USP 800 is a cleanroom compounding standard that was issued in March of 2014 by the United States Pharmacopeial Convention (USP). It’s primary focus is expanding the safety of healthcare workers, patients, and the environment for processing hazardous drugs. It’s scope reflects a number of stages in the delivery of sterile and non-sterile compounds, including:
Pre-engineered fabrication consolidates scheduling with minimal disruption and fewer variables. Difficult or expensive upgrades avoid overbearing noise, construction artifacts, and minimize if not eliminate the burden on facility staff for project management.
USP Chapter 797 cleanroom design requires that facilities pressurize non-hazardous compounding and storage areas. ISO 5, 7 and 8 environments support primary engineering controls, buffer rooms, and ante-rooms.
New USP guidelines may present challenges for compounding facilities. Some facilities need infrastructural and mechanical modifications for compliance. System evaluation includes duct systems, HEPA fan filters, differential pressure standards, air monitoring, and external air exhaust equipment.
Facilities unpacking hazardous drugs within a negative pressure room do not require procedural changes to meet USP unpacking area requirements. Facilities unpacking HDs within positive pressure ante rooms or facility spaces will require reconsideration.
The definitive cleanroom and sterile compounding glossary. Learn terminology and definitions for USP 797 and USP 800 compounding.
This post regards the specific construction components of ultra-clean cannabis grow rooms. Previously, we’ve written about the correlations of contaminated cannabis, and how it affects
The benefit of modular cannabis cleanrooms over traditional fixed wall grow rooms is that the configurable partitions of modular cleanroom designs lower the cost of installation or re-configuration for changing regulations. Divider rooms total environmental control, larger yields, and improve regulatory compliance at various stages of the growing cycle.
This guide provides a framework for employees entering a cleanroom.
Softwall cleanroom curtains, sometimes referred simply as “plastic strips” yield ISO Class 10,000 level particle control with minimal construction. This customer required a custom softwall installation that integrated into their existing building structure CleanPro to deliver a softwall cleanroom
What are the key determinants of cleanroom components? Learn about different types of cleanroom filtration, wall construction, lights, temperature, humidity and more.
Advantages for Modular Hardwall Design and Construction of ISO 14644-4 Cleanrooms.
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There are numerous considerations when evaluating cleanroom construction and design. The goal of this post is to touch on the basics. You may very well
1. Ignoring the Need to Wipe on a Regular Basis To assure quality is maintained in all cleanroom and restricted areas, housekeeping maintenance must be
Article reprinted from Clean Air Products, manufacturers of air showers, cleanrooms, and cleanroom accessories. A cleanroom provides a controlled environment in which companies can produce