| OBJECTIVE: | |
| To lay down a procedure for monitoring of temperature, relative humidity, and differential pressure in the production area. | |
| SCOPE: | |
| This procedure is applicable to the monitoring of temperature, relative humidity, and differential pressure in the production area. | |
| RESPONSIBILITY: | |
| Officer, Executive – Production Department | |
| Manager – Production Department | |
| PROCEDURE: | |
| Recording of Temperature and relative humidity: | |
| Ensure that the hygrometer is calibrated. | |
| Ensure that sufficient purified water is available in the hygrometer to keep the wick wet. | |
| Ensure that the top end of the wick covers the mercury bulb completely. | |
| Ensure that the wick is wet and the bottom end is always immersed in purified water. | |
| Check and ensure that there are no scale deposits on the wick. If it is found scale deposited then replace it. | |
| Check and record the dry bulb temperature and wet bulb temperature in the sling hygrometer of the respective area and record it as per Annexure-I. | |
| Check and record the relative humidity using the difference between dry bulb temperature and wet bulb temperature with the help of the Chart attached and record it as per Annexure-I. | |
| Frequency: At the start of the shift/start of activity / after product changeover / Once every four hours whichever is earlier. | |
| Limit of Temperature: Operating Limit: 230 C to 270 C. | |
| Limit of Relative Humidity: Operating Limit: 50 ± 5%. Note: The limit of temperature and relative humidity may change as per product Requirement. | |
| When the temperature exceeds operating limits, the respective responsible officer informs to quality assurance and engineering in charge to correct the situation, in such cases, only in-process material will be further processed to complete that stage. | |
| For example, Powder in the hopper of the compression machine will be processed to produce the tablets & no further processing shall be done and intimation will be sent to QA for such event. | |
| When the situation is corrected, the temperature shall be monitored continuously till observations are within limits and then further operations will be carried out. | |
| Recording of Differential Pressure: | |
| Ensure that the magnehelic gauge of the concerned area is calibrated. | |
| Ensure the zero error of the magnehelic gauge by opening the door of the concerned area. | |
| The production Officer shall ensure that all the doors are closed properly before recording the reading. | |
| The recording of differential pressure shall be done for the following production areas: Entry to Production AreaGranulation areaCompression Area I, & IICoating areaTablet Inspection Area I & IIBlister Packing Area IBlister Packing Area IIStrip packing areaCapsule Filling AreaTablet/ Capsule Inspection AreaIPQA room | |
| Check the magnehelic gauge reading and record the same in the format shown in Annexure II. The reading in the magnehelic gauge shall be not less than +1.5 mm of the water column. | |
| If there is any deviation in the differential pressure, the same has to be informed immediately to the engineering department as well as to the Quality Assurance department and activity has to be stopped. | |
| The differential pressure recording revealed has to be recorded by the production officer or the concerned responsible person. | |
| Frequency: At the start of the shift/start of activity / after product change over / twice in a shift whichever is earlier. Related: SOP on in-process checks | |
| ABBREVIATION(S): | |
| QA: Quality assurance 0C: Degree Celsius |
