CoolPac are specialists in cold chain 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.
Cold Chain Packaging
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 3.3Equipment 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.
USP 1079The recording of temperatures during the thermal mapping of a warehouse or cold room should be sufficient in time frame to capture workflow variation that may impact air flow and the resulting temperature fluctuation (i.e., a period of two weeks is recommended for data collection enabling the capture of two week/weekend workflow cycles).
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 2.4Personnel should receive initial and continuing training relevant to their role, based on written procedures and in accordance with a written training program.
ISPE GPG: Packing, Labeling and Warehouse Facilities“The purpose of temperature mapping is to identify the locations which are representative of the environmental extremes within the space, to assist in scientifically determining where the permanent area monitoring sensors should be placed.”
IATA Class 6 Packing Instructions 650If dry ice is used, the packaging must be designed and constructed to permit the release of carbon dioxide gas to prevent a build-up of pressure that could rupture the packagings.
WHO TRS 961 Annex 9: Section 4.10.3Check functionality of temperature and humidity alarms at least once every six months at the designated set points.
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.”
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.