Chemistry: analytical and immunological testing – Process or composition for sterility or package integrity test
Patent
1994-06-22
1996-02-13
Alexander, Lyle A.
Chemistry: analytical and immunological testing
Process or composition for sterility or package integrity test
436 3, 422 26, 422109, 422116, G01N 3054, A61L 224
Patent
active
054910927
ABSTRACT:
The operation of a steam sterilizer is monitored by a test unit and a controller which together comprise a system which can be operated in two principal method schemes: (1) the testing for completeness of air removal from a sterilizer chamber, and (2) the testing for effective sterilization conditions. These methods each have two principal modes of operation: (a) the performance of a Bowie and Dick type test, as is usually done on a once-a-day basis; and (b) monitoring the sterilizer during load conditions. In a preferred embodiment a test unit including temperature and pressure sensors, a moisture sensor and a heat sink are positioned within the chamber of a steam sterilizer and transmit by radio the conditions therein to an external controller. The test unit can employ a replaceable cartridge to assure effective operation even after a large number of cycles of operation.
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Bowie, J. H. et al, The Bowie and dick Autoclave Tape Test, The Lancet, Mar. 16, 1963, pp. 586-587.
Joslyn, L. J. citing Darmody et al, (1964) Disinfection, Sterilization and Preservation, S. Block, Ed., 3rd ed. 1983, p. 23.
Mayworm, D., The Bowie-Dick type test . . . Are there alternative ways?, Journal HSPD, Mar./Apr. 1984, pp. 31-34.
Ryan, P., The Bowie-Dick type test . . . The discrepancies between theory and practice, Journal HSPD, Mar./Apr. 1984, pp. 20-24.
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