| US 7,490,508 B2 | ||
| Bench scale apparatus to model and develop biopharmaceutical cleaning procedures | ||
| Alfredo J. Canhoto, Framingham, Mass. (US); Rod J. Azadan, Boston, Mass. (US); John Putnam, Littleton, Mass. (US); Michael Kreuze, Acton, Mass. (US); Brian Williams, New Hartford, N.Y. (US); Kristen Nobles, Somerville, Mass. (US); Jeff Chapman, Weare, R.I. (US); and Kelli Barrett, Providence, R.I. (US) | ||
| Assigned to Wyeth Research Ireland Limited, County Kildare (Ireland) | ||
| Filed on Oct. 12, 2005, as Appl. No. 11/248,966. | ||
| Claims priority of provisional application 60/618554, filed on Oct. 12, 2004. | ||
| Prior Publication US 2006/0117654 A1, Jun. 08, 2006 | ||
| Int. Cl. G01N 37/00 (2006.01); B08B 3/08 (2006.01) | ||
| U.S. Cl. 73—60.11 [134/18; 134/108; 134/113] | 35 Claims |
| 8. A method of testing a cleaning procedure, comprising:
directing a first fluid at a predetermined temperature and flow rate over a plurality of test coupons simultaneously;
recirculating the first fluid over the test coupons a predetermined number of times; and
determining whether one or more of the plurality of test coupons is clean;
wherein the cleaning procedure is tested on a worst case soil selected from a plurality of predetermined soils by a method
comprising:
for each of the predetermined soils, identifying the chemical nature and concentration or each component;
assigning a value to each component describing its cleanability; and comparing the sum of the values for each soil, wherein
the soil having the highest sum is denoted the worst case soil;
the method further comprising classifying soils as buffers or media, wherein the buffer having the highest sum is denoted
the worst case buffer soil, and the media having the highest sum is denoted the worst case media.
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