Fedegari Publications

Fedegari Publications
White Paper: An innovative way to thermally sterilize Hyaluronic Acid PFS
This article explains the R&D study that was presented during the 2016 PDA Universe of Pre-filled Syringes and Injection Devices, in California. Developed in collaboration with IBSA Farmaceutici Italy and Amphenol (Kaye).
Author: M.L. Bernuzzi, A. Giori
Revised: November 17th, 2016
Language: English
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White Paper: Why change is inevitable in aseptic manufacturing?
This article goes through all the main features of the gloveless robotic solution and describes a cluster tool concept for an advanced aseptic production facility.
Author: C. Fuchs, S. Mauri
Revised: February 11th, 2016
Language: English
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Revolutionary Isolator with GMP Robotic Arm: Cost-effectiveness for aseptic manufacturing.
Author: S. Mauri
Revised: November 2015
Language: English
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Key factors for developing a pharmaceutical cleaning strategy Part 2.
The removal of bacterial endotoxins in a washing process and the need for a continuous monitoring activity according to common cleaning validation practices. A comparison between conductivity analysis and Total Organic Carbon analysis.
Author: M. L. Bernuzzi/S. Ferretti
Revised: June 30th, 2015
Language: English
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White Paper: Key factors for developing a pharmaceutical 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: contributions of all these areas together can lead to a robust and reproducible cleaning process.
Author: M. L. Bernuzzi
Revised: February 25th, 2015
Language: English
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White Paper: Results interpretation of a chemical decontamination cycle performed with H2O2.
This article discusses the challenge of the unexpected growth of a positive biological indicator in a chemical decontamination cycle. Features regarding biological indicators used for the validation of decontamination cycles and practical solutions to avoid false positives are presented.
Author: M. L. Bernuzzi
Revised: January 9th, 2015
Language: English
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White Paper: 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: Conductivity sampling and the Total Organic Carbon analysis for washing machines.
Author: S. Ferretti
Revised: January 8th, 2015
Language: English
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White Paper: Moist-heat sterilization – 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 and its application in moist-heat sterilization processes is discussed.
Author: V.Mascherpa
Revised: June 27th, 2014
Language: English
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Case Study: Implementing a fully integrated solution for the food industry.
This paper describes the implementation of a fully integrated solution for optimizing sterilization process in one of the biggest European tuna can manufacturers.
Revised: December 5th, 2014
Language: English
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E-book: F0 Technical Note.
F.R.TN.00001.A.5.E.06.98
• What F0 means
• How to calculate F0
• How to use F0 for adjustment, control and validation of moist-heat sterilization processes
Authors: D.Pistolesi, V.Mascherpa
Revised: June 24th, 2014
Language: English
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White Paper: Decontamination by hydrogen peroxide: Use and technical developments.
• The concepts of sterilization, disinfection and decontamination and its applications
• Decontamination by hydrogen peroxide (H2O2) and its use in sterility test isolators
• New method for hydrogen peroxide (H2O2) vaporization and dosage control
Written by: V. Mascherpa
Revised: March 25th, 2014
Language: English
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White Paper: Emerging Gloveless Robotic Technologies in Aseptic Manufacturing for Cytotoxics.
• Trends for the Pharma/biotech industries 2014-2018
• New concepts in aseptic manufacturing
• Innovative robotized solution for cytotoxic drugs and small batches
Written by: S. Mauri
Revised: May 6th, 2014
Language: English
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