For communication satellites that remain within earth’s orbit, an ISO Class 6-8 cleanroom allows sufficient particle and contaminant control. Cleanroom engineers design each space so that particles from production surfaces are whisked away from critical components. A combination of softwall production areas and hardwall cleanroom facilities provide isolation of critical tasks.
For ISO 14644 compliance, all particle counting equipment requires a calibration certificate.
Modular cannabis grow room designs improve the longevity of grow room construction. Likewise, portable prefab grow rooms allow for more adaptable configurations when expanding, relocating, or re-purposing a grow room. There are also a number of tax and legal advantages when construction is non-permanent. Prefab modular grow rooms are cost-effective without the inconvenience of conventional “stick-built” construction.
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 standard issued in March of 2014 by the United States Pharmacopeial Convention (USP). The deadline for compliance may change, at the time of this articles publication the deadline is scheduled for December 2019. The date and scope of adoption may differ on a state-by-state basis, thus consulting with a compliance specialist is encouraged.
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?
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.
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