Meeting and exceeding the temperature sensitive requirements of pharmaceutical products.
Wilpak Group International partners with Pharmaceutical Companies and shares an understanding of the specific thermal risks faced by manufacturers when storing and transporting temperature sensitive goods around the world.
PHARMACEUTICAL
Pharmaceutical industry data suggests that up to 80% of pharmaceutical excursions are caused by logistics and packaging solutions that do not meet industry standards.
In response to these issues, Wilpak Group International collaborates with pharmaceutical partners to profile the specific thermal risks associated with their logistics and packaging.
We qualify the root cause of these issues, then tailor customised pharma protection solutions that manage the risk of potential thermal and physical damage on their high value assets.
With increased regulatory requirements, the global pharmaceutical industry is being significantly affected by higher compliance demands and with a growing need to manage pharma logistics in cold chain and controlled room temperature (CRT) environments.
Controlled Trial 1
Industry: Pharmaceutical.
Scenario:
15ml vial of liquid medication, boxed and palletised (1m3 approximately).
Required temperature range not greater than 30°C and not less than 0°C.
Simulated air freight shipment in a controlled temperature chamber.
Total trip time approximately 77 hours.
Melbourne to Chicago (via Hong Kong) with exposure profile designed to replicate the typical northern hemisphere winter.
Risk
Exposure to extreme high and/or low temperatures may cause product excursions
Thermal Protection Provided
- InsulCap® thermal blanket used as a fitted pallet cover with InsulBase® thermal pallet liner utilising InsulPlatinum® double foil, ultra-high performance thermal barrier material.
- InsulCap® thermal blanket used as a fitted pallet cover with InsulBase® thermal pallet liner utilising InsulGold® double foil, high performance thermal barrier material.
Data Collection
Temperature data was collected by six calibrated data loggers placed under the Insulcap® system plus one logger to monitor external temperatures.
Outcomes
InsulPlatinum®
The InsulCap® thermal blanket delivered temperature profiles that were well within the required temperature range with the product temperature inside the protected pallet not exceeding 300C nor dropping below 00C.
When exposed to a maximum external environment temperature of 34.50C for 5 hours the InsulCap® constructed from InsulPlatinum® controlled the internal product temperature to a maximum of 24.40C.
When exposed to a minimum external environment temperature of -70C for 4 hours the InsulCap® constructed from InsulPlatinum® controlled the internal product temperature to a minimum of 6.60C.
As a result, the InsulCap® was approved by the pharmaceutical company for use by their freight forwarder.
InsulGold®
The InsulCap® thermal blanket delivered temperature profiles that were well within the required temperature range with the product temperature inside the protected pallets not exceeding 300C nor dropping below 00C.
When exposed to a maximum external environment temperature of 34.50C for 5 hours the InsulCap® constructed from InsulGold® controlled the internal product temperature to a maximum of 27.50C.
When exposed to a minimum external environment temperature of -70C for 4 hours the InsulCap® constructed from InsulGold® controlled the internal product temperature to a minimum of 50C.
As a result, the InsulCap® was approved by the pharmaceutical company for use by their freight forwarder.
Controlled Trial 2
Industry: Pharmaceutical.
Scenario:
15ml vial of liquid medication, boxed and palletised (1m3 approximately).
Required temperature range not greater than 30°C and not less than 0°C.
Simulated air freight shipment in a controlled temperature chamber.
Total trip time approximately 68 hours
Melbourne to Brussels (via Dubai) with exposure profile designed to replicate the typical northern hemisphere summer.
Risk
Exposure to extreme high and/or low temperatures may cause product excursions
Thermal Protection Provided
Insulcap® thermal blanket used as a fitted pallet cover with InsulBase® thermal pallet liner utilising InsulPlatinum® double foil, ultra- high performance thermal barrier material.
Data Collection
Temperature data was collected by 6 calibrated data loggers placed under the InsulCap® system plus 1 logger to monitor external temperatures.
Outcomes
The Insulcap® thermal blanket delivered temperature profiles that were well within the required temperature range with the product temperature inside the protected pallet not exceeding +35°C nor dropping below +5ºC.
When exposed to a maximum external environment temperature of +42°C for 5 hours the InsulCap® constructed from InsulPlatinum® controlled the internal product temperature to a maximum of 29.9°C.
When exposed to a minimum external environment temperature of +4°C for 4 hours the InsulCap® constructed from InsulPlatinum® controlled the internal product temperature to a minimum of +7.8°C.
As a result, InsulCap® was approved by the pharmaceutical company for use by their freight forwarder.
