Glossary for Phase Change Materials

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A
Allowable Excursions – Acceptable range in which the payload temperatures can reach within a specified amount of time that does not compromise the payload’s integrity
Ambient temperature – Surrounding temperature. This term is not widely used due to significant variation in ambient temperatures. It means “room temperature” or normal storage conditions, which means storage in a dry, clean, well ventilated area at room temperatures between 15° to 25°C (59°-77°F) or up to 30°C, depending on climatic conditions
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B
Benchmark – A point of reference from which measurements may be made
Bill of Materials (BOM) – A listing of components, including descriptions and/or item numbers
BTU – The amount of heat required to raise or lower the temperature of one pound of water by one degree Fahrenheit
Brick – Rigid gel pack which maintains its shape both when frozen and thawed
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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 – An 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
Cold Chain Product – A product that is temperature sensitive and requires temperature controlled 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
Cold storage/temperature – Conditions in which temperature does not exceed 8°C (46 °F)
Cool storage/temperature – Conditions in which the temperature range is between 8°C and 15°C (46° and 59 °F)
Controlled room temperature – The temperature maintained thermostatically that encompasses at the usual and customary working environment of 20°-25°C (68°-77 °F). Excursions between 15°C and 30°C (59° and 86 °F) that are experienced in pharmacies, hospitals, and warehouses, and during shipping are allowed. Provided the mean kinetic temperature does not exceed 25°C, transient spikes up to 40°C are permitted as long as they do not exceed 24 hours. Spikes above 40°C may be permitted only if the manufacturer so instructs
Celsius – The metric temperature scale in which water freezes at zero degrees and boils at 100 degrees, designated by the symbol “C”. To convert to Fahrenheit, multiply a Celsius temperature by 9, divide by 5 and add 32 (25 x 9 equals 225, divided by 5 equals 45, plus 32 equals 77 degrees Fahrenheit)
Cold Chain Monitor Card (CCM) – A heat sensitive indicator in the form of a strip with four windows (A, B, C and D)
Chemical Temperature Indicators – these units are mostly single use devices, with average accuracy. Some chemical monitors can be permanently affected by temperature exposure, while others are reversible
Cold box – An insulated container that can be lined with savENRG™ Ice packs or Cool packs to keep vaccines and diluents cold during transportation and/or short period of storage (from 2 to 7 days)
Cold chain – All the storage and transport facilities necessary to ship a product requiring controlled low-temperature storage from the manufacturer to the end user
Cold Chain Failure – Occurs when the products are exposed to temperatures outside the recommended temperature range
Cold life -The length of time the warmest section of the payload remains within appropriate temperature range. Cold life in vaccine carriers: 37 h at 43°C, Picnic boxes: less than 24h
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D
Data Logger – Electronic device that records data over time or in relation to location either with a built in instrument or sensor or via external instruments and sensors. Increasingly, but not entirely, they are based on a digital processor
Deviation – The variance from the average (temperature)
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 (hospital, business, individual patient)
Distribution Temperature – Specified temperature range at which a product must be distributed
Dry Ice – A refrigerant that is solid carbon dioxide. It is used primarily as a cooling agent. Its advantages include lower temperature than that of water ice and not leaving any residue
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E
Efficacy – The ability to produce a desired outcome
Environmental chamber – Also called a climate chamber, is an enclosure used to test the effects of specified environmental conditions on biological items, industrial products, materials, and electronic devices and components
Eutectic or eutectic mixture – A mixture at such proportions that the melting point is a local temperature minimum, which means that all the constituents crystallize simultaneously at this temperature.
EPS – expanded polystyrene
Excursion – deviation from a specified limit
Excursion Limit – a specifically defined allowable deviation from a set criteria limitation
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F
Fast chain – A cold chain strategy that seeks to increase the effectiveness of campaigns by a reduction of the dependence on cold chain equipment through pro-active management and short supply lines
Film – A flexible material used to encapsulate savENRG™ refrigerants
Freeze Tag – An irreversible temperature indicator that shows if a product has been exposed to freezing temperatures. It consists of an electronic temperature measuring circuit with associated LCD-display. If the indicator is exposed to a temperature below -0.5°C ±0.5°C for more then 60min ± 3min (or 10 min) the display will change from the “good” status into the “alarm” status
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G
GLP – Good Laboratory Practices
GMP – Good Manufacturing Practices
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H
Heat sealing pressure – Sealing together two or more layers of film under high temperature to create a secure seal. Heat sealing is used by RGEES in savENRG™ PCM pouches
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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
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J
K
L
Latent heat – Energy released or absorbed, by a body or a thermodynamic system, during a constant-temperature process
Lean manufacturing – A systematic method for waste minimization (“Muda”) within a manufacturing system without sacrificing productivity
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M
MSDS – Material Safety Data Sheet
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N
NIST – National Institute of Science and Technology
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O
OEM
Original Equipment Manufacturer.
Operating cost
Cost of running your home comfort system, based on energy usage.
Orifice
An opening or hole; an inlet or outlet.
Outdoor coil (also Condenser coil)
In a heat pump, it takes in heat to warm your home. In an air conditioner, it dissipates heat from the refrigerant, changing the refrigerant from vapor to liquid to cool your home.
Outdoor Unit
The outdoor portion of a split system such as an air conditioner or heatpump. May also be a packaged system in which all heating and cooling components are located in one cabinet.
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P
Packout (Pack-out) – The steps and procedures necessary to assemble a shipping container with its thermal protection components and a 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
Passive Thermal Shipper – A thermally protected shipping container powered with savENRG™ Phase Change Materials 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)
PET – Polyethylene
Phase Change Materials (PCMs) – SavENRG™ PCMs are non-toxic, inorganic and organic products engineered for desired temperature control. During the process of phase change between solid to liquid or liquid to solid, thermal energy is absorbed or released while the temperature at phase change remains constant
Pre-conditioning – The preparation of temperature stabilization of a PCM based Cold Chain refrigerant per thermal requirements prior to container 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
Product data sheet – specifications used by RGEES for savENRG™ PCM, savENRG™ PCM packs and AkuraTemp™ thermal shippers
Prototype – A full-scale model or example of a new product prior to its final design
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Q
Qualification Report – A formally written 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
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R
Refrigerant – See savENRG™ Cold Chain refrigerants
Robust – The ability of a thermal shipping 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
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S
savENRG™ Cold Chain refrigerants – SavENRG™ PCM packs, AkuraTemp™ specimen holdover plates used in insulated thermal shippers for precise and reliable temperature control of shipped pharmaceuticals and other temperature sensitive payloads
Seasonal Packout – Shipping systems whose packouts will differ over the seasons (winter packout, summer packout).
Shipping – The process of transporting a package/container from one location to another
SOP – Standard Operating Procedures
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T
Temperature Packaging Solution – An efficient packaging system engineered to control the payload temperature during shipping within specified temperature ranges
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 integrity is impacted by temperatures outside a safe temperature range (i.e. medicine, specimen, vaccines, blood, live cultures)
Thermal Solutions – Insulated package designs that meet the thermal requirements of a temperature-sensitive product
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U
Universal Packout – An insulated shipping solution whose same Packout and conditioning procedures do not change depending of the season, year round
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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 with a high R-value insulation.
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W
Watt
The unit of electrical power equal to the flow of one amp at a potential difference of one volt.
Wet Bulb Thermometer
A thermometer whose bulb is covered with a piece of water-soaked cloth. The lowering of temperature that results from the evaporation of water around the bulb indicates the air’s relative humidity.
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X
Y
Z

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