master formula record amikacin sulphate injection

NAME OF PRODUCT : AMIKACIN SULPHATE INJECTION 100MG/2 ML VIAL

COMPOSITION : Each ml Contains:
Amikacin Sulphate
equivalent to Amikacine base 50 mg
Methyl paraben 0.08 mg
Propyl paraben 0.02 mg

BATCH SIZE :100 Litres

SELF LIFE : 2 Years

PACKAGING : 2 ml White Vial

MANUFACTURING FORMULA :

Sr. No.	Raw matarial	Qty Per ml	Overages	Total qty per ml	Quantity per batch
01.	Amikacin Sulphate I.P. Equivalent to Amikacine base	50mg	2 %	52mg	5.1 kg
02.	Sodium Metabisulphite	1.3mg	–	1.3mg	130.0gm
03.	Disodium EDTA	0.1mg	–	0.1mg	10.0gm
04.	Methyl paraben	0.8 mg	–	0.8mg	80.0gm
05.	Propyl paraben	0.2 mg	–	0.2mg	20.0gm
06.	Sodium citrate	0.5 mg	–	0.5mg	50.0gm
07.	Water for injection	Q.S.	–	Q.S.	Q.S.

CALCULATION : Amikacin sulphate I.P.

Equivalent to Amikacin base I.P.50.0 mg

For each ml

– 100

_____________ x 50 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.

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 Vial filling and sealing machine
(b) S.S.Container / Tray

5) VIAL WASHING

(a) Vial washing machine
(b) S.S.Boxes / Trays
(c) Dry Heat Sterilization (D.H.S.)

6) OPTICAL TESTING

(a) Optical testing tables.

7) BATCH PRINTING

(a) Batch printing machine

8) LABELLING and PACKING

(a) Labelling machine
(b) Taping machine
(c) Strepping machine

GENERAL DISPENSING PROCEDURES :

THE MAIN STEPS IN DISPENSING AREA :
Transaction with Raw Matarial Store :

Depending upon the production programme and availability of raw Matarial ,bulk requisitions duly authorized by

Production Manager / Mfg Chemist , must be given to store , 2 hour’s in advance . While receiving the Matarial 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 Matarial requisition, the Matarial are dispensed in the following manner.

DEPACKING
MASTERials contained in polythene bags are first depacked into s.s.container and duly labeled . material 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 Matarials 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 60 litres fresh distilled water in the tank and start nitrogen flushing 30 minutes.Then add disodium E.D.T.A.,sodium

metabisulphite with continuous stirring.
4. Collect 10 litres Water for injection heated and boiled,then add methyl paraben and propyl paraben.
5. 3+4+ Amikacine sulphate and then add sodium citrate,with continuous stirring.
6. Finally check and adjust the pH between 3.5 to 5.5 with sodium citrate.
7. 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.

VIAL WASHING :
a) Decarton the vials in clean plastic creates in aseptic area.
b) Transfer the creates in washing room.
c) Arrange these vials in S.S. trays.
d) Load tray in vials washing machine.
e) Put on the cycle.
f) Vials 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 Vials into 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 :
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 ° 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 properly and two sets are put into one sterilization box open loaded into the autoclave for sterilization . The sterilization cycle is 117 ° 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 vials with sterile solution is done in sterile area. Vials filling is done on one head vial filling and sealing machine.

Filling capacity of the machine is 30 vials 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 2.0 to 2.2 ml 30 minutes
b. Nitrogen gassing is proper or not every one hour
c. Sealing quality every one hour
d. 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 :

Sterilized vials 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 vials are checked by swirling its contects by wrist movement and observe for any particle or foreign matters . There should be a gapof 5to10 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

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