The security seal that protects the product, the planet and helps to save.
To protect our customers’ products, while reducing environmental impact, we are now able to offer the Tamper Evident Folding Box®, a simple, effective and innovative security seal, in response to the most stringent regulations governing tamper evident systems.
A patent that fits into the production process in a lean and efficient way in line with our Corporate Social Responsibility and produced for the cosmetic market by Pusterla 1880.
How it protects the environment
• There is no longer any need to cover secondary packaging with plastic films to protect it from tampering or theft;
• The elimination of plastic films allows you to enhance all of the aesthetic choices made on the box, while avoiding its flattening;
• The lack of adhesive safety labels facilities the recyclability of the box;
• Carton box for easy recyclability of every component: no plastic adhesive or use of hot glue during the packaging process;
• The carefully selected cartons used by Pusterla have a polluting impact reduced by 53% in terms of CO2 emissions;
• No additional energy required for the production and application of plastic film;
• Pusterla operates according to the ISO 14001 Environmental Management System: the environmental impact is constantly measured and improved.
How it helps to save
Lean TE: fewer production factors:
• No investment for labelling and gluing machines;
• No additional space needed in the packaging department;
• Less resources to devote to maintenance: no operators and additional products;
• Fewer incoming goods to check: only boxes;
• Less stock in the warehouse: only boxes, no adhesives or glue to store;
Lean TE: High OEE
• No set-up of labelling machines and glue devices
• No slowdown caused by adhesives
• No waste caused by badly applied adhesives
• Less goods to move between the departments: only boxes
• Less time to dedicate to maintenance;
• No downtime to replace spent adhesive rolls.
How it protects the product
• The Tamper Evident Folding Box® seal is an integral part of the box and must be torn to open the package;
• Since the Tamper Evident Folding Box® seal is an integral part of the box itself, when the package is authenticated and identified, the content is also authenticated and identified;
• The box clearly and irreversibly shows if it has been opened: the integrated seal breaks and a high visibility tab appears;
• Faithfully replicating the Tamper Evident Folding Box® would require significant investments, technologies and know-how;
• No risk of damaging the variable data when opening the box.
This system complies with the strictest standards governing tamper evident systems:
FMD – The European Directive on Falsified Medicines – 2011/62/EU;
ISO 21976: 2018 which certifies fulfilment of the necessary requirements.
Solution awarded as the safest, most efficient and ecological
Procarton: “Solutions in line with Corporate Social Responsibility”
Pharmintech: “The simplest, most effective and innovative solution in response to directive 2011/62/EU and in compliance with FDA guidelines”.
Pharmapack: “Simple and effective solution for a leaner and more efficient production process.”
What do the European directives and the FDA require?
Directive 2011/62/EU – FMD – “Relating to falsified medicines, require safety features that allow distributors and bodies authorized or enabled to supply medicines to the public, to identify the individual packages, as well as having a device that allows you to check whether the outer packaging has been tampered with….”
• Authenticity: the box must be authenticated
• Identification: the box must be unique
• Proof of tampering: the content must be original
The European regulation 2016/161 provides details on the identification code but not on the specifications relating to the anti-tampering device.
The European Commission’s Q&A document recommends following the UNI EN 16679: 2014 standard.
On 14/10/2020 the UNI EN16679: 2014 was withdrawn and replaced by the ISO 21976: 2018 standard.
ISO 21976: 2018: “The first opening of the box must lead to a visible and irreversible tampering with the integrity of the box.”
FDA*: “Cardboard boxes with sealing flaps sealed by gluing are not able to meet the necessary requirements.”
ISO 21976: 2018: “Tampering with the sealing label or adhesive or opening the packaging must lead to damage or a visible or irreversible change of the packaging and / or the label or sticker”.
FDA*: “..the stickers must not be able to be removed and reapplied again. Furthermore their tampering or removal must be immediately evident…”.
2011/62/EU: The directive indicates that the external packaging must be authenticated and identified, so since the adhesive labels are part of the external packaging, they should also be authenticated and identified.
The FDA* states that “… Adhesive labels must involve an identifying feature that cannot be readily duplicated.”
The Tamper Evident Folding box product is protected by patents No. EP3110703B1 and No. IT 1425110, and is produced for the cosmetic market by Pusterla 1880.