What is tamper-evident packaging?

Tamper-evident packaging is a security feature specifically designed to deter and visibly indicate any unauthorised opening or tampering with a product. It offers critical protection and safeguarding for products from the point of manufacture to the end-user. For pharmaceuticals and medical devices, tamper-evident packaging is a requirement referenced in regulations and standards including: 
  • Falsified Medicines Directive (FMD). 
  • ISO Standard 21976:2018 covering tamper verification features for medicinal product packaging.
  • FDA Tamper-Evident Packaging for OTC Drugs: Ensuring Safety and Integrity (21 CFR Part 211 Subpart G)

Tamper-evident features we test include:

  • Breakable seals, induction seals, adhesive label seals, shrink bands, tape seals, void labels, blister packs, tamper-evident caps, secure envelopes.

Smithers tamper-evident packaging assessments

We can test individual packs, components and materials as well as the performance full pallets in transport scenarios. From the simplest, to very complex applications and conditions, Smithers will help you evaluate the integrity and reliability of tamper-evident packaging. Our guided service, supported by packaging experts includes:
  • Test plan development: we will work with you to develop a test plan for your product and applications. This might involve suite of standard tests or a combination of tests and human anti-tamper assessments.
  • Comprehensive laboratory testing capabilities including physical, functional and integrity assessments:
    • Opening force / torque
    • Adhesion strength
    • Puncture resistance
    • Seal strength
    • Tear strength 
  • Environmental resistance: we can test in a variety of climatic conditions to assess the resistance of your anti-tamper mechanisms to temperature and humidity.
  • Custom anti-tamper assessments: controlled, repeatable simulation of a person attempting to bypass the security system/s of your product. These can be performed on any product but are specifically recommended when contents are valuable or secure, and the financial, security or health and safety consequences of any breach are significant. For example:
    • Bank cards and PIN mailers
    • Passports and identity documents
    • Anti-doping canisters
    • Medical samples and biohazards  
  • Full-pallet transport and handling simulation in our state-of-the-art laboratory to understand the resistance to stresses such vibration, shocks and drops.
  • Expert support interpreting and understanding results: recommending next steps and further testing as required.

See how we can help

At Smithers, we combine decades of packaging testing expertise with state-of-the-art facilities to help you evaluate the performance of tamper-evident packaging solutions. Whether you are launching a new product, improving an existing design or seeking regulatory approval, our experts can offer the support you need. For more information or to request a quote, please contact an expert:
 
Cancel
Show Policy

Latest Resources

See all resources