Over the last decade, Controlled Room Temperature (CRT) shipping requirements became stricter as the larger temperature ranges of “Do Not Freeze” and 0°C – 40°C started to tighten with USP requirements of 15°C to 30°C and 20°C to 25°C being implemented more thoroughly throughout the industry. This shift in regulation has changed the packaging from simple gel packs to next generation Phase Change Materials (PCMs) to ensure the products in the shipments can stay within the tighter temperature window. The challenge with the PCMs required for room temperature shipments is the proper conditioning to ensure they will work as intended. If the PCMs are not in a solid state for Summer shipping or a liquid state for Winter shipping, then the risk of temperature excursions will increase during transit.
EFP designed the first generation of Climatemp with functionality and simplified packing at the forefront. A single 22°C PCM brick is utilized to provide a solid state for Summer shipments and a liquid state for Winter shipments. With the use of our thermal conditioning chamber, the product successfully keeps a 20°C-25°C payload temperature for multi-day shipments.
Access to high-performance conditioning chambers is readily available for pharmaceutical manufacturers but is often not present for third party distribution centers or wholesale operations who rely on refrigerated storage rooms and large freezers for controlled conditioning. PCMs are conditioned in refrigeration units then benched at room temperature until they reach the appropriate temperature, but this was found to be a cumbersome process for the packaging procedure and a new conditioning protocol was required to be developed.
To overcome the problem of correctly conditioning CRT packaging in a warehouse environment, the next generation of Climatemp was developed to utilize a dual temperature PCM for effortless room temperature conditioning. By utilizing two PCM melting points instead of one, a straightforward conditioning process is implemented where the packaging and PCM are stored in a typical room temperature packing room or warehouse and achieve proper conditioning. This configuration allows for a universal packaging solution that creates simplified training for the packing personnel, taking the guesswork out of changing between a Summer packaging solution to a Winter packaging solution.
To learn more about Climatemp and how it can ensure your CRT products keep a proper temperature range during their shipment, download the Climatemp product information here and contact us today.
Written by Andrew Klasek, Product Engineering Manager.
Andrew began his career in the Environmental Chemistry field before coming to the packaging world where he currently runs the EFP Cold Chain Laboratory which develops shipping solutions for pharmaceutical and food shipments. Andrew also participates in the creation of whitepapers and industry guidance documents with the ISTA Pharma Committee covering topics such as developing temperature profiles for testing, lane testing, and simulation software.