翻譯：julia 來(lái)自：蒲公英

02.03.2017

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

法規(guī)對(duì)“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(jīng)常會(huì)看到標(biāo)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(yùn)輸過(guò)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(gè)問(wèn)題很容易回答?！八幤吩谶\(yùn)輸過(guò)程中應(yīng)維持在生產(chǎn)商給定的或在外包裝上指定的存貯條件范圍內(nèi)”（EU GDP指南）。根據(jù)PIC/S的GDP指南，這些條件也需要應(yīng)用于運(yùn)輸過(guò)程中（參見(jiàn)第9.2.1部分）。

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

第一個(gè)問(wèn)題則要更難回答一點(diǎn)。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(yùn)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(huán)境溫度存貯。該術(shù)語(yǔ)使用不廣泛，因?yàn)槌刈兓艽?。它表示“室溫”或常?guī)存貯條件，意思是說(shuō)存貯在15-25°C（59-77°F）之間的室溫、干燥通風(fēng)環(huán)境中，或者根據(jù)氣候條件可能達(dá)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(guó)藥典則有一些章節(jié)可供參考。在USP<659>章節(jié)“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(qū)域的主導(dǎo)溫度

受控室溫：在常規(guī)工作環(huán)境中采用溫控方式控制在20-25 ?C（68-77 ?F）。在藥房、醫(yī)院和倉(cāng)庫(kù)里，以及在運(yùn)輸中允許在15-30 ?C（59-86 ?F）之間波動(dòng)。如果平均動(dòng)力學(xué)溫度不超過(guò)25 ?C，允許在24小時(shí)以?xún)?nèi)溫度升至不超過(guò)40 ?C。只有生產(chǎn)商有說(shuō)明時(shí)，溫度才可以超過(guò)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(duì)檢測(cè)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(biāo)準(zhǔn)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(jiǎn)單匯總可以看出這些規(guī)定并不一致：

Pharm. Eur.

WHO

USP

JP

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

8°C – 15°C

8°C – 15°C

-

Room temperature

15°C – 25°C

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

-

-

EP

WHO

USP

JP

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

8°C – 15°C

8°C – 15°C

-

室溫

15°C – 25°C

15°C – 25°C

工作區(qū)域一般溫度

1°C – 30°C

受控室溫

-

-

20°C – 25°C

允許波動(dòng)范圍15°C – 30°C

-

常溫

-

根據(jù)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(shuō)明書(shū)和標(biāo)簽中給定的存貯條件應(yīng)該引用藥品穩(wěn)定性試驗(yàn)。

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)

or

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

or

store and transport refrigerated

Do not freeze

Below zero

Store in a freezer

or

store and transport frozen

藥品穩(wěn)定性的測(cè)試條件

標(biāo)簽聲明要求

其它的標(biāo)簽聲明

25°C/60%RH (長(zhǎng)期)

40°C/75%RH (加速)

或

30°C/65%RH (長(zhǎng)期)

40°C/75%RH (加速)

無(wú)

（要求有以下的標(biāo)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(zhǎng)期)

30°C/60 or 65%RH （中間條件）或

30°C/65%RH (長(zhǎng)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(zhǎng)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(zhǎng)期)

冰箱保存或

冷藏存貯和運(yùn)輸

不要冷凍

零下

冷凍柜存貯或

冷凍存貯和運(yùn)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(lái)說(shuō)，應(yīng)避免在存貯和運(yùn)輸盒上和包裝上僅僅使用像“常溫”、“室溫”及“冷鏈”之類(lèi)的術(shù)語(yǔ)，因?yàn)檫@些術(shù)語(yǔ)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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