WHITE PAPERS & CASE STUDIES
Adding Up The True Costs Of A False Positive Sterility Test
Use the following points to create your own list to examine just what aspects of ‘cost’ a false positive could be having on your business. They provide a base from which you can accurately determine the impact of false positives on your own production system. From this, you can begin to build a robust business case should you feel you need to mitigate risks for your own production process.
A QbD Approach To Freeze Drying Of Cytotoxic Compounds
Quality by Design (QbD) is a systematic approach to ensure that the quality of the product is built into production processes from the outset, rather than being tested once development has commenced. By Dr Kevin Ward
What Is A Mobile Cleanroom?
The Mobile Clean Room (MCR) is a self-contained manufacturing space fully constructed in our facility. It is shipped to customer facility on a double drop flatbed trailer in one piece and ready to hook up and use upon moving into place.
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 conditioning the Sterility Test Isolators are discussed. A technologically new method for the vaporization of the hydrogen peroxide and its dosage control is presented. By V. Mascherpa, Senior consultant R&D
Viscometer vs. Rheometer: Which Is The Better Choice?
This is the type of query that comes in from customers to instrument manufacturers on a frequent basis. It may go somewhat like the following set of statements and questions.
Emerging Gloveless Robotic Technologies In Aseptic Manufacturing For Personalized Cytotoxic Drugs
The blockbuster-model that was driving the pharmaceutical manufacturing industry in the last several decades has almost ended. Massive production, large batches, high speed lines have been designed to supply the patients with “multipurpose” small molecules drugs to cover the huge worldwide demand of health for the most common diseases. The next generation drugs will focus on the single patient and bespoke to cover the individual health demand. For instance, biotech products and large molecules are the most promising therapeutic means for treatment of different kinds of cancer. By Sergio Mauri, Manager, BU Integrated Projects, Fedegari Group