ATL’s Twelve (Cold-Chain) Anti-Counterfeiting Tips 

Recently, in Philadelphia, I spoke to pharmaceutical and bio-technology companies (the makers 
of life saving vaccines). I recommended a 12 step approach to strengthen their cold-chain (the 
logistical system of safely delivering their products). My advice to them was that they 
understand the following: 
	
1. Cold chain system weaknesses;
2. Quality System Management of the cold chain; 
3. Risk Management Tools (including FMEA - Failure Modes & Effects Analysis); 
4. Cold chain variation (Mean & Standard Deviation); 
5. The “68-95-99.7 Rule” (and the law of large numbers); 
6. Out of specification “assignable causes”; 
7. Packaging and equipment validation (including IQ-OQ-PQ); 
8. The risks of measurement error (Repeatability & Reproducibility); 
9. Layering of anti-counterfeiting techniques; 
10. How counterfeiters attack, their use of bucket shops; 
11. M&R (mix and rotate) overt and covert anti-counterfeiting measures; 
12. Forensic Codes (invisible, digital, and non-degradable) for “fail-safe” authentication.

To learn more about these twelve tips, please request a copy of the Cold Chain Management 
slide show by submitting a Request for Sample under the Contact section.

Thank you for your interest.

Donald J. Dobert
President
ATL