1. Purpose: To lay down the procedure for disassembling, cleaning, and assembling filter housing.
2. Applicable: This Standard Operating Procedure is applicable to the disassembling, cleaning, and assembling of filter housing on the production floor at Pharmaceuticals.
3. Responsibility:
3.1 The operators who are trained in the processes shall carry out the operation process.
3.2 Officers/ Sr. officers shall supervise the process.
3.3 Production Manager for the implementation of this SOP.
3.4 Head-Quality Assurance for compliance of SOP.
4. Safety Consideration:
4.1 Wear safety equipment (Goggles, Gloves, and mask) While handling the hot WFI.
5. Procedure:
5.1 Disassembling of filter housing:
5.1.1 Close the valve of a pipeline, where filter housing is installed.
5.1.2 Drain the contents of the line by opening the vent valve of the filter housing.
5.1.3 Open the “TC” clamp of filter housing.
5.1.4 Keep aside the clamp and gasket safely.
5.1.5 Keep the filter cartridge in the polybag safely and paste the status label.
5.2 Cleaning of filter housing:
5.2.1 wash the filter housing with purified water. (First wash)
5.2.2 Wash the inner surface with high pressure of purified water.
5.2.3 Then wash the filter housing with hot WFI from the outer and inner surfaces. (second wash).
5.2.4 Dry the filter housing with filtered compressed air.
5.3 Assembling of filter housing:
5.3.1 Fix the filter cartridge in the housing.
5.3.2 Assemble the filter housing and tighten it with the “TC” clamp.
5.3.3 Open the valve of the pipeline.
5.3.4 Drain the contents of line by opening the vent valve of the filter housing.
5.3.5 Keep the valve open until a smooth flow of water starts continuously that is removal of air.
6.0 Annexures: Training record (see Below)
7.0 Distribution:
7.1 Master Copy – Archived with Quality Assurance Department
7.2 Controlled Copy 1 – Quality Assurance Department
7.3 Subsequent controlled copies – Department (s) making a requisition
8.0 Abbreviations:
| HOD | Head of the Department | ||
| No. | Number | ||
| QA | Quality Assurance | ||
| Rev. | Revision | ||
| SOP | Standard Operating Procedure | ||
| VFP | Vaccine Formulation Plant |
Training Record Annexure
| S.No | Name of the Person trained | Signature | Date | Training imparted by | |
| Signature | Date | ||||
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