Procedure for measurement of fill weight during batch filling
- Objective:
- To lay down the procedure for measurement of fill weight during batch filling.
- Scope:
- This SOP is applicable for measurement of fill weight during batch filling in Injectable department.
- Responsibility:
- Operators/Technician – Responsible for measurement of fill weight during batch filling.
- Executive /Officers production – Responsible for implementation of the SOP.
- Accountability:
- HOD – Production shall be accountable for the compliance of the SOP.
- Procedure:
- Operating Personnel shall ensure that weighing balance used for fill weight checking has been calibrated as per the respective SOP.
- Production officer/ Executive shall update the status board with fill weight mentioned in respective batch BMR.
- Operating personnel shall adjust the fill weight as per details mentioned on status board.
- Operating personnel shall collect the fill weight samples after adjusting the fill weight.
- Operating personnel shall press the following icon on the filling machine PLC to perform the sampling for fill weight checking.
- The samples for the fill weight check as per the respective dosing will pass through the two sample collecting/rejection collecting belts which are parallel to outlet belts through the deviators.
- Operating personnel shall collect the samples from the sample collecting/rejection collecting belts which are parallel to outlet belts of the filling machine.
- Operating personnel shall mark and collect the sampled vials with serial number (starting from 1) based on the type of dosing done in respective batch in an SS tray.
NOTE: The operating personnel shall collect the sampled vials with help of Forceps.
- Operating personnel shall transfer the collected sampled vials to Weighing balance.
- Operating personnel shall ensure that the balance reading is zero before the start of the weighing activity.
- Operating personnel shall place a clean empty glass beaker on the weighing pan of the weighing balance.
- The operating personnel shall tare the weight of the glass beaker before the discharge of the API from the sampled vial.
- Operating personnel shall weigh the sampled vials as per the respective serial number as collected.
- The operating personnel shall print the weight of each and every individual vial after the completion of weighing.
- The operating personnel shall finally print the cumulative weight of the sampled vials as per the respective dosing.
- The operating personnel shall transfer the used vials and stoppers to the waste bin provided after the completion of weighing activity.
NOTE: The API collected during the fill weight checking shall be collected separately and shall be destroyed as per respective SOP after the completion of days filling activity.
- Production officer/Executive shall collect the print out of the sampled vials, record the weighing details and enclose the same to the respective batch BMR.
- The IPQA officer/Executive shall verify the details of the weighing from the attached weight print out and recorded details in the BMR.
- The production activity shall be continued if the fill weight measured from the sampled vials of the respective batch are with in the limits.
- The production activity shall not be continued if the fill weight measured from the sampled vials of the respective batch are not with in the limits.
- The fill weight shall be adjusted again and the sampled vials shall be weighed as per above procedure.
NOTE: In case of any fill weight adjustment failure the same shall be documented in the BMR.
- Frequency:
- The operating personnel shall carry out the fill weight checks through out the days filling activity as per the frequency mentioned in BMR.
- List of Annexure:
- Not Applicable.
- References (if any):
- SOP on calibration of Analytical Balance.
- SOP on operation and change over of vial filling and bunging machine.
- SOP on Handling of rejects generated at all stages of batch processing.
- Abbreviations:
- SOP : Standard Operating Procedure.
- IPQA : In Process Quality Assurance.
- HOD : Head of Department.
- BMR : Batch Manufacturing Record.
- PLC : Programmable logic control.
- API : Active Pharmaceutical Ingredient.
