A common approach utilized in validating the cleaning of multi-product equipment is to challenge
the cleaning cycle with the hardest-to-clean, or “worst-case”, soil. The worst-case soil is …

Cleaning validation programs are developed to demonstrate acceptable carryover of drug
substances/products when multiple drug substances are manufactured in shared process …

… Please submit comments to the column coordinator Rizwan Sharnez at rsharnez@amgen.com
or to journal coordinating editor Susan Haigney at shaigney@advanstar.com. …

For multiproduct cleaning validation, the conventional approach for setting an acceptance
limit for the process residue is based on the maximum allowable carryover (MAC) of the active …

Biopharmaceutical cleaning and sterilization processes denature and degrade the active
pharmaceutical ingredient (API) i into fragments that are pharmacologically inactive. A rational …

… These can be submitted either to column coordinator Rizwan Sharnez at rsharnez@amgen.…
Sharnez, R., “Strategies for Setting Rational MAC-based Limits: Part I-Reassessing the …

A previous series in this column on cycle development and validation for cleaning shows
how design space and control space are established for cleaning processes. The series also …

… Rizwan Sharnez and Angela To … These can be submitted to the column coordinator
Rizwan Sharnez at rsharnez@amgen.com. … Rizwan Sharnez and Angela To …

Chromatography resins used for purifying biopharmaceuticals are generally dedicated to a
single product. In good manufacturing practice (GMP) facilities that manufacture a limited …

Cleaning processes are often developed with a trial-and-error mindset that relies more on
afterthought than on deliberation and foresight. This “Quality-by-Chance” approach can lead …