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Method to Streamline Validation
of Dissolution Apparatus Proposed


PerkinElmer Multivendor Validation Leader's
Proposed Method Would Cut Costs 

Franklin, MA  (October 2006) - Joe Tehrani, Ph.D., Multivendor Validation Business Leader at PerkinElmer Inc., will discuss streamlining the validation process for dissolution apparatus at the dissolution testing conference “Strategies and Techniques for Dissolution.” 

The conference will be Oct. 19-20, 2006 in Boston. 

Validation of dissolution apparatus is a time-consuming process using the USP method 711, mainly due to the lengthy preparation of dissolution media solutions. The media preparation process requires a filtering apparatus and large volumes of water and various chemicals including potassium phosphate, sodium hydroxide, and phosphoric acid.

Estimated labor and other costs related to dissolution media preparation is approximately $600 – $900 for each dissolution apparatus. 

Dr. Tehrani proposes the concept of using low-cost certified media solutions for certification / validation of dissolution apparatus in conjunction with a streamed-lined and easy-to-follow validation protocol employing automated MS Excel macros to significantly reduce the validation man-hours. 

Benefits

The benefits of this streamlined validation process for dissolution apparatus includes:

bulletReducing labor and materials costs for preparation of dissolution media
bulletEliminating the time-consuming filtration of large volume media
bulletShortening the validation time
bulletEmploying a validated MS Excel macro for fast calculation of spectrophotometeric results
bulletInstituting a streamlined validation protocol to simplify review and audit of the validation/certification

Dr. Tehrani speaks at 4:30 Thursday, Oct. 19, at the SWE Conference held at the Tremont Marriott in Boston.

This is Dr. Tehrani’s second appearance as a speaker at an SWE conference this year. Last spring, Dr. Tehrani presented a case study covering the logistics of moving regulated laboratories. 

The case study highlighted the relocation of Hospira Laboratories’ 180,000 square-foot GLP/GMP compliant facility near Chicago.

PerkinElmer, which specializes in moving multivendor labs, was selected Project Manager for the lab relocation.

For more information regarding lab relocation,  visit our lab relocation resources. For more information regarding our multivendor validation / qualification services visit our IQ OQ PQ pages

 
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