master formula record ascorbic acid injection

COMPOSITION : Each ml Contains:

– Ascorbic Acid 100 mg/ml

– Water for injection q.s.

BATCH SIZE : 100 Litres

SELF LIFE : 1.5 Years

PACKAGING : 5 ml Amber ampoule

MANUFACTURING FORMULA :

Sr. No.	Raw Material	Qty Per ml	Overages	Total qty per ml	Quantity per batch
01.	Ascorbic Acid	100mg	6.0%	106mg	10.6 kg
02.	Sodium Hydroxide	2.425%	–	2.425%	2.425kg
03.	Methyl paraben	0.08mg	–	0.08mg	80.0gm
04.	Propyl paraben	0.01 mg	–	0.01mg	10.0gm
05.	Water for injection	Q.S.	–	Q.S.	Q.S.

CALCULATION : Ascorbic Acid 100.0mg/ml

For each ml

– 100

-_____________ x100 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

THE MAIN STEPS IN DISPENSING AREA :
Transaction with Raw Matarial Store :
Depending upon the production programme and availability of raw Matarials,bulk requisitions duly

authorized by Production Manager / Mfg . Chemist , must be given to store , 2 hour’s in advance .

While receiving the Matarials 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 Matarials requisition, the Matarials are dispensed in the following manner.

DEPACKING
Matarials contained in polythene bags are first depacked into s.s.container and duly labeled .

Matarials received in fibre drums and carbous need not be depacked, only external cleaning with a clean dry cloth is sufficient.

WEIGHING
The Matarials are dispensed as per the requisition duly authorized by Production Manager / Mfg.Chemist

received from the production department. The Matarials are weighed on electronic balance.

All the Matarials 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 20 litres fresh distilled water in the tank and start nitrogen flushing 30 minutes.

Then add Sodium hydroxide stir to dissolve.Lid tightly and keep it over night solution no. 1.
4) Collect 50 litres water for injection heat to boil.Then add propyl paraben and stir well to clear solution.

Then add methyl paraben and stir well to dissolve. Keep it over night in sterile area solution no. 2.
5) Next day take second part in the tank and start nitrogen flushing 30 minutes.Then add

Ascorbic Acid slowly and stir till clear solution with continuous stirring.
6) Then add sodium hydroxide pouring small quantity along with vigorous stering. Ring with

fresh water for injection and again add to Ascorbic Acid.Check the pH to abaut 7.0.
7) Finally check and adjust the pH between 5.0 to 7.0 with sodium hydroxide and ascorbic acid.
8) Make-up the volume upto 100 litres.

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 0 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 :
a) Decarton the ampoules in clean plastic creates in aseptic area.
b) Transfer the creates in washing room.
c) Arrange these ampoules in S.S. trays.
d) Load tray in ampoules washing machine.
e) Put on the cycle.
f) Ampoules are washed through unit with 5 micron filtered D.M. water with alternate the flushing with filtered compressed air.
g) Unload the machine and arrange.
h) The ampoules into S.S. tray for dry heat sterilizations.

STERILIZATION
To be sterilized at minimum 200 o 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 :
1. 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 0 C for 30 minutes.

2. 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.
3. 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.
4. 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 1170 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.

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