CoolPac are specialists in cold chain packaging and temperature monitoring in Australia.
We deliver cold chain products and services the pharmaceutical and biomedical industry. CoolPac are experts in cold chain packaging and cold chain logistics. Using CoolPac's proprietary cold chain delivery system, we have developed pre-qualified shippers for temperature-controlled distribution of mediations and biological products worldwide.
Cold Chain Packaging
TGA GWP: Section 8.2Any new equipment used for the storage of cold chain medicines should be commissioned according to the manufacturer’s written procedure and the storage conditions validated before becoming operational.
EU GDP 2013: Section 3.3Appropriate alarm systems should be in place to provide alerts when there are excursions from pre-defined storage conditions. Alarm levels should be appropriately set and alarms should be regularly tested to ensure adequate functionality.
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.
ISPE GDP: Cold Chain Management: 6.2.5The (facility temperature) monitoring system used for the critical environmental parameters should be qualified./p>
EU GDP 2013: Section 2.4All personnel involved in wholesale distribution activities should be trained on the requirements of GDP. They should have the appropriate competence and experience prior to commencing their tasks.
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.