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SOP for Sampling and Analysis of Wash Water from Production Equipment

Purpose
The purpose of this SOP is to define the Sampling and analytical procedure for wash water.

Scope
This procedure is applicable for sampling of wash water from production equipments and analysis of wash water in the Quality Control laboratory of Pharmasky Ltd.

Responsibility
Production Executive 
  • To co-ordinate to collect the sample as per defined procedure
  • To send duly filled Wash Water Sampling Advice Form to QC/QA Department.
  • To maintain the proper documentation.

Quality Assurance Executive
  • To withdraw the sample as per the defined procedure.

QC Executive
  • To analyze the sample as per defined procedure
  • To ensure that this procedure is kept up to date.

Quality Control Manager
  • To ensure appropriate personnel from the section are trained on this procedure.
  • To confirm that SOP is technically sound and reflects the required working practices.

Head of Quality Assurance
  • To ensure the overall implementation of the SOP.
  • Approval of the SOP.


Definitions

Procedure ‘A’:
  • Cleaning with the help of potable / purified water (Wet Cleaning). Procedure ‘A’ follows every product to product changeover and after 5 consecutive batches of the same product 0.5% SLS shall be used as cleansing agent in case of water insoluble product.

Procedure ‘B’:
  • Cleaning with the help of Clean, dry cloth (Dry Cleaning). Procedure ‘B’ follows every batch to batch changeover

Procedure
  • Production personnel clean the equipment as per standard cleaning procedure, intimates QC/QA for wash water sampling with the “Wash Water Sampling Form” in duplicate.
  • 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 5 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 amber color sampling bottle and label the bottle, duly filled and signed.
  • 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.

Quality Control Executive inspects the equipment and its parts for cleanliness and then collects the sample as follows:

Sr.

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

Rapid Mixer Granulator

30 ml

Rinse the equipment bowl and top lid with 30.0L of Purified water and collect the water into a clean bowl through the discharge taking care that the whole surface of the bowl and top lid is rinsed properly and rinse the dismantled parts (clamp for binder addition, charging port, spray nozzle, vent filter, chopper blade, impeller blade discharge valve and all gaskets) with 5 liters of purified water and collect into the same bowl.

3

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.

4

Comminuting mill (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.

5

Fluid Bed Dryer

30 ml

Rinse the retarding chamber internally with 10.0 L of Purified water and collect it into a clean bowl.

Similarly rinse the FBD trolleys with 10.0 L of Purified water each and collect 30mlof the sample separately from the two bowls. Rinse the cartridge filters/FBD bag with 5-liters of purified water and collect the water into the clean bowl.

6

Container Blender

 

Rinse the colloid mill with 3.0 L of Purified water and collect it into a clean bowl.

7

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.




8

Vibratory Shifter

30 ml

Attach the sieve on the body of the sifter and wash with 3.0 L of Purified water and collect the sample at the receiver into a clean bowl. Rinse the dismantled parts (Lid, clamp, hopper and silicon gasket) with 2 liters of purified water and collect into the same bowl.

9

Compression Machine

30 ml

Rinse the hoppers, butterfly valve, tri-clover clamp, force feeder, inlet connector, Turret guards, Powder scrapper, Acrylic guards, feeder shaft, Exhaust pipes with 5 liters of purified water and collect in a clean bowl. Collect approximately 30 ml of this sample into an amber colored bottle for analysis. Similarly rinse the y – chute, Gravity pipe with 5 liters of purified water and collect in the clean bowl.

10

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.

11

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.

12

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.

13

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.

14

Tablet Coating Machine

30 ml

Rinse the pan with 10.0L of Purified water and collect the sample into a clean bowl through the discharge taking care that the whole surface and the Baffles are rinsed properly. Rinse the dismantled parts (Silicon tube, Gun assembly, inlet duct and outlet duct) with 5 liters of purified water and collect into the same bowl.

15

Capsule Filling Machine

30 ml

Rinse the capsule loading channel, hopper, loading ring, Auger, locking pin assembly with 5 liters of purified water and collect in to clean bowl. Collect approximately 30 ml of this sample into an amber colored bottle for analysis.

16

Capsule Polishing Machine

30 ml

Rinse S.S cover of polishing Machine and polishing brush with 2 liters of purified water and collect in to clean bowl.



17

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.

18

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.

19

Jacketed Mixer Cum Homogenizer

30 ml

Rinse volume is 5.0 litres of purified water

20

Storage Container For Gel/ Ointment

30 ml

Rinse volume is 10.0 litres of purified water

21

Pulveriser

30 ml

Rinse volume is 2.0 litres of purified water

22

Filter Press

30 ml

Rinse volume is 20.0 litres of purified water

23

Four (04) Head Rotary Filling M/C

30 ml

Rinse volume is 20.0 litres of purified water

24

Transfer Pumps and Pipes

30 ml

Rinse volume is 10.0 litres of purified water

25

Clitmill

30 ml

Rinse volume is 5.0 litres of purified water

26

Centrifuges Hydroextractor

30 ml

Rinse volume is 5.0 litres of purified water

27

Fabrica Four (04) Head Filling M/C

30 ml

Rinse volume is 2.0 litres of purified water

28

RMG – II

30 ml

Rinse volume is 10.0 litres of purified water

29

RMG – I

30 ml

Rinse volume is 15.0 litres of purified water

30

FBD Bowl – I

30 ml

Rinse volume is 10.0 litres of purified water

31

FBD Bowl – II

30 ml

Rinse volume is 10.0 litres of purified water

32

Sifter Cum Multi Mill

30 ml

Rinse volume is 10.0 litres of purified water

33

Tipper

30 ml

Rinse volume is 10.0 litres of purified water

34

Sifter

30 ml

Rinse volume is 5.0 litres of purified water

35

Starch Kettle

30 ml

Rinse volume is 5.0 litres of purified water

36

Neo Cota

30 ml

Rinse volume is 10.0 litres of purified water

37

Sejong Compression Machine

30 ml

Rinse volume is 5.0 litres each of purified water from chute, hopper and other parts

38

Cadpress Compression Machine

30 ml

Rinse volume is 5.0 litres each of purified water from chute, hopper and other parts

39

RMG

30 ml

Rinse volume is 5.0 litres of purified water

40

FBD Bowl

30 ml

Rinse volume is 4.0 litres of purified water

41

Kenwood Mixer

30 ml

Rinse volume is 1.0 litres of purified water

42

Hand Filling Machine

30 ml

Rinse volume is 5.0 litres of purified water

 

Blank Sample:
While collecting wash water sample, collect Purified water about 30 ml into an amber colored bottle.

Analysis:
  • After getting sampling advice form from production department, QC personnel will entryin the wash water register and assign a lab control number as WW-000X/MM/XX
Where,
WW for Wash Water, 
000X- Sequential number of four digits, 
MM-Month
YY-Last twodigits of year. 

For example: WW-0001/08/XX). Then the compliance personnel will collect the sample and send to Quality Control department for analysis.

  • QC analyses the sample by scanning through 190-400 nm on UV-VIS Spectrophotometer, using Purified water (collected as explained earlier) as blank.
  • Observe for any abnormal peaks and/or peaks having same wavelength maximum of active material of previous product.
  • Reject the sample in case of any abnormal peak or if a peak of previous product having more absorbance that of a 10 ppm standard solution of active of previous product and send the information to the concerned department.
  • Take the spectrum print out on the back side of the wash water report copy (QC copy) and inform production for rewash.
  • If absorbance is less than that observed in standard graph, intimate the concerned department by sending the original copy of the report after making necessary entries and approving the clean card. Retain the duplicate copy of the report and file it after makingnecessary entries in the register.


Annexure
Annexure-I: Wash Water Sampling Advice Form.
Annexure-II: Wash Water Register.


Abbreviations
BMR – Batch Manufacturing Record
IPQA – In-process Quality Assurance
SOP – Standard Operating Procedure
QA – Quality Assurance
QC – Quality Control
SS – Stainless Steel

Revision History
Nil

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