For ISO 14644 compliance, all particle counting equipment requires a calibration certificate.
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.
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.
Proper cleanroom cleaning procedure and maintenance protocol is an immediate, low-cost measure to enhance overall cleanliness, consistency, and contamination control within manufacturing and aseptic cleanrooms. This guide provides a framework for cleanroom management, protocol standards, specifications, and processes for general manufacturing and bio-medical applications.
Advantages for Modular Hardwall Design and Construction of ISO 14644-4 Cleanrooms.
Why Is Static Dissipative PVC a Better Option than Acrylic?
High-traffic cleanrooms use tightly controlled procedures with repeatable processes to maximize the passage of people in and out of sanitary environments. Cleanroom facilities of all
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