ORAL DOSAGE FORM SOPs

1.0 PURPOSE

To provide procedure for Breakdown Maintenance of Equipment/Instruments.

2.0 SCOPE

This SOP applies for performing Breakdown Maintenance of equipment installed in Manufacturing, Packaging, Warehouse & Utility For Complete SOP

5.0 PROCEDURE:

5.1  The process for performing Breakdown Maintenance of equipment is stated below:

5.1.1     Concern department personnel shall inform the Engineering department about any breakdown work through Maintenance Job Order.

5.1.2     After receiving the Maintenance Job order form, shall collect all the necessary tools and spares required for the rectification.

5.1.3     Enter the respective area by following all entry and exit procedures.

5.1.4     Before performing any breakdown work in production department, ensure that the breakdown work shall not affect the quality or purity of material or product pertaining/adjacent to    concern equipment/instrument/area.

5.1.5     If required, material or product shall be removed from concern equipment/instrument and kept in  suitable containers at proper storage condition till completion of breakdown work.

5.1.6     Take the approval of QA stating the nature of breakdown and replacement of any spares not  affecting the quality of product.

5.1.7     Prior approval from QA, shall attend the breakdown by referring trouble shooting procedure given in machine manual.

5.1.8     After completion of rectification, shall run the performance test in the presence concerned department person.

5.1.8     After satisfactory performance of Equipment/Instrument handover to the concerned department by taking acceptance signatory.

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1.0 PURPOSE

      To provide procedure for Preventive Maintenance of both the exterior and interior of all AHU's, Coils, Switches, check and clean the riser, Pre and Fine filters.

2.0 SCOPE: 

      This work procedure applies to the performance of Preventive Maintenance of all Air treatment system.

5.0 PROCEDURE:

5.1       Procedure for cleaning of pre-filters, fine filters and return riser filters.

5.1.1    All the filters i.e. Pre filter and fine filter shall be cleaned as per Annual filter cleaning schedule/ during product change over.

5.1.2    Ensure that no manufacturing, packing, sampling etc activity is going on in relevant area.

5.1.3    Ensure that the AHU under maintenance is electrically shut down.

5.1.4    Wear Nose Mask and hand gloves.

5.1.5    Remove the required filter(s) to be cleaned, inspect visually and number them.

5.1.6    Place the numbered filters in a polythene bag.

5.1.7    Remove filters from poly bag in wash area. Check if there need replacement or maintenance.

5.1.8    Apply compressed air (1.5-2.0 kg/cm²) on the filter form opposite side of suction, till the filter surface is free from traces of powder, particles fiber etc.

5.1.9    Use pressurized portable water to wash the filter from opposite to direction of air flow.

5.1.10   Ensure the exhaust blower of filter cleaning area is in the ON position.

5.1.11   After rinsing, dry the filters with compressed air.

5.1.12   After drying visually inspect the filter for any damage. If any damage observed replace the filter with new one and record it.

5.1.13   Cover the filters with clean polythene bags and take it to its respective AHU.

5.1.14   Remove filters from poly bag and fix them in respective positions and maintain the record.

5.1.15   Check the heater bank, blower, motor and “V” belt

5.2       Procedure for cleaning interior and exterior of AHU

5.2.1     Open all doors air handling unit blower.

5.2.2     Use a wet cloth with clean water to clean both the interior and exterior of AHU.

5.2.3     Clean the drain tray and condensate drain by anti-infecting liquid (Dettol)

5.2.4     Inspection and cleaning of filters shall be carried out as schedule (once a month) or during product change over.

5.2.5     Inspection of filters for granulation, compression and blending areas is once in seven (7) days or during product change over.

5.2.6     After cleaning filters, ensure filter cleaning kid and area is kept clean.

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