Introduction
In industries regulated by strict standards such as FDA 21 CFR Part 11 and EU GMP, choosing the right RFID tags ensures seamless integration with software platforms such as MES, QMS, and tracking systems. This article describes a scalable automation solution for passive RFID tags in pharmaceutical production.
RFID Application Scenarios in Pharmaceutical Production
1.Batch and Serial Number Tracking
Embed HF RFID tags on primary packaging (e.g., vials, blister packs) to store unique serial numbers for anti-counterfeiting and recall management.
2.Cold Chain Monitoring
Use high-temperature resistant UHF tags with integrated sensors for real-time tracking during storage and transportation of vaccines and biologics.
3.Raw Materials Management
Attach chemical-resistant UHF tags to bulk raw material containers for automatic inventory verification.
4.Aseptic production environments
Deploy autoclavable RFID tags on equipment to validate sterilization cycles (e.g., in compliance with ISO 17665).
5.High-speed packaging lines
Install UHF RFID tags on cartons and pallets for fast, error-free rollup.
Pharmaceutical RFID tag types and materials
1.Passive HF RFID tags (13.56MHz)
Material: polyimide film or medical-grade epoxy.
Key features:
- Short range (5-15 cm), ideal for secure item-level tracking.
- Resistant to moisture, solvents, and gamma radiation (for sterilization).
Applications:
- Serialization of vials and syringes.
- Integrate with ePedigree systems for theft prevention.
2.Passive UHF RFID tags (860-960MHz)
Material: PEEK (polyetheretherketone) or chemically resistant TPU.
Key Features:
- Long-range detection (up to 12 meters) for warehouse automation.
- Works in extreme temperatures (-40°C to 150°C) for cold chain and autoclave applications.
Applications:
- Pallet/carton tracking in GMP-compliant facilities.
- Monitoring temperature-sensitive pharmaceuticals during transport.
2.Pharmaceutical Compliance Labels
Tamper-evident labels:
Material: Fragile PET with destructible antenna.
Use case: Alerts on unauthorized access to high-value pharmaceuticals.
Sensor-integrated labels:
Material: PPS (polyphenylene sulfide) with built-in sensor.
Use case: Real-time humidity/temperature logging for biologics.
Chemically Resistant Labels:
Material: Ceramic or fluoropolymer coated labels.
Use case: Tracking of corrosive raw materials (e.g., APIs).
Integration Tips for Software Providers:
- Ensure serialization is compliant with GS1 standards and FDA DSCSA requirements.
- Use EPC Gen2 (ISO 18000-6C) to provide batch reading capabilities for UHF systems.
- Data encryption (e.g. AES-256) is preferred to protect sensitive pharmaceutical data.
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