Pharmaceutical Tamper Evident

Manostaxx

The text that follows is owned by the site above referred.

Here is only a small part of the article, for more please follow the link

SOURCE: http://vertassets.blob.core.windows.net/download/40166c6e/40166c6e-560c-44d0-9b8c-013aea21029b/howtoensuretamper_evidentpharmaceuticalpackaging.pdf

Gluing

Gluing folding boxes is a common technique used to seal packaging. However, in the future gluing will double up as a security feature as packaging must be incapable of being opened at gluing points without manipulation being apparent. A solidified glue layer between two cardboard areas with dispersion glues cannot be separated without damaging the fibers of the cardboard surface. Manipulating a glued point is difficult because solidified cold glue cannot be restored to its original state, even by adding water or other substances. After a box is opened by manipulation and reglued, the packaging will no longer be flat in the glued area.

tamperevident1

Special Folding Techniques

Using a specially-constructed folding box is another option to meet the EU regulations. The flaps and body of this type of box are designed to activate the security feature when the flaps are inserted during the packaging process to seal the box. First time opening of the box leads to visible, irreversible damage. Alternatively, the opening flaps can incorporate a perforation that tears when the box is first opened. A disadvantage of this solution is that boxes must be handled with great care in the packaging and shipping process to prevent premature opening. However, as tamper verification features are integrated directly into the structure of the folding box, additional materials such as glue or labels can be eliminated entirely. In addition, using special folding techniques can help manufacturers achieve optimal Overall Equipment Effectiveness (OEE) for their packaging line as they allow the speed of machinery to be maintained.

tamperevident2

 

Film Wraps

 

Another option to prevent unauthorized opening of medicinal products is to cellophane a filled folding box or shrink wrap it in a film, which must be ripped or broken to gain access to the product. However, both cellophane and film wrapping without additional safety features can be replaced at any time and do not protect the actual product. Another disadvantage of film wrapping is that it can reduce the readability of the serialization code on packaging, which could complicate a potential aggregation process where all serialization codes have to be read to generate an aggregation code. In addition, cellophaning makes it more difficult to feel Braille dots. Shrink wrapping can also prove tricky for elderly or disabled patients to remove. In addition, the cellophane must be joined to the folding box, for example by gluing, so that the supplying pharmacist can recognize whether the wrapping has been removed from the packaging.

tamperevident3

 

Adhesive Seals

Self-adhesive seals that have to be destroyed before a box is opened for the first time provide another tamper-evident solution. A number of options are available, including adhesive tear-off labels that damage the surface of a box when pulled off, or void seals that leave behind a visible pattern or text when removed. Additional options include tamper-proof labels with perforations and those made of ultra-destructive specialty film. Among the various security options, the advantage of sealing with labels is that the packaging itself does not need to be altered, which means that existing packaging machines do not require modification. Moreover, such labels are not merely restricted to folding boxes; they can also be used to seal fluid containers such as bottles or ampoules. Applying a label to the sealing edge of a folding box provides secure tamper evidence. In addition to protecting against manipulation, this method provides the option to integrate security features into the product label.

tamperevident4

Leave a Reply

Your email address will not be published. Required fields are marked *