As a packaging technologist we are aware of this kind of packaging. But most of us are aware of only few options that can make a pack tamper evident. But first we need to see, why this tamper evident feature is of utmost importance for pharmaceutical packaging?
As per AMG – German Pharmaceutical Products Act, pharmaceuticals for human use must have security features, as well as the possibility to detect potential tampering, on their outer packaging.
The AMG also defines “Falsified Medicine” as product containing false information concerning it’s-
1. Identity, packaging, name or composition relating to one or several ingredients, including additives and the content of these ingredients,
2. Origin, including the manufacturer, country of manufacture, country of origin and owner of commercialization approval or
3. The distribution channel described in records and documents.
This definition extends the traditional term of a falsification as a brand and/or patent infringement and significantly expands the protection rights to include the prerequisites of GMP/GDP conformance.
To identify a falsified medicine, EU has defined a standard to describe tamper verification features for outer packaging as-
1. “Security features which make it possible for wholesalers and persons who are empowered or authorized to dispense medicines to the public to verify the authenticity of the medicine and to identify single packs
2. As well as a device which makes it possible to check if the outer packaging has been tampered with.”
There are various options for providing tamper evident seals that includes-
- Glue Dots
- Folding Construction
- Self Adhesive Seals
- Penetration Indicators
- Tearing Fibres
- Void effect
- Other sealing techniques such as film wraps, blisters and sleeves today are playing only a minor part in secondary packaging of pharmaceuticals.
You can find the detailed description on these options through this interesting article –
http://www.packagingconnections.com/tamper-proof-pharmaceutical-packaging.htm
Comments
I wounder when such things will be realized and implemented in India! Consumers need to be made aware.
Yes. Here in India we can generally see only "void effect". Infact there are many other options also available globally but awareness is missing
Manufacturers use a low-cost
Manufacturers use a low-cost flexible packaging on the inside to provide the barrier and anti-static properties, and a rigid packaging on the outside for the protection.
David Morgan || mobilak.co.il