A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Y | Z
483: An auditing observation by the FDA when a non-conformance is found – given to pharmaceutical and biotech manufacturers
A
Acceptance Criteria: A basis of acceptance - numerical or descriptive.
Allowable Excursions: Acceptable range in which payload or 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
ASTM D-3101: ASTM Industry Standard Test Method for Thermal Insulation Quality of Packages
B
Bricks: A PCM of phenaliic foam that maintains uniform in shape while frozen or thawed.
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.
CFC: Chlorofluorocarbons - a refrigerant known to cause depletion of atmospheric ozone.
CFR (21) Part 11: Code of Federal Regulations stating that electronic records and signatures are considered equivalent to paper records.
cGMP: Current Good Manufacturing Practices: related cGDP and cGLP
Chamber Controller: An electronic instrument used to regulate the ambient temperature of an environmental chamber.
Change Control: Process, authorities, and procedures used for all computerized or system data changes.
Chart Recorder: An electronic instrument that records the ambient temperature of an environmental testing chamber.
Cold Chain Management: Management of all phases of the cold chain, including products in transit, in process, in storage, and in display.
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.
Conductive Heat Transfer: Having the quality or power of conducting heat or electricity or sound; exhibiting conductivity.
Convective Heat Transfer: Caused or accomplished by convection; as a convective discharge of electricity.
CRT: Controlled Room Temperature – generally defined as 20c – 25c
D
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).
DEA: Drug Enforcement Agency
DEA Schedules 3N, 4, and 5: Federal and local licenses to hold controlled substances.
Design Development/Design Evaluation (Pre-qualification) (n=1): Design phase in which shipping systems (shipping containers, insulation, refrigerants) are tested to evaluate its performance.
Design Evaluation (DE) or Pre-qualification Testing (PQ): A detailed evaluation, and development of a thermal package design that is tested for its performance under simulated conditions.
Design Evaluation: A detailed review of an existing shipping container system.
Deviation: The variance from the average.
Distribution Temperature: Specified temperature at which a product must be distributed.
DOT: United States Department of Transportation
DOT Sec. 173.199: Packaging regulations by DOT.
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.
Duration: A length of time, i.e., a 24-hour minimum post stabilization or until stabilization occurs at the specified temperature.
E
Edge Crush Test (ECT): A structural test for measuring the strength in column stacking corrugate containers.
Efficacy: The ability to produce a desired outcome.
Environmental Chamber: A thermally isolated chamber typically capable of maintaining temperatures within a minimum and maximum (e.g., -30°C to 85°C) by means of a programmable controller. A quality environmental chamber is one that is capable of maintaining its controlled temperature throughout the entirety of the chamber without drop offs or hot pockets. Additionally, a quality chamber must be draft free, preventing direct air blowing upon the tested product.
EPA: Environmental Protection Agency
EPS: Expanded polystyrene - a lightweight, cost effective, cushioning insulating material used in packaging for temperature-sensitive goods.
ETC: External Temperature Cycle, the ambient temperature that the payload/product experiences for each step of the transit process (packaging, warehouse, transit, etc.).
Eutectic Mixture: A mixture of two or more substances with a melting point lower than that of individual substances.
Eutectic Point: A eutectic point is the temperature that is maintained as the mixture transforms from solid to liquid (or visa versa).
Excursion: Deviation from a specified limit.
Excursion Limit: A defined allowable deviation from a specified limit.
F
FDA: United States Food and Drug Administration, regulates pharmaceutical and biotech manufacturers using United States Pharmacopoeia (USP) guidance document <1079>
Final Qualification: Upon completion of an acceptable design, the Final Qualification is performed demonstrating reproducibility with 3 tests. The final qualification includes all data, certifications, and proof of validated equipment necessary for the rigorous review of a full audit.
G
Gel Bottles: Heavy-duty refrigerants that feature a tough, puncture-proof, blow-molded high-density plastic bottle. Ideal for rough environments or reuse.
Gel Paks and Mats: Long-lasting, economical refrigerants available in a variety of pouch materials, freezing points, gel structures, and in a saddlebag design (compartmentalized gel packs that wrap around the uneven contour of the payload) Also called gel packs, gel paks, blue ice, refrigerant packs, gel refrigerants, ice substitute, food ice pack, ice bricks, ice packs, and saddlebag refrigerant.
cGDP: Current Good Distribution Practices
cGLP: Current Good Laboratory Practices
H
HACCP: Hazard Analysis and Critical Control Point
I
IATA: International Air Transport Association – guidance document Chpter 17 for air transport and handling of temperature sensitive products
IQ/OQ/PQ/CQ: Installation Qualification, Operational Qualification, Performance Qualification, Component Qualification
ISTA: International Safe Transit Association
ISTA 1A: ISTA's basic requirements for fixed displacement vibration and shock testing.
ISTA 2A: ISTA's basic requirements for atmospheric conditioning, compression, fixed displacement or random vibration and shock testing.
ISTA 5B: ISTA's focused simulation guide for thermal performance testing of temperature controlled packaging and thermal boxes.
ISTA 7D: Ambient profile guidelines
ISTA 7E: New ambient profile guidelines to be released by ISTA in Spring 2010
J
K
L
LD3 and LD9: Identifier for large metal containers, used in air transport, and capable of holding one and four U.S. sized pallets, respectively.
Lyophilized Product: A material that is freeze-dried.
M
Maximum Packout: Package configuration that includes the maximum amount of product to be utilized within the shipping system.
Minimum Packout: Package configuration that includes the minimum amount of product to be utilized within the shipping system
Molded Shipping Container: A one piece construction product produced under pressure and heat in a forming tool. Container may have a second molded part for a lid.
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.
O
P
Packout (Pack-out): The steps and procedures necessary to assemble a shipping container with its refrigerants, buffering materials, and product payload.
Payload: The contents of an inner container (e.g., pharmaceutical products).
PCM: Phase Change Material - A material that changes phases from solid to liquid (or liquid to gas) at a single temperature. Phase Change Materials are either salt or organic based and are capable of changing pases from below -50°C to over 100°C.
PDA PCCIG: PDA Pharmaceutical Cold Chain Interest Group
PDA: Parenteral Drug Association
Phase Change: See PCM. A change from one physical form to another at a specific temperature.
Polymer Gel: A material used in gel packs.
Polyurethane Insulated Panel: (PUR) A flat piece of polyurethane designed to fit as a panel in a temperature-sensitive container (also called rigid thermal protection, rigid foam board insulation, rigid polyurethane foam sheet, rigid urethane foam, foam insulation panel, panel sheet insulated containers, expanded packaging polystyrene).
Pre-conditioning: Temperature stabilization of a material per requirements (e.g., freezing a gel pack) prior to pack out.
Pre-qualification: A preliminary study, which is generally the first test taken to ensure that a package will meet the objectives in the Final Qualification study.
Profile: The time and temperature for each step of the transit process (e.g., packaging, warehouse, transit, etc.)
Protocol: Detailed instructions and requirements used in the execution of a test and/or procedure (e.g., qualification testing).
Q
QA: Quality Assurance
QbD: Quality by Design
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
Room Temperature: Typically refers to 22°C or 72°F.
R-Value: A measure of thermal resistance of an insulated material. A higher R-value indicates greater insulative properties.
S
Seasonal Packout: Shipping systems whose packouts will differ over the seasons (e.g., winter packout, summer packout).
Secondary Container: The container that holds one or more primary containers.
Shelf Life: The length of time that a product or device maintains its effectiveness.
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
TC: See Thermocouple
Temperature Packaging Solution: An efficient packaging system designed to control the temperature during shipping of a payload per specific requirements (also called a refrigerated shipping container, refrigerated packaging).
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.
Thermodynamics: The branch of physics that deals with the conversions from one to another of various forms of energy and how these affect temperature, pressure, volume, mechanical action, and work.
Tolerance: The acceptable range for a specified measurement.
Transit Duration: Transit duration is the amount of time that a shipping system remains in transit.
Transport Duration: Same as Transit Duration
U
UN 3373: United Nations - 3373 package labeling specifications.
Universal Packout: A shipping system whose packout and conditioning of components are the same year round.
USDA: United States Department of Agriculture
USP: United States Pharmacopoeia
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 panel – currently in the market there are various base materials used to create VIPs.
W
WHO: World Health Organization
X
Y
Z
courtesy of ContractPharma 2009