Cold Chain Testing
Protocol for Cold Chain Management in Community Pharmacy
An essential component of good pharmacy practice is the correct monitoring of community pharmacy refrigeration to ensure that temperature-sensitive products such as vaccines and insulin are stored at appropriate temperatures.
The stability of vaccines is dependent upon refrigeration storage control. Vaccines should be stored at temperatures between 2 and 8 degrees Celsius. In Australia, freezing of vaccines has been shown to be the major cause of vaccine damage in both tropical and temperate climates.
From January 2004, pharmacies wishing to comply with QCPP mandatory standards must have an approved vaccine refrigerator.
Various procedures need to be in place to ensure that these purpose built refrigerators perform up to standard, these may include the following:
- Door openings are kept to a minimum and a warning sign reading: ‘WARNING; DO YOU NEED TO OPEN THIS DOOR?" is attached to the door. One person is appointed to be responsible for reading, recording and resetting at the same time each day, both the minimum and maximum temperatures over the 24 hours. Readings outside 2 and 8 degrees Celsius are to be assessed by the Pharmacist in Charge.
- If the minimum temperature falls below freezing, vaccine should be discarded.
- The power point used by the refrigerator should be taped over in the "on" position. A warning sign not to disconnect the power supply should be attached above the power point. A ten-centimetre space should be left around the refrigerator to allow proper ventilation.
To obtain a thermocron please download (below), or contact the Pharmacy Guild by phoning (02) 9467 7140 and asking for Health Services Manager.
The Cold Chain Testing Centre will monitor pharmacy refrigerators for compliance with the QCPP standard, using the Thermocron temperature logger .The Thermocron is a tamper-proof, re-programmable computer logger capable of recording 2,000 + temperature readings.
- The Thermocron can be programmed to record half hour temperatures.
- The intervals selected for monitoring of pharmacy refrigerators are every half hour for a period of seven days.
- Each Thermocron will be programmed to monitor one pharmacy before being returned to the Guild for downloading to the database and producing a hard copy report to be returned to the pharmacy.
- Community pharmacies identified by the Thermocron monitor as failing to comply with the required temperature range of 2 to 8 degrees Celsius are advised as to action necessary to ensure compliance.
- A second monitoring is conducted to guarantee the action taken is appropriate.
- Community pharmacies compliant with the QCPP standard are recorded on the Cold Chain Testing Centre database and a verification certificate will be provided for sighting by appropriate authorities inspecting community pharmacy premises.