Labels for first opening indication and protection against tampering for pharmaceutical folding boxes and primary containers.
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.
We develop your application-specific sealing solution based on various functional mechanisms and functional requirements, after extensive testing and with individually combinable options.
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.
Film tear: When removed, the label tears and is irreversibly destroyed.
Void effect: When the label is opened for the first time, an irreversible text or holographic effect appears.
When realizing your customized seal, we take into account all relevant security requirements, functional aspects as well as special challenges.
We perform extensive testing with materials and adhesives to meet your defined requirements for the desired seal.
For your unique, corporate identity (CI)-compliant, and secure seal, you can choose from different options and combinations.
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.
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.
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.
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.
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