| 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. Protect your room temperature pharmaceuticals from hot and cold extremes with KoolTemp GTS controlled ambient solutions. |
| Analytical Thermal Modeling |
Quickly develop temperature controlled packaging solutions that will maintain your product’s integrity throughout the cold chain – with KoolDesigns analytical thermal modeling. |
| 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 |
| Audits |
A professional examination of quality control and validation systems. |
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| Bag |
A non-rigid container used for holding product. |
| Barrier |
A material that blocks the transfer from one area to another. For example, Cold Chain Technologies’ KoolTemp™ Insulated Envelopes have a multi-layered metalized barrier that minimizes heat loss by reflecting radiant heat transfer. |
| 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. |
| BLA (Biologic License Application) |
An application to the FDA to request permission to market a biologically derived pharmaceutical product based on all of the available |
| BOM |
Bill of Materials – See definition above for Bill of Materials |
| Bricks |
Refrigerants that remain uniform in shape while frozen or thawed. Cold Chain Technologies manufactures Koolit® Foam Bricks (also called freezer bricks). |
| Burst Strength |
The strength of material in pounds per square inch. |
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| 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. |
| Cardboard |
A thick paper-based material. |
| Carry Paks |
A thermal container system with a handle that makes personal transportation easy and efficient. Ideal for medical samples, food, perishables, or valuables (also called carry packs). |
| CFC |
Chlorofluorocarbons – a refrigerant known to cause depletion of atmospheric ozone. |
| 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 |
| 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. |
| Clinical Investigation |
Any experiment in which a drug is administered or dispensed to or used involving one or more human subjects. For the purpose of this part, an experiment is any use of a drug except for the use of a marketed drug in the course of medical practice. (FDA Regulation 312.3, Investigation New Drug Application). |
| Clinical Research |
Patient oriented research including epidemiology (retrospective, cross-sectional, or prospective study of disease(s) in populations), and studies of behaviors, outcomes, and health services. |
| Clinical Trial |
“Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or pharmacodynamic effects of an investigational product with the object of determining safety and/or efficacy.”
(ICH GCP, International Conference on Harmonization / WHO Good Clinical Practice Standard) |
| Clinical Trial Volunteer |
Individuals who are participating in a clinical research study. |
| Chipboard |
A paperboard product that is most commonly manufactured from mixed, unbleached paper stock. |
| CMC |
Carboxymethlycellulose – A gel used in Cold Chain’s 400, 500 and 800 series Koolit® gel paks |
| Cold Chain Laboratories (CCL) |
See Engineering and Technical Services |
| Cold Chain Management |
Management of all phases of the cold chain, including products in transit, in process, in storage, and in display. |
| Cold Chain Packaging Consultant |
An individual with expertise in the area of cold chain packaging. |
| Cold Chain Product |
A product that is temperature sensitive. |
| Cold Chain Project Management |
Cold Chain Technologies is committed to partnering with you throughout the management of your cold chain project. Our thermal package design and testing staff members will help you identify effective solutions to your temperature-sensitive packaging needs, and implement an efficient, comprehensive cold chain shipping system. |
| Cold Chain Solution |
Development of a thermal package design using thermodynamic knowledge and expertise. |
| Cold Chain Storage Consulting |
Advice from an expert in the design and application of cold chain solutions. |
| Cold Chain Technologies |
A leading source for engineering-based thermal packaging solutions. |
| 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. |
| Corrugate |
Refers to the alternating ridges and grooves in a cardboard carton. |
| CS |
Cut Sheet – See definition below for cut sheet |
| Customer Support |
Any assistance provided to the customer, including interpretation of results, assistance with procurement and scheduling of materials, and development of internal SOPs. |
| Customs |
Each country’s department that reviews in-coming materials, including clinical trials materials. The area at a port, airport, or border where baggage and freight are examined for duty status. |
| Cut Sheet (CS) |
Individual precision-cut sheets of insulation. Cold Chain Technologies’ KoolTemp® EPS Panel Sheet Insulated Containers have six panels of lightweight expanded polystyrene (EPS) insulation panels in a variety of thicknesses. |
| CRT |
Controlled Room Temperature |
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| Data Acquisition Units (DAU) |
A calibrated device that logs data acquired from an electronic unit (e.g., GE Infrastructure Sensing, Kaye Validator 2000s), which includes thermocouples, temperature reference bath, and NIST calibrated Intelligent Resistant Temperature Device [IRTD] probes. |
| 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. |
| DI |
See Dry Ice |
| Die-Cut |
A process by which a box is cut to create a customized product. |
| Dimensions |
Description of an object in physical terms (e.g., length x width x depth, or length x width x height). |
| 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. This may include 3PL (third party logistics), freight forwarders, freight consolidators, wholesalers and expedited shippers (FedEx®, UPS™, DHL™, etc.). |
| 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. |
| Double-blind Trial |
In a double-blind or double-masked study neither the participants nor the study staff know which participants are receiving the experimental treatment and which ones are receiving either a standard treatment or a placebo. These studies are performed so that neither the patients’ nor the doctors’ expectations about the experimental drug can influence the outcome. |
| Double Wall Corrugated Board |
A box made by joining three flat facings and two intermediate corrugated parts. This box is usually stronger than a single wall corrugated box. |
| Dry Ice (DI) |
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. Cold Chain Technologies offers a new listing of dry ice shippers – the KoolTemp STS Frozen Shipment Systems. |
| 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. |
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| FDA |
United States Food and Drug Administration |
| Film |
A non-fibrous, flexible material used to encase a refrigerant gel or refrigerant brick. Cold Chain Technologies (CCT) uses film to encase its foam brick and gel pack refrigerants. CCT provides refrigerants in a variety of sizes and in a sweat-proof configuration. |
| Final Qualification |
Upon completion of an acceptable design, the Final Qualification is performed demonstrating reproducibility (often at n=3). The final qualification includes all data, certifications, and proof of validated equipment necessary for the rigorous review of a full audit. |
| Flute |
A wave shape in the inner portion of combined corrugated fiberboard. |
| FRZ |
Abbreviation for Frozen |
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| GE Infrastructure Sensing |
Manufacturer of a temperature recording system (also called a data acquisition unit) that generates thermal testing data traceable to NIST standards. |
| 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. |
| GLP |
Good Laboratory Practices |
| GMP |
Good Manufacturing Practices |
| GreenSmart™ |
Cold Chain Technologies offers GreenSmart ECO, the first commercially available thermal containers made from reprocessed EPS moding beads – and reusable high performance boxes that combine Koolit PCM refrigerants and foam bricks to extend the duration of temp control and maximize its phase change energy. Cold Chain also offera a GreenSmart return-reuse program that can easily be customized for each customer application, allowing for the economical reuse of many types of cold chain systems. |
| GTS |
Cold Chain Technologies’ KoolTemp® GTS (Global Transport System) series provides protection for your small- to pallet-sized payloads of temperature sensitive products. Pre-qualified in our ISTA-certified and cGMP-compliant lab, our thermal engineers have tested our GTS products under a variety of conditions, including room temperature, refrigerated, frozen, and at minimum and maximum loads. |
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| HACCP |
Hazard Analysis and Critical Control Point |
| HCFC |
Hydrochloroflurocarbons – a class of refrigerants that have often replaced CFCs. HCFCs are known to deplete atmospheric ozone, but to a lesser extent than CFCs. |
| HCPC |
Healthcare Compliance Packaging Council |
| Heat Sealing |
Sealing together two or more layers of film under high temperature and pressure to create a secure seal. Heat sealing is used in refrigerant gel packs and refrigerant bricks. |
| Half Slotted Carton |
A half slotted carton, applies to corrugate containers. |
| HP High Performance |
KoolTemp HP solutions protect products requiring tight temperature range protection. |
| HSC |
See definition above for half slotted carton. |
| Human Subject Research |
Research involving the behavioral and/or biomedical assessment of treatment of patients, including study of their tissue, specimens, medical records, genetic material. |
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| IATA |
International Air Transport Association – Packing instruction 650 for the WHO Risk Groups 2 and 3, a regulation used for Cold Chain Technologies’ diagnostic and infectious substance kits. |
| IDE (Investigational Device Exemption) |
An application to FDA to request permission to conduct human testing of unapproved devices. |
| IND |
Investigational New Drug |
| INDA (Investigational New Drug Application) |
An application to the Food and Drug Administration (FDA) by a drug sponsor in which permission is requested for the human testing of the drug product, which is called the investigational new drug. Prior to initiating Phase I for a clinical trial, the applicant must submit a detailed protocol, preclinical data, and investigator credentials. |
| Innovation |
The development and introduction of new ideas, goods, and services. |
| Investigational Product |
A pharmaceutical form of an active ingredient, or placebo, device, biologic or therapeutic agent that is being tested in a clinical trial. This includes: a product assembled in a way that is different from the approved form; the use of a product for an unapproved indication; or gaining further information about an approved use of the product |
| IPIC |
International Pharmaceutical Industry Congress |
| IQ/OQ/PQ |
Installation Qualification, Operational Qualification, Performance Qualification |
| IRTD |
Intelligent Resistant Temperature Device |
| IRB |
Institutional Review Board |
| 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 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. |
| IVRS |
Interactive Voice Response System |
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| LD3 and LD9 |
Designation for metalized containers capable of holding one and four U.S. sized pallets, respectively. |
| Lean Initiatives |
By implementing Lean core values at Cold Chain Technologies, we’re optimizing our operation to minimize our energy usage, waste of raw materials, and reject rate among finished goods. |
| LIR |
Laboratory Investigation Report |
| Logistical Challenge |
The requirement to ensure that a product will travel through the distribution system(s) as needed and designed. |
| Lyophilized Product |
A material that is freeze-dried. |
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| Manufacturer’s Joint (MJ) |
The part of a case that is joined together by the manufacturer. |
| Maximum Packout |
Package configuration that includes the maximum amount of product to be utilized within the shipping system. |
| Metalized Film |
A plastic or resin film that has been coated on one side with a metalized layer. |
| 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 |
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| n = 3 |
The number of tested shipping systems (including the product load and refrigerants) per design. In this case, the number is three. |
| NDA (New Drug Application) |
An application to the FDA in which the study sponsor seeks permission to market a drug, based on all data known about the drug. |
| Needs Assessment |
Scope of work required to meet a particular objective, and preparation of budget estimate. |
| NDE (New Device Exemption) |
An application to the FDA in which the study sponsor seeks permission to market the product based on all known data. |
| 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. |
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| ODC |
Ozone Depleting Chemicals – Chemicals that are known to be harmful to the atmospheric ozone layer (e.g., CFCs, HCFCs). |
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| Packout (Pack-out) |
The steps and procedures necessary to assemble a shipping container with its refrigerants, buffering materials, and product payload. |
| Pad |
A material used to add protection and minimize shock between layers of products within shipping container, or between containers (e.g., corrugated or solid fiberboard, EPS). |
| Pallet Containers |
Thermal shipping containers, or pallet shippers, designed to hold an entire pallet. Cold Chain Technologies’ ZX2300 and ZX4500 hold up to 23 and 45 cubic feet, respectively. |
| 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 phases from below -50°C to over 100°C. Our PCM bottles are used in our HP systems. |
| PDA PCCDG |
PDA Pharmaceutical Cold Chain Discussion Group |
| PDA |
Parenteral Drug Association |
| PET |
Polyethylene (PET) – A plastic material used in the manufacture of some gel packs. |
| Phase I Clinical Trial |
A clinical trial that is performed to determine how the drug affects the human body, how much medicine is safe, and how the drug should be administered. Phase I trials may involve a small number of patients (usually 15 to 30) with the disease under study or healthy human volunteers. |
| Phase II Clinical Trial |
A clinical trial that provides information about how well a drug works, and generates more information on its safety and benefit. Generally 100 to 200 take part in Phase II trials. |
| Phase III Clinical Trial |
A clinical trial conducted to determine whether the current treatment practice is the best way to treat a patient, or better treatment would be provided by a new drug treatment. Phase III trials compare a new drug, combination of drugs, device, or procedure with a current standard of treatment. Phase III clinical trials involve approximately 1,000 to 3,000 people nationwide or worldwide. |
| Phase IV Clinical Trial |
A clinical trial in which further evaluation is conducted on a drug has received approval from the FDA. |
| Phase Change |
A change from one physical form to another at a specific temperature. |
| Polymer Gel |
A material used in Koolit® series 600 gel packs. |
| Polyurethane Insulated Panel |
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 Testing (PQ) or Design Evaluation (DE) |
The initial development of a thermal package design based on the needs assessment of the user. |
| 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. |
| Pre-Test Conditioning |
Storage temperature prior to packout and shipment. |
| Primary Container |
The container that holds product (e.g., syringe, vial). |
| Product Data Sheets |
Cold Chain Technologies’ specification product information. |
| Profile |
The time and temperature for each step of the transit process (e.g., packaging, warehouse, transit, etc.) |
| Project Management |
See Cold Chain Project Management |
| Protocol |
Detailed instructions and requirements used in the execution of a test and/or procedure (e.g., qualification testing). |
| Prototype |
A full-scale model or example of a new product prior to its final design. |
| PUR |
Rigid Polyurethane – Cold Chain Technologies produces a line of KoolTemp™ PUR containers for the safe shipment of temperature-sensitive products. |
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| 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. |
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| Ramp |
A programmed change from one set-point to another. |
| Refrigerants |
See Koolit® refrigerants. |
| Reproducibility |
The repeatability of a measurement. |
| RFG |
Abbreviation for Refrigerated |
| RFP |
Request for Proposal |
| RFQ |
Request for Quotation |
| Robust |
The ability of a container system to maintain its required internal minimum and maximum temperature under varying ambient conditions. Also called thermally robust. |
| Room Temperature |
Typically refers to 22°C or 72°F. |
| RSC |
Regular Slotted Carton, a type of corrugated carton. |
| R-Value |
A measure of thermal resistance of an insulated material. A higher R-value indicates greater insulative properties. |
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| Saddlebag |
A type of gel pak that surrounds the product to provide a temperature-stabilizing environment. |
| Score |
A fold or crease used to facilitate folding corrugated or solid fiberboard. |
| 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. |
| Set-ups (SU) |
Preassembled thermal shipping containers. |
| 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, etc.). |
| Single-blind Trial |
A clinical trial in which the investigator is aware of the treatment for each patient, but the patient is not. In this type of trial, there is no placebo effect based on the patient’s knowledge of treatment (new or another). Bias is possible, however, since the investigator may treat the patient differently, possibly even hinting treatment-related details. |
| Single Wall Corrugated Board |
A structure formed when one corrugated inner member is glued between two flat facings. |
| SKU |
Stock Keeping Units – A numerical system used to track inventory of a specific product. |
| Soak |
Maintenance of a temperature set point for a chosen time. |
| SolidWorks® |
A software program that enables the user to create three-dimensional models. |
| 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. |
| STS Seasonal Transport Systems |
KoolTemp dry ice and suppressed temperature solutions for frozen shipments. |
| SUP |
See Suppressed Temperature |
| Suppressed Temperature (ST) |
The Koolit® ST series gels freeze/thaw at -27°C (-16.6°F). Cold Chain Technologies also offers a new listing of suppressed temperature shippers – the KoolTemp STS Frozen Shipment Systems. |
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| TC |
See Thermocouple |
| Temperature Cycle |
See External Temperature Cycle. |
| 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 Soak |
See soak. |
| 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. |
| Thermal Solutions |
Package designs that meet the thermal requirements of a temperature-sensitive product. |
| Thermally Robust |
See Robust |
| 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. |
| Tongue and Groove |
The interlocking of two parts to create an effective seal in a package. |
| Transit Duration |
Transit duration is the amount of time that a shipping system remains in transit. Testing will be performed to simulate actual shipping conditions. |
| Transport Duration |
The amount of time that a shipping system remains in transit. |
| Triple-blind Trial |
Triple-blind trials are double-blind trials in which the statistician interpreting the results also does not know which intervention has been given. Sometimes triple-blind is used to mean that multiple investigators are all blinded to the protocol (such as the clinician giving the treatment and a radiologist or pathologist who interprets the results). The use of the term triple-blind experiments is disputed. |
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| UN |
United Nations – 3373 package labeling specifications, which are adhered to by Cold Chain Technologies’ diagnostic kits. |
| Universal Packout |
A shipping system whose packout and conditioning of components are the same year round. |
| USDA |
United States Department of Agriculture |
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| Vaccine Trial |
A clinical trial to study the efficacy of a vaccine. |
| 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 offer high R-value insulation. Our High Performance HP Series features high R-value VIPs and our Koolit Refrigerant Phase Change Material (PCM) bottles. |
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| WFI |
Water for Injection |
| WHO |
World Health Organization |
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| X |
| XPS |
Extruded Polystyrene |
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| Z |
| ZU Systems |
Cold Chain Technologies’ urethane based shipping systems. |
| ZX Systems |
Cold Chain Technologies’ extruded polystyrene based shipping systems. |
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