Proforma XV

Details of Plant Capacity

Find below the statement

Part A :- Chemical Process

Name of the equipment & Designed capacity No. of equipment Available Position/ Code No. of the equipment Reaction/ operation carried out in the equipment Batch Size Material Occupancy time Hour Yield % W/W. Remarks By product/Recoveries of solvents etc. (Kg./Ltr.)
        input/batch (Kg/Ltr.) output/batch (Kg/Ltr.)   Stage Cumulative  
                   
                   
                   
NOTE :- In case any other product is produced in the above set equipment, similar data, may please be furnished for such item, and allocation of time at each equipment along with basis of allocation may be given.


Part B :- Fermentation Process

If the drug / intermediate is manufactured by fermentation process, give the following information year wise for last three years :
1. No. of fermentors with their operating capacity/volume and Average fermentation hours :
2. Average fermentation broth potency achieved :
3. Stage-wise and overall percentage recovery of both drug/intermediate from the fermentation broth volume.
4. Average potency/purity of the finished drug :


Part C :-Annual Maintenance of Plant & Machinery for last three years

Year Total No.of Working Days Scheduled Maintenance No. of Days Unscheduled/Breakdown Total No. of Days of production loss in a year
Utility Service Manufacturing Operation
1 2 3 4-A 4-B 5
           

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