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:
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.