The basic function of a clean room is to protect the manufactured product from contamination. In pharmaceutical production, the survival of a drug manufacturer is heavily invested the safety of the finished product. So, it is necessary to identify any potential source of contamination, which includes the working environment itself. Requirements of the quality of …
After reading this article you will: understand the principles of sterile compounding understand the requirements for sterile compounding understand the principles of operation of a laminar airflow hood Introduction Health care is increasingly moving into the home setting, creating new challenges for pharmacists. Pharmacists may be asked to fill prescriptions for intravenous solutions, and prepare …
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Is your hospital affiliated with Premier, Inc? Aseptic Enclosures is a contracted supplier through Premier Inc. Our two agreements with Premier; Pharmacy Planning and Conceptual Design and Primary Engineering Control Devices, allow us to help you achieve USP 800 and USP 797 compliance with the savings of Premier membership. With all the ever-changing rules compliance …
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USP <797> outlines three risk levels for compounding sterile preparations: low, medium, and high. The risk level is determined based on the likelihood of contamination, the number of manipulations involved in compounding, and the environment in which compounding occurs. For low-risk compounding, which involves aseptic manipulations using only sterile components and equipment, the minimum requirement …
Aseptic Enclosures has been traveling across the United States to bring State Boards of Pharmacy the latest updates and innovations for USP 797 and USP 800 compliance while providing lunch for the day! Call us or Live chat us today to schedule your State Board of Pharmacy Lunch and Learn! Aseptic Enclosures has decades of …
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August 24 2016. Aseptic Enclosures. St. Louis, MO. The purpose of this post is to help you evaluate the type of hood you do your sterile and containment work in. It is our strong contention that much more laboratory work should be done in a class III ACI a.k.a. Glove-box, Isolator, etc. Aseptic Containment Isolator keeps you …
The Situation: A Hospital Upgrades Cleanroom that was not meeting the USP<797> requirements(1) for an ISO class 7 (2) grade cleanroom. The existing cleanroom was deficient in both Air Changes Per Hour (ACPH) and lacked low wall returns. The Challenge: After multiple meetings with pharmacy staff, facilities, maintenance, engineering and architectural, it was determined that …
“First air principle is the last defense against contamination, that’s why The importance of first air principle in aseptic processing and sterile compounding is very high” It can help guard against bad technique being utilized in upstream processes. The USP goes to great lengths to describe first air and unidirectional airflow. Significant testing and airflow …
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USP Publishes Standard on Handling Hazardous Drugs in Healthcare Settings Rockville, Md., February 1, 2016—The United States Pharmacopeial Convention (USP) published today an important new standard as part of a suite of healthcare quality standards included in the United States Pharmacopeia-National Formulary (USP-NF). USP 800 policy of Hazardous Drugs Management: The new general chapter, USP …
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