Parenteral drug delivery systems and many medicinal products, such as dressings and sutures, must be sterile in order to avoid the possibilities of microbial degradation or infection occurring as a result of their use.
STERILE
PHARMACEUTICAL PRODUCTS
INTRODUCTION
Parenteral drug delivery systems and many medicinal products, such as
dressings and sutures, must be sterile in order to avoid the possibilities of
microbial degradation or infection occurring as a result of their use.
Sterility is also important for any material or instrument likely to contact
broken skin or internal organs. Although pathogenic bacteria, fungi or viruses
pose the most obvious danger to a patient, it should be also realized that
micro-organisms usually regarded as non-pathogenic and which inadvertently gain
access to body cavities in sufficient numbers may cause a severe, possibly
fatal infection. Consequently, injections, ophthalmic preparations, irrigation
fluids, dialysis solutions, sutures and ligatures, implants, and certain
surgical dressings, as well as instruments necessary for their use or
administration, must be presented in a sterile condition.
Although there is always a chance of an idiosyncratic reaction between a
medicine and a patient caused by sensitivity, allergic reaction or unwanted
side effects, for sterile products there is the added requirement that they
must be free of viable microorganisms. This consequently means the product
should be manufactured in a manner that reduces to the lowest likelihood the
risk of microbial contamination. Thus a sterile product should not contain
viable bacteria, yeasts or fungi, nor other microorganisms such as rickettsiae,
mycoplasmas, protozoa or viruses. The absence of prion particles is also
desirable but difficult to demonstrate. Sterilization processes concentrate on
the destruction or removal of microorganisms. Each process is designed to remove
the most problematic microorganism (i.e. the smallest bacteria in filtration or
the most heat-resistant bacterial spores in heat sterilization processes) on
the basis that, once a sterilization process has been chosen, elimination of
the most problematic species will have led to the elimination of all less
resistant microorganisms.
The choice of method is determined largely by the ability of the
formulation and container to withstand the physical stresses applied during the
sterilization process. All products intended for sterilization should be
manufactured under clean conditions and therefore will be of low microbial
content (bioburden) prior to sterilization. Under these conditions, the
sterilization process will not be overtaxed and will generally be within the
safety limits needed to provide the required level of sterility assurance. The
next section emphasizes parenteral products, but the practices described apply
to many other types of sterile product.
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