PURPOSE:

To validate whether the purified water supplied in the system confirms to the operational Requirements

SCOPE:

This procedure applied to the supply of Purified water produced by Demineralized water generation unit and supplied through tank no. 1 and tank no. 2 at user points as per list.

RESPONSIBILITY  : 

Production supervisor

Maintenance supervisor

PROCEDURE:       

Equipment identification :

• Equipment Type                :  Ion  exchange 
• Equipment Location          :  Pump Room
• Manufacturers Serial No.  :   D-013013
• Purified water tank (I)     
• Purified water tank (II)
• Purified water tank location (I & II)  : Roof of second floor on entrance  hall
• Construction material of supply system : SS pipe  .

User points and location :

• Purified water storage tank (I) User Point No PW01
• Liquid  Syrup section  area User point No PW02
• Liquid manufacturing  area User point No PW03
• Liquid : Bottle washing  area User point No PW04,
•  Tablet section  granulation User point No PW05
• Tablet section  Coating User point No PW06

Materials Required :

• 1000 ml flask  thoroughly cleaned and rinsed with Distilled water.
• Sterilized container for Microbiological tests.
• Protective clothing and hand gloves.
• Bacteriological incubator.
• Sterile incubation media.
• Sterile petriplates.

Validation parameters :

• Chemical Parameters as per Pharmacopoeia.
• Microbiological parameters:-
• Not more than 100 C.F.U.  per 1 ml
• E. coli ( To be Absent )
• Salmonellae ( To be Absent )
• S. Aureus (   To be absent )
• Pseudomonas ( To be absent )
• Procedure :
• Wear clean dress and rubber gloves.
• Wipe exterior of the sample collection point with non-particle shredding material soaked in  70 % IPA .
• Open out-let valve and flush with at least 10 liters of water or for 30 seconds.
• Collect the Purified water sample in container for chemical tests. Close the container & Label it properly.
• Collect Purified water sample for microbiological test in a sterile bottle and stopper it with a sterile aluminium foil or sterile glass stopper. Label the container properly.
• Test the Purified water sample for chemical analysis as per IP and microbiological test as per validation parameters.
• Purified water sample are to be collected from all the outlets for Microbiological  test  and prepare a composite sample for chemical test . Collect the water sample on at least five consecutive working days.

Results :

All the samples must pass the tests on  ten consecutive days.

Incase of failure at any of the outlet it should be Retested on ten more consecutive days.

Attach the following documents to this report:

Chemical analysis report.

Microbiological test report.

                         (Review date on or before 12 months from date of authorization)