Design of fill and finish facility for active pharmaceutical ingredients (Api)

Nuur Laila Khairuddin, Norliza Abd Rahman, Nur Syafiqah Kamarudin

Research output: Contribution to journalArticle

Abstract

Fill and finish operations continue to be one of the most heavily outsourced activities in the biopharmaceutical manufacturing market today. There are a few aspects that need to be consider in outsource activities like logistic, storage condition, facility certification and audit as regulations and standards which the manufacturer should adhere. Risk would be greater and extra care should be taken when outsource from foreign fill and finish facility. Thus, the internal aseptic fill and finish facility with audit checklist will help to minimize the risk during logistic and storage and also minimize the cost for outsource fill and finish facility. The data collections are through survey and conceptual design with simulation as the execution part.

Original languageEnglish
Pages (from-to)1135-1154
Number of pages20
JournalJournal of Engineering Science and Technology
Volume11
Issue number8
Publication statusPublished - 1 Aug 2016

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Drug products
Logistics
Conceptual design
Costs

Keywords

  • Active pharmaceutical ingredients
  • Aseptic
  • Design
  • Facility

ASJC Scopus subject areas

  • Engineering(all)

Cite this

Design of fill and finish facility for active pharmaceutical ingredients (Api). / Khairuddin, Nuur Laila; Abd Rahman, Norliza; Kamarudin, Nur Syafiqah.

In: Journal of Engineering Science and Technology, Vol. 11, No. 8, 01.08.2016, p. 1135-1154.

Research output: Contribution to journalArticle

Khairuddin, Nuur Laila ; Abd Rahman, Norliza ; Kamarudin, Nur Syafiqah. / Design of fill and finish facility for active pharmaceutical ingredients (Api). In: Journal of Engineering Science and Technology. 2016 ; Vol. 11, No. 8. pp. 1135-1154.
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