Are the terms sterile and aseptic used interchangeably? Is a cleanroom sterile? What is aseptic processing?
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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.
Definitive Cleanroom Construction FAQ: How much does a cleanroom cost? How does the level of ISO classification impact build and operating costs? How much supporting space will I need for a cleanroom addition or ISO class upgrade? What’s the advantage of a turnkey cleanroom system?
Cannabis Cleanroom Construction This post regards the specific construction components of building a cleanroom for medical cannabis cultivation. Previously, we’ve written about the dangers of
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.
A comparison of cleanroom classifications and specifications.
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
Industrial workbenches and workstations provide integrated design features such as power bars, application specific surface materials, and custom drawer and cabinet configurations for safe, organized storage. This laboratory enlisted for a complete laboratory outfit, with ergonomic seating and Lista drawer cabinet workstations.
This modular, sterile compounding cleanroom is designed for ISO 797 and ISO 800 compliance, particularly for compounding chemotherapy drugs. Safe handling of sterile compounds requires special considerations: heat-welded floors, anterooms and buffer areas.