RFID-Technology for the Pharmaceutical Industry

Traceability for the highest cleanroom and GMP requirements

The MK RFID system enables GMP-compliant, audit-ready traceability of gloves, RTP containers, and other process-critical components throughout their entire lifecycle. Through unique RFID-based identification, integrity tests, usage data, and lifecycle histories are seamlessly documented in a digital format, ensuring complete transparency and traceability at any time.

Our innovative RFID system enables seamless, audit-proof traceability of application-relevant objects such as gloves, RTP containers, and additional components — fully compliant with GMP Annex 1. Each glove is equipped with a unique RFID ID, ensuring automatic and cross-system identification at all times. All integrity tests as well as the complete lifecycle history are directly assigned to the corresponding RFID ID and digitally documented.

The Glove Life Cycle System (GLCS®) further enhances these capabilities by enabling comprehensive tracking throughout the entire glove lifecycle. The RFID-supported identification ensures that every glove can be uniquely assigned at any time. This reduces the risk of operator errors, supports compliance with regulatory requirements, and enables the safe and efficient handling of glove components throughout their entire service life.

A key advantage of the system is the high durability of the implemented RFID technology. The RFID chips are securely integrated into a high-quality PTFE housing and designed to withstand at least 250 autoclave cycles under demanding process conditions. As a result, functionality, readability, and reliability remain consistently intact even after repeated sterilization — making the system ideal for regulated pharmaceutical manufacturing processes.

Thanks to its robust design, the RFID system is compatible with standard sterilization methods used in the pharmaceutical industry and meets the highest cleanliness requirements without generating additional particle sources. This makes the solution ideally suited for critical cleanroom and GMP environments.

In addition, the contactless RFID technology enables the simultaneous detection of multiple gloves via bulk reading, as well as reliable and low-error writing and reading of relevant test data. The need for manual intervention is significantly reduced.

The result is an efficient, secure, and fully digitalized RFID-based traceability process that minimizes operator effort while sustainably improving quality, compliance, and process reliability.

All product information contained in this text has been reviewed and approved by Patrick Muth, Product Manager.

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