Biomedical Engineering Reference
In-Depth Information
10
ASEPTIC PROCESSING: TWO
EDWARD C. TIDSWELL
10.1
INTRODUCTION
One area of the healthcare industry especially vulnerable to hazard and therefore
a potential risk to patient health is the provision and administration of parenteral
therapies and medical devices. The omnipresent microbial challenge typically
inhabiting sterile manufacturing, aseptic manufacturing facilities, compounding,
hospital, healthcare, and community healthcare environments represents a sig-
nificant hazard. Recoverable and culturable microorganisms, their products, the
vestiges of microorganisms (for example, endotoxin, exotoxin, and peptidogly-
can) and the more controversial dormant/nonculturable microorganisms all fall
into this category of microbial hazard. In each context, the microbial hazards pose
a risk to product quality and the potential to realize risk of infection to the recip-
ient patient population. The absence of microorganisms from products processed
via adequately validated and controlled terminal sterilization processes is scientif-
ically and statistically recognized [1]. In contrast, the absence of microorganisms
in products generated by the aseptic pharmaceutical manufacture of parenterals,
aseptic intervention during admixing, compounding, and administration in the
healthcare setting are perhaps not so equally (scientifically and statistically)
assured. By the fundamental nature of aseptic processing, the successful genera-
tion of sterile products is primarily governed by effectively excluding potentially
contaminating microorganisms. The ingress of contaminating microorganisms
must follow the mechanics of vectors and transfer from originating source to
vulnerable product in accordance with the laws of physics. We can therefore
recognize that
there is some recognizable predictability; however,
this is
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