Aseptic Archives

The Big Little Things, Part II: Port Disinfection Subsystem

Posted on September 23, 2014

By Walter Eliuk, P.Eng. RIVA is a fully automated IV compounding system that produces IV bag and syringe medications in a Hospital pharmacy. The Port Disinfection Subsystem (PDS) is a powerful feature unique to RIVA. This feature helps to assure reliable aseptic processing of compounded products. A state-of-the-art UV light source is used to disinfect... Read more

Recent Regulatory Actions: Focus on Quality in Compounding

Posted on August 6, 2014

by Craig A. Boyce , RPh Over the past month, a number of regulatory changes have occurred surrounding aseptic and sterile compounding. Some of the significant regulatory actions include: FDA release of the cGMP Interim Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act (7-1-2014) Massachusetts passage and signing of... Read more

Sanitizing Aseptic Compounding Consumables

Posted on July 2, 2014

Craig A. Boyce , RPh All consumables entering into an ISO-7 buffer zone must be sanitized by saturating the object with sterile isopropyl alcohol (sIPA) and wiping, leaving an adequate residual amount of sIPA so that the object remains wet for at least 30 seconds to kill viable organisms. Upon introduction into the ISO-5 zone,... Read more

The Big Little Things, Part II: Port Disinfection Subsystem

Recent Regulatory Actions: Focus on Quality in Compounding

Sanitizing Aseptic Compounding Consumables

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