Tamper evident labels help meet new regulations

Tamper evident labels help meet new regulations

‘With the new requirement for stringent drug authentication processes through the supply chain coming into force, we were determined to help our pharmaceutical customers meet the challenge. By thinking through the problem together we’ve developed a tamper evident label that’s just the job.’

The Customer

Our customer specialises in drug development, delivery and supply; working with major pharmaceutical companies, medicine wholesalers and retailers on a global basis.

One of their specific aims is to ensure a safe and reliable supply of medicines to consumers and, as such, they are heavily involved in the successful implementation of the Falsified Medicines Directive (FMD) throughout the medicine supply chain.

The Customer’s Challenge

The new regulation, officially EU 2016/161, a supplement to the FMD, is intended to prevent fake medication entering the supply chain. It requires individual pharma packaging to bear a serial number so that the content can be traced back to its original source.

The regulation states that traceability must be maintained throughout the supply chain – from bulk manufacture to wholesale repackaging, right through to the end consumer.

In addition, the directive requires the use of tamper evident seals to aid product authentication.

Our Approach

Having discussed the requirements with our customer, the challenge was to to develop a tamper evident label that worked across a wide variety of packaging types, including branded and gloss finished surfaces. The self-adhesive labels also needed to work with different label application methods – from fully automated labelling systems to hand application.

In addition, we set our own challenge to design a tamper seal that could also be overprinted with variable data serial numbers to support the traceability requirement outlined by the new regulation.

We discussed the viability of various tamper evident labelling techniques, including void labels which leave label fragments intact if they are tampered with, but decided that this technique would not give the versatility needed.

What we delivered

Having rigorously tested various adhesive label substrates we agreed on a clear, synthetic material with an aggressive adhesive.

The material is ISEGA approved, and compliant with Title 21 of the Code of Federal Regulations (CFR) dealing with Food and Drug Administration.

The aggressive adhesive was key to the success of the tamper evident label and ensures that the cardboard fibres of the drug packaging would always tear, whatever the carton material, when the label was tampered with.

The use of a clear material means that labels can be applied to branded boxes without affecting the look or requiring lengthy re-approval of the medicine packaging. In addition, the synthetic material can be over printed with batch serial numbers so that the tamper seal can also be used to support the new requirement for complete drug traceability though the supply chain.

The impact on the customer’s business

By understanding the needs of the customer and the requirements of the new directive we were able to develop a versatile tamper evident label that supports compliance with the new regulations. Specific benefits include:

  • tamper evident seals that will meet the new regulation, EU 2016/161, and be reliable across multiple carton materials
  • dual-purpose tamper labels that can also be used to support the requirement for serialisation; saving money on having to develop a second batch code label
  •  clear, ISEGA approved, synthetic label material that doesn’t interfere with branding or require re-approval of pharmaceutical packaging.