82% der führenden Pharmaunternehmen nutzen RFID, um die FDA- und EU-GMP-Standards zu erfüllen. Für Systemdienstleister, this represents a high-value opportunity to provide mission-critical automation solutions. Here is an actionable guide:
RFID Applications in Pharmaceutical Automation
1.Drug Substance Tracking
- Anwendung: RFID tags on raw material containers track API (active pharmaceutical ingredients) batches to ensure compliance with FDA DSCSA regulations.
2.Aseptic Manufacturing Control
- Isolator Monitoring: RFID-tagged vials in the filling line verify sterilization parameters (time/temperature) to meet ISO 13408 standards.
- Tool Tracking: Pfizer uses RFID to manage freeze-drying equipment lifecycles in a Class A environment.
3.Packaging and Serialization
- UDI Compliance: RFID tags encode GTIN, Chargennummer, and expiration date for automated GS1 compliance in 120+ markets.
- Manipulations-Beweise: Encrypted labels on vaccine packaging (piloted by Moderna) prevent counterfeiting in cold chain logistics.
4.Clinical Trial Management
- Sample Integrity: RFID cryogenic tags track trial medications at -80°C, maintaining FDA 21 CFR Part 312 chain of custody.
- Patient Adherence: Smart blister packaging with RFID records dosing times for real-time trial data collection.
5.Waste and Sustainability
- Hazardous Waste Tracking: RFID tags on cytotoxic waste containers automatically generate EPA RCRA compliance reports.
- Reusable Asset Management: RFID stainless steel totes at Roche facility achieve 99% recycling rate.
Non-automated scenarios and RFID opportunities
| Manual Process | RFID-Lösung | Impact |
|---|---|---|
| Paper-based batch records | RFID + eDHR (Electronic Device History Record) | Eliminieren 95% documentation errors |
| Visual inspection of labels | RFID-enabled vision systems | Reduce mislabeling by 88% |
| Manual sample logging | RFID-tagged cryoboxes | Cut lab processing time by 50% |
Pharma RFID system components
1.Hardware
- Markierungen: Autoclave-safe, cryogenic variants
- Lesern: Cleanroom-compatible (ISO 14644) fixed/handheld readers
- Antennen: Near-field for vial scanning, wide beam for trays
2.Software
- Middleware: Integration with MES (z.b.. Werum PAS-X) and QMS (Veeva)
- Analytik: Real-time dashboards for OEE, deviations, and audit trails
3.Integrations
- ERP connectivity (SAP S/4HANA, Oracle)
- DSCSA-compliant blockchain platforms
Recommended RFID tags for the pharmaceutical industry
| Anwendung | Recommended Tag | Hauptmerkmale |
|---|---|---|
| Cryogenic Storage | UHF Ultra Small RFID Tag | -196°C stable, 2×5.8mm, ISO 10993 konform |
| Drug Packaging | UHF RFID Inlay | Encrypted, embeddable in foil blisters |
| Reusable Containers | Ceramic RFID Tags | IP69K, withstands CIP/SIP cleaning |
Compliance: Fda 21 CFR Part 11, EU Annex 11, ISO 14644
Wir bieten:
RFID tracking in sterile manufacturing
RFID inventory management for pharmaceutical production
UHF RFID tags for medical packaging
RFID solutions for pharmaceutical serialization
Why work with a pharmaceutical specialty supplier?
Pharmaceutical Customer Needs:
✅ Regulatory Mastery: Expertise in FDA/EU GMP Computerized System Validation
✅ Contamination Control: Hardware Design for USP <800> Compliance
✅ Global Serialization: Solutions to support DSCSA, FMD, and China DMC
[Kontaktieren Sie uns] to design an RFID solution that delivers:
- 100% DSCSA compliance
- 60% faster batch release
- Real-time deviation alerts
