Nigel Halls

CONTENTS

Introduction 85

1 Susceptibility of Pharmaceutical Preparations to Microbiological Problems 86

2 Microbiological Contamination Limits in Pharmaceutical Preparations 88

2.1 The Microbial Limit Tests 88

2.2 Counts for Compliance 88

2.3 Tests for Absence of Specific Indicator Microorganisms 89

2.4 International Pharmacopoeial Guide Limits 90

2.5 Objectionable Microorganisms 91

3 Microbiological Contamination Control Principles 96

3.1 Sources and Vectors for Contamination 96

4 Control of Contamination in Practice 102

4.1 Facility Design and Mode of Operation 102

4.2 Process Design and Mode of Operation 105

4.3 Formulation-Related Microbiological Control 108

5 Microbiological Monitoring of the Manufacturing Facility 110

References 114

INTRODUCTION

Pharmaceutical preparations are expected to be efficacious, safe and affordable.

© 2004 by CRC Press LLC 85

The presence of microorganisms in pharmaceutical preparations may reduce their efficaciousness and make them unsafe for the patient.

The severity of the consequences of microorganisms present in pharmaceutical preparations differs according to the purpose of the preparation and its route of administration. Some preparations for instance, must be free from all viable microorganisms (sterile preparations); others are not required to be sterile, but are subject to certain restrictions on the number and types of tolerable microorganisms to ensure their efficaciousness and safety.

This chapter is concerned with the microbiological control of aqueous-based nonsterile preparations — topical (lotions, creams, gels, ointments), aqueous oral (solutions, suspensions, syrups) and aqueous inhalation preparations — because they are more susceptible to microbiological problems than other nonsterile dosage forms.

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