CoolPac are specialists in temperature controlled packaging and temperature monitoring.
We service the pharmaceutical and biomedical industry. CoolPac are experts in cold chain logistics and cold chain packaging. Using CoolPac's proprietary cold chain technology, we have developed pre qualified shipping systems for temperature controlled distribution.
PICS GDP: Section 3.4.5Adequate records of repair, maintenance and calibration activities for key equipment should be made and the results should be retained. Key equipment would include for example:– cold stores, monitored intruder alarm and access control systems, refrigerators, thermo hygrometers, or other temperature and humidity recording devices, air handling units and any equipment used in conjunction with the onward supply chain.”
WHO TRS 961 Annex 9: Section 4.7Qualify new temperature-controlled storage areas and new refrigeration equipment before it becomes operational
WHO TRS 961 Annex 9: Section 4.10.1Calibrate devices against a certified, traceable reference standard at least once a year, unless otherwise justified.
TGA GWP: Section 8.3Temperature monitoring equipment should be installed within facilities used to store cold chain medicines to enable air and/or product temperature as appropriate to be recorded. Such devices should be able to operate in the event of a mains power failure.
TGA GWP: Section 2.2Facilities need to be provided that allow for temperature monitoring and recording in case of power failures.
PICS GDP: Section 3.5.1Before a computerised system is brought into use, it should be demonstrated, through appropriate validation or verification studies, that the system is capable of achieving the desired results accurately, consistently and reproducibly.
TGA GWP: Section 8.7The calibration and function of all temperature monitoring equipment, , including alarms and other associated equipment, should be checked on an annual basis.
PICS GDP: Section 3.4.2Equipment used to control or to monitor the environment where the medicinal products are stored should be calibrated at defined intervals based on a risk and reliability assessment.
EU GDP 2013: Section 3.3.1
Before a computerised system is brought into use, it should be demonstrated, through appropriate validation or verification studies, that the system is capable of achieving the desired results accurately, consistently and reproducibly.