How to handle deliveries of temperature sensitive medications
Raj Patel avatar
Written by Raj Patel
Updated over a week ago

Introduction

NowPatient adopts reasonable measures to make sure that intended storage conditions defined by the pharmaceutical manufacturer of your medication are maintained when being transferred from our facility to your delivery address.

Reasonable measures include:

  • Choosing appropriate validated transit packaging

  • Accurate and unambiguous labelling with name and address of intended delivery point and intended storage conditions

  • Use of specialist logistics provider or other approved provider

  • Driver instructions as appropriate

What to do when you receive a temperature sensitive delivery from NowPatient

You will be sent a tracking code when you delivery is dispatched. You should make sure you are at the address that is accepting the delivery, on that day.

As soon as you are in receipt of the delivery. Please open the outer packaging and remove the contents.

Separate the medication from the packaging and place it immediately into your fridge.

Cool boxes

NowPatient uses cold-chain transit containers and cool packs from a recognised medical supply company. Domestic cool boxes are not used.

The cool box manufacturer provides assurance that a stable temperature within the specified range will be maintained for a specified time.

We follow the process below when preparing cold chain shipments.

How do you validate Cold Chain packaging?

We validate our cold chain shipment method. This ensures that your medication will be stored and transported within the manufacturers approved temperature guidelines, at all times.


Test method for validation:

Results that validate the method we use:


Conclusion of results:

The qualification tests show that the IcerTech insulated boxes, along with Easi-Chill coolants can be used as a total solution to provide a reliable temperature of between 2 and 8oC under the testing conditions used. A summary of the performance of each solution during the testing is given in the table below:

The testing was performed under ‘ambient’ conditions of approx. 20oC, which is representative of typical room temperatures, or summertime weather within the UK. It is likely that below this temperature, the product will be kept at between 2 and 8oC for a much longer period of time than indicated in these tests. IcerTech recommends that for journeys with an average outside temperature of not more than 10oC that the amount of coolants used as indicated above is halved.

Ultimately the onus is on the customer to ensure that adequate performance is achieved, and IcerTech will not accept any extended liability. As a qualification, this report proves that the solutions will work for the purpose intended, but where necessary the customer must perform their own validation trials.

Suppliers of cold chain products should have a cold chain distribution strategy that conforms to the requirements of the MHRA (for pharmaceutical) or the FSA (for food). Some guidance on this is given in the discussion section of this report.

How we prepare cool packs

Before use, cool packs are stored in accordance with the manufacturer’s instructions, usually at 2°C to 8°C. In general, ice packs and frozen cool packs are not used unless the cool box manufacturer’s instructions specifically recommend them. This is because they may create cold spots, and result in the medicines freezing.

How we pack cold chain deliveries

Individual manufacturers’ instructions for packing the cool box are strictly adhered to. It is important to prevent direct contact between the medicine and the cool packs to protect the medicine from risk of damage from excessive cooling. Medicines are packed carefully to avoid breakage.

Re-validation

Cool boxes are re-validated according to the manufacturer’s instructions and under simulated conditions of actual use. This is an internal control that validates the method we use.


References

[1]. Taylor, J. Recommendations on the control and monitoring of storage and transportation temperatures of medicinal products.
http://www.mhra.gov.uk

[2]. Guidance on Temperature Control Legislation in the United Kingdom. EC Regulation 852/2004. The Food Hygiene Regulations 2006 (as amended). Food Standards Agency, September 2007

[3]. Todd, S. Refrigerated medicinal products: what pharmacists need to know. Article originally written for and published in The Pharmaceutical Journal, October 2008

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