ABSTRACT

This chapter discusses the risk of infection from contaminated solid dosage forms and reviews the pharmacopoeial limits for oral solid formulations and raw materials. Many pharmaceutical materials are regarded as crystals, but in fact the surfaces can be made partially amorphous by processing. Most of the bacterial and fungal species isolated from dry pharmaceutical products do not present a direct hazard of infection to the patient. The conditions required for the survival of yeasts, moulds and bacteria are completely different from those required for rapid growth. The quantity and nature of water in a solid dosage form will depend on the environment in which it is stored and the physical properties of the product. Capillary condensation will result in significantly greater amounts of water adsorbing to microporous materials than would occur for smooth surfaces. Soft gelatin capsules contain product formulated in oil, semi-solid or semi-organic basis, which are unlikely to be favourable for microbial growth.