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Date of Award

1978

Document Type

Dissertation - Pacific Access Restricted

Degree Name

Doctor of Philosophy (Ph.D.)

Department

Pharmacy

First Advisor

Donald Y. Barker

First Committee Member

Donald Floriddia

Second Committee Member

Warren J. Schneider

Third Committee Member

Donald M. Pace

Fourth Committee Member

Elizabeth P. Barbour

Abstract

The presence of contaminants in parenteral solutions is a constant nemesis against which pharmaceutical manufacturers, as well as medical, pharmacy , and nursing practitioners mus t vigilantly struggle to provide quality health care. At each level in the parenteral drug delivery system, contamination is possible before the patient actually receives the infusion. The implementation of better practices and procedures continues in the quest of contaminant-free parenterals, nevertheless, the literature is replete with articles documenting contamination of parenteral medication.

Foreign body particulate matter has been found sequestered in the lungs of patients who have received intravenous therapy. The entrapment of foreign bodies can occur in other body organs besides the lungs. The hazardous effects of this particulate matter has been the subject of much concern. Other forms of parenteral contaminants have been reported in the literature. These include both bacterial and fungal contaminants.

Contaminant detection in parenteral solutions has been accomplished by several methods. These have included: visual inspection, nephelometric methods, methods of membrane filtration with subsequent microscopic examination, and methods employing various electronic adaptations.

No references have been published describing viral contamination of parenterals or methods for viral detection in parenteral solutions . Yet, viral contaminants infused directly into the blood of a patient may be of grave clinical significance. Thus, the objective of this project was to develop a method for detecting the presence of viruses in small and bulk parenteral solutions.

Both small and large volumes of Sodium Chloride Injection U.S.P. and 5 percent Dextrose Injection U.S.P. were inoculated with 100 I.U . or 1 I.U. of Tobacco Mosaic Virus (TMV) per ml of solution . The contents of these parenterals were concentrated to a retentate volume using molecular filtration . The retentate volume was examined for viral content using transmission electron microscopy with negative staining techniques.

Efficacy was determined by comparison of the results of the contaminated controls with the contaminated test groups . Statistically significant differences were observed between the control groups, which were not subjected to the test method, and the test groups for both small and large volume parenteral solutions.

Efficiency, which denotes the viral contamination level at which viruses are detectable, was determined by comparing the control groups of uncontaminated parenteral solutions with contaminated test groups of the same solutions . Both groups were subjected to the test methodology. The control and the test groups showed statistically significant differences at the 100 and the 1 I.U. TMV contamination levels.

The results showed that the defined method of viral detection is efficacious and efficient at the tested TMV contamination levels . This method could probably be applied to the detection of other viral contaminants of parenteral solutions as well as to biological viral analysis methods.

Pages

81

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