Case study: Application of SORS (RapID) to In-Container Testing of Raw Materials
In this case study, Cobalt Light Systems discusses Application of SORS (RapID) to In-Container Testing of Raw Materials…
Since Japan joined PIC/S in July 2014 , Astellas Pharma Tech Co., Ltd. has investigated how to guarantee effective identification of packaged raw materials, as stipulated in EU GMP Annex 8.
In a 2013 publication, the company presented the results from real-world tests using a fixed Raman spectrometer (Raman RXN2 1000) and a portable Raman spectrometer (TruScan RM). Following this, further investigations were carried out into PIC/S GMP Annex 8 compliance using a spatially offset Raman spectrometer (RapID). The results, summarised here, showed that the instrument was capable of detecting materials inside both a paper sack and a nontransparent polyvinyl sack – something that the existing Raman spectrometers failed to do. This makes it possible to complete acceptance testing at the same time as economising on manpower. It also reduces the risk of foreign material or microbial contamination at the point of sampling to zero.
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