Proceeding International Applied Business and Engineering Conference
Vol. 2 (2022): Proceeding International Applied Business and Engineering Conference 2022

Investigating The Risk of Glove Punctures in Aseptic Processing Barrier Technology Systems: A Case Study

Kemlall Ramsaroop Ramdass (University of South Africa)
Phumzile Mabaso (University of South Africa)
Bongumenzi Mncwango (University of South Africa)

Article Info

Publish Date
09 Jan 2023

Abstract

Aseptic processing is a method of production that is free of microbiological, pyrogen, and particulates and thus it is perceived as one of the most complex manufacturing processes in the pharmaceutical industry. Due to the significant risks associated with aseptic processing a quality risk management (QRM) program is necessary to protect the patient from injury. This study aims to investigate the process followed when glove punctures are detected on glove sleeves of barrier technology systems in a sterile manufacturing facility. Further, this paper utilizes an example of a risk assessment method to illustrate how a risk assessment can be useful in aseptic processing operations. The specific activity being investigated involves glove punctures during aseptic filling operations. The risk assessment approach adopted is in the form of a Fishbone diagram. The findings of the study will provide insights that will aid developing organizations to overcome challenges associated with aseptic processing

Copyrights © 2022




Citation Download
RIS
EndNote, Reference Manager, ProCite
BibTex
Latex, Jabref
Full PDF
1337.311 KB
Original Source
Download Original
Google Scholar
Check in Google Scholar
Journal Info
Proceeding International Applied Business and Engineering Conference
Website

Abbrev

iabec

Publisher

ABEC: Konsorsium Politeknik Se-Sumatra

Subject

Religion Agriculture, Biological Sciences & Forestry Humanities Automotive Engineering Biochemistry, Genetics & Molecular Biology Chemical Engineering, Chemistry & Bioengineering Chemistry Civil Engineering, Building, Construction & Architecture Computer Science & IT Control & Systems Engineering Decision Sciences, Operations Research & Management Earth & Planetary Sciences Economics, Econometrics & Finance Education Electrical & Electronics Engineering Energy Engineering Environmental Science Industrial & Manufacturing Engineering Languange, Linguistic, Communication & Media Law, Crime, Criminology & Criminal Justice Materials Science & Nanotechnology Mathematics Mechanical Engineering Physics Social Sciences Transportation Other

Description

Proceedings of the Sumatra Polytechnic conference, scope: electrical engineering, mechanical engineering, computer engineering, civil engineering, social sciences, business administration, accounting, English, agriculture, ...