Gerald Dallmann
SGS INSTITUT FRESENIUS GmbH, Dresden, Germany

Abstract

A key element in the pharmaceutical industry is to avoid any product contamination by foreign material such as solved impurities or particles. Particles detected during product inspection have to be identified to find and eliminate the root cause. Besides particles, surface contamination of equipment parts, packaging material or medical devices is also a common source of product contamination.

This paper describes some special analytical techniques, their advantages and disadvantages and their application for particle material identification as well as for surface contamination characterization.

INTRODUCTION

Production cleanliness is becoming increasingly important in many industries (electronics, automotive, medical devices, pharmaceutical industry). Pharmaceutical products are subject to strong quality requirements with regards to any contamination.

The USP General Chapter <1> Injections- Foreign and Particulate Matter requires that every lot of parenteral preparations is essentially free from visible particulates (1).

Particulate matter in injections and parenteral infusions consists of extraneous mobile undissolved particles, other than gas bubbles, unintentionally present in the solutions (2). 

A 100% container inspection for particulate contamination is typically implemented to reject every container showing evidence of visible particulates. In addition to the final product inspection, water, air, excipient and API filters can be used as sources to detect and identify particles during production, allowing for identification of their sources. Furthermore, complaint samples of finished products require particle material identification and root cause analysis and elimination.

About 25% of recalls from the US marke ...