Why do you need to worry about Temperature Controlled Transport?
If you’re shipping food stuffs for human consumption or pharmaceuticals, you have a huge concern for controlling the temperature of your products during transport. Chemical producers and distributors also are concerned with transporting, sometimes volatile chemicals, at a certain temperature, or protecting them from freezing. A temperature sensitive shipment could be completely ruined and result in a transportation claim if it is not protected adequately.
In addition, anything for human consumption requires a high level of diligence to protect it from spoilage and ensure it’s safe for the consumer.
What does the Government of Canada have to say about Temperature Controlled Transportation?
For drug products the Government of Canada has published (GUI-0069) that pertains to temperature controlled transport:
- Drug products must be transported in a manner that ensures the products will be maintained within an acceptable temperature range as defined in the approved labelling and supported by stability data. Temperature excursions outside of their respective labelled storage conditions, for brief periods, may be acceptable provided stability data and scientific/technical justification exist demonstrating that product quality is not affected.
- The transport process and containers should be designed to prevent damage and maintain the integrity and quality of the drug products. For example, transport conditions for ampoules should limit their exposure to physical stress to avoid the development of hairline cracks.
- Written procedures for the shipping of drug products should be established. Such procedures should take into account the nature of the drug products, local conditions, modes of transport and any seasonal variations experienced, as well as describe any special handling precautions. These procedures should be qualified to ensure that appropriate conditions are maintained under probable extremes of ambient temperature and should also account for possible unforeseen delays which may occur in shipping/transportation (for example, delays at the border).
- Where controlled storage conditions (for example, temperature, relative humidity, light, etc.) are required during transit, the necessary environmental controls must be in place.
- Within a transportation container, the packaging configuration, which provides the primary means of environmental control for the drug product, should ensure that the drug product remains within the acceptable temperature range.
- Refrigerated vehicles/transportation containers should be mapped and monitored, if they provide the primary means for environmental control. However, this may not be necessary if a qualified insulated container/package, or an appropriate temperature monitoring device on the package or selected packages, or gel packs or similar approved means, or lane profile data are used as the primary means of environmental control.
- Temperature and humidity monitoring devices, such as data loggers, should be calibrated at predetermined intervals. Single use monitoring devices should be qualified (for example, verification of performance for indicator strips or freeze indicator units).
- Transportation practices by carriers, including any storage and/or transportation activities performed by sub-contractors, should be verified by reviewing documentation. A record of the review should be kept and any discrepancies should have a follow up.
- Vehicles and equipment used to distribute, store, or handle drugs should be suitable for their use and appropriately protective of the products to prevent exposure to conditions that could affect their stability and packaging integrity, as well as prevent contamination of any kind.
- Loading activities (loading and unloading) should be done in a manner that preserves the quality of the drugs.
These are good practices for all your temperature controlled shipments. The key is to identify where the risks are and to ensure you have a method to minimize the risks.
Where the risk occurs
|Loading/Pick up||Temperature conditions in the trailer before loading are key to ensure the proper temperature during transport.||At XTL our TempSolutions trailers are all monitored and tracked in real time on the internet. It’s easy to verify loading temperature to mitigate risk.|
|During Transit||During transit, many issues can affect the performance of the refrigeration/heating units. Breakdown, ambient temperature outside the trailer, doors opening and tampering.||XTL’s TempSolutions trailers are engineered with high R value insulation to minimize the effect of ambient temperatures outside the trailer.Plus, in the event of a mechanical issue with the refrigeration/heating unit, the insulation protects the shipment for an extended period.You also have the option of real time monitoring and alerts with XTL’s TempSolution which will automatically alert you of any temperature incursions, so you can rest easy that your shipment is maintaining the proper temperature.|
|During Unloading||During unloading, there’s always the risk that the trailer doesn’t arrive at the right temperature. Arrival temperature is key, along with a quick unloading time to ensure the product is not exposed to ambient temperature.||With XTL’s TempSolution you’re able to easily monitor, track and report on arrival temperature. There will be no debate about how well your product was protected during transit.|
|After the shipment is complete||Many people don’t consider the risks after a shipment is complete. However, if there is ever a safety concern with your products, you’ll be asked to prove the shipment was protected properly.||XTL’s TempSolution is a great way to keep records of your in-transit temperatures. XTL’s TempSolution records and monitors your temperatures so you don’t have to. This saves you time. Plus, you can also pull reports about the temperature details of your shipments at any time. Saving your time on regulatory requirements for record keeping.|
How XTL’s TempSolution will help you with best practice Temperature Controlled Transport
- Trailers engineered for temperature control with high R value insulation reduces the risk of temperature incursions.
- Real-time temperature monitoring ensures you have a constant record of temperature to help you meet regulatory requirements and minimize the time you need to spend keeping records.
- Full reporting suite available on-line so you can pull reports anytime. This makes your due diligence a snap! Any quality investigation goes smoothly when you have the data at your finger tips.