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…
Apr, Wed, 2023
The Essentials of Surface Wipe Sampling for Pharmacies
Any organization, both sterile and nonsterile, handling hazardous drugs (HDs) should be tested for surface contamination. This best practice…
The Essentials of Surface Wipe Sampling for Pharmacies
Any organization, both sterile and nonsterile, handling hazardous drugs (HDs) should be tested for surface contamination. This best practice…
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…
Sep, Mon, 2022
Proper Environmental Surface Sampling with Agar Plates
Environmental monitoring (EM) is a key element in ensuring that aseptic processing areas are maintained in an adequate state…
Proper Environmental Surface Sampling with Agar Plates
Environmental monitoring (EM) is a key element in ensuring that aseptic processing areas are maintained in an adequate state…
Jul, Fri, 2021
Environmental Monitoring Analyses: Early Warning Opportunities for Sterile Compounders
Environmental monitoring (EM) is an important element of the quality assurance program at sterile compounding facilities. These facilities need…
Environmental Monitoring Analyses: Early Warning Opportunities for Sterile Compounders
Environmental monitoring (EM) is an important element of the quality assurance program at sterile compounding facilities. These facilities need…
Mar, Wed, 2021
Cost of Quality and the Price of Nonconformance
Recalling and disposing of products, enduring lengthy litigation proceedings, processing reimbursements, and repairing a damaged reputation are among the daunting tasks that no compounding business ever wants to face.
Cost of Quality and the Price of Nonconformance
Recalling and disposing of products, enduring lengthy litigation proceedings, processing reimbursements, and repairing a damaged reputation are among the daunting tasks that no compounding business ever wants to face.
Jan, Wed, 2021
Pharmaceutical Supply Chain Infiltrated with Methanol
According to FDA, the pharmaceutical supply chain has been penetrated with ethanol that is contaminated and sometimes substituted with methanol.
Pharmaceutical Supply Chain Infiltrated with Methanol
According to FDA, the pharmaceutical supply chain has been penetrated with ethanol that is contaminated and sometimes substituted with methanol.
Nov, Fri, 2020
FDA Finalizes Insanitary Conditions Guidance for Compounding Facilities
The FDA has issued a statement with further emphasis on its intentions to increase enforcement against Insanitary conditions at compounding facilities.
FDA Finalizes Insanitary Conditions Guidance for Compounding Facilities
The FDA has issued a statement with further emphasis on its intentions to increase enforcement against Insanitary conditions at compounding facilities.
Oct, Wed, 2020
What Do FDA Investigators Look For At Compounding Facilities?
Recent FDA-483’s and Warning Letters reveal patterns of common observations by the FDA at compounding facilities.
What Do FDA Investigators Look For At Compounding Facilities?
Recent FDA-483’s and Warning Letters reveal patterns of common observations by the FDA at compounding facilities.