Cleanroom wipes and gloves undergo LAL and Agar Overlay Analysis when testing for pyrogen and endotoxin levels. This post details the methodology, historical relevance, and explores cleanroom solutions for pyrogen-free and low-endotoxin gloves and garments.
As of November 22nd, 2019, the USP will delay implementing previously suggested changes to USP 795 and 797 chapters until further notice.
In this post, we overview technical considerations for clean room fan filter unit selection, installation, and features. You’ll learn how PAC approaches design and configuration
How is a medical device cleanroom built? Here’s a component-by-component guide to ISO Class 7 cleanroom construction.
There are a few options available to cleanroom facilities who require new upgrades for USP 800 compliance. The best option will depend on the variables
What equipment and engineering controls do USP 800 cleanrooms require? What types of storage and monitoring systems will I need?
Updated November 2019: Where can I find updated USP 800, 797, and other compounding documentation? Are there any recent changes to USP documents? When is the official deadline for USP 800 compliance?
What are the essential requirements for USP 800 gowning? What kind of gloves and gowns do USP 800 hazardous drugs require?
View USP 797 gowning standards and core requirements. For sterile processing, additional precaution is needed to assure that no sterile surfaces contact non-sterile surfaces during gowning, processing, or cleaning. Sterile garments and gloves are recommended during aseptic workflows.
USP <1072> outlines decontamination practices for critical environments.In this post, we’ll outline the types of chemical disinfectants and sterilants used in cleanrooms and laboratories. This includes isopropyl alcohol, bleach, formaldehyde, hydrogen peroxide, and peracetic acid.
First published in 2004, USP Chapter <797> has undergone proposed revisions as of July 2018. These revisions are now available for public comment.
Updated: USP 800 is a cleanroom standard issued in March of 2014 by the United States Pharmacopeial Convention (USP). The deadline December 2019 for compliance may change.
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. Updated: 4/18/2019
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 modular, sterile compounding cleanroom is designed for USP 797 and USP 800 compliance, particularly for compounding chemotherapy drugs. Safe handling of sterile compounds requires special considerations: heat-welded floors, anterooms and buffer areas.
Learn more about the requirements of stainless steel tables during sterile processing.
Is sterile 3D printing possible? Are 3D printed parts sterile? This comprehensive guide to 3D printing sterile parts provides materials that withstand various sterilization techniques such as autoclaving, heat, ETO, and gamma. Here’s how 3D printing will enhance medical tooling and device manufacturing.
