master formula record multivitamin injection
NAME OF PRODUCT : multivitamin injection 3 ML
COMPOSITION : Each 3ml Contains:
Thiamine Hcl. I.P. 100.0 mg
Pyridoxine Hcl. I.P. 100.0mg.
Cyanocobalamine I.P. 1000mcg.
Niacinamide I.P. 100mg.
D- Panthenol I.P. 50mg.
Benzyl Alcohol I.P. 2% w/v
Water for injection I.P. q.s.
BATCH SIZE :100 Litres
SELF LIFE : 2Years
PACKAGING : 3 ml Amber ampoule
MANUFACTURING FORMULA :
| Sr. No. | Raw Material | Qty Per ml | Overages | Total qty per ml | Quantity per batch |
| 01. | Thiamine Hcl. | 33.33mg | 12.0% | 3.999mg | 3.7 kg |
| 02. | Pyridoxine Hcl. | 33.33mg | 12.0% | 3.999mg | 3.7 kg |
| 03. | Cyanocobalamine | 333.33mcg | 35.0% | 445mcg | 45.0gm |
| 04. | Niacinamide | 33.33 mg | 12.0% | 3.999mg | 3.7 kg |
| 05. | D- Panthenol | 16.66 mg | 11% | 18.49mg | 1.85 kg. |
| 06. | Benzyl Alcohol | 0.66 % | 0.66% | 700 ml | |
| 07. | Ferric Ammonium Citrate | 0.06% | 0.06% | 60 gm | |
| 08. | Disodium EDTA I.P. | 0.1 % | 0.1% | 100gm. | |
| 09. | Thioglycerol | 0.1 % | 0.1% | 100 ml | |
| 10. | Diethalamine | 0.045% | 0.045% | 45 ml | |
| 11. | Water for Injection | q.s. | q.s. | q.s. |
CALCULATION : 1) Thiamine Hcl I.P.33.33mg
For each ml
100
_____________ x 33.33 mg x 100 Litres
(Assay – Water)
( Assay according to Quality Control Report )
2) Pyridoxine Hcl. I.P.33.33mg
For each ml
100
_____________ x 33.33 mg x 100 Litres
(Assay – Water)
( Assay according to Quality Control Report )
3) Cyanocobalamine I.P. 333.33mcg
For each ml
100
_____________ x 333.33 mcg x 100 Litres
(Assay – Water)
( Assay according to Quality Control Report )
4) Niacinamide I.P. 33.33mg
For each ml
100
_____________ x 33.33 mg x 100 Litres
(Assay – Water)
( Assay according to Quality Control Report )
5) D-Panthenol I.P. 16.66 mg
For each ml
100
_____________ x 16.66 mg x 100 Litres
(Assay – Water)
( Assay according to Quality Control Report )
EQUIPMENT USED :
PROCESS STEGE EQUIPMENT AND VESSELS
1) DISPENSING
(a) Weighing Machine
(b) S.S.Scoop
(c) S.S.Containers/Polybags
2) BULK MANUFACTURING
(a) 50 Litre S.S.Tank with lid and stirrer.
(b) 100 Litre S.S.Tank with lid and stirrer.
(c) 142 mm/293 mm filter assembly.
3) FILTERATION
(a) Bubble point Apparatus
(b) Filtration Assembly – 142 mm /293 mm
(c) 20 litres/50 litres receivingVessels / filling tank
(d) Autoclave .
4) FILLING & SEALING
(a) Automatic Ampoule filling and sealing machine
(b) S.S.Container / Tray
5) AMPOULE WASHING
(a) Ampoule washing machine
(b) S.S.Boxes / Tray
(c) Dry Heat Sterilization (D.H.S.)
6) LEAK TESTING
(a) Vaccum Pump
(b) Autoclave
7) OPTICAL TESTING
(a) Optical testing tables.
8) BATCH PRINTING
(a) Batch printing machine
9) LABELLING & PACKING
(a) Labelling machine
(b)Taping machine
(c) Strepping machine
GENERAL DISPENSING PROCEDURES :
THE MAIN STEPS IN DISPENSING AREA :
Transaction with Raw Material Store :
Depending upon the production programme and availability of raw materials,bulk requisitions duly
authorized by Production Manager / Mfg . Chemist , must be given to store , 2 hour’s in advance .
While receiving the materials should be checked by concerned Supervisor for the following :-
a) Label
b) A.R. Number from Q.C.
c) Quantity
d) Checking of weight in the weighing room
e) Physical damage if any.
DISPENSING
On receiving the raw materials requisition, the materials are dispensed in the following manner.
DEPACKING
Materials contained in polythene bags are first depacked into s.s.container and duly labeled . Materials received in fibre drums and carbous need not be depacked, only external cleaning with a clean dry cloth is sufficient.
WEIGHING
The materials are dispensed as per the requisition duly authorized by Production Manager / Mfg.Chemist
received from the production department. The materials are weighed on electronic balance.
All the materials dispensed are weighed by on Supervisor and counter checked by another Supervisor.
BULK MANUFACTURING :
1) Clean all the equipment /containers required for bulk manufacturing with (teepol/liquid soap) rinse it with tape water and D.M.Water
2) In the bulk manufacturing area rinsed twice all the above mentioned items with fresh distilled water.
3) Collect 15 litres fresh distilled water and heat add Niacinamide just to boil and keep aside. Then add Benzyl Alcohal after cooling to solution of Niacinamide in the tank and start nitrogen flushing 30 minutes.
4) Take about 15 litres water for injection add disodium EDTAto it and stir well along with nitrogen bubbling till clear solution. Then add Thiamine Hcl and Pyridoxine Hcl along with stirring & bubbling nitrogen till clear solution.
5) Dissolve seperataly Cyanocobalamine making paste into 10th of fresh water for injection.Then add solution of Ferric ammonium citrate & shake it well keep it aside.
6) Teke about 5th lit. hot water and dissolve D-Panthenal into it.
7) Now add solution of B12 & Ferric ammonium citrate to solution of B1&B2 slowly with stirring & bubbling nitrogen gas.
8) Then add solution of Niacinamide into main solution and stir.
9) Then add solution of D-Panthanol and stir.
10) Then add Diethanalamine solution predissolved in1lit.of water for injection to main solution.
11) Then add Thioglycerol solution predissolved in 1 lit. of water for injection to main solution. with continuous sterring.Make up the volume upto 100 litres.
12) Finaly check and adjust the pH between 3.7 to 4.2
PREPARATION OF FILTER ASSEMBLY :
To be done under controlled environment , use 142 mm / 293 mm filter assembly . Before using , dismantle all parts of the assembly like plates, lower plate, upper plate, clamps, nozzles , distributors, gasket , distributing net etc . wash them with teepol , raw water and then washed with hot distilled water .cool them for better handling.
Mounting is done as follows:
1) Put lower plate on legs.
2) Put distributing net on lower plate on that the sieve is kept.
3) Put membrane filter on sieve, do not touch the paper on any surface. Put some distilled water on the paper so it get soaked. Put the pre filter on it,
4) Put the upper plate with gasket properly fitted.
5) Clamp the filter assembly. Tighten the opposite clamps at a time to avoid any leakages.
6) Fix latex tubing.
7) Perform bubble point test at 40 pound pressure. If it passes the bubble point then sterilize it.
If it fails then mount the filter paper again . Filter assembly should not be fully airtight while sterilizing.
Sterilization of filter assembly is done at 117 °c for 30 minutes. After sterilization , filter the prepared
batch , filtered the solution in sterilized S. S. receiving vessels . Bubble point test perform before and after the filtration.
AMPOULE WASHING :
1. Decarton the ampoules in clean plastic creates in aseptic area.
2. Transfer the creates in washing room.
3. Arrange these ampoules in S.S. trays.
4. Load tray in ampoules washing machine.
5. Put on the cycle.
6. Ampoules are washed through unit with 5 micron filtered D.M. water with alternate the
flushing with filtered compressed air.
7. Unload the machine and arrange.
8. The ampoules into S.S. tray for dry heat sterilizations.
STERILIZATION :
To be sterilized at minimum 200 ° C for 1 hour.
STERILIZATION OF SOLUTION :
The product is aseptically filled . Sterilization is achieved by filtering through a membrane filter.
Filteration is done through a 142 mm/293 mm membrane filter of 0.22 micron size. Prefilter1.5micron used is 142 mm/293 mm.
FILLING :
- FILLING UNIT :
It consist, of S.S. syringes, holders, filling needles, gassing needles, silicone tubing etc.
The above should be first cleaned carefully with teepol, raw water and then washed with hot distilled water.
After cleaning. Syringes deeped in distilled water and kept in S.S. tank which are then invaded into
the autoclave for sterilizing. The sterilization cycle is 117 ° c for 30 minutes.
- RECEIVING VESSELS :
Vessels which are used to collect the filtered solution have to be first washed with teepol solution steamed,
then washed with hot distilled water and taken into the unit preparation area. Here they are rinsed twice
with fresh distilled water . The opening of vessals are then sterilized at 117 0 C for 30 minutes.
- GARMENTS :
Garments that are used in the sterile filling area are first checked if they are torn . Torn garments are rejected.
Clean garments are then folded property and two sets are put into one sterilization box open loaded into the
autoclave for sterilization . The sterilization cycle is 117 o C for 30 minutes . After sterilization
the perforation are closed . The garments are taken to the air lock and are hanged on to hangers.
- GLOVES :
New gloves are washed thoroughly with DM water and then with distilled water. The gloves are also
checked for any tearing and if found any, rejected . These gloves are then put into s.s. unit boxes
with the perforation open and sterilized at 117 0 C for 30 minutes.
FILING OPERATION :
Filling of ampoules with sterile solution is done in sterile area. Ampoules filling is done on four
head ampoule filling and sealing machine.
Filling capacity of the machine is 80 ampoules per minute . During filling, the production
supervisor has to conduct creation in process control test at regular interval.
In process Test Frequency
a. Fill volume 3.0 to 3.15 ml 30 minutes
b. Nitrogen gassing is proper or not every one hour
c. Optical checking every one hour
write filing is going on movement should be restrained and there should be less talking. The machine should be kept clean.
During lunch break the full area should be cleaned , spraying of antiseptic solution should be taken up at regular intervals.
STERILIZATION :
Sterilization by filteration.
VISUAL INSPECTION :
Next day sterilized ampoules are taken for visual inspection. Visual inspection is done on inspection table.
The inspection is fitted with a source of illumination such as tube light . The screen has half the area painted
with white and half the area painted in black. The front of the light is covered so that the direct light does
not fall on the a separate table . The ampoules are checked by swirling its contents by wrist movement and
observe for any particle or foreign matters . There should be a gap of 5 to 10 minutes after one
hour of working. Trained operators should only be allowed.
Type of rejection:
1. Black particles
2. White particles
3. Fibres
4. Glass particles
5. Shining matters
6. Sealing rejection
7. Less / high volume
8. Breakage
Product Name : multivitamin injection 3 ml ampoule
Self life : 2 Years
Colour : Clear red colour solution.
Contents : 3.15 ml
pH : 3.0 to 4.0
Assay : Multivitamin injection
Limit not less then 90 %
Theoretical yield at different stages :
Scheduled fill : 31746 yield permissible limit
Filling rejection 1.5 % : 476 31270 0 to 2.5%
Optical checking rejection 6% : 1904 29366 0 to 8.0 %
Total rejection : 2380
Normal yield : 29366
After optical inspection ampoules are kept on labeling machine .
PACKING DETAILS : Box of 50 x 3 ml
Outer of 20 x 50 x 3 ml.
INPROCESS CONTROLS :
PRINTING :
At the start of the batch the printing of the labels should be checked and signed by competent person.
LABELLING :
Periodic check has to be done so that the labeled ampoules have a good aesthetic appearance.
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