Product Solution

First Opening Indication and Tamper Evidence

Labels for first opening indication and protection against tampering for pharmaceutical folding boxes and primary containers.

Threat Scenario: Illegal Replacement of Medicines

Counterfeit drugs can enter the distribution chain by manipulating outer packaging or reusing disposed, empty primary containers and filling them with illegal substitutes. Specialty security labels with first-opening indication and tamper evidence can reduce this danger. The globally uniform standard ISO 21976 (EN ISO 21976 at the European level) provides guidance on how to use security features and verify tampering with pharmaceutical packaging and specifies tamper-evident requirements.

Schreiner MediPharm's security labels irreversibly and clearly indicate the attempted removal and initial opening of a packaging seal, a syringe or a vial and comply with the requirements of EU Directive 2011/62/EU on secondary packaging. In addition, they ensure the integrity of primary containers and can serve as proof of authenticity.

Our Customized Labels for Tamper Evidence – Your Reliable Protection of Drug Safety

Schreiner MediPharm product portfolio of labels for first-opening indication and tamper protection for folding cartons, syringes and vials.

Closure Seals for Packaging

We develop your application-specific sealing solution based on various functional mechanisms and functional requirements, after extensive testing and with individually combinable options.

Effective peel-off and destruction mechanisms

To irreversibly indicate the first opening of a seal, various peel-off and destruction effects can be used and combined.

Fiber tear:
When the seal is removed, the cardboard surface is destroyed.

Closed and opened fiber crack seal for initial opening indication of a folding box.

Film tear:
When removed, the label tears and is irreversibly destroyed.

Closed and opened film crack seal for initial opening indication of a folding box.

Void effect:
When the label is opened for the first time, an irreversible text or holographic effect appears.

Closed and opened closure seal with void effect for initial opening indication of a folding box.

Functional requirements

When realizing your customized seal, we take into account all relevant security requirements, functional aspects as well as special challenges.

Extensive tests

We perform extensive testing with materials and adhesives to meet your defined requirements for the desired seal.

Wide range of possible combinations

For your unique, corporate identity (CI)-compliant, and secure seal, you can choose from different options and combinations.

Possible combinations of Schreiner MediPharm's safety seals.

Do you need a customized and secure closure seal?
Contact us. We will be happy to advise you!

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First-Opening Indication and Integrity Protection of Prefilled Syringes

Syringe-Closure-Wrap

Innovative marking solution for prefilled syringes: The label wraps around the syringe body and syringe cap. The first-opening indication is triggered when the upper part of the label is pulled off. In addition, a warning message appears. Besides, the label is destroyed by security die-cuts and cannot be closed again unnoticed. For increased product and counterfeiting protection, overt, covert or digital authentication features can be integrated.

Cap-Lock

Combination of security label and cap adapter for Luer-Lock syringes: A cap is placed on the primary closure of the syringe to equalize the different radii of the syringe body and closure. Subsequently, a label is applied that wraps around the syringe body and the lower part of the adapter. When the syringe cap is opened, the label is partially destroyed at an integrated perforation and irreversibly indicates the initial opening. Optionally, an RFID chip can be integrated for a digital first-opening indication.

Tamper Evidence for Vials

A tamper-evident security label wraps around a vial

Security Label for Vials

The tamper-evident security label wraps around the vial up to the level of the cap. To open the vial, a label-integrated tear strip has to be peeled off that cannot be resealed unnoticed. In addition, a warning message clearly indicating that the vial has been opened emerges.

A multi-part label that tightly encloses vial and cap

Pharma-Comb Void

The Pharma-Comb Void security concept features a multi-part label that tightly encloses the vial and cap. It is opened by means of a tear strip. This reveals covert inscriptions on special indicator fields. These and additional security die-cuts help to prevent unnoticed reuse of the vial with the original label.