Dividella tamper-evident packaging solutions

An update to U.S. Food & Drug Administration (FDA) CFR Title 21 regulations (Section 211.132) in 2013 required pharmaceutical manufacturers and packagers to protect OTC drug products with ‘tamper-evident’ packages that provides one or more barriers to entry that if breached or missing, will provide visible evidence to consumers that tampering has occurred.

Compliant tamper-evident package may involve an immediate closure system or secondary carton system.

However, many of the strategies adopted, particularly those involving applied labels or seals, have been found to be ineffective.

Dividella’s NeoTOP packaging systems are designed for the secondary packaging of parenterals, such as syringes, vials, ampoules, injects, pens, eyedrops, cartridges – in short: an infinite variety of Rx/Gx injectables, vaccines etc. The packaging machines allow effective tamper-evident safeguards to be applied simply and inexpensively during inline process.

Dividella NeoTOP solutions for tamper-evident seals

The ideal tamper-evident solution needs to combine user-friendliness (it remains easy for the end-user to open the package) with transparency (it should be immediately evident if anyone has opened the package beforehand).

Dividella has been concerned with guaranteeing originality for many years and has solved the tamper-evident problem quite simply by applying a spot of hot-melt glue in the right place.

Applying the hot-melt glue seal involves virtually no extra machine costs and has no effects at all on the performance of Dividella’s packaging machinery. Yet it is immediately apparent to the user if the carton has been opened.

The Dividella NeoTOP pack style allows the integration of a number of protection features:

• The hot-melt glue solution can be applied to a carton, placing a glue spot on one or all the three flaps of the carton before the fully automated, inline closing.
• Smart package design allows tamper evidence to be applied both to the outer carton and also to the individual products inside the pack.
• As an alternative or supplement to the Tamper Evident glue spot, Dividella NeoTOP can also apply a tamper evident label inline, after the closing process.
• The standard tamper evident closing feature is a tuck in flap that is glued and needs to be broken to open the carton.
• The extended tamper evident closing feature uses a tuck in flap plus additional dust flaps that must be unsealed to open the carton).
• Individual protection of the products in the carton uses a cover panel glued over the products. To remove the products, the individual carton tab that protects the product needs to be broken and removed.

Dividella’s Application Navigator allows customers to explore ideal tamper evident solutions across a broad range of products and packaging formats. See ‘Resources’ below for a link to the Navigator.

Resources

Click on Dividella tamper-proof packaging solutions for other information.