Application and Technology News
Engineering Controls for Sterile Compounding — USP Requirements and Equipment Selection
Sterile compounding is one of the most critical activities performed in healthcare pharmacies, where product sterility and personnel safety must be maintained simultaneously. As sterile preparations become increasingly complex and hazardous drugs are more widely used in clinical practice, healthcare facilities face growing challenges in designing compounding environments that comply with regulatory requirements while remaining practical to operate and maintain.
What Pharmacies Often Miss in USP <800> Compliance
An isolator alone does not guarantee USP <800> compliance. Explore the system-level requirements behind hazardous drug containment in modern hospital and pharmacy compounding facilities.
Selecting Barrier Technologies for Aseptic Processing: A Risk-Based Decision Framework Aligned with EU GMP Annex 1
The 2022 revision of EU GMP Annex 1 requires manufactures to ensure a high level of sterility assurance through the implementation of validated and controlled manufacturing processes prior to sterile product release. While previous versions offered a checklist of cleanroom requirements, the updated document is focused on a Quality Risk Management (QRM) and Contamination Control Strategy (CCS).
Empowering Glove Integrity Testing: Successful End User Training on the Esco IntelliGlove Tester (EIGT) in Bangladesh
Esco Bangladesh conducts End User Training on the Esco IntelliGlove Tester (EIGT), enhancing glove integrity testing, compliance, and contamination control in pharmaceutical manufacturing.
0.45 m/s ±20% at Working Position in Closed Sterility Testing Isolators: Requirement or Convention?
Sterility testing is a mandatory release test for non-terminally sterilized aseptic products. Before a batch can be released to market, it must demonstrate the absence of viable microorganisms that could harm patients upon administration. A confirmed sterility failure is a serious regulatory event that may result in product recall, warning letters, or even suspension of manufacturing authorization.
Redefining Glove Integrity Testing: Esco IntelliGlove Tester (EIGT)
Ensure compliance and consistent glove integrity testing with the Esco IntelliGlove Tester (EIGT). Wireless, portable, and ISO 14644-7 compliant, EIGT delivers traceable, repeatable results for pharmaceutical, aseptic, and biocontainment environments.
Turnkey Dismantling, Modification, and Relocation of a Multi-Glove Isolator System for a Biopharma Manufacturer
Turnkey Dismantling, Modification, and Relocation of a Multi-Glove Isolator System for a Biopharma Manufacturer
ISPE SG 2022: Here We Come!
Esco Aster with the Healthcare team is making a huge comeback during this year’s International Society for Pharmaceutical Engineering (ISPE) conference in Suntec Singapore Convention & Exhibition Centre, from Aug. 18-19.
