USP 797 Archives

A Breath of Fresh Air

Posted on December 3, 2015

By: Mitch Valdmanis, Senior System Designer Part III: Of Pass-through Chambers and Control Systems In parts I and II of this series we described how RIVA has been designed to achieve ISO level 5 air cleanliness by sealing the compounding chamber, filtering incoming air, and maintaining laminar airflow inside of the cell. So far so... Read more

A Breath of Fresh Air

Posted on November 4, 2015

By: Mitch Valdmanis and Ron Rob Part II: Air Cleanliness In Part 1 of this series we discussed the importance of laminar airflow and the impacts it had on the design of RIVA’s air handling system. Laminar airflow is critical to preventing the spread of any contaminants in the airflow, but even better would be... Read more

A Breath of Fresh Air

Posted on October 8, 2015

By: Mitch Valdmanis and Ron Rob One of the interesting challenges to solve in the design of IV automation is to create and maintain an environment where the compounding process can be carried out in air conditions compliant with ISO Class 5 and USP<797>. There are many factors to consider in the design – far... 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

Pharmacy Automation – Is it Rocket Science?

Posted on June 23, 2014

By Cornel Van Egmond MSEE, C.I.M. (Source: NASA) Implementing automation in the pharmacy can be a daunting task. There are many different options available and it can be difficult to determine the right choice for your pharmacy. In the end, automation should make your pharmacy more efficient and safer for your patients. Read more

A Breath of Fresh Air

A Breath of Fresh Air

A Breath of Fresh Air

Recent Regulatory Actions: Focus on Quality in Compounding

Sanitizing Aseptic Compounding Consumables

Pharmacy Automation – Is it Rocket Science?

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