Tag: Fedegari

Fedegari: Highlights on “Equivalent Time” F0

This paper summarizes the concept of Fo and its related parameters (D, z). Essential notions on sterilization kinetics are explained. The idea of physical and biological “equivalent time” is presented...

Fedegari: Flexibility and Cost-Effectiveness for Advanced Aseptic Production

The use of robotics and automation in the industry is not new. For several decades now, many assembly lines have utilized production robots in different functions to increase productivity. Although hu...

Fedegari: Continued Process Verification Methods in Cleaning Validation

An increasing interest in continued process verification has brought to the spread of on-line assay methods in cleaning processes . This paper deals with two different on-line applications: conductivi...

Fedegari: Results after Chemical Decontamination Cycle with Vaporized Hydrogen Peroxide

This article discusses the challenge of the unexpected growth of a positive biological indicator in a chemical decontamination cycle. Specific features to be considered regarding biological indicators...

FEDEGARI: Cost-effective Solution for Sterile Antibiotic Powder Filling of Al-kegs

According to the FDA (Food and Drugs Administration), pharmaceutical manufacturing has been well known for its inefficient and costly operations (2004). Recently, the need to increase efficiency and r...

Key Factors in Choice and Development of Cleaning Strategy, II

This article discusses the removal of bacterial endotoxins in a washing process and the need for a continuous monitoring activity according to common cleaning validation practices. Results of washing ...

Fedegari, Innovative Way to Thermally Sterilize Hyaluronic Acid Pre-Filled Syringes

Several reports on degradation of HA involving microwaves, UV or γ-rays have been published. Rheological studies also show that HA solutions degrade at high temperature: viscosity of the solutions dec...

Workshop for Pharmaceutical Inspectorate in Moscow

A 3-day training workshop for experts of the pharmaceutical inspectorate with international participation has been started. The event has been organized by FSI «SID & GP» of Minpromtorg of Russia ...

Key Factors in the Choice and Development of a Cleaning Strategy

Many aspects need to be considered in setting up a cleaning procedure. This is certainly a multidisciplinary issue that involves various company areas: from “Regulations” to Engineering, from Quality ...

Fedegari, Decontamination by Hydrogen Peroxide: Use and Technical developments

This article compares the concepts of sterilization, disinfection and decontamination with reference to the different scopes thereof. Decontamination by hydrogen peroxide vapor and its use for conditi...