Bench scale cleaning characterization of drug products in a fill-finish facility

BIOT 305

Nitin Rathore, nrathore@amgen.com1, Nishant Bhasin2, Parag Kolhe2, Rich Law2, Ahmad Abdul-Fattah2, Linda Li2, Wenchang Ji2, and Keith Murphy2. (1) Drug Product and Device Development, Amgen, Inc, One Amgen Center Dr, Thousand Oaks, NC 91320, (2) Global Drug Product & Device Development, Amgen, MS 30W-3-A, One Amgen Center Drive, Thousand Oaks, CA 91320
Characterization and validation of equipment cleanliness is a key requirement for a bio-pharmaceutical facility. Manufacturing scale cleaning cycle has to be developed and validated for its ability to clean all the equipment parts for a given soil. Cleaning validation in a multi-product fill-finish facility could benefit from using a worst-case based approach which involves cleaning and validating the most difficult to clean product. Such an approach will minimize the number of required validation runs. Scaled down cleaning evaluation can prove helpful in determining the worst case product. Our current study will present the bench scale characterization of the cleaning process for several drug products. The presentation will cover the effect of several process parameters including cleaning conditions on the cleanabiltiy and establish a bench scale process to be used as a platform for comparing the relative cleanabiltiy of different drug products.
 

Poster Session
5:30 PM-7:30 PM, Wednesday, August 22, 2007 BCEC -- Exhibit Hall - B2, Poster

Division of Biochemical Technology

The 234th ACS National Meeting, Boston, MA, August 19-23, 2007