A quest to find the cause of unknown peaks in cleaning verification chromatography following the manufacture of pharmaceutical preparations

Research output: Contribution to conferencePoster

Abstract

Cleaning equipment following the manufacture of pharmaceutical products is of paramount importance to ensure that the following batch of product manufactured is not contaminated with therapeutic levels of the prior manufactured product. The patient must only receive the therapeutic effect expected from the drug they take. During a number of cleaning verification studies, it was discovered that unknown peaks were present in the chromatography, the source of which was unclear. A study was performed to examine a theory that the gloves used by the operator during the cleaning procedure, in combination with the solvent based cleaning products were responsible for the unknown peaks that were evident in the chromatography. NASA had performed a similar study for the critical parts of the space shuttle in the space shuttle program. The following poster examines the conclusions that were made from the data that was attained for the study. The data will answer the question: ‘Are the gloves themselves responsible by way of
leachables for the unknown peaks in the cleaning verification chromatography.‘

Conference

Conference7th APS International PharmSci Conference
CountryUnited Kingdom
CityGlasgow
Period5/09/167/09/16
Internet address

Fingerprint

Chromatography
Drug products
Cleaning
Pharmaceutical Preparations
United States National Aeronautics and Space Administration
Space shuttles
Posters
Therapeutic Uses
Equipment and Supplies
NASA
Therapeutics

Keywords

  • chromatography
  • cleaning verification
  • leachables
  • safety
  • contaminant

Cite this

@conference{219bbaa3b2f145d8882317507d642a19,
title = "A quest to find the cause of unknown peaks in cleaning verification chromatography following the manufacture of pharmaceutical preparations",
abstract = "Cleaning equipment following the manufacture of pharmaceutical products is of paramount importance to ensure that the following batch of product manufactured is not contaminated with therapeutic levels of the prior manufactured product. The patient must only receive the therapeutic effect expected from the drug they take. During a number of cleaning verification studies, it was discovered that unknown peaks were present in the chromatography, the source of which was unclear. A study was performed to examine a theory that the gloves used by the operator during the cleaning procedure, in combination with the solvent based cleaning products were responsible for the unknown peaks that were evident in the chromatography. NASA had performed a similar study for the critical parts of the space shuttle in the space shuttle program. The following poster examines the conclusions that were made from the data that was attained for the study. The data will answer the question: ‘Are the gloves themselves responsible by way ofleachables for the unknown peaks in the cleaning verification chromatography.‘",
keywords = "chromatography, cleaning verification, leachables, safety, contaminant",
author = "N. Lord and S.J. Ford and M. Elliott and G.W. Halbert",
year = "2016",
month = "9",
day = "5",
language = "English",
note = "7th APS International PharmSci Conference ; Conference date: 05-09-2016 Through 07-09-2016",
url = "https://www.ukpharmsci.org/",

}

A quest to find the cause of unknown peaks in cleaning verification chromatography following the manufacture of pharmaceutical preparations. / Lord, N.; Ford, S.J.; Elliott, M.; Halbert, G.W.

2016. Poster session presented at 7th APS International PharmSci Conference, Glasgow, United Kingdom.

Research output: Contribution to conferencePoster

TY - CONF

T1 - A quest to find the cause of unknown peaks in cleaning verification chromatography following the manufacture of pharmaceutical preparations

AU - Lord, N.

AU - Ford, S.J.

AU - Elliott, M.

AU - Halbert, G.W.

PY - 2016/9/5

Y1 - 2016/9/5

N2 - Cleaning equipment following the manufacture of pharmaceutical products is of paramount importance to ensure that the following batch of product manufactured is not contaminated with therapeutic levels of the prior manufactured product. The patient must only receive the therapeutic effect expected from the drug they take. During a number of cleaning verification studies, it was discovered that unknown peaks were present in the chromatography, the source of which was unclear. A study was performed to examine a theory that the gloves used by the operator during the cleaning procedure, in combination with the solvent based cleaning products were responsible for the unknown peaks that were evident in the chromatography. NASA had performed a similar study for the critical parts of the space shuttle in the space shuttle program. The following poster examines the conclusions that were made from the data that was attained for the study. The data will answer the question: ‘Are the gloves themselves responsible by way ofleachables for the unknown peaks in the cleaning verification chromatography.‘

AB - Cleaning equipment following the manufacture of pharmaceutical products is of paramount importance to ensure that the following batch of product manufactured is not contaminated with therapeutic levels of the prior manufactured product. The patient must only receive the therapeutic effect expected from the drug they take. During a number of cleaning verification studies, it was discovered that unknown peaks were present in the chromatography, the source of which was unclear. A study was performed to examine a theory that the gloves used by the operator during the cleaning procedure, in combination with the solvent based cleaning products were responsible for the unknown peaks that were evident in the chromatography. NASA had performed a similar study for the critical parts of the space shuttle in the space shuttle program. The following poster examines the conclusions that were made from the data that was attained for the study. The data will answer the question: ‘Are the gloves themselves responsible by way ofleachables for the unknown peaks in the cleaning verification chromatography.‘

KW - chromatography

KW - cleaning verification

KW - leachables

KW - safety

KW - contaminant

M3 - Poster

ER -