Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Experiment Videos

Total organic carbon method for aspirin cleaning validation

A J Holmes1, A J Vanderwielen

  • 1Chemistry Department, Western Michigan University, Kalamazoo, USA.

PDA Journal of Pharmaceutical Science and Technology
|July 1, 1997
PubMed
Summary

Total Organic Carbon (TOC) analysis effectively quantifies residual aspirin on pharmaceutical manufacturing surfaces. This validated method ensures equipment cleanliness, preventing cross-contamination and meeting Good Manufacturing Practices.

Related Concept Videos

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

Author Correction: Confronting racially exclusionary practices in the acquisition and analyses of neuroimaging data.

Nature neuroscience·2023
Same author

Effects of plyometric- and cycle-based high-intensity interval training on body composition, aerobic capacity, and muscle function in young females: a field-based group fitness assessment.

Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme·2023
Same author

Confronting racially exclusionary practices in the acquisition and analyses of neuroimaging data.

Nature neuroscience·2022
Same author

Publisher Correction: Brain charts for the human lifespan.

Nature·2022
Same author

Brain charts for the human lifespan.

Nature·2022
Same author

Caries.

The American journal of dental science·2019

Area of Science:

  • Pharmaceutical manufacturing and quality control
  • Analytical chemistry techniques
  • Surface residue analysis

Background:

  • Cleaning validation is critical for ensuring pharmaceutical product quality and preventing cross-contamination.
  • Regulatory bodies like the World Health Organization mandate Good Manufacturing Practices (GMP) for pharmaceutical production.
  • Residual product detection on manufacturing surfaces is essential for effective cleaning validation.

Purpose of the Study:

  • To develop and validate a Total Organic Carbon (TOC) analysis method for measuring residual aspirin.
  • To assess the applicability of the TOC method across various pharmaceutical equipment surfaces.
  • To establish the method's detection limits and analytical performance for cleaning validation.

Main Methods:

Related Experiment Videos

  • Application of Total Organic Carbon (TOC) analysis for residue detection.
  • Development of a specific TOC method for residual aspirin quantification.
  • Testing the method on common pharmaceutical equipment materials: aluminum, stainless steel, painted carbon steel, and plexiglass.

Main Results:

  • The developed TOC method demonstrated low detection capabilities, reaching parts per million levels.
  • Rapid sample analysis time was achieved with the TOC method.
  • Recovery values for residual aspirin ranged from 25% on aluminum to 75% on plexiglass, with precision under 13%.

Conclusions:

  • The Total Organic Carbon (TOC) method is a viable and effective tool for determining residual aspirin on pharmaceutical surfaces.
  • This validated TOC method supports cleaning validation processes, ensuring equipment safety and product integrity.
  • The method's sensitivity and speed make it a valuable asset in pharmaceutical quality control.