title: Towards the development of a rapid, portable, surface enhanced Raman spectroscopy based cleaning verification system for the drug nelarabine.
abstract: OBJECTIVE
  Cleaning verification is a scientific and economic problem for the pharmaceutical industry. A large amount of potential manufacturing time is lost to the process of cleaning verification. This involves the analysis of residues on spoiled manufacturing equipment, with high-performance liquid chromatography (HPLC) being the predominantly employed analytical technique. The aim of this study was to develop a portable cleaning verification system for nelarabine using surface enhanced Raman spectroscopy (SERS).
  
  
  METHODS
  SERS was conducted using a portable Raman spectrometer and a commercially available SERS substrate to develop a rapid and portable cleaning verification system for nelarabine. Samples of standard solutions and swab extracts were deposited onto the SERS active surfaces, allowed to dry and then subjected to spectroscopic analysis.
  
  
  RESULTS
  Nelarabine was amenable to analysis by SERS and the necessary levels of sensitivity were achievable. It is possible to use this technology for a semi-quantitative limits test. Replicate precision, however, was poor due to the heterogeneous drying pattern of nelarabine on the SERS active surface. Understanding and improving the drying process in order to produce a consistent SERS signal for quantitative analysis is desirable.
  
  
  CONCLUSIONS
  This work shows the potential application of SERS for cleaning verification analysis. SERS may not replace HPLC as the definitive analytical technique, but it could be used in conjunction with HPLC so that swabbing is only carried out once the portable SERS equipment has demonstrated that the manufacturing equipment is below the threshold contamination level.
authors.affiliation: Cranfield Health, Cranfield University, Bedfordshire, UK. damioncorrigan@gmail.com
authors.forename: Damion K
authors.initials: DK
authors.lastname: Corrigan
authors.forename: Neale A
authors.initials: NA
authors.lastname: Salton
authors.forename: Chris
authors.initials: C
authors.lastname: Preston
authors.forename: Sergey
authors.initials: S
authors.lastname: Piletsky
mesh_terms: D001087:Arabinonucleosides / Q000032:analysis*; D002851:Chromatography, High Pressure Liquid / Q000379:methods; D003666:Decontamination / Q000379:methods*; D003890:Desiccation; D004340:Drug Contamination / Q000517:prevention & control*; D004866:Equipment Contamination; D019999:Pharmaceutical Solutions; D013059:Spectrum Analysis, Raman / Q000379:methods*; D013499:Surface Properties
chemical_list: D001087:Arabinonucleosides; D019999:Pharmaceutical Solutions; C104457:nelarabine