Global Traceability: From Factory Floor to Pharmacy -Craig Stobie, Domino Printing Sciences

Jul 1, 2015

An update on progress as the final countdown to compliance begins. Craig Stobie, head of the Life Sciences team at Domino Printing Sciences, looks at the current progress within the EU and beyond, exploring how some of the greatest concerns for manufacturers around serialisation – equipment effectiveness and data collection and interrogation – can be remedied as the deadline for compliance edges closer. ...

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Inspection Technology – Patient Safety and Product Quality Come First – Joachim Baczewski, Bosch

Jul 1, 2015

Thorough inspection is a key quality safeguard for pharmaceuticals, and contributes significantly to patient safety. With the advent of new and highly potent drugs, quality requirements have dramatically increased. Joachim Baczewski, President of Bosch Packaging Technology K.K. in Japan and Head of Inspection Technology, reflects upon patient safety and product quality, and he explains the demand for highly potent medicines. ...

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Accelerating and Automating Sterility Testing in Microbial Quality Control -Anna Mills, Rapid Micro Biosystems

Jul 1, 2015

In 2009 the influenza A (H1N1) pandemic struck the United States and, according to CDC estimates, affected approximate 60.8 million people with 274,304 hospitalisations, and 12,469 deaths. While this strain of the flu virus continues to circulate worldwide, the rapid and significant impact of this pandemic revealed the need to find ways to speed response to future events. One area of opportunity is the sterility test. Anna Mills, Senior Validation Specialist at Rapid Micro Biosystems, deals with accelerating and automating sterility testing in microbial quality control. ...

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Freeze-drying with Collapse is not Necessarily Bad for Stability and can Reduce Cost – Sophie Declomesnil, LYOFAL – Groupe SYNERLAB

Jul 1, 2015

Lyophilisation is often used to increase the stability and shelf-life proteins which are physically and/or chemically unstable in aqueous solution. Freeze-drying removes water protein solutions, including water from the protein surface which plays a major role within the protein structure, and this frequently causes damage. In this editorial Sophie Declomesnil, R&D Manager, LYOFAL- Groupe SYNERLAB, focuses on freeze-drying, stability and cost reducing. ...

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Syringe Siliconisation Trends, Methods, Analysis Procedures -Claudia Petersen and Bernd Zeiss, Gerresheimer

Jul 1, 2015

Ready-to-fill, i.e. sterile, prefillable glass syringes, are washed, siliconised, sterilised and packaged by the primary packaging manufacturer. They can then be filled by the pharmaceutical companies without any further processing. These days the majority of prefillable syringes are made of glass and the trend looks set to continue. Within this article, Claudia Petersen and Bernd Zeiss from Gerresheimer deliver updates on syringe siliconisation trends, methods, and analysis procedures. ...

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