Method of testing IV admixtures for contaminants

Details Method of testing IV admixtures for contaminants Method of testing IV admixtures for contaminants

1994-06-27

1996-07-23

Spear, Frank

Liquid purification or separation

Processes

Liquid/liquid solvent or colloidal extraction or diffusing...

210 94, 210410, B01D 6502

Patent

active

055386385

ABSTRACT:
A method and apparatus for testing a pharmacological IV admixture for contaminants, following filtering of turbid liquids such as emulsions through a micropore filter, includes the step of first air purging or gas purging residual emulsion particles through the micropore filter using pressure, before admitting a growth medium to the upstream side of the filter. The air purging of these emulsion particles, so that they are substantially removed from the upstream side of the filter, enables the successful sterility testing of the filter by admitting clear growth medium, waiting the required culturing time and observing for turbidity which evidences growth of microbes. The described procedure removes residual emulsion particles simply and effectively so that the visual test is effective. In a preferred embodiment the procedure is carried out using a sealed, sterile growth medium bag connected to the filter assembly, the bag having a quantity of sterile air along with the liquid growth medium. The bag is squeezed to create a pressure differential between the two sides of the filter, pushing residual emulsion particles through the filter and out the outlet end. Then the bag is inverted to admit growth medium to the filter, first squeezing the bag to rinse the filter assembly, then sealing off the filter assembly.

REFERENCES:
patent: 3951798 (1976-04-01), Haldopoulos
patent: 4036698 (1977-07-01), Bush et al.
patent: 4640777 (1987-02-01), Lemonnier
Addi-Chek Quality Control System, pp. 11-12 (undated).
"Method for Testing the Sterility of Total Nutrient Admixtures" American Journal of Hospital Pharmacy vol. 45 (Jun., 1988).
The United States Pharmacopeia, USP XXII, pp. 1483-1485 (Jan., 1990).
Healthtek Document No. IPA005C "Q.C. Tester" (Sep. 1990).

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