Sofrigam focus on storage and transportation of heat-sensitive insulin

Diabetes has become an increasing concern in many developed pharmaceutical markets, placing ever-greater focus on the storage and transport of heat-sensitive insulin.

Sofrigam provides a wide range of insulated and refrigerated storage and transport solutions for this market and also insights into the correct handling of insulin.

Background: diabetes as a cool chain market

Today, diabetes is today considered as a real pandemic by the WHO: the disease affects 415 million people throughout the world, it kills one person every 6 seconds and its progression is substantial.

Insulin is a high-performance treatment, which has evolved markedly over the past decade. While diabetic treatments have become much more accessible and user-friendly, it is still necessary to observe precautions when storing and transporting insulin so as to guarantee its efficacy.

Temperature-controlled handling of insulin

Insulin can be administered in three ways in diabetic treatments:

1. The most common form of administration is by subcutaneous injection, increasingly carried out using disposable or prefilled insulin pens that are easy to manage and use, or by external subcutaneous insulin pump; a belt-mounted device connected to a subcutaneous needle with a catheter.
2. Intravenously: this type of injection by syringe is mainly used by medical staff in emergencies.
3. Intraperitoneal administration in which an insulin pump is implanted into the abdominal cavity.

In all three cases, the insulin must be kept and transported in temperature-controlled conditions, with requirements differing, depending on whether the manufacturer package has been opened or not. The vials and pens contain extremely low doses of product that change temperature very quickly according to the external temperatures experienced.

Before opening, insulin must be stored between +2°C and +8°C up to the expiry date indicated on the box.

After opening, insulin can be stored at room temperature (between +15°C and +25°C) for up to 30 days, so long as it is kept in its packaging, away from heat and light.

Insulin should also be administered at room temperature to aid absorption and to enhance the patient experience.

In all cases, insulin must never be allowed to freeze (below 0°C) nor subjected to excess heat (above 25°), both of which will destroy its efficacy. Regardless of storage conditions, insulin must be discarded one month after opening.

Storage and transport of insulin

Temperature controlled insulin transport and storage solutions need to cover the three principal stages in the medicine’s journey from manufacturer to end-user:

1. Cool chain delivery to and storage in pharmacies
2. Cool chain distribution from pharmacy to patient
3. Cool chain and temperature-controlled storage and personal transport by end-user

In practice, this means insulin should be kept and carried in an insulated pouch to avoid sudden temperature changes and protect it from environmental extremes of head and cold.

Where dealing with unopened insulin in transit between refrigerators, transport should be by refrigerated bag incorporating cooling media such as eutectic gel, to maintain the insulin at the desired temperature (+2/+8°C or +15/+25°C) for several hours, or even days.

Sofrigam experts can provide more detailed advice on the ideal insulated packaging solutions to store and transport insulin and other heat-sensitive medicines between manufacturer and pharmacy, and also for distribution and use by patients.

Resources

Click on insulated pouches for product information.
Click on Sofrigam advice for expert help.