TIPS TO MANAGE MENTAL HEALTH
TEMPERATURE MAINTENANACE IN PHARMACEUTICAL SOP
TEMPERATURE MAINTENANCE IN PHARMACEUTICAL SOP
1.0 Introduction & Temperature Control
Temperature Control is defined as the extent to which a product retains within its specified limits and throughout its period of storage and uses. So, the substances and finished products described in the pharmacopeia should be stored under conditions that prevent contamination and as for as possible. Precautions that should be taken about the effects of the atmosphere, moisture, heat, and light are indicated where appropriate in monographs.
1.1 Temperature Specification:
1.1.1 Refrigerator:
Any temperature b/w 8 — 15C (46 — 59F) an article for which storage in a cool place is directed may alternatively be stored in the refrigerator. Unless otherwise specified by individual monograph.
1.1.2 Cold:
Any temperature b/w 2 — 08C an article for which storage in a cool place is directed may alternatively be stored in the refrigerator. Unless otherwise specified by individual monograph.
1.1.3 Temperature:
The temperature prevailing in working area. (15C — 30C)
A temperature maintained thermostatically that encompasses the usual and customary working environment of 20 — 25C (68 — 77F) that results in mean kinetic temperature.
2.0 LIST OF THERMO HYGROMETERS
Sr. No Nature of Meter Location
1. Thermo Hygrometer Reference Room QC
2. Thermo Hygrometer Raw Material Store
3. Thermo Hygrometer Packing Material Store
4. Thermo Hygrometer Finished Goods Store
5. Thermometer Refrigerator in QC
6. Thermo Hygrometer Cool Room Store
7. Thermo Hygrometer Packing Hall
8. Thermo Hygrometer Coating Section
9. Thermo Hygrometer Capsule Section
10. Thermo Hygrometer Granulation room
11. Thermo Hygrometer Tray dryer room
12. Thermo Hygrometer Compression room
3.0 VALIDATION OF PLACES FOR TEMPERATURE
We have validated temperature by putting thermometer or Thermo hygrometer at different places at different heights and found that at a height of two meters, the temperature is the mean of the total hall.
4.0 LOCATION OF THE THERMO HYGROMETER
4.1 WAREHOUSE
The temperature of the following portions of the warehouse is controlled through a central air condition system by an external thermometer method. In this method temperature and humidity of the warehouse are noted.
4.1.1 Packing Material Store As packing material is composed of different color printings, papers, boxes, labels, leaflets, unit packs, glass bottles, plastic bottles, caps, outer cartons, PVC/PVDC, Alu. Foils, R.O. Caps, Aluminium Tubes, 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 the above-mentioned conditions the materials may damage or be destroyed or some defects may occur so packing materials must be stored properly.
A Thermo hygrometer is hung at a height of two meters in the approximate center of the store for the determination of temperature and relative humidity below 300 and 65+10 respectively.
4.1.2 Raw Material Store
Several raw materials are stored according to BP/USP or other prescribed specifications. Usually, raw material, which is not heat, light, and temperature-sensitive, is stored in this area according to their nature or as required. Normally raw material should be stored at room temperature (15 - 30C), which is thermostatically maintained by a central air condition system.
Thermo hygrometer is hung at a height of two meters in the approximate center of the store for the determination of temperature and relative humidity below 300 and 65+10 respectively.
4.1.3 Finished Material Store
Finished Goods Store should facilitate with air-conditioning to maintain the required temperature as well as avoid moisture, direct sunlight, and excessive heat. Mostly finished products are stored at room temperature (e.g. 15 - 30C) at a dry place in well-closed containers protecting from heat, light, and moisture. In absence of the above-mentioned conditions, the product will lose its activity as well as may damage or be destroyed and the shelf life of the product will not retain the expiry according to the label claim.
4.1.4 COLD STORAGE REFRIGERATOR:
The products are temperature sensitive and lose their potency above 08C so such types of raw materials are stored at 2 - 08C maintained by Refrigerator.
4.2 Reference Sample Store
In Quality Control Department there is a separate reference room which is facilitated with air-conditioning as well as racks, in this room quality control retaining samples of finished products intermediate products and reference samples of raw material are stored according to specified procedures with the record at room temperature protected from moisture, excessive heat and light at least for 2 years after the date of product expiry.
Any change in temperature or humidity can alter the potency of keeping samples of raw material and finished products.
Thermo hygrometer is hung at a height of two meters in the approximate center of the store for the determination of temperature and relative humidity below 25 + 5C0 and 65+10.
4.3 PACKING HALL:
In this area packing of the finished product is done.
Thermo hygrometer is hung at a height of two meters in the approximate center of the store for the determination of temperature and relative humidity below 25 + 5C0 and 65+10.
4.4 INTERMEDIATE STORE:
The intermediate store is located in the production area, which is also facilitated with necessary conditions i.e. Air-condition, exhaust away from excessive heat, and direct sunlight. The intermediate product e.g. tablets granules, tablets cores, filled capsules before blistering, processed cream before final packing, etc.
Thermo hygrometer is hung at a height of two meters in the approximate center of the store for the determination of temperature and relative humidity below 25 + 5C0 and 45+10.
4.5 CAPSULE SECTION:
The thermometer is attached to the wall in front of the door and right side of the capsule machine. In this section temperature and humidity play a great role. Any increase in temperature and humidity can alter the potency of the product.
Thermo hygrometer is hung at a height of two meters in the approximate center of the store for the determination of temperature and relative humidity below 25 + 5C0 and 45+10.
4.6 COATING SECTION
In this section temperature and humidity play a great role.
Thermo hygrometer is hung at a height of two meters in the approximate center of the store for the determination of temperature and relative humidity below 25 + 5C0 and 45+10.
4.7 TABLET MIXING, GRANULATION, DRYING & COMPRESSION SECTION
Thermo hygrometer is hung at a height of two meters in the approximate center of the store for the determination of temperature and relative humidity below 25 + 5C0 and 45+10.
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