Protecting the Public - Pharmaceutical Technology

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Protecting the Public
Overt and covert packaging technologies evolve to authenticate drugs and fight counterfeits.


Pharmaceutical Technology
Volume 36, Issue 11

Holograms. Holograms continue to be a popular authentication tool and can be applied to a variety of packaging materials and labelstock. Holograms can incorporate covert features and/or be combined with other anticounterfeiting features such as micro letters, color-shifting ink, embossing, temperature-sensitive ink, UV ink, and digital watermarks. Traditional embossed holograms provide a horizontal three-dimensional effect, plus high resolution and luminance. More difficult-to-counterfeit Lippmann Holograms rely on a laser-based production process. Vertical as well as horizontal three-dimensional effects present a more true-to-life image that is visible from any angle. Combining multiple images produces an animated effect. The addition of a two-dimensional barcode adds traceability functionality (Secureimage Hologram, DNP America).


Figure 1: Non-removable features are laser-etched during the rolling process to produce difficult-to-duplicate foil for blisters, flexible packaging or induction seals (CPI Security Foil, Constantia Flexibles).
Security materials. Security paper relies on random fiber orientation in the paper media to ensure each label, tag, or seal possesses its own fingerprint for authentication. A unique printed identifier, such as a QR, two-dimensional, or alphanumeric code on each label, links to a random embedded fiber image. The fiber image and code are recorded during printing and stored for instant recall and comparison when an end user verifies authenticity with a smartphone or other device (Neenah Secure Labels with the Prooftag Security System, Neenah Paper).

Difficult-to-copy security foil is available for push-through, child-resistant, or cold-formed blisters, pouches, sachets, and induction seals (see Figure 1). Fine-line graphics, text, logos, and micro-features are laser-etched into the surface of the foil during the rolling process and cannot be removed (CPI Security Foil, Constantia Flexibles).


Figure 2: Removing the tear strip on the label reveals messages showing the container has been opened and discourages improper reuse (Pharma-Comb Void Label, Schreiner Medipharm).
A multipart label with integrated covert inscriptions helps prevent empty vials from being refilled with fake drugs and resold. Removing the label’s tear strip, which also encircles the cap, reveals the messages, “Opened” and “Used” (see Figure 2). This makes the undetected reuse of a glass container with an original label virtually impossible (Pharma-Comb Void Label, Schreiner MediPharm).

Another brand-protecting label, already in use on audio equipment like microphones, combines overt and covert features. One area reveals different colors under direct light, and the last character of the alphanumeric security code is repeated in an enlarged format. Codes can be quickly checked online to confirm product authenticity at any point in the supply chain. The pressure-sensitive labels also can include a two-dimensional DataMatrix code (tesa PrioSpot technology, tesa scribos).

References

1. US Attorney’s Office, Eastern District Of Missouri, “California Man Sentenced for Importing Adulterated Cancer Drugs; Forfeits $1.4 Million and Land Rover Automobile,” Press Release (St. Louis, Mo., August 23, 2012).

2. S. 3187, US Senate, 112th Congress, 2nd Session (Washington, DC), June 27, 2012.

3. EC Directive 2011/62/EU, Falsified Medicines Directive (Brussels, July 2011).

4. FDA, “Buying Medicines Online? Be Wary, FDA Says,” Consumer Updates, http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm321121.htm, accessed Oct. 3, 2012.

5. FDA, Guidance for Industry: Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting (Silver Spring, MD, Oct. 2011).

6. WHO, “Medicines: Spurious/Falsely-Labelled/ Falsified/Counterfeit (SFFC) Medicines, Fact Sheet No 275, May 2012,” http://www.who.int/mediacentre/factsheets/fs275/en/, accessed Oct. 3, 2012.

7. USP, “Reducing the Threat of Counterfeits, Investing in the Future of Safe Medicines,” Press Release (Rockville, MD, April 09, 2012).

8. EFPIA, “Tackling the Rise of Counterfeit Medicines,” http://www.efpia.eu/news/tackling-rise-counterfeit-medicines, accessed Oct. 1, 2012.

Hallie Forcinio is Pharmaceutical Technology's Packaging Forum editor, 4708 Morningside Drive, Cleveland, OH 44109, tel. 216.351.5824, fax 216.351.5684,
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