Introduction Mandated by regulatory requirements such as USP <797> Pharmaceutical Compounding – Sterile Preparations and Current Good Manufacturing Practices…
The Appropriateness of the ScanRDI® Sterility Testing Method
Introduction Mandated by regulatory requirements such as USP <797> Pharmaceutical Compounding – Sterile Preparations and Current Good Manufacturing Practices…
Oct, Tue, 2023
Facility Design and Construction Requirements | USP 795 & 797 Revisions
It is important to note that there have been significant changes made to the regulations governing Nonsterile Preparations and…
Facility Design and Construction Requirements | USP 795 & 797 Revisions
It is important to note that there have been significant changes made to the regulations governing Nonsterile Preparations and…
Oct, Thu, 2023
Sterility Testing | USP 795 & 797 Revisions
The quality attribute “sterile” attribute describes a condition that “cannot be applied to actual items labeled as sterile because…
Sterility Testing | USP 795 & 797 Revisions
The quality attribute “sterile” attribute describes a condition that “cannot be applied to actual items labeled as sterile because…
Sep, Thu, 2023
Beyond-Use Dates | USP 795 & 797 Revisions
The USP published updates to the USP General Chapters on compounding nonsterile (USP 795) and sterile (USP 797)…
Beyond-Use Dates | USP 795 & 797 Revisions
The USP published updates to the USP General Chapters on compounding nonsterile (USP 795) and sterile (USP 797)…
Jul, Tue, 2023
Antimicrobial Effectiveness | USP 795 & 797 Revisions
Antimicrobial preservatives are substances added to sterile and nonsterile dosage forms to inhibit the growth of microorganisms in multiple-dose…
Antimicrobial Effectiveness | USP 795 & 797 Revisions
Antimicrobial preservatives are substances added to sterile and nonsterile dosage forms to inhibit the growth of microorganisms in multiple-dose…
Jun, Wed, 2023
Water Activity | USP 795 & 797 Revisions
The new practice of using water activity as a tool for establishing the BUD of a CNSP is described…
Water Activity | USP 795 & 797 Revisions
The new practice of using water activity as a tool for establishing the BUD of a CNSP is described…
May, Tue, 2023
Cleanroom Certification | USP 795 & 797 Revisions
A cleanroom certification shall be performed prior to initiating sterile operations and must be repeated at least every six…
Cleanroom Certification | USP 795 & 797 Revisions
A cleanroom certification shall be performed prior to initiating sterile operations and must be repeated at least every six…
Mar, Thu, 2023
Surface Wipe Sampling Technique
In the following video, we demonstrate how to correctly conduct surface wipe sampling using Eagle’s SurfaceShield kit for the…
Surface Wipe Sampling Technique
In the following video, we demonstrate how to correctly conduct surface wipe sampling using Eagle’s SurfaceShield kit for the…
Mar, Thu, 2020
USP Issues a Decision on: 795, 797, and 825
USP has published a notice communicating the final decisions from the Appeals Panel in relation to USP <795>, <797>,…
USP Issues a Decision on: 795, 797, and 825
USP has published a notice communicating the final decisions from the Appeals Panel in relation to USP <795>, <797>,…
Feb, Wed, 2020
Environmental Monitoring & Why it Matters: Part 3
Data collected from an environmental monitoring program for compounding facilities are often analyzed using less sensitive metrics. Compounders often focus on whether the number of CFUs recovered per plate falls below the limits outlined in USP <797>.
Environmental Monitoring & Why it Matters: Part 3
Data collected from an environmental monitoring program for compounding facilities are often analyzed using less sensitive metrics. Compounders often focus on whether the number of CFUs recovered per plate falls below the limits outlined in USP <797>.