Pharma packaging
in Pharmaceutical

Overview

In the pharmaceutical sector, ensuring drug stability, safety, and regulatory compliance requires precise monitoring of environmental conditions, particularly temperature and relative humidity, throughout the entire product lifecycle. Traditional sensing solutions, often bulky, battery-powered, and limited to external or room-level readings, fall short of delivering actionable insights at the individual package level.

To address this critical gap, Radio6ense has developed a cutting-edge passive sensor platform that leverages wireless, battery-free RFID technology to provide real-time, in-situ environmental monitoring directly inside pharmaceutical packaging. These innovative probes enable data-driven decisions, improve quality assurance, and support regulatory frameworks with unprecedented granularity.

Challenge

Pharmaceutical packaging presents a complex environment for sensing applications:

  • Sealed containers cannot be opened or tampered with during monitoring.

  • Miniaturized formats pose strict dimensional constraints.

  • Real-time data is required throughout development, manufacturing, and distribution phases.

Existing monitoring systems often rely on room-level measurements or destructive sampling, offering only partial insight into the actual environmental conditions experienced by the drug. Additionally, the diversity in packaging types (blisters, bottles, ampoules, pouches), materials (glass, plastic, aluminum), and drug formulations (tablets, gels, oral solutions) demands customized, embedded sensor solutions.

Solution

The solution is based on ultra-miniaturized, passive T/rH (temperature and relative humidity) sensors that can be integrated directly within primary pharmaceutical packaging—such as vials, bottles, and blister packs—without compromising packaging integrity or requiring batteries.

These sensors communicate wirelessly using UHF RAIN RFID protocols, powered remotely by standard RFID readers. Data is transmitted from within the packaging and processed via integrated dashboards, enabling scalable deployment even within metallic stability chambers, thanks to an optimized multi-antenna architecture.

Benefits

  • Continuous, Real-Time Monitoring: Enables real-time collection of environmental data from inside packaging.
  • Non-Invasive and Battery-Free: Passive RFID sensors require no internal power source and preserve container integrity.
  • High Accuracy: Temperature accuracy of ±1 °C and humidity accuracy of ±5%, compliant with pharma standards.
  • Versatile Form Factors: Suitable for a wide variety of packaging materials, shapes, and drug forms.
  • Scalable Architecture: Supports large-scale deployment in industrial setups including crowded, metallic stability chambers.
  • Regulatory Support: Facilitates ICH/FDA/EMA-compliant accelerated stability studies and packaging validation.
  • Process Insight: Acts as a sentinel during critical production transitions, enabling localized, item-level process control.
  • Cold Chain Validation: Allows lab-based reproduction of field conditions for quality assurance, complaint resolution, and risk mitigation.

Applications

The technology supports multiple use cases across the pharmaceutical lifecycle:

  • Stability Studies: Enables in-package monitoring in climatic chambers, offering accurate insight into degradation kinetics, particularly for moisture-sensitive APIs.
  • Packaging Evaluation: Assists in head-to-head comparison of materials and supports early selection of optimal packaging solutions, especially sustainable formats like ALU-free blisters.
  • Manufacturing: Provides granular monitoring of sensitive process steps (e.g., sealing, freeze-thaw) often missed by conventional PAT systems.
  • Supply Chain & Cold Chain: Builds actionable thermal profiles at the item level, critical for managing complaints and validating distribution environments.
  • Lifecycle Traceability: Transforms passive containers into intelligent, data-generating assets, enhancing digitalization efforts and supporting Industry 4.0 in pharma.

Downloadable Documents

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How can we help you?

Via della Tenuta di Torrenova 142, 00133, Roma

+39 06 35291 188

info@radio6ense.com

Radio6ense S.R.L

Via della Tenuta di Torrenova 142, 00133, Roma 
C.F./P.IVA 12270181006

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