Solution Herbal Company Pvt.

Ltd
BMR No.: SHC/QA-6-28
Batch No.:S001
Batch Size: 200 Lts
Siddhalake- 1, Dhading, Nepal
Swashbhusan 15/30/60/110 ml Doc. No.: 6/28-4
Batch Manufacturing Record Mfg. Date:-
Exp. Date:-

1. Ingredients Details:
Decoction 93 %, and Alcohol 7%:

SN Name of Latin Name Parts Use Each 5Ml Contains Ratio %

Ingredients
1 Zingiber offiminale Rhizomes 12 mg
z'07L 8
2 Solanum surattense WP 25 mg 16.66
s06sf/L
3 Adhatoda vasica Rhizomes 25 mg 16.66
jf;f
4 Hibiscus abelmoschus Seeds 12 mg 8
Nftfs:t'/
L
5 Cinnamomum Barks 20 mg 13.33
bfnlrgL zeylanicum
6 Piper longum Fruits 14 mg 9.33
lkKknL
7 Elettaria Fruits 12 mg 8
;'s'd]n cardamomum
8 Abies webbina Leaf 15 mg 10
tfln;kq
9 Hyssopus officinalis WP 15 mg 10
h"kmf
10 Ethanol (Medicinal edible alcohol) (Excipients QS.) (14 lts.)
;'/f
TOTLA 150 mg 100

2. Description:

Product Description: Light brown with natural falvoured base & pungent taste.
The liquid is filled in umber colour Pet bottle with tight capping by silver colour
aluminum cap.
Labeled by colour printed label with batch containing details.
Packed Size: 60/100 Ml.
Mfg. Lic. No: ………
Self Life: 2 Years.
Storage Precaution: Store in a cool & dry place, protect by direct sun light, do not refrigerate.

3. Manufacturing Precautions:
i. Wear clean gown, head cover, slipper, gloves, mask etc.
ii. Observe daily hygiene while manufacturing.

Page 1
 Solution Herbal Company Pvt. Ltd
Siddhalake- 1, Dhading, Nepal
BMR No.: SHC/QA-6-28 Swashbhusan 15/30/60/110 ml Doc. No.: 6/28-4
Batch No.:S001 Batch Manufacturing Record Mfg. Date:-
Batch Size: 200 Lts Exp. Date:-

iii. Observe the all documents with on process.

iv. Observe the area clear & equipments cleanness
4. Raw Materials Dispensing:
For Decoction 93 %:

S Ingredients Ratio % Qty/Bth Issued Kg Issued by Checked by Issued Date

N Kg
1
z'07L 8 4
2 16.66
s06sf/L 8.33
3 16.66
jf;f 8.343
4 8
Nftfs:t'/
L 4
5 13.33
bfnlrgL 6.66
6 9.33
lkKknL 4.66
For Alcohol Extraction 7 %:

S Ingredients Ratio % Qty/Bth Issued Kg Issued by Checked by Issued Date

N Kg
7 8
;'s'd]n 4
8 10
tfln;kq 5
9 10
h"kmf 5
10 (14 lts.)
;'/f (28 lts.)
Total 100 50

Remarks if any:-

5. Disintrigation Process:
- Inspect the cleanness of area, room, door, window, equipments etc, as per check list.
- Break in to the small pieces of hard bark, wood, stem, root and hard seeds as require as
separately for Decoction and Alcohol extraction.

Page 2
 Solution Herbal Company Pvt. Ltd
Siddhalake- 1, Dhading, Nepal
BMR No.: SHC/QA-6-28 Swashbhusan 15/30/60/110 ml Doc. No.: 6/28-4
Batch No.:S001 Batch Manufacturing Record Mfg. Date:-
Batch Size: 200 Lts Exp. Date:-

1. Done by 2. Done by Checked by Approved by

Starting Time: Ending Time:

 Put the status label on bucket.

 Transfer the API on boiling section to prepare decoction (Kwath).

6. Soaking:
- Inspect the boiling vessel properly its cleanness, condition, electric connection etc.
- Put the status label on require space.
- Pour the raw material except Talispatra, Jufa and Sukumel.
- RO water is added to it. The desire quantity of water is eight times (Aprox 300 lts) w/v that of
ingredients.
- Continue Stirrer for half an hour.
- Allowed to proper soaked for a whole night.

1. Done by 2. Done by Checked by Approved by

Starting Time: Ending Time:

Vessels Raw Material RO water

1 Theo. Wt.Kg. Actual Wt.Kg. Theo. Wt.Lts. Actual Wt.Lts.
36 300

7. Boiling:
- Checked the area cleanness & hygiene, equipment cleanness as check list.
- Connect the electricity from control panel to heater of vessel for boiling purpose.
- Put the status label on require space.
- Maintain the temperature at 100 to 110°c with the help of thermometer. Check every 30
minutes, If increased more than 110°c, drain the cold water on jacketed space of vessel.
- Boiling is continuous with frequent stirring for seven hours & allowed to one hour for cooling.
(After seven hours boiling & one hour cooling, among above 300 lts. Water should be evapoured
114 lts. {±5%})

Page 3
 Solution Herbal Company Pvt. Ltd
Siddhalake- 1, Dhading, Nepal
BMR No.: SHC/QA-6-28 Swashbhusan 15/30/60/110 ml Doc. No.: 6/28-4
Batch No.:S001 Batch Manufacturing Record Mfg. Date:-
Batch Size: 200 Lts Exp. Date:-

Theoretical (Lts) Actual (Lts) Loss (Lts)

186

1. Done by 1. Done by Checked by Approved by

Sign & Date Sign & Date Sigh & Date Sigh & Date

Starting Time: Ending Time:

8. Filtration: (1st )
- After cooled, filtered the decoction through # 100 SS mesh by manually & collect in a clean & dry
SS container.
9. Filtration: (2nd )
- Checked line clearance floor, window, door, sealing etc as check list.
- Inspect the proper cleanness, condition, electric connection, filter, pipe transit, valve etc of
Filter Press.
- Put the status label.
- Pass the five lts RO water to inside pipe & filter cleaning.
- Connect the pipeline with storage vessel & filter press.
- Connect the electricity.
- Pass the liquid in idly & collect in SS clean & dry mixing vessel.

Filtrated Decoction Kg Theo. 249.937 Lts ( ± 5%)

Residue Choker Kg NA

Note:If not found (249.937 Lts ± 5%)

- If more, reduced by evaopured.
- If less, add require qty by boiling & filtered from residue choker as above boiling and filtration method.

1. Done by 1. Done by Checked by Approved by

Sign & Date Sign & Date Sigh & Date Sigh & Date

Page 4
 Solution Herbal Company Pvt. Ltd
Siddhalake- 1, Dhading, Nepal
BMR No.: SHC/QA-6-28 Swashbhusan 15/30/60/110 ml Doc. No.: 6/28-4
Batch No.:S001 Batch Manufacturing Record Mfg. Date:-
Batch Size: 200 Lts Exp. Date:-

Starting Time: Ending Time:

10. Alcohol extraction (Ethanol base)

- Taken Talispatra, Jufa and Sukumel coarse 14 kg in a SS vessel and pour two times quantity (28
lts) Ethanol and proper closed the opening then allowed to proper soak for a whole night.
- After a whole night, shake the vessel for half an hour and filter thorough 200 mesh muslin cloth.
- Collect the extract in a cleaned SS vessel with tightly closed of vessel mouth.

Theoretical (Lts) Actual (Lts) Loss (Lts)

14

1. Done by 1. Done by Checked by Approved by

Sign & Date Sign & Date Sigh & Date Sigh & Date

Starting Time: Ending Time:

11. Mixing:
- Taken the cleaned and dry mixing SS vessel and pour the above decoction and alcoholic
extracting with continuous stirring. (Sura mixed only seven percentage that of decoction)
- Mixed the Sodium Methyl Paraben 0.05 % (0.100Kg), Sodium Propile Paraben 0.025 % (0.05 Kg)
& Sodium Benzoite 0.0.05 % (0.05 Kg) as preservative with frequent stirring.

Particulars Theory Actual Remarks

Decoction Lts. 186
Soln alcoholic ext. lts. 14
Excipients (Preservative & Flavour, QS)

Page 5
 Solution Herbal Company Pvt. Ltd
Siddhalake- 1, Dhading, Nepal
BMR No.: SHC/QA-6-28 Swashbhusan 15/30/60/110 ml Doc. No.: 6/28-4
Batch No.:S001 Batch Manufacturing Record Mfg. Date:-
Batch Size: 200 Lts Exp. Date:-

S. Methyl P. 0.100
Sodium Propyl P. 0.050
Sodium Benzoate 0.050

Theoretical (Lts) Actual (Lts) Loss (Lts)

200.00

1. Done by 1. Done by Checked by Approved by

Sign & Date Sign & Date Sigh & Date Sigh & Date

Starting Time: Ending Time:

12. Filtration: (3nd )

- Checked line clearance floor, window, door, sealing etc as check list.
- Inspect the proper cleanness, condition, electric connection, filter, pipe transit, valve etc of
Filter Press.
- Put the status label.
- Pass the five ltr RO water to inside pipe & filter cleaning.
- Connect the pipeline with SS storage clean & dry container & filter press.
- Connect the electricity.
- Pass the liquid in idly & collect in with tightly closed of opening.

Theoretical (Lts) Actual (Lts) Loss (Lts)

200.00

1. Done by 1. Done by Checked by Approved by

Sign & Date Sign & Date Sigh & Date Sigh & Date

Page 6
 Solution Herbal Company Pvt. Ltd
Siddhalake- 1, Dhading, Nepal
BMR No.: SHC/QA-6-28 Swashbhusan 15/30/60/110 ml Doc. No.: 6/28-4
Batch No.:S001 Batch Manufacturing Record Mfg. Date:-
Batch Size: 200 Lts Exp. Date:-

Starting Time: Ending Time:

Page 7