Intelsius Glossary of Convenient Terms
Absorbent: Material, typically fabric sheet, required by UN DG regulations to go between primary and secondary packaging to absorb liquid if the primary is ruptured*
ADR: European agreement concerning the international carriage of dangerous goods by road, dangerous goods regulations.
API: Active Pharmaceutical Ingredient. Often produced remote from the finished pharmaceutical.
Biochill: Intelsius brand name for semi-rigid sealed pouch water based PCM used within systems.
Biotherm: Intelsius brand name for temperature controlled packaging ranges for sample/specimen transport.
Category A: UN Dangerous goods classification for infectious substances*
Category B: UN Dangerous goods classification for biological substances*
Class 6.2: UN Dangerous Goods classification for infectious materials*
Class 9: UN Dangerous Goods classification for miscellaneous materials (inc Dry Ice)*
Conditioning: The preparation process for PCM materials required in a specific phase before use within a system.
Coolpack: Typically a semi-rigid sealed pouch of material, usually water based, for use within systems. Can be used generically for any sealed PCM system component.
EMA: European Medicines Agency (European federal pharmaceuticals regulator).
Environmental Testing: Term to describe the testing of systems under simulated external environmental challenges most commonly thermal, shock and vibrational and humidity/moisture.
EPS: Expanded Polystyrene, moulded or sheet insulation material.
Eutectic: Term for the optimised melting point of a blend of different chemicals.
FDA: Food and Drug Administration (US federal pharmaceutical and medical regulator).
Gel Packs/Gel Bags: Sealed pouches of gel material, usually water based, for use as PCM within systems.
GDP/cGDP: Good Distribution Practice (current c) a quality system for distribution (storage and transport)
GLP/cGLP: Good Laboratory Practice (current c) a quality system for laboratory operation and reporting
GMP /cGMP: Good Manufacturing Practice (current c) a quality system for manufacturing of product
Greentherm: INTELSIUS brand name for a number of environmentally aware initiatives to increase sustainability
Hydraulic Test: A means of testing, by pressurised fluid, the ability of a container to remain leakproof at a given pressure (see 95kPa)
IATA: International Air Transit Association (publisher of regulations).
ICAO: International Civil Aviation organisation (author of regulations).
IMDG: International Maritime dangerous goods regulations.
IMP: Investigational Medical Product.
ISTA: International Safe Transit Association, a testing and oversight body on transport of goods.
MKT: Mean Kinetic Temperature, a (disputed) measure of temperature exposure for products.
NDC: National Drug Code (US FDA)
OQ: Operational Qualification, a quality process using a system to determine its efficacy.
Pathopak: Intelsius brand name for sample/specimen transport of category A substances.
Pathopouch: Intelsius brand name for 95kPa pneumatic and hydraulic tested leakproof pouches.
Pathoseal: Intelsius brand name for 95kPa vacuum tested leakproof pouches.
Pathoshield: Intelsius brand name for sample/specimen transport of category B substances.
PCR: Perishable Cargo Regulations (issued by IATA) see Chapter 17 for relevant to Intelsius.
Pharmatherm: Intelsius Brand name for temperature controlled packaging ranges for finished pharmaceutical goods.
Phase I / II / III / IV Trials: Clinical trials stages prior to approval, each corresponds to a different component of the federal approvals process.
Phase Change Material / PCM: A material which is intended to change physical phase (melt/freeze/sublime) at a specific temperature thereby providing thermal stability.
PI602: Packing Instruction for Dangerous Goods, superseded by PI620.
PI620: Packing Instructions for Dangerous Goods, UN 2814 & UN 2900 IATA & ADR*
PI650: Packing instructions for Dangerous Goods, UN 3373 IATA & ADR*
Pneumatic Test: A means of testing, by pressurised air, the ability of a container to remain leakproof at a given pressure (see 95kPa).
PQ: Performance Qualification, a quality process testing a system to show its capability.
PU – PUR: PolyUrethane Foam, moulded or sheet insulation material.
Qualification: A process often involving testing of a component, specific system of components or process to determine whether a necessary standard of performance has been met.
RID: Dangerous goods regulations covering the transport of dangerous goods by rail
Stability: The character of a pharmaceutical or ingredient in response to different temperature exposures.
STP: Specimen or Sample transport packaging.
TCP: Temperature Controlled/Compliant Packaging
Temperature Sensitive Health Care Products: Regulatory term for the materials covered in IATA PCR*
Tooling: Moulds, Dies, Fittings and Stereos to permit production of a specific product.
TOR: Time out of Refrigeration: A measure of the stability of drug exposure to adverse temperatures.
T&TS: Time and Temperature sensitive
UN / United Nations: Body responsible for the publication of model dangerous goods regulations which are followed to a greater or lesser extent in all subsequent DG regulations.
USP: United States Pharmacopeia Federal guidance on good manufacturing practices in pharmaceutical production, storage and distribution.
Validation/VMP Validation Master Plan: A complex quality process using PQ, OQ and other means to determine the suitability of a proposal for use within a quality compliant system.
Vacuum Test: A means of testing, by placing within a vacuum, the ability of a container to remain leakproof at a given pressure (see 95kPa).
VIP: Vacuum Insulation Panel, high performance sheet insulation material.
XPS: Extruded Polystyrene, sheet insulation material.
*See appropriate International Regulations for more details