Compliant protection for pharmaceutical products

The pharmaceutical industry requires the most rigorous control standards to preserve drug efficacy, safety and regulatory compliance. Temperature represents the critical parameter for maintaining active ingredient stability, while humidity can compromise bioavailability and the shelf-life of medicines. Uncontrolled thermal excursions can denature therapeutic proteins, degrade vaccines and alter critical formulations.

Our solutions range from continuous cold chain monitoring with the Propatherm range, to precise humidity control with Propametic, Propasec Food Contact and Propasil with Tyvek® coating registered Drug Master File.

Cold chain monitoring

The pharmaceutical cold chain requires particular attention to comply with FDA, EMA and ICH regulations that govern the transport of temperature-sensitive drugs. Our Propatherm devices provide continuous monitoring of pharmaceutical shipments by signaling if the temperature has reached critical points for drugs during transport. The Propatherm Descending indicators provide irreversible evidence of excursions below 0°C that could compromise vaccines and insulin, while the Propatherm Ascending detect thermal exceedances harmful to drugs that require refrigeration.

The GO PDF Biomed data loggers offer superior precision of 0.0625°C specific for vaccines and biotechnology, automatically generating detailed PDF reports with NIST calibration certificates for regulatory compliance.  The GO Wireless version allows real-time remote monitoring with immediate alarms for timely interventions during critical events.

Humidity control for pharmaceutical stability

Humidity control is fundamental for maintaining the chemical and physical stability of pharmaceuticals, preventing degradation hydrolysis, formation of undesired polymorphs and loss of therapeutic potency. PROPAMETIC films play an important role in protecting pharmaceuticals from humidity as they are particularly suitable for long-term preservation of materials that require a stable atmosphere to maintain their characteristics intact. Propasec Food Contact, FDA certified, effectively protects pharmaceuticals from humidity without releasing substances that could contaminate the active ingredients. Propasil, with Tyvek® DuPont coating registered Drug Master File type III, offers superior protection for particularly hygroscopic drugs and lyophilized formulations.

For critical applications such as API (Active Pharmaceutical Ingredients) and pharmaceutical intermediates, Propasieve molecular sieves achieve very low humidity levels, essential for preventing degradation reactions. Propasecard humidity indicators provide, instead, immediate visual control of humidity present in primary packaging, allowing compliance verification without compromising the integrity of sterile packages.

Safety during transport

In the pharmaceutical sector, safety during transport and storage is fundamental to protect products from potential damage. During handling, packages could slip, with the risk of compromising the integrity of the cargo. Or breakage of vials containing liquids could occur, wetting the rest of the cargo and therefore putting the integrity of medicines and medical devices at risk, with serious economic and quality consequences.

The Propagrip and Propagrip DryGuard represent the ideal solution to these problems. These are paper interlayers with special anti-slip treatment, which increase pallet stability by drastically reducing the risk of unwanted movements during transport and storage. The Propagrip DryGuard, moreover, also offers a barrier against liquids, protecting packages from accidental leakage from liquid medicines. These interlayers are therefore perfect for the pharmaceutical sector, where maximum care in packaging integrity is essential to preserve product quality and comply with regulatory standards.