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Challenges and Innovation in Aseptic Filling: Case Study with the Closed Vial Technology

  • Benoît Verjans
Chapter
Part of the AAPS Advances in the Pharmaceutical Sciences Series book series (AAPS, volume 6)

Abstract

Aseptic filling of injectable drugs is one of the most critical manufacturing processes in the pharmaceutical manufacturing industry as it presents a significant risk for the patient in case of bacterial contamination. Therefore, a series of constraints are imposed to the manufacturers, leading to a very complex process requiring intensive validation, training and care during operation. To optimize this process, several improvements have been made, focusing on (1) the design of pharmaceutical facilities to ensure an optimal environment for the filling area, (2) optimal gowning of operator, and (3) separation of the operators from the filling area. Regarding containers, the pharmaceutical industry disposes of a wide range of solutions to aseptically fill injectable products. The most classical ones such as ampoules and vials are now challenged by new technologies which offer several advantages to the pharmaceutical manufacturer, to the healthcare practitioner and/or to the patient. Four recent technologies came to the market in the last decades, all of them with their own profile of advantages: on one side, the prefilled syringe and the cartridge which provide a ready-to-inject solution to the practitioner and the patient; on the other side, the blow-fill-seal container and the Closed Vial technology which offer a safer solution and an easier solution for the manufacturer. In this article, these new solutions are compared to the well-established ones and their profiles of advantages and disadvantages are detailed.

Keywords

Clean Room Healthcare Practitioner Water Vapor Transmission Rate Product Path Filling Area 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Abbreviations

API

Active pharmaceutical ingredient

BFS

Blow-fill-seal

cfu

Colony forming unit

CMO

Contract manufacturing organization

COC

Cycloolefin copolymer

COP

Cycloolefin polymer

EMA

European Medicine Agency

EPO

Erythropoietin

FDA

Food and Drug Administration

OEL

Overall exposure limit

PFS

Prefilled syringe

RABS

Restricted Access Barrier System

SOP

Standard operating procedures

TPE

Thermoplastic elastomer

VHP

Vapor hydrogen peroxide

WFI

Water for injection

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Copyright information

© American Association of Pharmaceutical Scientists 2013

Authors and Affiliations

  1. 1.Aseptic TechnologiesGemblouxBelgium

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