歐美日對“常溫”、“室溫”和“冷鏈”的定義大全

時間：2025-01-26 21:58:53來源：food欄目：冷鏈新聞閱讀：

翻譯：julia 來自：蒲公英

02.03.2017

What are the regulatory Definitions for "Ambient"， "Room Temperature" and "Cold Chain"?

法規對“常溫”、“室溫”和“冷鏈”的定義是什么？

On the outer packaging of pharmaceutical products one often 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 during transport?

在藥品的外包裝上，我們經常會看到標簽上有存貯的要求，如“常溫”、“室溫”以及“冷鏈”。它們是什么意思呢？這些條件是否也適用于運輸過程？

The second question is easy to answer: "The required storage conditions for medicinal products should be maintained during transportation within the defined limits as described by the manufacturers or on the outer packaging." (EU GDP Guidelines). But according to the PIC/S Good Distribution Guide these conditions should also be applied for transportation (see section 9.2.1).

第二個問題很容易回答?！八幤吩谶\輸過程中應維持在生產商給定的或在外包裝上指定的存貯條件范圍內”（EU GDP指南）。根據PIC/S的GDP指南，這些條件也需要應用于運輸過程中（參見第9.2.1部分）。

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

第一個問題則要更難回答一點。在不同的地方有不同的界定。

The European Pharmacopoeia (Pharm.Eur.) gives some hints in chapter 1.2 (Other provisions applying to general chapters and monographs) with referring to analytical procedures:

歐洲藥典在第1.2章給出了一些暗示，引用了分析方法（其它條款適用于通則和各論）

Deep-freeze: below -15°C;

Refrigerator: 2°C to 8°C;

Cold or cool: 8°C to 15°C;

Room temperature: 15°C to 25°C.

深冷： -15°C以下

冷凍：2-8°C

低溫或涼溫：8-15°C

室溫：15-25°C

There are also some definitions in the WHO Guidance:

在WHO指南中，也有一些定義：

Store frozen: transported within a cold chain and stored at -20°C (4°F).

Store at 2°-8°C (36°-46°F): for heat sensitive products that must not be frozen.

Cool: Store between 8°-15°C (45°-59°F).

Room temperature: Store at 15°-25°C (59°-77°F).

Ambient temperature: Store at the 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.

冷凍存貯：需要冷鏈運輸，并存貯在-20°C（4°F）

2-8°C（36-46°F）存貯：不能冷凍的熱敏藥品

低溫：在8-15°C（45-59°F）存貯

室溫：在15-25°C（59-77°F）存貯

常溫：環境溫度存貯。該術語使用不廣泛，因為常溫變化很大。它表示“室溫”或常規存貯條件，意思是說存貯在15-25°C（59-77°F）之間的室溫、干燥通風環境中，或者根據氣候條件可能達到30°C。

And the U.S. Pharmacopeia (USP) has some references.USP <659> "Packaging and Storage Requirements" gives various examples for different storage conditions， for example:

美國藥典則有一些章節可供參考。在USP<659>章節“包裝和存貯要求”中給出了不同存貯條件的例子，例如：

Cold: Any temperature not exceeding 8°C (46 °F).

Cool: Any temperature between 8° and 15° (46° and 59 °F)

Room temperature: The temperature prevailing in a work area.

Controlled room temperature: The temperature maintained thermostatically that encompasses at the usual and customary 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 not exceed 25°， transient spikes up to 40° are permitted as long as they do not exceed 24 h. Spikes above 40° may be permitted only if the manufacturer so instructs.

Warm: Any temperature between 30° and 40°C (86° and 104 °F).

Excessive heat: Any temperature above 40° (104 °F).

低溫：8 ?C（46 ?F）以下

涼處：8-15 ?C（46-59 ?F）

室溫：工作區域的主導溫度

受控室溫：在常規工作環境中采用溫控方式控制在20-25 ?C（68-77 ?F）。在藥房、醫院和倉庫里，以及在運輸中允許在15-30 ?C（59-86 ?F）之間波動。如果平均動力學溫度不超過25 ?C，允許在24小時以內溫度升至不超過40 ?C。只有生產商有說明時，溫度才可以超過40 ?C。

暖溫：30-40 ?C之間（86-104 ?F）

熱溫：高于40?C（104 ?F）

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

日本藥典對檢測和存貯溫度描述如下：

Cold: 1°C - 15°C

Standard temperature: 20°C

Ordinary temperature: 15°C - 25°C

Room temperature: 1°C - 30°C

Lukewarm: 30°C - 40°C

低溫：1-15 ?C

標準溫度：20 ?C

常溫：15-25 ?C

室溫：1-30 ?C

暖溫：30-40 ?C

This is not overall harmonised， as this simple summary shows:

下面的簡單匯總可以看出這些規定并不一致：

Pharm. Eur.

WHO

USP

Frozen/ deep-freeze

>-15°C

-20°C

Refrigerator

2°C – 8°C

Cold

8°C – 15°C

2°C – 8°C

<8°C

1°C – 15°C

Cool

8°C – 15°C

Room temperature

15°C – 25°C

temperature prevailing in a work area

1°C – 30°C

Controlled room temperature

20°C – 25°C

excursions between 15°C and 30°C are allowed

Ambient temperature

15°C – 25°C or 30°C depending on climatic conditions

WHO

USP

冷凍/深冷

>-15°C

-20°C

冷藏

2°C – 8°C

低溫

8°C – 15°C

2°C – 8°C

<8°C

1°C – 15°C

涼處

8°C – 15°C

室溫

15°C – 25°C

工作區域一般溫度

1°C – 30°C

受控室溫

20°C – 25°C

允許波動范圍15°C – 30°C

常溫

根據氣候條件

15°C – 25°C 或 30°C

And then there is the EMA GUIDELINE on DECLARATION OF STORAGE CONDITIONS from 2007， requiring that the storage conditions given in the package leaflet (PL) and the labelling of medicinal products should refer to the stability studies made for the finished product:

還有EMA在2007年的存貯條件聲明中要求藥品說明書和標簽中給定的存貯條件應該引用藥品穩定性試驗。

Testing conditions where the product is stable

Required labelling statement

Additional labelling statement， where relevant

25°C/60%RH (long term)

40°C/75%RH (accelerated)

30°C/65%RH (long term)

40°C/75%RH (accelerated)

None

(The following PL statement is required:

This medicinal product does not require any special storage conditions.)

Do not refrigerate or freeze

25°C/60%RH (long term)

30°C/60 or 65%RH (intermediate) or

30°C/65%RH (long term)

Do not store above 30°C or Store below 30°C

Do not refrigerate or freeze

25°C/60%RH (long term)

Do not store above 25°C or Store below 25°C

Do not refrigerate or freeze

5°C ± 3°C (long term)

Store in a refrigerator

store and transport refrigerated

Do not freeze

Below zero

Store in a freezer

store and transport frozen

藥品穩定性的測試條件

標簽聲明要求

其它的標簽聲明

25°C/60%RH (長期)

40°C/75%RH (加速)

或

30°C/65%RH (長期)

40°C/75%RH (加速)

無

（要求有以下的標簽聲明：藥品不需要任何特殊存貯條件）

不能冷藏或冷凍

25°C/60%RH (長期)

30°C/60 or 65%RH （中間條件）或

30°C/65%RH (長期)

勿在30°C以上存貯或

30°C以下存貯

不要冷凍或冷藏

25°C/60%RH (長期)

勿在25°C以上存貯或

25°C以下存貯

不要冷凍或冷藏

5°C ± 3°C (長期)

冰箱保存或

冷藏存貯和運輸

不要冷凍

零下

冷凍柜存貯或

冷凍存貯和運輸

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

總體來說，應避免在存貯和運輸盒上和包裝上僅僅使用像“常溫”、“室溫”及“冷鏈”之類的術語，因為這些術語并不總是很清晰，可能在世界上其它地方有不同的含義。存貯條件最好是指定清晰的溫度范圍（例如，15-25°C或+2至+8°C）。尤其要注意避免液體和半固體的冷凍。

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