GIOVANNI B. GOLINELLI
Bonfiglioli Engineering S.r.l., TASITEST Packaging Test & Inspection, Vigarano Pieve (Fe), Italy

Abstract

The application of Vacuum Decay Method for 100% In-line high speed Container Closure Integrity Test to pre-filled syringes is a technological innovation that allows pharmaceutical companies to increase their quality assurance for sterility and stability. Main reasons are linked to the high control given by such a very sensitive tool to identify possible leakages linked to imperfect assemblies and pinholes that also gives the possibility to be validated in a simple, reliable and repeatable manner by means of calibrated leakers. An established technology, based on ASTM standard F2338 (1), FDA consensus standard since 2004 (2), applied on most pharmaceutical containers can now be used also with high performances in terms of throughput and sensitivity for PFS’s.

INTRODUCTION

Prefilled syringes have become very popular in pharmaceutical industry as a parenteral drug delivery device, in fact, many are the benefits of this format including eliminating dosing errors and reducing accidental needle sticks by hospital staff. Since its introduction, several methods have been developed and applied for the performance of Container Closure Integrity Test (CCIT), both as in process control and in line.

Stringent requirements from the industry have brought to the development of different technologies and implementations by pharmaceutical companies both as in-process control and as in-line control; up to now all the available methods presented limitations either from the aspect of 100% usability or from the aspect of reliability.

The innovative technical solution, here presented, which utilizes Vacuum Decay Method, compliant with the ASTM F2338 “Standard Test Method for Non Destructive Detection of Leaks in Packages” (1), recognized as a Consensus Standard by the US Food and Drug Administration (2), is able to perform a reliable and efficient CCI test in a 100%high speed in-line pharm ...