Monday, 5 June 2006: 8:00 AM-11:30 AM
Magnolia D (Hershey Lodge and Convention Center)
Analytical Chemistry (ANYL)
Cleaning Validation Topics in the Pharmaceutical World
Cleaning validation provides documented proof that one can consistently and effectively clean pharmaceutical or food systems or equipment to predetermined limits so as to prevent contaminants from leaving residues that may adulterate and adversely affect the safety and quality of the next product manufactured. The current Good Manufacturing Practices recognize that the cleaning process is a critical issue to assuring product quality. Experts from the US and abroad will present their views on and research into various facets of this important subject as they relate to the pharmaceutical world.
Organizer:Michael Shifflet
Presider:Michael Shifflet
8:00 AM Welcoming Remarks
8:05 AM105Swabbing protocols for cleaning validation
Lara Soltis
8:25 AM106Establishing acceptance criteria for cleaning validation
Matthew McMenamin
8:45 AM107Benefits of utilizing total organic carbon analysis for cleaning validation
Will McHale, Brian Wallace
9:05 AM108A sensitive and accurate method for determining trace sorbitol levels
Michael J. Shifflet
9:25 AM Break
9:35 AM109The use of ion mobility spectrometry in pharmaceutical and biopharmaceutical manufacturing cleaning validation
Cynthia Liu
9:55 AM110Risk matrix approach to control cleaning validation utilizing an access database
Carsten Wangnick
10:15 AM111Cleaning validation by direct swab NIR analysis
Bronwyn Grout
10:35 AM Break
10:45 AM112Updating and overhauling your current cleaning validation program
Amy A. Davis
11:05 AM113 TOC v. HPLC: implementation of an alternative analytical procedure and method for cleaning validation
Will McHale, Brian Wallace

Back to The 38th Middle Atlantic Regional Meeting (June 4-7, 2006)