In the Pharmaceuticals manufacturing and storage areas Temperature and Humidity Control in Pharma is very import. There are so many precaution are necessary for Temperature and Humidity Control in Pharma .
INTRODUCTION
Temperature and Humidity Control in Pharma 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. So, the substances and finished products described in the pharmacopoeia should be stored under conditions that prevent contamination and as for as possible. Precautions that should be taken in relation to the effects of the atmosphere, moisture, heat and light are indicated where appropriate in monographs. Further precaution may be necessary when some materials are stored in tropical climates or under other severe conditions.
Temperature and Humidity Control in Pharma Specification:
General Humidity limit in Plant, particularly Manufacturing Areas, is Not More Than 45%RH. While General Temperature Limit is Not More Than 25C. Important terms used to explain different Temperatures (Reference: B.P.2015) are:
Cool or Cold:
Any temperature between 8° — 15°C (46° — 59°F) is called Cool or Cold.
Room Temperature:
The temperature between 15°C — 25°C is called Room Temperature.
Refrigerator:
The temperature prevailing in the range 2°C — 8°C is called Refrigerator.
LIST OF THERMO HYGROMETERS SHOULD PLACE IN PHARMA
| Maximum/ Minimum Thermo Hygrometer | Raw Material Store |
| Maximum/ Minimum Thermo Hygrometer | Dispensing Room |
| Maximum/ Minimum Thermo Hygrometer | Packing Material Store |
| Maximum/ Minimum Thermo Hygrometer | Finished Goods Store |
| Maximum/ Minimum Thermo Hygrometer | Granulation Area |
| Maximum/ Minimum Thermo Hygrometer | Drying Area |
| Maximum/ Minimum Thermo Hygrometer | Mixing Area |
| Maximum/ Minimum Thermo Hygrometer | Compression Machine |
| Maximum/ Minimum Thermo Hygrometer | Coating Machine |
| Maximum/ Minimum Thermo Hygrometer | Blister Machine (I) |
| Maximum/ Minimum Thermo Hygrometer | Blister Machine (II) |
| Maximum/ Minimum Thermo Hygrometer | Capsule Section manufacturing |
| Maximum/ Minimum Thermo Hygrometer | Capsule Section Filling Area |
| Maximum/ Minimum Thermo Hygrometer | Quarantine Area |
| Maximum/ Minimum Thermo Hygrometer | other Manufacturing facilities |
LOCATION OF THE THERMO HYGROMETER
Raw Material store
Raw materials are stored according to BP/USP or other prescribed specifications. Usually raw materials are stored in this area according to their nature or as required. Normally raw materials are stored at room temperature (15° – 25°C), which is thermostatically maintained.
Maximum/ Minimum thermometer is hanged on wall of store at height of approximately two meters for determination of Temperature and Humidity Control in Pharma .
Dispensing Room
Dispensing of all raw materials is done in this area and dispensed materials are stored for time being in the cages made of Stainless Steel. Temperature of dispensing area is maintained at room temperature (15° – 25°C), which is thermostatically maintained.
Maximum/ Minimum thermometer is hanged on wall of room at height of approximately two meters for determination of Temperature and Humidity Control in Pharma .
Packing Material Store
Packing material comprises of different color printed papers, boxes, labels, leaflets, unit packs, glass bottles, plastic bottles, caps, outer cartons, PVC, Aluminum Foils, PP. Caps, and Gelatin Capsules etc.
These materials should be stored in well-closed containers protecting from heat, light and moisture, at room temperature or according to their nature or as required because in absence of above mentioned conditions the materials may damage or destroyed or some defects may occur.
Maximum/ Minimum thermometer is hanged on wall near door at height of about two meters for determination of Temperature and Humidity Control in Pharma .
Finished Material Store
Finished Goods Store should be facilitated with air-conditioning system to maintain the required temperature as well as avoiding moisture, direct sunlight, and excessive heat. Mostly finished products are stored at room temperature (i.e. 15°C – 25°C) at dry place in well-closed containers protecting from heat, light and moisture. In absence of above mentioned conditions the product will lose their activity as well as may damage or destroyed and the shelf life of the product will not retain the expiry according to the label claim.
Maximum/ Minimum thermometer is hanged on left side wall in centre at height of two meters for determination of Temperature and Humidity Control in Pharma.
Double Cone Mixer Room
Final mixing of the grains for tablets is performed in this area. Temperature of double cone mixer room is maintained at room temperature (15° – 25°C), which is thermostatically maintained.
Maximum/ Minimum thermometer is hanged on front wall in centre at height of about two meters for determination of Temperature and Humidity Control in Pharma .
Compression Room # 01 & 02
Compression of tablets is performed in this area. Temperature of this area is maintained at room temperature (15°C – 25°C), which is thermostatically maintained.
Maximum/ Minimum thermometer is hanged on a wall the door wall at height of two meters for determination of Temperature and Humidity Control in Pharma .
Blister Machine (Alu/ Alu)
Blistering of the tablets and capsules is performed in this area. Temperature of this area is maintained at room temperature (15° – 25°C), which is thermostatically maintained by Split AC unit.
Maximum/ Minimum thermometer is hanged on side to the door wall at height of two meters for determination of Temperature and Humidity Control in Pharma .
Blister Machine (Alu/PVC)
Blistering of the tablets and capsules is performed in this area. Temperature of this area is maintained at room temperature (15° – 30°C), which is thermostatically maintained by AC Split unit.
Maximum/ Minimum thermometer is hanged on the wall at height of two meters for determination of Temperature and Humidity Control in Pharma .
Capsule Section (Manufacturing Area)
In this section temperature and humidity play a great roll. Any increase in temperature and humidity can alter the potency of the product. Temperature of this area is maintained at room temperature (15° – 25°C), which is thermostatically maintained by HVAC system.
Maximum/ Minimum thermometer is hanged on side wall at height of about two meters for determination of Temperature and Humidity Control in Pharma .
Capsule Section (Filling Area)
In this section temperature and humidity play a great role. Any increase in temperature and humidity can alter the potency of the product. Temperature of this area is maintained at room temperature (15° – 25°C), which is thermostatically maintained by HVAC system.
Maximum/ Minimum thermo-hygrometer is hanged on wall at height of about two meters for determination of Temperature and Humidity Control in Pharma .
Monitoring Frequency:
Temperatue and Humidity monitoring in pharmaceuticals industry of each Area are monitored twice daily by its Area Supervisor (A.S.) or Incharge. First reading is taken in 1st Half of the day around 10:00am, while Second reading is taken in 2nd Half of the day around 3:00pm. These recorded readings are counter checked by In-Process Controller (I.P.C.) / Q.A. Officer.