Microbial Spoilage, Infection Risk and Contamination Control

MICROBIAL SPOILAGE, INFECTION RISK AND CONTAMINATION CONTROL

INTRODUCTION

Pharmaceutical products used in the prevention, treatment and diagnosis of disease contain a wide variety of ingredients, often in quite complex physicochemical states. Such products must not only meet current good pharmaceutical manufacturing practice (GPMP) requirements for quality, safety and efficacy, but also must be stable and sufficiently attractive to be acceptable to patients. Products made in the pharmaceutical industry today must meet high microbiological specifications; i.e. if not sterile, they are expected to have no more than a minimal microbial population at the time of product release.

Nevertheless, from time to time a few rogue products with an unacceptable level and type of contamination will occasionally escape the quality assurance net. The consequences of such contamination may be serious and far-reaching on several accounts, particularly if contaminants have had the opportunity to multiply to high levels. First, the product may be spoiled, rendering it unfit for use through chemical and physicochemical deterioration of the formulation. Spoilage and subsequent wastage of individual batches usually result in major financial problems for the manufacturer through direct loss of faulty product. Secondly, the threat of litigation and the unwanted, damaging publicity of recalls may have serious economic implications for the manufacturer. Thirdly, inadvertent use of contaminated products may present a potential health hazard to patients, perhaps resulting in outbreaks of medicament-related infections, and ironically therefore contributing to the spread of disease. Most commonly, heavy contamination of product with opportunist pathogens, such as Pseudomonas spp., has resulted in the spread of nosocomial (hospital-acquired) infections in compromised patients; less frequently, low levels of contamination with pathogenic organisms, such as Salmonella, have attracted considerable attention, as have products contaminated with toxic microbial metabolites, such as mycotoxins in herbal medicines.