以下是冷链管理中的常用术语:

A
Aerobic bacteria: Bacteria that need oxygen in order to live and grow.
验收标准(Acceptance Criteria):  一种以数值描述为形式的可接受的标准.
胶粘剂(Adhesive): 一种粘贴相同或相似物体表面的材料。
允许偏差(Allowable Excursions):产品的温度变化发生在一定的时间和可接受的温度范围内,不至于损害产品的完整性质。
环境温度(Ambient Temperature):外部环境的温度。
Anaerobic bacteria: Bacteria that do not require oxygen in order to live and grow.
API: 活性药物成份
AOAC: AOAC International is a non-profit scientific association with headquarters in Gaithersburg, Maryland, USA. It publishes standardized, chemical analysis methods designed to increase confidence in results of chemical and microbiologic analyses. Government agencies and civil organizations often require that laboratories use official AOAC methods.
ASTM:美国材料与试验协会
Assay: A test. In pharmacology: to subject (a drug) to an analysis for the determination of its potency or composition.
ATP: Adenosine triphosphate (ATP) is the nucleotide known in biochemistry as the "molecular currency" of intracellular energy transfer; that is, ATP is able to store and transport chemical energy within cells. ATP also plays an important role in the synthesis of nucleic acids. ATP molecules are also used to store the energy plants make in cellular respiration. All organic matter gives off ATP
审计(Audits): 对质量控制和验证系统的专业考试检查
B
Bacteria: Bacteria are microscopic organisms, usually consisting of one cell, that lack chlorophyll (a green pigment found in plants that allows for the production of food). Except for viruses, they are the smallest living things on Earth.
Bacteriological Analytical Manual (B.A.M.): FDA's Bacteriological Analytical Manual (The BAM) is a collection of procedures preferred by analysts in U.S. Food and Drug Administration laboratories for the detection in food and cosmetic products of pathogens (bacterial, viral, parasitic, plus yeast and mold) and of microbial toxins. Except for some rapid methods listed in its Appendix 1, all these methods have been used and peer reviewed by FDA scientists as well as by scientists outside FDA. However, not all of these methods have been fully validated by collaborative studies. In some instances, collaborative studies are not possible because uniform test samples cannot be prepared (as with encysted parasites). In other instances, FDA needs to use a method before the time it takes to achieve full validation. At first (1965, Edition 1), the BAM was intended to be only a vehicle for information and standardization within FDA. However, the manual's reputation as useful spread beyond the agency. Requests for copies proliferated and it was decided to make the BAM generally available.
BAM: FDA's Bacteriological Analytical Manual (BAM) presents the agency's preferred laboratory procedures for microbiological analyses of foods and cosmetics. AOAC International published previous editions of this manual in a loose-leaf notebook format, and, more recently, on CD-ROM. This online BAM is now available to the public.
基准(Benchmark):一个测量参照点。
Biofilm: A biofilm is an aggregate of microorganisms in which cells adhere to each other and/or to a surface with sticky by-products formed by these cells. Biofilm can adhere to living or non-living surfaces and can hide harmful bacteria.
Bioluminescence: Bioluminescence is the production and emission of light by a living organism.
C
校准(Calibration): 根据标准值调谐仪器。
校准验证(Calibration Verification): 确认设备或仪器是正确校准的。
CFR: 联邦法规
CFR (21) Part 11: 联邦法规指出:电子记录和签字被视为等同于纸面记录。
Colony Forming Unit (CFU): CFU is a measure of viable (live) bacterial or fungal numbers. Unlike direct microscopic counts where all cells, dead and living, are counted, CFU measures viable cells. Results are given as CFU/mL (colony-forming units per milliliter) for liquids, and CFU/g (colony-forming units per gram) for solids
GMP: 良好的制造规范
图表记录仪(Chart Recorder): 一个记录环境测试室温度的电子仪器。
冷链管理(Cold Chain Management): 温度控制的供应链?;跷镌诶淞瓷媳匦氡3衷谝桓鲆恢碌奈露?。
冷链产品(Cold Chain Product): 对温度敏感的产品
冷链(Cold Chain): 一个不间断的温度流程记录,涵盖整个温度敏感产品的制造、包装及分销环节。
Colorimetric assay: A test using instruments that measures the concentration of a known constituent of a solution by comparison with colors of standard solutions. These instruments are used to determine or specify colors, as by comparison with spectroscopic or visual standards.
Culture medium: A growth medium or culture medium is a liquid or gel designed to support the growth of microorganisms or cells,[1] or small plants like the moss Physcomitrella patens.[2]There are different types of media for growing different types of cells.[3]
D
危险区(Danger Zone): 温度范围从41°F到135°F(5°C至57°c),该范围内食品最容易滋生细菌。
数据记录仪(Data Logger): 一个记录运输温度的仪器,测量在指定的时间段的温度(也称为数字数据记录仪,数据监测,温度数据记录仪,运输温度记录仪)。
偏差(Deviation): 与平均水平的差异
分销(Distribution): 在多个地点之间转移产品,其中包括生产、储存设施和最终用户(诊所、商业、病人)。
分销过程(Distribution Process): 产品从制造转移到最终用户的过程。
分销温度(Distribution Temperature):产品必须在特定温度下分发。
DNA: DNA, or deoxyribonucleic acid, is the hereditary material in humans and almost all other organisms. Nearly every cell in a person's body has the same DNA.
DOT: 美国交通运输部
干冰(Dry Ice): 固态二氧化碳制冷剂,在极冷的温度升华为气体。干冰用于制药和食品服务绝缘冷却/热包装。
充气袋(Dunnage): 用来填充集装箱的空间。
有效期(Duration): 一段时间长度,如:在指定的温度下24小时内发生的最低限度的稳定或不稳定。
E
E. coli: Escherichia coli or E. coli is a Gram-negative rod-shaped bacterium that is commonly found in the lower intestine of warm-blooded organisms (humans, birds etc). Most E. coli strains are harmless, but some, such as serotype O157:H7, can cause serious food poisoning in humans, and are occasionally responsible for product recalls.
功效(Efficacy): 能够产生理想的结果。
EIASee ELISA: ELISAEnzyme-linked immunosorbent assay (ELISA), also known as an enzyme immunoassay (EIA), is a biochemical technique used mainly in immunology to detect the presence of an antibody or an antigen in a sample. The ELISA has been used as a diagnostic tool in medicine and plant pathology, as well as a quality-control check in various industries.
Enterobacteriaceae: Enterobacteriaceae are a large family of gram-negative bacteria, including many familiar pathogens, such as Salmonella and E. coli.
Enterococcus: Enterococci are regular inhabitants of the bowel. The genome of E. faecalis is more than 25% exogenously acquired DNA. Enterococci are the leading cause of hospital-acquired secondary infections.
Enzymes: Enzymes are proteins that catalyze (i.e., increase the rates of) chemical reactions. At any given moment, all of the work being done inside any cell is being done by enzymes. The purpose of an enzyme in a cell is to allow the cell to carry out chemical reactions very quickly. These reactions allow the cell to build things or take things apart as needed. This is how a cell grows and reproduces.
偏差(Excursion): 偏离规定限额。
偏差限值(Excursion Limit): 一个允许偏离的规定限额。
外部温度周期(External Temperature Cycle): 集装箱经历的环境温度,涉及运输过程的每个步骤(包装、仓储、运输等)
F
False Negative: A result that appears negative but fails to reveal a situation. As an example an assay test concludes that there is no prescence of Salmonella when in fact Salmonella is present is a false negative result.
False Positive: A result that is erroneously positive when a situation is normal. As an example an assay test concludes that there is the prescence of Salmonella when in fact there is not Salmonella present is a false positive result.
FDA: 美国食品和药物管理局
Fecal Coliforms: Fecal coliform bacteria are present in large numbers in the feces and intestinal tracts of humans and other warm-blooded animals, and can enter water bodies from human and animal waste. Fecal coliform by themselves are usually not pathogenic; they are indicator organisms, which means they may indicate the presence of other pathogenic bacteria.
Fluorescence: Fluorescence is luminescence that occurs where the energy is supplied by electromagnetic radiation, usually ultraviolet light. The energy source kicks an electron of an atom from a lower energy state into an "excited" higher energy state; then the electron releases the energy in the form of light (luminescence) when it falls back to a lower energy state. Examples: fluorescent lights, the red glow of rubies in sunlight.
Fluorometer: A fluorometer or fluorimeter is a device used to measure parameters of fluorescence: its intensity and wavelength distribution of emission spectrum after excitation by a certain spectrum of light. These parameters are used to identify the presence and the amount of specific molecules in a medium. Modern fluorometers are capable of detecting fluorescent molecule concentrations as low as 1 part per trillion.
Fluorogenic: Having the quality of emitting light or Fluorescence.
食源性疾?。‵oodborne Illness): 任何因为进食或饮用受污染的食物造成的疾病。
G
GLP:  良好的实验室规范
Gram-negative bacteria: Gram-Negative Bacteria are simply called so because of their detection by the Gram's Stain test in which they do not retain the crystal violet color (dye) in their cell wall. The Gram-Negative bacteria cell-wall holds the pink or reddish dye once a counter stain chemical is used. There are many groups of Gram-Negative bacteria such as Cyanobacteria, Spirochaetes, Green-Sulphur and Green Non-Sulphur Bacteria and Proteobacteria etc. Out of which, proteobacteria is one of the major group of known Gram-Negative bacteria (it includes bacteria like E-coli, Salmonella, Pseudomonas, Moraxella, Helicobacter, Stenotrophomonas, Legionella, Acetic Acid Bacteria etc.)
Gram-positive bacteria: Gram-positive bacteria are those that are stained dark blue or violet by Gram staining. This is in contrast to Gram-negative bacteria, which cannot retain the crystal violet stain, instead taking up the counter stain (safranin or fuchsine) and appearing red or pink. Gram-positive organisms are able to retain the crystal violet stain because of the high amount of peptidoglycan in the cell wall. Gram-positive cell walls typically lack the outer membrane found in Gram-negative bacteria. Gram-positive organisms include Staphylococcus, Streptococcus, Enterococcus, Bacillus, Corynebacterium, Nocardia, Clostridium, Actinobacteria and Listeria.
GMP: 良好的制造规范
GRAS:  Generally recognized as safe; 通过美国FDA给予的特殊地位,证明某些成分和方法长久以来没有造成伤害人类或动物的历史。
Growth medium: Growth medium - a source of nutrients in which a microorganism is placed to permit its growth, cause it to produce substances, or observe its activity under defined conditions; also called culture medium or growth medium . The medium is usually a solution of nutrients in water (nutrient broths), or a similar solution solidified with gelatin or agar.
H
HACCP: Hazard Analysis Critical Control Point -- 危害分析关键控制点。 确定食源性危害的计划和实施步骤,以尽量减少或消除危害。许多领域需要食品服务部门的雇员实施HACCP,保存HCFC文件。
HCPC: Healthcare Compliance Packaging Council 遵守保健包装协会
Heterotrophic microorganisms: Heterotrophic organisms or Heterotrophs are organisms that are not able to make their own food. They must ingest or absorb food produced by other organisms. Therefore, the heterotrophs rely on other organisms for their nutrition. Heterotrophic organisms include animals, fungi, and some single-celled protozoa (e.g., ameba, paramecia) and bacteria. While autotrophs make their own food by converting inorganic nutrients into organic forms, heterotrophs cannot do this. Heterotrophs require most nutrients in an already produced, organic form. They use these nutrients both as a source of energy and as building blocks to form cell and body parts. In a food web the heterotrophs are the consumers. There are many different types of heterotrophs in a food web, depending on what they consume.
Hydrolyzed: Refers to the act of: Hydrolysis a chemical process of decomposition involving the splitting of a bond and the addition of the hydrogen cation and the hydroxide anion of water.
I
Immunology: Immunology is the study of our protection from foreign macromolecules or invading organisms and our responses to them. These invaders include viruses, bacteria, protozoa or even larger parasites. In addition, we develop immune responses against our own proteins (and other molecules) in autoimmunity and against our own aberrant cells in tumor immunity.
Incandescence: Incandescence is light from heat energy. If you heat something to a high enough temperature, it will begin to glow. When an electric stove's heater or metal in a flame begin to glow "red hot", that is incandescence. When the tungsten filament of an ordinary incandescent light bulb is heated still hotter, it glows brightly "white hot" by the same means. The sun and stars glow by incandescence.
Internal performance data: In house testing data performed throughout the product development
IPIC: International Pharmaceutical Industry Congress 国际医药产业大会
IQ/OQ/PQ: Installation Qualification/Operational Qualification/Performance Qualification,安装资质/运行资质/业绩资质
ISO 9001:2000: 为认证制造商质量控制体系而建立的国际标准质量管理组织。
ISPE: 国际制药工程协会
ISTA:国际安全运输协会
ISTA 5B: ISTA对温度控制下的包裹和热包装盒的热性能测试的模拟重点指南。
J
JCAHO: Joint Commission on Accreditation of Healthcare Organizations. 评审医疗机构的联合委员会,一个评审医院是否达到为病人服务标准的会议组织。
K
L
Light: Light is a form of energy. To create light, another form of energy must be supplied. There are two common ways for this to occur, incandescence and luminescence.
Listeria: Listeria monocytogenes is a Gram-positive rod-shaped bacterium. It is the agent of listeriosis, a serious infection caused by eating food contaminated with the bacteria. The disease affects primarily pregnant women, newborns, and adults with weakened immune systems. Listeriosis is a serious disease for humans; the overt form of the disease has a mortality greater than 25 percent. The two main clinical manifestations are sepsis and meningitis. Meningitis is often complicated by encephalitis, a pathology that is unusual for bacterial infections.
Luminescence: Luminescence is "cold light" that can be emitted at normal and lower temperatures. In luminescence, some energy source kicks an electron of an atom out of its lowest energy "ground" state into a higher energy "excited" state; then the electron returns the energy in the form of light so it can fall back to its "ground" state. With few exceptions, the excitation energy is always greater than the energy (wavelength, color) of the emitted light.
M
Methicillin Resistant Staphylococcus Aureus (MRSA): Methicillin-resistant Staphylococcus aureus (MRSA) is a bacterium responsible for several difficult-to-treat infections in humans. It may also be called multidrug-resistant Staphylococcus aureus or oxacillin-resistant Staphylococcus aureus (ORSA). MRSA is, by definition, any strain of Staphylococcus aureus that has developed resistance to beta-lactam (class of antibiotics) antibiotics which include the penicillins (methicillin, dicloxacillin, nafcillin, oxacillin, etc.) and the cephalosporins (class of beta-lactam antibiotics0. MRSA is especially troublesome in hospitals and nursing homes where patients with open wounds, invasive devices and weakened immune systems are at greater risk of infection than the general public.
平均动力学温度(MKT): Mean Kinetic Temperature。美国药典(MKT定义为“单一计算温度的退化总额,等于在超过某一特定时期在不同温度下所有单个温度退化的总和)。
MSDS: Material Safety Data Sheet 材料安全数据表
N
NAAT: A nucleic acid test, often called a "NAT" test, (or nucleic acid amplification test - "NAAT") is a biochemical technique used to detect a virus or a bacterium. These tests were developed to shorten the window period, a time when a patient has been infected and when they show up as positive by antibody tests.
NIST: National Institute of Standards and Technology- 国家标准与技术研究所,政府机构设置标准(包括温度) 。
Non-Conformance: 不能够符合或执行既定标准。
NSF: NSF International,非营利非政府组织,是世界领先的标准开发,产品认证,教育和公共健康和安全风险管理组织。
Nucleic acid test: See NAAT
O
P
托盘集装箱(Pallet Containers): 热集装箱或托盘托运,旨在保持整个托盘。
Pathogen: An agent of disease. A disease producer. The term pathogen most commonly is used to refer to infectious organisms. These include bacteria (such as staph), viruses (such as HIV), and fungi (such as yeast).
PCR: The polymerase chain reaction (PCR) is a scientific technique in molecular biology to amplify a single or a few copies of a piece of DNA across several orders of magnitude, generating thousands to millions of copies of a particular DNA sequence. PCR technique is often used in NAAT, to allow for rapid copying of DNA.
Peroxidasa Enzyme: Enzyme that breaksdown hydrogen peroxide in cells. Foods containing peroxidase include radishes, turnips, cabbage, cauliflower, horseradish, uncooked broccoli, cucumbers, mushrooms, green beans, artichokes, melons and potatoes.
PDA PCCDG: PDA医药冷链小组讨论
PDA: Parenteral Drug Association 注射药物协会
pH: 衡量酸性或碱性内容的一个指标。
Picomole: A unit of substance equal to one trillionth (10-12) of a mole. The mole is a unit of measurement for the amount of substance or chemical amount. It is one of the base units in the International System of Units, and has the unit symbol mol. The mole is defined as the amount of substance that contains as many elementary entities (e.g., atoms, molecules, ions, electrons) as there are atoms in 12 g of the isotope carbon-12 (12C).
Potentially Hazardous Foods (PHF): 具有潜在危险的食品( PHF )
PTM AOAC Performance Tested Methods: The AOAC's method of validation testing
Q
QA:质量保证
资格报告(Qualification Report): 一个正式的研究生产资格的书面或电子记录详图。
资格(验证)Qualification (Validation): 测试以提供合理保证,确保合格的产品或生产过程会产生类似指定条件的结果。
R
坡道(Ramp): 从一个设定点到另一个的编程变化。
Reagent: A reagent is a substance that, because of the reactions it causes, is used in analysis and synthesis. A reagent is a "substance or compound that is added to a system in order to bring about a chemical reaction, or is added to see if a reaction occurs.
S
Salmonella: Salmonella bacteria are rod-shaped, flagellated, Gram stain-negative, and are known to cause disease in humans, animals, and birds (especially poultry) worldwide. The two major diseases caused by Salmonella spp. are gastroenteritis and typhoid fever (typhoid and paratyphoid fevers) in humans.
消毒(Sanitization): 一般通过使用化学、热或两者兼施进行裁减微生物及其孢子到达安全水平的过程。
保质期(Shelf Life): 产品或设备保持其效力的时间长度。
运输(Shipping): 包装的货物从一个位置运输到另一个位置的过程。
运输系统(Shipping System): 绝缘集装箱及其内部的热包装组件(制冷剂,缓冲材料,充气等)
SOP: Standard Operating Procedures - 标准作业程序
SPE: Society for Pharmaceutical Engineering - 制药工程学会
稳定性(Stability): 常常指产品在不同温度/时间下保持其功效的能力。
储藏温度(Storage Temperature): 产品在该温度下存储。
Substrate: In biochemistry, a substrate is a molecule upon which an enzyme acts. Enzymes catalyze chemical reactions involving the substrate(s). In the case of a single substrate, the substrate binds with the enzyme active site, and an enzyme-substrate complex is formed. The substrate is transformed into one or more products, which are then released from the active site. The active site is now free to accept another substrate molecule. In the case of more than one substrate, these may bind in a particular order to the active site, before reacting together to produce products.
T
温度滥用(Temperature Abuse): 当温度敏感的商品暴露在高于或低于其安全温度区
温度探头(Temperature Probe): 一种测试特定的环境温度的装置。
温度敏感产品(Temperature-Sensitive Product): 一个产品的稳定性受特定范围以外的温度影响(例如疫苗)。
热图(Thermal Mapping): 指一段时间内,见证许多环节经历的温度变化?;肪橙韧际侵甘占跷镌谡龇窒讨幸贫本谋匾幕肪澄露缺浠?。
热电偶(Thermocouple): 采用一对不同的金属丝(如铜,铁)精确测量温度的装置。
公差(Tolerance): 对某一特定测量误差的可接受范围。
Total Organisms: Total Organisms gives a quantitative idea about the presence of microorganisms such as bacteria yeast and mold in a sample. To be specific, the count actually represents the number of colony forming units (cfu) per g (or per ml) of the sample.
U
UN: United Nations - 联合国 3373包装标记规格,为冷藏链技术公司的诊断试剂所遵循。
USDA: United States Department of Agriculture - 美国农业部
USP: United States Pharmacopeia - 美国药典
V
验证(资格) Validation (Qualification) :研究和提供证据,以确保某个特定的程序或系统将不断满足预先确定的规格。 
W
WHO: World Health Organization - 世界卫生组织
X
Y
Z