Update:

Serialization / Tamper Evident

1. Serialization

Technical Equipment:

Our packaging lines are equipped with integrated solutions of our partner OCS. The OCS stations are able to fulfill the requirements according to the EU guideline (printing of 20 digits serial no., printing of product code (PPN; GTIN, NTIN), 2-D-Datamatrix-Code).

The following equipment is in use:

All packaging lines are able to accomplish the serialization of folding boxes. Other serialization levels or aggregation can be accomplished upon request.

Software solution:

For handling and creation of serialization data and reports we chose ARVATO CSDB software solution. We are working together with SYSTEC & SERVICES as our IT partner for the implementation of the software and the on-boarding and connection to the customer software solutions.

2. Tamper Evident (safety closure feature)

The existing lines are prepared for the installation of technologies in order to apply safety closures on folding boxes.

The following technologies are in place:

1. Hot Melt:

The favored solution for Klocke to ensure the safety closure of the folding boxes is via hot melt on the dust flaps of the folding boxes.

2. TE labels:

For some specific packaging lines tamper evident labels are used to ensure the safety closure. These labels are spent on the folding boxes inline via the OCS equipment. The labels are standard labels suitable for the safety closure of folding boxes.

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Serialization

The continuous increase of drug counterfeits and the hereby resulting threat to the drug market makes it indispensable to implement a complete retraceability of medicines. In the EU guideline 2011/62/EU, which was published in June 2011, security features for the examination of the authenticity and for the identification of each single package of ethical drugs in the EU were defined in order to protect the legal supply chain of the intrusion of counterfeit drugs. The guidelines and technical requirements were defined in the delegated provision (EU) 2016/161 to transform them into national law. With the beginning of the compulsory implementation on February 9th, 2019, only prescription drugs which are marked with an individual serial number and whose intactness is visible via a security closure are allowed to be marketed.

The facilities of the Klocke group are well equipped:

We equipped the packaging lines with serialization stations. Therefore we used integrated solutions of our partners OCS and Systec & Services, which completely fulfill the legal and technical requirements. Currently there are TQS-SP (for serialization) as well as TQS-HCA stations (serialization and control weighing) in use. In addition one line for serialization and aggregation of multiple packaging levels (e.g. for the Chinese market) was implemented.

Furthermore the existing lines are prepared for the installation of several technologies in order to apply safety closures on folding boxes (safety labels, glued folding boxes, design-engineered original closure of the folding box, etc.). Thus we can offer different solutions for the implementation of the legal guidelines to our clients.

Your personal contact
Tanja Hefke
Fon
+49 (7805) 401 231
Mail
tanja.hefke@klocke-pharma.de