Who are your problem children?

In creating our Raw Material Characterization initiative, one of the first steps was to identify and prioritize which materials to focus on.  We used a risk factor weighting system to do this.  Factors that we chose to consider in assessing our risk with each raw material were:

• Frequency used in media formulations
• Combined quantity and purchase costs percentile
• Number of suppliers for that material
• Raw material origin
• Quality/compendia status
• Quality history with that component
• Animal component containing status
• Component complexity (simple or complex)

By making this assessment for each of the 400-500 raw materials that are used most commonly in the manufacture of our cell culture products, we derived a Top 100 list.  Below, I’ve indicated the Top 20 items that fall on our list with our current criteria:

1. L-lysine HCl
2. I-Inositol
3. D-Calcium pantothenate
4. Riboflavin
5. Biotin
6. L-Cystine
7. Folic acid USP
8. L-Tryptophan
9. L-Phenylalanine
10. Sodium pyruvate
11. L-Tyrosine 2Na salt
12. L-Glutamic acid anhydrous
13. Niacinamide
14. Cyanocobalamin (B12)
15. Soy Hydrolysate
16. L-Valine
17. Polyvinyl Alcohol
18. L-Cysteine free base
19. L-Asparagine H20
20. DL-Alpha-Lipoic Acid

These raw materials will receive increased scrutiny in our new program as we endeavor to gain even tighter control using both analytical and biological assays - and subsequently driving findings back through our quality system and supply chain. 

How does this compare to your situation?  Who are your problem children?

Let us know.

Posted by Bruce Lehr Jan 15, 2010