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Line clearance risk assessment in secondary packaging areas

Line clearance risk assessment in secondary packaging areas

This document describes the basis for performing a risk assessment for line clearance (LC) activities and failures. It contains a general description about the process and a template. This template is meant to support the documentation of the assessment of risks related to the LC process in secondary packaging lines handling pharmaceutical products and combination devices.

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Standardized methodology to support particle investigations and classification in biopharmaceutical parenteral products

Standardized methodology to support particle investigations and classification in biopharmaceutical parenteral products

This paper provides a framework to support investigations related to atypical or frequently occurring particles observed during VI or related to field complaints – which require detailed and systematic assessment of risk to the quality of the batch. The proposal for a standardized risk investigation methodology outlined in this paper may support such risk assessments, where the total risk related to foreign particles is assessed by considering a variety of risk factors (type, frequency, etc.) and applying a failure mode and effects analysis (FMEA) tool to calculate a total risk-based score.

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Rising to the challenge of BioPhorum’s small flexible filler URS

Rising to the challenge of BioPhorum’s small flexible filler URS

This paper delivers a seminal example of how BioPhorum can partner with biopharmaceutical suppliers to address the needs of the industry, support new technology adoption in biopharma and facilitate positive and lasting change. BioPhorum’s Small Flexible Filler (SFF) URS allowed Groninger to build a line that would otherwise not exist, defining a strategic direction for the future of liquid fill and finish for the biopharmaceutical industry. Within two and a half years of BioPhorum publishing the SFF URS, Groninger, a German supplier to the industry, has developed a gloveless, robot-based, automated filling line that aligns with the URS and relevant current regulatory expectations.

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