Glossary
Below is a list of commonly used terms in cold chain management.
Glossary of Terms
A
Acceptance Criteria: A numerical or descriptive basis of acceptance.
Adhesive: A material that bonds together the surfaces of similar or different materials.
Allowable Excursions: Acceptable range in which the product temperatures 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.
API: Active Pharmaceutical Ingredient
ASTM: American Society for Testing and Materials
Audits: A professional examination of quality control and validation systems.
B
Benchmark: A point of reference from which measurements may be made.
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.
CFR: Code of Federal Regulations
CFR (21) Part 11: Federal regulations stating that electronic records and signatures are considered equivalent to paper records.
cGMP: Current Good Manufacturing Practices
Chart Recorder: An electronic instrument that records the ambient temperature of an environmental testing chamber.
Cold Chain Management: A temperature-controlled supply chain. Goods in a cold chain must be maintained throughout at a consistent temperature.
Cold Chain Product: A product that is temperature sensitive.
Cold Chain: An uninterrupted flow of a specific thermal profile throughout the manufacturing, packaging and distribution of a temperature-sensitive product.
D
Danger Zone: The temperature range from 41°F to 135°F (5°C to 57°C) at which bacteria are most likely to grow in food.
Data Logger: An in-transit temperature recorder that measures temperature during a specified time period (also called a digital data logger, data monitor, temperature data logger, in-transit temperature recorder).
Deviation: The variance from the average.
Distribution: Transfer of a product among multiple locations that may include a manufacturer, storage facility, and end user (clinic, commercial business, patient).
Distribution Process: The process by which product moves from the point of manufacturing to the end user.
Distribution Temperature: Specified temperature at which a product must be distributed.
DOT: United States Department of Transportation
Dry Ice: A refrigerant that is solid carbon dioxide, which sublimates to a gas at very cold temperatures. Dry ice is used as a pharmaceutical and food services coolant in insulated/thermal packaging.
Dunnage: Padding used to fill empty space in a shipping container.
Duration: A length of time, i.e., a 24-hour minimum post stabilization or until stabilization occurs at the specified temperature.
E
Efficacy: The ability to produce a desired outcome.
Excursion: Deviation from a specified limit.
Excursion Limit: A defined allowable deviation from a specified limit.
External Temperature Cycle: The ambient temperature that the shipping container witnesses for each step of the transit process (packaging, warehouse, transit, etc.).
F
FDA: United States Food and Drug Administration
Foodborne Illness: Any illness or disease caused by eating or drinking contaminated food.
G
GLP: Good Laboratory Practices; according to 21 CFR Part 58, regulations to ensure quality of nonclinical laboratory studies related to safety.
GMP: Good Manufacturing Practices; according to 21 CFR Parts 210, 211, 600 and 610, current manufacturing practices (cGMPs) influence the manner in which biopharmaceuticals and other drugs are produced.
GRAS: Generally recognized as safe; a special status afforded by FDA to ingredients and methods that have a proven, longstanding history of causing no harm to humans or animals.
H
HACCP: Hazard Analysis Critical Control Point – a plan of identifying foodborne hazards and implementing steps to eliminate or minimize the hazard. Many jurisdictions require food service employees to implement and document a HACCP plan.
HCPC: Healthcare Compliance Packaging Council
I
IPIC: International Pharmaceutical Industry Congress
IQ/OQ/PQ: Installation Qualification, Operational Qualification, Performance Qualification
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
ISTA 5B: ISTA's focused simulation guide for thermal performance testing of temperature controlled packaging and thermal boxes.
J
JCAHO: Joint Commission on Accreditation of Healthcare Organizations. An organization that grants accreditation to hospitals meeting its standards for patient care.
K
L
M
MKT: Mean Kinetic Temperature. The USP (United States Pharmacopeia defines MKT as the “single calculated temperature at which the total amount of degradation over a particular period is equal to the sum of the individual degradations that would occur at various temperatures.
MSDS: Material Safety Data Sheet
N
NIST: National Institute of Standards and Technology, a government agency that sets standards (including temperature).
Non-Conformance: A failure to conform or act in accordance with established standards.
NSF: NSF International, a not-for-profit, non-governmental organization, is the world leader in standards development, product certification, education and risk-management for public health and safety.
NSF: NSF International, a not-for-profit, non-governmental organization, is the world leader in standards development, product certification, education and risk-management for public health and safety.
O
P
Pallet Containers: Thermal shipping containers, or pallet shippers, designed to hold an entire pallet.
PDA PCCDG: PDA Pharmaceutical Cold Chain Discussion Group
PDA: Parenteral Drug Association
pH: A measurement of the acid or alkaline content of an item.
Potentially Hazardous Foods (PHF): Foods that need temperature control because they support the rapid growth of microorganisms or the formation of toxins.
Q
QA: Quality Assurance
Qualification Report: A formally written or electronically produced record detailing a qualification study.
Qualification (Validation): Testing that provides reasonable assurance that the qualified product or process will produce similar results under stated conditions.
R
Ramp: A programmed change from one set-point to another.
S
Sanitization: The process of reducing microorganisms and their spores to generally safe levels through the use of chemical, heat or both.
Shelf Life: The length of time that a product or device maintains its effectiveness.
Shipping: The process of transporting a package from one location to another.
Shipping System: The insulated shipping container and its internal thermal packaging components (refrigerants, buffering materials, dunnage, etc.).
SOP: Standard Operating Procedures
SPE: Society for Pharmaceutical Engineering
Stability: Often refers to the ability of a product to remain efficacious under varying temperature/time exposures.
Storage Temperature: The temperature at which a product is stored.
T
Temperature Abuse: Whenever a temperature-sensitive commodity is exposed to a temperature either above or below its safe temperature zone.
Temperature Probe: A device that measures the temperature of a specified environment.
Temperature-Sensitive Product: A product for which stability is impacted by temperatures outside a prescribed range (e.g., vaccine).
Thermal Mapping: Defining the temperatures witnessed throughout many points in the container over time. Thermal mapping of the environment refers to collection of the data necessary to model the ambient temperatures witnessed by a shipment as it moves throughout the distribution process.
Thermocouple: A device with a pair of wires of dissimilar metals (e.g., copper and iron) that accurately measures temperature.
Tolerance: The acceptable range for a specified measurement.
U
UN: United Nations - 3373 package labeling specifications, which are adhered to by Cold Chain Technologies' diagnostic kits.
USDA: United States Department of Agriculture
USP: United States Pharmacopeia
V
Validation (Qualification): A study that provides documented evidence that assures that a specific process or system will consistently meet predetermined specifications.
W
WHO: World Health Organization
