Standard Operating Procedure of Temperature & Humidity Control in Pharmaceutical is describe in this post.
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1. PURPOSE
The purpose of this SOP is to define Temperature and Humidity Control in Pharmaceuticals.
2. SCOPE
It is applicable to all departments in Pharmaceuticals.
3. RESPONSIBILITIES
3.1 HOD / Section Incharge of all departments are responsible to ensure and maintain the Temperature & Humidity Control of their respective areas.
3.2 Maintenance department is to assist in controlling the Temperature & Humidity in all departments of plant.
3.3 Q.A Department is responsible to verify and ensure the updating of Temperature & Humidity record.
4. MATERIAL & EQUIPMENT
4.1 Hygrometers (Digital / Wet & Dry Bulb)
5. PROCEDURE
5.1 DEFINITION
Temperature Control is defined as the extent to which a product retain within its specified limits and throughout its period of storage and use i.e. (its shelf life) the same properties and characteristics that it possessed at the time of its manufacturing.
5.2 TEMPERATURE SPECIFICATION
5.2.1 Following are different type of storage conditions:
|
Storage Condition
|
Description
|
|
Room
Temperature
|
20 to 25°C (Excursion permitted
between 15-30°C)
|
|
Cool
Condition
|
8
to 15°C
|
|
(Refrigerator)
Cold Condition
|
2
to 8°C
|
|
Freezer
Storage
|
-25
to -10°C
|
5.2.2 Storage of Material/Product is carried out as per specified storage condition mentioned on the Specification / COA/ in Monograph by respective department.
5.2.3 Temperature and Humidity of each area is checked by respective section Officer and verified by QA.
5.2.4 Digital & Dry/Wet Bulb Hygrometers are installed in the premises.
5.2.5 Each department is responsible for maintain the temperature & humidity requirement of their area with the help of maintenance department.
5.2.6 Before Line clearance of the area and also during the routine working temperature and humidity of the area is checked by respective section Officer and verified by QA.
5.2.7 In case of any breach from set specification immediately actions should be taken.
|
Section
|
Area
|
Temperature
|
Relative Humidity
|
|
Tablet
/ Bolus
|
Manufacturing
|
15 - 30°C
|
NMT 60 %
|
|
Compression & Blistering
|
15 - 30°C
|
NMT 50 %
|
|
Packaging
|
15 - 30°C
|
NMT 60 %
|
|
Powder
|
Manufacturing to Filling
|
15 - 30°C
|
NMT 45 %
|
|
Packaging
|
15 - 30°C
|
NMT 60 %
|
|
Capsule
|
Manufacturing to Blistering
|
15 - 30°C
|
NMT 45 %
|
|
Packaging
|
15 - 30°C
|
NMT 60 %
|
|
Syrup
/ Drench
|
Manufacturing
to Packaging
|
15 - 30°C
|
NMT 60 %
|
|
Injectable
/Aerosol
|
Manufacturing
to Filling
|
15 - 25°C
|
NMT 60 %
|
|
Packaging
|
15 - 30°C
|
NMT 60 %
|
|
Warehouse
|
RM
/ FG Warehouse
|
15 - 30°C
|
NMT 60 %
|
|
Dispensing Areas
|
15 - 30°C
|
NMT 45 %
|
|
QC/Micro
|
Retained Samples Area
|
15 - 30°C
|
NMT 70 %
|
|
QC Hall
|
15 - 30°C
|
NMT 70%
|
5.3 TEMPERATURE & HUMIDITY REQUIREMENTS
5.3.1 A chart of controlled environmental conditions is as follows:
5.4 Incase of Wet & Dry Bulb hygrometer check the humidity by consulting the relative humidity chart. For example if Temperature on Dry Bulb is 22°C and on wet Bulb it is 16°C and difference is 6 then check the row of 22°C of dry bulb against the difference of 6. It is the relative humidity of the area (i.e. 53%).
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