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Time to Start your Compliance process

Complying with all the current compounding regulations can seem like a steep hill to climb for health facilities professionals. Trying to understand all of the standards that must be met, facility and budget obstacles that pose challenges to implementing the measures needed to be in full compliance, and uncertainty over what lies ahead make navigating …

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Case Study: Hospital Upgrades Cleanroom for a Fraction of the Anticipated Time and Cost

Here’s a case study about a customer that saved a lot of time and money by implementing Aseptic Enclosures’ HEPACirc™ for their facility. Aseptic Enclosures’ HEPACirc™ is a general purpose, “Plug-and-Play” Clean Room Grade, air purification upgrade system ideally suited to many types of clean mechanical or processing work. It is designed to provide an …

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Let Us Help Your Facility Create the Most Aseptic and Safest Working Environment!

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 …

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Environmental Monitoring and Sampling Test Supplies

It is important for each facility to understand their environment and potential sources of contamination and implement appropriate controls that comply with USP <797>. This requires proper aseptic facilities, the development of policies and procedures for cleaning, aseptic technique, sterility testing, personnel testing, and environmental monitoring. USP <797> indicates that sampling frequency is to be …

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Aseptic Enclosures Lunch and Learn Meetings For Your State BOP

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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ACI’s keeps you, and your research safer – Aseptic Containment Isolators do a superior job!

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.  They provide …

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Hospital Upgrades Cleanroom for a fraction of the anticipated time and cost.

The Situation:  A hospital pharmacy had an existing 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 …

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The importance of first air in aseptic processing and sterile compounding

“First air is the last defense against contamination.” 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 characteristic patterning is also routinely done in the pharmaceutical manufacturing segment. It is tremendously important when set against …

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USP 800 Chapter

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). The new general chapter, <800> Hazardous Drugs – Handling in Healthcare Settings, …

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