【ECA新闻】环境、室温、冷——是什么？

麦田.守望

26.09.2018

"Ambient","Room Temperature", "Cold " - what is what?

“环境”、“室温”、“冷”－什么是什么？

On the outer packaging of pharmaceutical products oneoften finds labels with storage requirements like for example"ambient", "room temperature" and "cold chain".But what do they exactly mean? And do these conditions also apply duringtransport?

在药品的外包装上，经常发现具有储存要求的标签，例如“环境”、“室温”和“冷链”。 但他们究竟是什么意思呢？这些条件在运输过程中也适用吗？

The second question is easy to answer: "Therequired storage conditions for medicinal products should be maintained duringtransportation within the defined limits as described by the manufacturers oron the outer packaging." (EU-GDP Guidelines). But also according to the PIC/SGood Distribution Guide these conditions should be applied also fortransportation (see section 9.2.1).

第二个问题很容易回答：“药品所需的储存条件应在运输过程中保持在制造商或外包装所规定的限定范围内。”（欧盟GDP指南）。而且根据PIC/S良好分销指南，这些条件也适用于运输（见第9.2.1节）。

With the first question, it is more difficult. Here,different definitions can be found.

第一个问题更难回答。在这里，可以找到不同的定义。

The European Pharmacopoeia (Pharm.Eur.) givessome hints in chapter 1.2 (Other provisions applying to general chapters andmonographs) with referring to analytical procedures:

欧洲药典（EP）在1.2章节（适用于通则和专论的其他规定）给出了的一些提示，并提及分析程序：

●      Deep-freeze:below minus 15°C;  深冻：低于零下15℃；

●      Refrigerator:2°C to 8°C;  冰箱：2℃~8℃；

●      Coldor cool: 8°C to 15°C;  冷或凉：8℃~15℃;

●      Roomtemperature: 15°C to 25°C.  室温：15℃~25℃。

There are also some definitions in the WHO guidance:

WHO指南中也有一些定义：

●      Storefrozen: transported within a cold chain and stored at -20°C (4°F).
冷冻储存：冷链运输并储存在-20℃（4℉）。

●      Storeat 2°-8°C (36°-46°F): for heat sensitive products that must not be frozen.
储存在2℃~8℃（36~46℉）：适用于不能冷冻的热敏性产品。

●      Cool:Store between 8°-15°C (45°-59°F).
凉爽：储存在8℃~15℃（45~59℉）之间。

●      Roomtemperature: Store at 15°-25°C (59°-77°F).
室温：储存在15℃~25℃（59~77℉）。

●      Ambienttemperature: Store at the surrounding temperature. This term is not widely useddue to significant variation in ambient temperatures. It means "roomtemperature" 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.
环境温度：在环境温度下储存。由于环境温度变化显著，此术语没有被广泛使用。它表示“室温”或正常储存条件，这意味着在室温15~25℃（59~77℉）或最高30℃的条件下储存在干燥、清洁、通风良好的区域，具体取决于气候条件。

And the U.S. Pharmacopeia (USP) has somereferences:

美国药典（USP）也有一些参考：

USP <659> "Packaging and StorageRequirements" gives various examples for different storage conditions, forexample:

USP <659>“包装和储存要求”给出了不同储存条件的各种示例，例如：

●      Cold: Any temperature not exceeding 8°C (46°F).
冷处：不超过8℃（46℉）的任何温度。

●      Cool: Any temperature between 8° and 15° (46°and 59 °F)
凉处：在8℃和15℃（46和59℉）之间的任何温度。

●      Roomtemperature: Thetemperature prevailing in a work area.
室温：在工作区域的普遍温度。

●      Controlledroom temperature: Thetemperature maintained thermostatically that encompasses at the usual andcustomary working environment of 20°-25° (68°-77 °F). Excursions between 15°and 30° (59° and 86 °F) that are experienced in pharmacies, hospitals, and warehouses,and during shipping are allowed. Provided the mean kinetic temperature does notexceed 25°, transient spikes up to 40° are permitted as long as they do notexceed 24 h. Spikes above 40° may be permitted only if the manufacturer soinstructs.
受控室温：温度保持恒温，包围在20~25℃（68~77℉）的通常和习惯的工作环境下。在药店、医院和仓库以及在运输过程中，经历在15℃和30℃（59℉和86℉）之间的偏移是允许的。如果平均动力学温度（MKT）不超过25℃，则允许不超过40℃的瞬时峰值，只要它们不超过24小时。只有当制造商说明时，才允许40℃以上的峰值。

●      Warm:Any temperature between 30° and 40°C (86° and 104 °F).
暖处：在30℃和40℃（86和104℉）之间的任何温度。

●      Excessiveheat: Any temperature above 40° (104 °F).
极热处：高于40℃（104℉）的任何温度。

The Japanese Pharmacopeia (JP) describestemperature for tests or storage as follows:

日本药典（JP）描述了测试或储存的温度如下：

●      Cold:1°C - 15°C  冷：1℃~15℃

●      Standardtemperature: 20°C  标准温度：20℃

●      Ordinarytemperature: 15°C - 25°C  普通温度：15℃~25℃

●      Roomtemperature: 1°C - 30°C  室温：1℃~30℃

●      Lukewarm:30°C - 40°C  微热：30℃~40℃

This is not overall harmonised, as this simple summaryshows:

这没有全面一致化，正如这个简单的摘要所示：

	Pharm. Eur.	WHO	USP	JP
Frozen/ deep-freeze    冷冻/深冻	>-15°C	-20°C	-	-
Refrigerator冰箱	2°C - 8°C	-	-	-
Cold   冷	8°C - 15°C	2°C - 8°C	<8°C	1°C - 15°C
Cool   凉	8°C - 15°C	8°C - 15°C	8°C - 15°C	-
Room temperature    室温	15°C - 25°C	15°C - 25°C	"temperature prevailing in a work  area"    在工作区域的普遍温度	1°C - 30°C
Controlled room temperature    控制室温	-	-	20°C - 25°C   excursions between 15°C and 30°C are allowed    20-25℃，允许在15℃和30℃之间偏移	-
Ambient temperature    环境温度	-	15°C - 25°C or 30°C depending on climatic  conditions    取决于气候条件	-	-

And then there is the EMA GUIDELINE on DECLARATION OF STORAGE CONDITIONS from2007, requiring that the storage conditions given in the package leaflet (PL)and the labelling of medicinal products should refer to the stability studiesmade for the finished product:

此外，还有2007年EMA关于储存条件声明的指南，要求药品包装说明书（PL）和标签中给出的储存条件应参考对成品的稳定性研究：

Testing conditions where the product is  stable    产品稳定的测试条件	Required labelling statement    要求的标签声明	Additional labelling statement, where  relevant    附加标签声明，    如果相关
25°C/60%RH (long term)   40°C/75%RH (accelerated)   or           （加速）   30°C/65%RH (long term)   40°C/75%RH (accelerated)	None  无   (The following PL statement is required:   "This medicinal product does not require any special storage  conditions".)    （以下标签声明是必需的：“这种药品不需要任何特殊的储存条件”。）	Do not refrigerate or freeze    不要冷藏或冷冻
25°C/60%RH (long term)   30°C/60 or 65%RH (intermediate) or  中间   30°C/65%RH (long term)	Do not store above 30°C or Store below  30°C    不要在高于30℃储存或储存于30℃以下	Do not refrigerate or freeze    不要冷藏或冷冻
25°C/60%RH (long term)                （长期）	Do not store above 25°C or Store below  25°C    不要在高于25℃储存或储存于25℃以下	Do not refrigerate or freeze    不要冷藏或冷冻
5°C ± 3°C (long term)              （长期）	Store in a refrigerator  储存于冷藏箱   or  或冷藏储存和运输   store and transport refrigerated	Do not freeze    不要冷冻
Below zero  零下	Store in a freezer  储存于冷冻箱   or  或冷冻储存和运输   Store and transport frozen	-

So as a resume, terms like "ambient","room temperature" and "cold chain" should be avoided asthe only labelling for storage or transport because they are not always clearand might have different meanings in other parts of the world. Storageconditions are always better explicitly specified in terms of a definedtemperature range (e.g., 15°C -25°C or +2°C to +8°C). Particular attentionshould be given to avoiding freezing of liquids and semi-solids.

因此，作为一个概略，诸如“环境”、“室温”和“冷链”的术语应避免作为储存或运输的唯一标识，因为他们并不总是清楚的，并可能在世界其他地方有不同的含义。储存条件总是按照确定的温度范围（例如15℃~25℃或+2℃至+8℃）明确地指定更好。应特别注意避免液体和半固体冻结。

syhorchid

谢谢分享

qcl1236

谢谢分享，学习一下

xqliu

很系统，谢谢提供分享。

zhaosc8326

谢谢分享

18980646549

谢谢分享。

麦田.守望

中国药典要求	GSP要求	GSP(征求意见稿）要求	USP要求	BP要求
阴凉处 不超过20度；                    冷处 2－10度；         常温 10－30度	常温库温度为0-30℃，          阴凉库温度不高于20℃，      冷库温度为2-lO℃                 各库房相对湿度应保持在45-75%之间	常温2～30℃、               阴凉2～20℃、              冷藏2～10℃储存；            储存药品相对湿度为35%～75%；	Cold     Any temperature not exceeding 8  (46  F) is “cold.”     Cool     Any temperature between 8  and  15  (46   and 59 F) is“cool.”                                                    Controlled Cold Temperature     “Controlled cold temperature” is defined as temperature maintained  thermostatically between 2  and 8  (36   and 46  F) , that allows for  excursions in temperature between 0   and 15  (32  and 59   F) that may be experienced during storage, shipping, and distribution  such that the allowable calculated mean kinetic temperature is not more than  8  (46   F)                                     Controlled Room Temperature     “Controlled room temperature” indicates a temperature maintained  thermostatically that encompasses the usual and customary working environment  of 20  to 25                                                                           Room Temperature     “Room temperature” indicates the temperature prevailing in a working  area.	deep-freeze:  below -     15 °     C;     _— in a refrigerator: 2 °C to 8 °C;     _— cold or cool: 8 °C to 15 °C;     _— room temperature: 15 °C to 25 °C.

http://bbs.sfdaied.org/read.php?tid=246575

小金库

感谢分享。

公羊羽先生

政哥出来统一一下吧，一个相同的温度咋这么多说法。