Tamper evident devices must be traceable & unique; Rx-360

Tamper evident devices present an obstacle for adulterators and counterfeiters of pharmaceutical raw materials, which, in turn, gives confidence to companies sourcing supplies. However, devices must be well designed to offer an effective deterrent to counterfeiters eyeing large profits.

“With the use of a well designed tamper evident device, the strength of the security measure will be far greater than that of a poorly designed or unsuitable tamper evident device​”, said Rx-360 in a briefing document​.

In the document Rx-360, a supply chain security consortium, details the elements suppliers and buyers of pharmaceutical raw materials should look for in a tamper evident device.

A device needs a distinct design, such as a break-away cap, which uses materials that would be very difficult for a counterfeiter to source. Unique identifying characteristics, for instance a logo, which are difficult to fake or steal, are also needed.

Use of a generic device, such as a zip tie, which can be obtained easily and reapplied, can actually be harmful by providing a “false sense of security​”, Rx-360 said. Traceability and physical robustness, to survive transport, are also highlighted by Rx-360.

When to use tamper evident devices​

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Rx-360 recommends taking a risk-based approach to use of tamper evident devices. High-risk materials include those: that could generate significant revenues for counterfeiters; are critical to the production process; or pose a threat to patient safety.

“Excipients, for example, pose a much higher risk to patient safety than a media solution used upstream in a process. Both materials would benefit from some form of tamper evident device, but the benefit is far greater to have a robust tamper evident device for the excipient​”, Rx-360 said.