吉晟藥品Veritas Biomedical 
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Q&A

Question

What is Phase Change Material (PCM)?

A phase change material is a substance which releases/absorbs sufficient energy at phase transition to provide useful heat/cooling. Generally the transition will be from one of the first two fundamental states of matter - solid and liquid - to the other. For temperature controlled shipping applications, this means that PCMs can be used for Industry standard temperature ranges, such as -20M, +2C to +8C, +15C to 25C for example. PCMs give reliable, consistent performance and combined with high performance insulation, can give durations in excess of 120 hours. PCMs commonly found in bottle, TIC (Thermal Insulation Chamber) or encapsulated foam BRIC form.

Question

How to precondition the TIC® System?

Pull open the tab on the front of the corrugate box (or open latches if applicable) and remove the insulator lid in order to expose the TIC® panels. Remove the TIC® System (6 panels) from the insulator base and condition them by using either the Optimized or Universal conditioning methods.

SERIES 22
(For Taiwan) Place TIC® System panels flat in a 15 to 21°C conditioning environment for 24 hours minimum. PCM will be completely solid after conditioning. After 24 hours shake several panels to ensure no liquid can be heard.

SERIES 4
Place the TIC® system in a ‐18°C freezer (or colder) for a minimum of 24 hours, until frozen hard. Once the TICs have been properly preconditioned, move the bin into a refrigerated environment (4°C ±2°C) for no less than 48 hours. After 48 hours in the refrigerated environment the TICs have reached an operating temperature of 2°C and are ready to use.

SERIES 20M
Place the TIC˚ system in a -65˚C freezer, or below, for a minimum of 24 hours. Ensure that the TICs lay flat. Freeze times may vary depending on amount of units being frozen and equipment specifications. The TIC system may be conditioned in a freezer as warm as -25°C but the conditioning time must be increased. To ensure the TIC is fully frozen, shake the panels to verify no liquid can be heard.

Question

How to Clean Your Credo Components?

TIC System (6 panels):
Clean the TIC panels by using warm water and soap or alcohol. Sanitize by using an isopropyl alcohol and water mixture (typically 70/30 mix alcohol to water) or other salt-based disinfectants.

Insulator lid and base:
Clean the insulator lid and base by using a damp towel with soap or a rag with isopropyl alcohol.

Plastic corrugated outer box:
Clean the plastic outer box by using a damp towel with a non-abrasive soap or a rag with isopropyl alcohol.

DO NOT:
1. Autoclave any of the components.
2. Use any organic solvents such as acetone or methyl ethyl ketone (MEK) on any of the components.
3. Expose any of the TIC components or insulator to extreme heat (+75° C or above.)
4. Use any abrasive cleaners on any of the components.

Question

How to Perform a Thermal and/or Transit Qualification?

Pelican BioThermal offers thermal and transit qualification services, to industry standards, via our thermal laboratory. We also offer a NIST traceable PC-based temperature data logger that fits inside the container and provides accurate, continuous time and temperature data in a spreadsheet format. We utilize and follow ISTA procedure 7D or 7E, which are ASTM D3103 compliant to guide you through your thermal testing process. We recommend ISTA procedure Series 1, 2, or 3, or ASTM D4169 to guide you through your transit testing. Many of our units are already transit tested to ISTA procedure 3A. The certification can be found on the bottom of the shipper.

Question

How to Inspect and Replace Vacuum Insulation Panels?

The Vacuum Insulation Panels (VIPs) in Credo containers are extremely effective as long as they hold an internal vacuum. Periodically inspect the VIP lid and base surfaces. Loss of rigidity indicates a compromised panel. A loose skin or non-rigid panel indicates vacuum loss and the product should be recycled (refer to Section 4). Avoid removing the VIP base from the outer corrugated box. Replace the VIP lid and VIP base before the expiration date printed on each panel.

Question

How does NanoCool differ from other products?

NanoCool features innovative push button activation, meaning conventional pre-conditioning, using refrigeration, is not necessary. The system uses evaporative cooling technology along with phase change materials (PCM) and advanced insulation VIPs for an easy-to-activate shipping system which is ideal for low-volume shipping or for applications where refrigeration is not available.

Open the system, remove the cooling engine and place silver foil side down on a clean, hard, flat surface. With your thumb, push straight down on the button. Between 30 seconds and 3 minutes the NanoCool logo turns blue, indicating the cooling has begun. Load product in the chamber, replace cooling engine snugly, close the container and tape it shut.

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