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Mar-2019-Packaging-Considerations-Tamper-evident.pdf (147 KB)

Tamper-evident packaging was introduced to create barriers or seals on the product which when broken, provides an indicator to consumers if tampering of the product has taken place.

Breakable Caps

These are designed to contain a feature on the plastic or metal cap such as a ring which when broken, remains on the neck of the container so it cannot be removed or reapplied without leaving a mark of tampering. The consumer must break the ring to be able to remove the cap.

Blister Packs

These are designed to seal individual doses e.g. tablets or capsules in individual pockets between a pre-formed tray and a lidding material or between two layers of material bonded together. The consumer must either break or rip the individual pocket to access the product.

  • Must be intact and complete
  • The two bonded layers cannot be separated or replaced without leaving a mark of tampering

Inner Seals

These are designed to seal the mouth of the container under the cap all the way around to remain intact and complete. The consumer must either break or rip the seal to access the product.

  • Can be made of paper, polystyrene foam, plastic film, thermal plastic or foil
  • Requires a distinctive design
  • A mark of tampering must be visible once the seal is removed to avoid easy replacement
  • Heat induction seals provide a better tamper-evident seal compare to pressure sensitive adhesives

Tape Seals

These are designed to seal over all possible openings of cartons or containers so it cannot be removed or reapplied without leaving a mark of tampering. The consumer must either break or rip the tape seal to access the product.

Tear Away Caps

These are designed to feature a tear away component to be torn off the plastic or metal cap. The consumer must tear away the component from the cap to be able to remove the cap to access the product.

Transparent Film Wrappers

These are designed to be securely and tightly wrapped around the entire product to form a complete seal. The consumer must either break or rip the wrapper to access the product.

  • Requires a distinctive design
  • Tinted wrappers without a distinctive design and cellophane wrappers are unacceptable since they are easily replaceable after possible tampering.
  • The use of overlapping end flaps is only acceptable when the ends cannot be opened and resealed without leaving a mark of tampering.

Sachets

These are designed to be torn or peeled open to access the product.

  • Requires a distinctive design
  • The two sealed layers cannot be separated or replaced without leaving a mark of tampering.

Tamper-evident packaging must:

  • Remain intact during handling
  • Have a tamper-evident statement on the packaging
  • Not block mandatory label information

Two-piece capsules must use a minimum of TWO tamper-evident packaging features. For example, a breakable cap with an induction seal on the mouth of the container.

Author: Michelle Nguyen