Bench scale apparatus to model and develop biopharmaceutical...

Details Bench scale apparatus to model and develop biopharmaceutical... Bench scale apparatus to model and develop biopharmaceutical...

2005-10-12

2009-02-17

Larkin, Daniel S (Department: 2856)

Measuring and testing

Liquid analysis or analysis of the suspension of solids in a...

Cleaning or foaming ability

C134S018000, C134S108000, C134S113000

Reexamination Certificate

active

07490508

ABSTRACT:
An apparatus for testing a cleaning procedure for a material. The apparatus includes a rack having a seat configured to retain a plurality of test coupons at a predetermined angle, an upper tray that distributes a solution along the lines of the rack, a lower tray for receiving solution passed over coupons disposed on the rack, a meter that gauges a flow rate of the solution, a thermostatic heater adapted to bring the solution to a predetermined temperature, and a variable speed pump that directs the solution from a reservoir to the upper tray.

REFERENCES:
patent: 4277290 (1981-07-01), Andrews et al.
patent: 5039349 (1991-08-01), Schoeppel
patent: 2004/0194810 (2004-10-01), Strothoff et al.
Canhoto, “A Novel Bench Scale Apparatus to Model and Develop Biopharmaceutical-Cleaning Procedures”,Journal of Validation Technology, 11(1): 16-24, 2004.
Canhoto, “A Semi-Quantitative Matrix for Selecting an Appropriate Cleaning Validation “Worst-Case” Challenge Soiling Solution”,Journal of Validation Technology, 11(1): 6-15, 2004.
Rousseau, “How to solve complex cleaning validation problems”,Journal of Validation Technology, 4(1): 22-30, 1997.

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