SOP for Drain Point Sanitization
SOP for Drain Point Sanitization
Objective : To lay down a procedure for Drain point sanitization.
Scope : This SOP is applicable for cleaning and sanitization of drain points available in all sections of formulation plants of pharma industries.
Responsibility
Operator/Technician – To perform the procedure.
Production personnel (Officers & above) to ensure the procedure is followed is in compliance with SOP.
Accountability
Production Head and QA Head are accountable for the compliance of SOP.
Procedure
Clean the drain point with water and remove the accumulated dust.
Pour sufficient water into the drain point.
Prepare the disinfectant solution as per SOP No. SOP/QA-037
Measure the 100ml duly prepared disinfectant solution.
Pour the Measure disinfectant solution in each drain point at the end of the shift record the activity in the logbook as per Annexure No. l
Disinfectants should be changed weekly as per the schedule.
Forms and Records
Drain Cleaning Record – Annexure – I
Drain Cleaning Record – Annexure-II
Drain Cleaning Record – Annexure – III
Drain Cleaning Record – Annexure-IV
Distribution
Master Copy – Documentation Cell (QA)
Controlled Copies – Quality Control, Quality Assurance, Stores, Production Engineering.
History
Drain Cleaning Record
Date/Week/Disinfectant Used
Frequency: Weekly
| Department | Area | id No. |
| Liquid Line-1 | Bottle Filling Area (Near Digipack Machine) | D-01 |
| Bottle Filling Area (Near Washing Machine) | D-02 | |
| Liquid Line -2 | Bottle Filling Area (Near Linear Bottle Filling Machine ) | D-03 |
| Bottle Filling Area (Near Washing Machine) | D-04 | |
| Bottle Filling Area (Near Washing Machine) | D-05 | |
| Sugar Syrup Preparation Area | Sugar syrup Preparation Area (Near Transfer Pump L-05) | D-06 |
| Sugar Syrup Preparation Area (In Gallery) | D-07 | |
| Oral Liquid Batch Room | Near Storage Tank L-17 | D-08 |
| Near Filter Press | D-09 | |
| Near Sugar Vacuum Pump | D-10 | |
| Opposite Side of Filter Press | D-11 |
Note: Disinfectant must be rotated from week to week.
Date/Week/Disinfectant Used
Frequency: Weekly
| Department | Area | id No. |
| Tablet | Batch Room | D-12 |
| Coating Solution Prep. Area | D-13 | |
| Starch Prep. Area | D-14 | |
| Capsule | Washing Area | D-15 |
| Ointment | Batch Room (Near Planetary Mixer) | D-16 |
| Batch Room (Near Manufacturing Tank) | D-17 |
Note: Disinfectant must be rotated from week to week.
Date/Week/Disinfectant Used/
Frequency: Weekly
| Department | Area | id No. |
| Warehouse
| In Dispensing Washing Area | D-18 |
| In Sampling Change Room | D-19 | |
| Near Sampling Dispensing Booth | D-20 |
Note: Disinfectant must be rotated from week to week.
Date/ Week Disinfectant Used
Frequency: Weekly
| Department | Area | id No. |
Injection | Change Room | D-21 |
| Batch Room | D-22 | |
| Washing Area (Near Vials Washing Machine-I) | D-23 | |
| Washing Area (Near Ampule Washing Machine) | D-24 | |
| Washing Area (Near Vials Washing Machine-II) | D-25 |
Note: Disinfectant must be rotated from week to week
Annexure-I
| Department | Area | id No. | Done by (Sign and Date) | Checked By (Sign & Date) |
| Liquid Line-1 | Bottle Filling Area (Near Digipack Machine) | D-01 | ||
| Bottle Filling Area (Near Washing Machine) | D-02 | |||
| Liquid Line -2 | Bottle Filling Area (Near Linear Bottle Filling Machine ) | D-03 | ||
| Bottle Filling Area (Near Washing Machine) | D-04 | |||
| Bottle Filling Area (Near Washing Machine) | D-05 | |||
| Sugar Syrup Preparation Area | Sugar syrup Preparation Area (Near Transfer Pump L-05) | D-06 | ||
| Sugar Syrup Preparation Area (In Gallery) | D-07 | |||
| Oral Liquid Batch Room | Near Storage Tank L-17 | D-08 | ||
| Near Filter Press | D-09 | |||
| Near Sugar Vacuum Pump | D-10 | |||
| Opposite Side of Filter Press | D-11 |
Note: Disinfectant must be rotated from week to week.
