What does USP 797 cover?

USP 797 is the standard in place governing the sterile preparation of compounded pharmaceuticals. USP 797 covers the compounding of both hazardous and nonhazardous drugs with a focus on the protection of sterile compounds and environments from contamination.

Is USP 797 finalized?

The United States Pharmacopeia (USP) in June 2019 released several new and revised pharmacy compounding standards. Due to pending appeals, the effective date of USP <797> remains postponed until further notice and USP <800> remains “informational” until <797> is finalized.

What items do you need to take care of first when you walk into the IV room?

Basic hygiene in preparation of compounded sterile products for IV administration

  • Personal hygiene: hand washing and gloves.
  • Handling bottles and bags of sterile fluids.
  • Handling vials of sterile materials for preparation of IV treatments.
  • Handling needles and syringes.
  • Low-risk level compounded sterile products.

What should never be in the compounding area?

You should not leave and reenter the compounding area without performing proper garbing and hand washing techniques. True. Leaving jewelry in place when washing hands is acceptable as the washing process sterilizes those items well.

What should be done before entering clean room?

Before entering the cleanroom, DO: Wear cleanroom garments (frock or bunny suit). Wear a bouffant cap & beard cover (if necessary). Wear gloves (if necessary). Wipe down any hand or power tools.

Which solution is recommended for cleaning a biological safety cabinet?

Decontamination and Cleaning Decontaminate the BSC before and after every use to prevent cross-contamination. Use a 1:10 fresh bleach solution followed by a 70% ethanol rinse to prevent corrosion and achieve good disinfection, or contact EHS if you need a bleach alternative.

How often are clean rooms cleaned?

Floors will be damp mopped weekly with a cleanroom detergent, distilled water, and a HEPA filter vacuum. Wipe walls with a damp cleanroom sponge and distilled water and vacuum dry once weekly. Windows and cleanroom pass-throughs are to be washed and wiped dry daily with lint-free 70% IPA wipes.

What is the immediate-use provision in USP <797>?

The immediate-use provision allows for the preparation and dispensing of compounded sterile products (CSPs) without the need to be in compliance with USP <797> requirements such as ISO Class 5 hood or isolator, facility design, environmental controls, personnel cleansing and garbing.

What are the USP 797 guidelines?

USP 797 Guidelines & Standards. The objective of the USP 797 Guidelines is to describe conditions and practices to prevent harm, including death, to patients resulting from a contaminated or improperly made compounded sterile preparations (CSPs). USP 797 provides minimum practice and quality standards for CSPs of drugs and nutrients,…

What is USP Chapter 797?

USP Chapter <797> is a set of enforceable sterile compounding standards issued by the United States Pharmacopeia (USP) that set the standards that apply to all settings in which sterile preparations are compounded. 7.

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