Kaye Validator ITMS used for Rapid Contamination Mapping in an Antibiotics Plant

Detailed results produced in two days without laboratory tests.
Pforzheim, Germany. 30 March 2009.

 

The Kaye Validator ITMS, from Amphenol Advanced Sensors, has recently been used to demonstrate the advantages of ion trap mobility spectrometry (ITMS) over conventional laboratory-based techniques in cross contamination control in pharmaceutical environments. One technician was able to carry out cross contamination mapping of a plant manufacturing antibiotics in just two days and the instrument proved just as capable of operating in the less hygienic environments of the plant warehouse as in the environmentally controlled production and packaging departments.

The pharmaceutical plant involved in this study manufactures antibiotics, belonging to the ß-Lactam family. These drugs are used to treat bacterial infections and their high allergic potential requires rigid cross-contamination control, during production and packaging. At the production site investigated areas are designated high, low and no contamination levels. High contamination is expected in the incoming raw materials department, in granulation, in tableting and in packaging. Low contamination is likely for storage areas, areas where finished packages are commissioned and where preparations are made for final transport. The area where commissioned packages are stored ready for transport should have no contamination. All areas are protected against cross contamination through connecting airlocks and entry into any area of possible contamination is possibly only through special decontamination locks.

Conventionally, the detection of penicillin-derived compounds carried out using techniques such as High Performance Liquid Chromatography (HPLC), Enzyme-linked immuno sorbent assay (ELISA) or bacterial growth tests. All these techniques need to be performed in a laboratory and there is usually a waiting period of several hours between test and availability of results.

With the Validator, various surfaces which could possibly be contaminated were identified and then directly swabbed using the Validator hand wand and polyamide fibre material sample traps. Sample traps were wetted with a 70% ethanol solution and the sampling area was typically 100cm². The dried sample was introduced into the Validator, which was located close to the sampling point. By using patented ITMS technology, using a proprietary ion trap that increases ionization efficiency, the Validator delivers simultaneous positive and negative ion detection from a single sample. By using a 60 second measurement time and appropriate temperature settings in the desorber and detector, the Kaye Validator ITMS can quantify the investigated antibiotic in a range from 100 to 7300ng.

A complete contamination map of the various areas of the pharmaceutical plant was obtained by this methodology within two days by a single technician. The analysis confirmed the contamination levels in those areas where contamination was expected. However, it also revealed unanticipated contamination around the airlocks, in the decontamination area and in areas where automated surface cleaning procedures are restricted. These discrepancies have now been addressed.

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