- 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.
- To withdraw the sample as per the defined procedure.
- To analyze the sample as per defined procedure
- To ensure that this procedure is kept up to date.
- 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.
- To ensure the overall implementation of the SOP.
- Approval of the SOP.
- 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.
- Cleaning with the help of Clean, dry cloth (Dry Cleaning). Procedure ‘B’ follows every batch to batch changeover
- 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.
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 |
- 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
- 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.
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