ABSTRACT
Introduction The selection of the appropriate packaging materials and processes for sterile products presents a series of challenges of considerably greater complexity than for non-sterile products. A sterile product may be defined as a product which is totally devoid of all forms of life, both vegetative and sporing. Most important in this area is contamination by bacteria, fungi or moulds and yeasts. In all pharmaceutical products it is also becoming highly desirable to work towards much lower bioburdens. This involves the application of microbiological standards to both raw materials and finished products. These normally exclude certain pathogens such as Salmonella typhi and Clostridium botulinum, but it should be noted that even some non-pathogens can also cause problems.
