Compounding Pharmacy Product Guide

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USP 797 is changing the requirements for how pharmacies need to clean and disinfect compounding areas. Fisher Scientific can help with an unrivaled portfolio of products to help our customers meet these new, quality standards.

Overview

What is USP 797?

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USP 797 is issued by U.S. Pharmacopoeia (USP), and this regulation governs any pharmacy that prepares "compounded sterile preparations". The goal of the regulation is to cut down on infections transmitted to patients through pharmaceutical products and to better protect staff working in pharmacies in the course of their exposure to pharmaceuticals. You can learn more about USP 797.

While the USP 797 certification process is voluntary, compounding pharmacies are evaluating all cleaning processes for improvement, particularly sterile applications. Fisher Scientific recognizes the challenge that our customers are experiencing when trying to identify cleaning products that are USP 797 compliant.

Common challenges for compounding pharmacies include:

  • Contamination of sterile products is the most common compounding error
  • 30% of microbial detection in a sterile cleanroom is on clothing
  • Pharmacy inspections are increasing, as well as FDA Form 483 citations

Fisher Scientific has been committed to providing high-quality cleaning products to laboratories and production environments for more than 100 years. USP 797 and its cGMP driven quality measures is rapidly changing the compounding pharmacy landscape and we are here to help.

Building on Fisher Scientific's experience and relationships with the industry's leading manufacturers, we are uniquely positioned to help our customers identify products to support USP 797 compliant cleaning processes. Whether you are considering certifying your compounding pharmacy or you simply want to improve your current procedures, Fisher Scientific has the resources to help you reduce the risk of contamination.

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Products
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Decon™ CiDehol™ ST Sterile Isopropyl Alcohol

Sterile, ready to use 70% IPA solution

  • Solution is filtered to 0.2µm, individually double-bagged in an ISO Class 5 environment, and sterilized via gamma irradiation, producing a Water-For-Injection Quality (WFIQ™) product
  • Each lot undergoes sterility and pyrogen testing and meets WFI limits in endotoxin
  • Each case shipped with a lot-specific document which details QC, irradiation and testing

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