Glossary

 

-A-

Allowable Excursions: Acceptance range in which the product temperature can reach within a set amount of time that does not compromise the integrity of the product

Ambient Temperature: The temperature of an outside environment

-B-

Bill of Materials (BOM): a listing of components, including descriptions and or/ item numbers

-C-

Calibration: the tuning of an instrument according to a standard value

Calibration Verification: the act of confirming that a device or instrument is properly calibrated

Clinical Trial: any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or pharma dynamic effects of an investigational product with the objective of determining safety and/or efficacy. (ICP, GCP, WHO Good Clinical Practice Standard)

Cold Chain Product: a product that is temperature sensitive required a controlled thermal environment

Conditioning: the process of exposing materials to predetermined environmental (temperature/humidity) conditions for specific lengths of time in order to render the material fit for use

Controlled Room Temperature (CRT): a need for temperature maintenance requirement between 15° to 25°C with allowable excursion from 15 to 30°C

-D-

Data Logger: an in-transit temperature recorder that measures temperature during a specified time period

Dimensions: description of an object in physical measurement terms (i.e. length x width x depth or height)

Distribution Cycle: transfer of a product among multiple locations that may include a manufacturer, storage facility and end user (clinic, commercial business, patient)

Dry Ice (DI): a refrigerant that is solid carbon dioxide, which sublimates to a gas at very cold temperatures.

-E-

Efficacy: the ability to produce a desired outcome

Excursion: deviation from a specified limit

Excursion Limit: a specifically defined allowable deviation from a set criteria limitation

-G-

GLP: good laboratory practices

GMP: good manufacturing practices

-I-

IATA: International Air Transport Association

ISO 9001:2000: the International Organization for Standards’ Quality Management System for accreditation of quality control for manufacturers

ISPE: International Society for Pharmaceutical Engineering

ISTA: International Safe Transit Association

-N-

NIST: National Institute of Science and Technology

-P-

Packout (Pack-out): the steps and procedures necessary to assemble a shipping container with its thermal components and product payload

Pallet Containers: Thermal shipping containers or pallet shippers designed to hold an approximate 4' x 4' -sized transport shipment mobilized by fork lift operation. The Crēdo XTREME° full pallet holds 890 liters and the half pallet holds 406 liters. Cool Pall Vertos (¼ PMC, ISOPAD, ½ PAG, ½ PMC) accepts pallet loads between 1382 liters and 3174 liters

Passive Thermal Shipper: a thermally protected shipping container which requires no additional active separate source of energy (electricity, dry ice, wet ice, etc.) to provide insulation and maintain the desired internal temperature for the pre-determined time duration

Payload: the interior volume size liter capacity of an inner container/contents (e.g. pharmaceutical products)

Phase change material (PCM): a encapsulated chemical formulation that can change form from a range of solid to liquid to maintain a desired exterior temperature. MTS’ phase change material is uniquely formulated for specific temperature ranges and is embedded within the TIC (thermal isolation chamber) system

Pre-conditioning: the preparation of temperature stabilization of a PCM material per thermal requirements prior to container pack out

Prototype: a full scaled model or example of a product design prior to its final approval/build

-Q-

Qualification Report: a formally written or electronically produced quality controlled record detailing a thermal performance range over pre-defined time range and temperature conditions

Qualification (Validation): testing that provides reasonable assurance that the qualified product or process will produce similar and consistent results under stated conditions

-R-

Robust: the ability of a container system to maintain its required internal minimum and maximum temperature under varying ambient conditions

Room Temperature: typically refers to a range between 15-25°C (or 59-77°F)

R-Value: a measure of thermal resistance of an insulated material. A higher R-value indicates greater insulative properties

-S-

Shipping: the process of transporting a package/container from one location to another

SOP: acronym for standard operating procedures

-T-

Temperature Packaging Solution: an efficient packaging system designed to control the temperature during shipping of a payload per specific requirements

Temperature Probe: a device which measures local temperature within a calibrated tolerance

Temperature Profile: the temperature set points and exposure times experienced by the insulated shipper within the environmental chamber

Temperature-sensitive Product: a product for which stability is impacted by temperatures outside a prescribed range (i.e. vaccines, blood, tissues)

Thermal Solutions: package designs that meet the thermal requirements of a temperature-sensitive product

Thermal Isolation Chamber (TIC) - PBT patented, precision-formed, interconnected panels surrounding payload with a tight, protective thermal seal

-U-

Universal Packout: a container shipping solution whose single Packout and conditioning procedure is the same year round

-V-

Validation (Qualification): a study that provides documented evidence that assures that a specific process or system will consistently meet predetermined specifications

VIP: vacuum insulated panels that offer a high R-value insulation.  Pelican BioThermal’s™ VIP’s are durable and encapsulated with a continuous thermal barrier with an extremely high R-value