Sampling of Wash Water

By
Pharma pathway
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0
9863
1.0 Objective
To lay down a procedure for sampling of Wash Water of equipments.
2.0 Scope
This Standard Operating Procedure is applicable for formulation plant.
3.0 Responsibility
3.1    Executive/ Officer – IPQA shall be responsible for the implementation of the procedure as per this SOP.
3.3    Head- QA/ designee shall be responsible for compliance of this SOP.
4.0 Abbreviations and Definitions
BMR               –           Batch Manufacturing Record
IPQA              –           In-process Quality Assurance
SOP                 –           Standard Operating Procedure
QA                  –           Quality Assurance
QC                  –           Quality Control
SS                    –           Stainless Steel
Procedure ‘A’ –           Cleaning with the help of potable / purified water (Wet Cleaning). Procedure ‘A’ follows every product to product changeover and after eight consecutive batches of the same product 0.5 % SLS shall be used as cleansing agent in case of product containing Nimesulide and product of soft gel department.
Procedure ‘B’  –           Cleaning with the help of Clean, dry cloth (Dry Cleaning). Procedure ‘B’ follows every batch to batch changeover
5.0 Procedure
  • Wash water sampling shall be performed after cleaning the equipment for every product to product changeover e.g. after cleaning of Procedure ‘A’ and after eight consecutive batches of the same product.
  • Officer / Executive- IPQA shall receive request for Sampling / Analysis of Wash Water of equipment used in production department.
  • Officer / Executive-IPQA shall collect the wash water sample in clean, dry sampling bottle.
  • Take required quantity of purified water in clean SS container for particular equipment as specified in annexure-I. Pour into cleaned equipment (contact part of equipment) and rinse the equipment with purified water.
  • Then collect wash water from equipments in clean, dry glass bottle and label the bottle, duly filled and signed as per annexure-II
  • Sample for the microbial analysis shall be taken by Microbiologist in sterile, clean glass bottle.
  • Submit the sample to QC department for Wash water Analysis.
  • QC shall analysis the sample, prepare the analysis report and same shall be sent to production department.
  • After receiving wash water analysis report for its compliance, Production department shall affix ‘CLEANED’ label on the equipments duly filled and signed.
  • IPQA person shall prepare the wash water sampling procedure with respect to equipment as per format given in annexure-I and submit to QA.
  • QA person shall review the wash water sampling procedure with respect to equipment, which is submitted by IPQA, prepare Master and same shall be distributed to all concerned department.
6.0 Forms and Records
  • Format for Wash Water Sampling Procedure   –           Annexure-I
  • Wash Water Sample Label                                  –           Annexure-II
  • Flow Chart                                                             –           Annexure-III
7.0 Distribution
  • Master Copy –           Documentation Cell (QA)
  • Controlled Copies –           Production, Quality Control and Quality  Assurance
8.0 History
            Date
       Revision Number
                 Reason for Revision
              –
                00
                        New SOP
 
                                                                           Annexure-I
                                                   WASH WATER SAMPLING PROCEDURE
  S.No.
EQUIPMENT NAME
SAMPLE SIZE
SAMPLING PROCEDURE
 
Prepared By:_______________                                                                   Checked By:________________
Form No.:
                                                            Annexure-II
                                  WASH WATER / SWAB SAMPLE LABEL
QUALITY ASSURANCE
WASH WATER/SWAB SAMPLE
Previous Product:________    Batch No.:______________
Equipment Name:________________________________
EQ.ID. No.:_____________  Quantity Sampled:________
Form No.:                                Sampled By     (Sign/Date)
                                                                        Annexure – III
                                        SAMPLING OF WASH WATER FLOW CHART
Sampling of Wash Water    ←         After Product to Product Changeover or after eight consecutive                     ↓                                          batches of the same product.
 Production to Inform IPQA Sampling / Analysis Request for sampling of wash water

↓

Rinse the equipment with specified quantity of purified water (as per annexure-I)
                                                ↓                →     For Microbial analysis, Microbiologist to collect the wash                                                                            water sample in sterile, clean glass bottle

↓                      ←                                    ↓

Collection of wash water in clean, dry sampling Bottle and label as per annexure-II

↓

 Submission of Wash Water sample to QC along with Sampling / Analysis Request

↓

QC to perform testing of wash water sample and prepare report and send to Production

                                               ↓

Affix ‘CLEANED’ label on the equipment after compliance report
                                                                                                                                   
                                        WASH WATER SAMPLING PROCEDURE
S.
No.
EQUIPMENT
SAMPLE
SIZE
PROCEDURE OF SAMPLING
1.
MASS MIXER
30 ml
Add approximate 15 litre purified water for final rinsing of the mass mixer, do the mixing for 5 minutes, tilt the mass mixer and then collect the sample in previously cleaned glass bottle.
2.
MULTIMILL
30 ml
Add 5.0 litre purified water from the hopper and collect the sample in previously cleaned glass bottle from outlet of S.S. cover of multimill.
3.
COMMINUTINGMILL (CADMILL or CLITMILL)
30 ml
Add 5.0 litre purified water from the hopper covering whole surface area and then collect the sample in previously cleaned glass bottle from outlet of cadmill.
4.
FBD BOWL
30 ml
Tilt the bowl, add 10.0 litre purified water covering whole surface area of the bowl and then collect the sample in previously cleaned glass bottle.
5.
BIN
BLENDER
Capacity:
1200 L
800 L
400 L
200 L
50 L
30 ml
Add 20.0 litre purified water into bin blender and after closing rotate the blender for 5 minutes, open it and then collect the sample in previously cleaned glass bottle.
Add 15.0 litre purified water into bin blender and after closing rotate the blender for 5 minutes, open it and then collect the sample in previously cleaned glass bottle.
Add 10.0 litre purified water into bin blender and after closing rotate the blender for 5 minutes, open it and then collect the sample in previously cleaned glass bottle.
Add 5.0 litre purified water into bin blender and after closing rotate the blender for 5 minutes, open it and then collect the sample in previously cleaned glass bottle.
Add 4.0 litre purified water into bin blender and after closing rotate the blender for 5 minutes, open it and then collect the sample in previously cleaned glass bottle.
6.
SIFTER
30 ml
Add 5.0 litre purified water on the top of the sifter covering whole surface area of the sifter and then collect the sample in previously cleaned glass bottle from the outlet of the sifter.
7.
COMPRESSION MACHINE
30 ml
Add 10 litre purified water through each chute and hopper. Collect the sample at the outlet chute of the machine.
8.
ROLL COMPACTOR
30 ml
Add 5.0 litre purified water from the hopper and collect the sample in previously cleaned glass bottle from outlet of the bottom end of roll compactor.
9.
TRAY DRYER
30 ml
Add 500 ml purified water in each tray and spread it covering whole inner surface area. Collect purified water of all trays in an SS Container, collect sample in previously cleaned glass bottle from the container.
10.
DOUBLE CONE BLENDER
30 ml
Add 5.0 litre purified water into Double cone blender and after closing rotate the blender for 5 minutes. Open it and then collect the sample in previously cleaned glass bottle.
11.
COATING PAN
30 ml
Pour 10.0 litre of purified water in the coating pan and run for 5 minutes. Collect sample in previously cleaned glass bottle.
12.
S.S. ITEMS
S.S. TANKS and STIRRER
30 ml
Keep S.S. items in S.S. Tub, add 5.0 litres purified water, collect sample from the tub.
13.
COLLOID MILL
30 ml
Close the outlet valve, add 2.0 litres of purified water, run the Colloid Mill for 5 to 7 minutes. Open the outlet valve and collect the sample.
14.
JACKETED MIXER CUM HOMOGENIZER
30 ml
Rinse volume is 5.0 litres of purified water
15.
STORAGE CONTAINER for GEL/ OINTMENT
30 ml
Rinse volume is 10.0 litres of purified water
16.
PULVERISER
30 ml
Rinse volume is 2.0 litres of purified water
17.
FILTER PRESS
30 ml
Rinse volume is 20.0 litres of purified water
18.
FOUR (04) HEAD ROTARY FILLING M/C
30 ml
Rinse volume is 20.0 litres of purified water
19.
TRANSFER PUMPS AND PIPES
30 ml
Rinse volume is 10.0 litres of purified water
20.
CLITMILL
30 ml
Rinse volume is 5.0 litres of purified water
21.
CENTRIFUGES HYDROEXTRACTOR
30 ml
Rinse volume is 5.0 litres of purified water
22.
FABRICA FOUR (04) HEAD FILLING M/C
30 ml
Rinse volume is 2.0 litres of purified water
23.
RMG – II
30 ml
Rinse volume is 10.0 litres of purified water
24.
RMG – I
30 ml
Rinse volume is 15.0 litres of purified water
25.
FBD Bowl – I
30 ml
Rinse volume is 10.0 litres of purified water
26.
FBD Bowl – II
30 ml
Rinse volume is 10.0 litres of purified water
27.
Sifter cum Multi mill
30 ml
Rinse volume is 10.0 litres of purified water
28.
Tipper
30 ml
Rinse volume is 10.0 litres of purified water
29.
Sifter
30 ml
Rinse volume is 5.0 litres of purified water
30.
Starch Kettle
30 ml
Rinse volume is 5.0 litres of purified water
31.
Neo cota
30 ml
Rinse volume is 10.0 litres of purified water
32.
Sejong Compression machine
30 ml
Rinse volume is 5.0 litres each of purified water from chute, hopper and other parts
33.
Cadpress Compression machine
30 ml
Rinse volume is 5.0 litres each of purified water from chute, hopper and other parts
PDL
34.
RMG
30 ml
Rinse volume is 5.0 litres of purified water
35.
FBD Bowl
30 ml
Rinse volume is 4.0 litres of purified water
36.
Kenwood Mixer
30 ml
Rinse volume is 1.0 litres of purified water
37.
Hand filling machine
30 ml
Rinse volume is 5.0 litres of purified water

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