Intelsius Glossary of Convenient Terms - Intelsius - A DGP Company | Cold Chain Packaging Solutions
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Intelsius Glossary of Convenient Terms

A

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.

B

Biotherm: Intelsius brand name for temperature controlled packaging ranges for sample/specimen transport.

C

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.

E

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.

F

FDA: Food and Drug Administration (US federal pharmaceutical and medical regulator).

G

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

H

Hydraulic Test: A means of testing, by pressurised fluid, the ability of a container to remain leakproof at a given pressure (see 95kPa)

I

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.

M

MKT: Mean Kinetic Temperature, a (disputed) measure of temperature exposure for products.

N

NDC: National Drug Code (US FDA)

O

OQ: Operational Qualification, a quality process using a system to determine its efficacy.

P

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.

Q

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.

R

RID: Dangerous goods regulations covering the transport of dangerous goods by rail

S

Stability: The character of a pharmaceutical or ingredient in response to different temperature exposures.

STP: Specimen or Sample transport packaging.

T

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

U

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.

X

XPS: Extruded Polystyrene, sheet insulation material.

*See appropriate International Regulations for more details

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