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
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.
EU GDP 2013: Section 2.4A record of all training should be kept, and the effectiveness of training should be periodically assessed and documented.
WHO TRS 961 Annex 9: Section 3.9.2Develop and maintain a contingency plan to protect TTSPPs in the event of power failure which places products at risk. Alternative emergency cooling systems
USP 1079A new facility would require a validation incorporating an Installation Qualification (IQ), Operational Qualification (OQ), and a Performance Qualification (PQ) as defined in FDA’s CPG Sec 490.100 Process Validation Requirement for Drug Products and Active Pharmaceutical Ingredients Subject to Pre-Market Approval, 2004.
SPE GPG: Packing, Labeling and Warehouse FacilitiesMany commercial HVAC (BMS) control systems provide adequate control, data handling, and alarming capability. Such systems should be validated when used for recording critical parameters.
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.
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.”
PICS GDP: Section 3.4.1Planned maintenance should be in place for key equipment vital to the functionality of the operation.
WHO TRS 961 Annex 9: Section 4.9Implement a maintenance program for all temperature-controlled rooms, cold rooms, freezer rooms, refrigerators and freezers: • Carry out regular planned preventive maintenance on all temperature controlling equipment. • Make arrangements to ensure that emergency maintenance is carried out within a time period that does not place TTSPPs at risk of damage. • Ensure that there is a contingency plan to move products stored in nonfunctioning equipment to a safe location before damage to the product occurs in the event that equipment cannot be repaired in a timely manner.
EU GDP 2013: Section 3.2.2Temperature monitoring equipment should be located according to the results of the mapping exercise, ensuring that monitoring devices are positioned in the areas that experience the extremes of fluctuations.
WHO TRS 961 Annex 9: Section 4.10.1Calibration should demonstrate the accuracy of the unit across the entire temperature range over which the device is designed to be used.
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.
WHO TRS 961 Annex 9: Section 4.10.1Single-use devices that are supplied with a manufacturer’s calibration certificate do not need to be re-calibrated.
PICS GDP: Section 9.2.2A procedure should also be in place for investigating and handling temperature excursions
TGA GWP: Section 8.1Refrigerated areas for the storage of cold chain medicines should be correctly set up and operate continuously.
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).
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.