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-1Bottle Filling Area (Near Digipack Machine)D-01
Bottle Filling Area (Near Washing Machine)D-02
Liquid Line -2Bottle 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 AreaSugar syrup Preparation Area (Near Transfer Pump L-05)D-06
Sugar Syrup Preparation Area (In Gallery)D-07
Oral Liquid Batch RoomNear Storage Tank L-17D-08
Near Filter PressD-09
Near Sugar Vacuum  PumpD-10
Opposite Side of Filter PressD-11

 

Note: Disinfectant must be rotated from week to week.

Date/Week/Disinfectant Used

Frequency: Weekly

DepartmentAreaid No.
TabletBatch RoomD-12
Coating Solution Prep. AreaD-13
Starch Prep. AreaD-14
CapsuleWashing AreaD-15
OintmentBatch 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 AreaD-18
In Sampling Change RoomD-19
Near Sampling Dispensing BoothD-20

 

Note: Disinfectant must be rotated from week to week.

Date/ Week Disinfectant Used

Frequency: Weekly

DepartmentAreaid No.

Injection

Change RoomD-21
Batch RoomD-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-1Bottle Filling Area (Near Digipack Machine)D-01  
Bottle Filling Area (Near Washing Machine)D-02  
Liquid Line -2Bottle 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 AreaSugar syrup Preparation Area (Near Transfer Pump L-05)D-06  
Sugar Syrup Preparation Area (In Gallery)D-07  
Oral Liquid Batch RoomNear Storage Tank L-17D-08  
Near Filter PressD-09  
Near Sugar Vacuum  PumpD-10  
Opposite Side of Filter PressD-11  

Note: Disinfectant must be rotated from week to week.