master formula record dicylomine hydrochloride injection

NAME OF PRODUCT : DICYLOMINE HYDROCHLORIDE INJECTION

COMPOSITION : Each ml Contains:
Dicyclomine Hydrochloride 10.0 mg
Water for injection q.s.
BATCH SIZE :100 Litres

SELF LIFE : 2 Years

PACKAGING : 2 ml White ampoule

MANUFACTURING FORMULA :

Sr. No.	Raw Material	Qty Per ml	Overages	Total qty per ml	Quantity per batch
01.	Dicyclomine Hydrochloride	10.0mg	5.0%	10.5mg	1.050kg
02.	Sodium Metabisulphite	1.0mg	–	1.0mg	100.0gm
03.	Sodium Acetate Anhydrous	2.0mg	–	2.0mg	200.0gm
04.	Sodium Chloride	9.0 mg	–	9.0mg	900.0gm
05.	Benzyl Alcohol	1.0%	–	1.0%	1.00 litre
06.	Glacial Acetic acid	0.03%	–	0.03%	30 ml
07.	Water for injection	q.s.	–	q.s.	q.s.

CALCULATION : Dicyclomine Hydrochloride I.P. 10.0 mg

— For each ml

— 100

— _____________ x10 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

(b) 100 Litre S.S.Tank with lid and stirre.

3) FILTERATION (a) Bubble point Apparatus

(b) Filtration Assembly – 142 mm /293 mm

(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

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

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 :

Clean all the equipment /containers required for bulk manufacturing with (teepol/liquid soap) rinse it with tape water and D.M Water .
In the bulk manufacturing area rinsed twice all the above mentioned items with fresh distilled water.
Collect 60 litres fresh distilled water in the tank and start nitrogen flushing 30 minutes and pH set 5.5
Then add Sodium metabisulphite ,sodium chloride and then Benzyl Alcohol with continuous sterring.
Finaly add Dicyclomine Hydrochloride stir well till complete solution .
Finaly check and adjust the pH between 4.5 to 5.5 with sodium acetate and glacial acetic acid.
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 ⁰C 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 :

Decarton the ampoules in clean plastic creates in aseptic area.
Transfer the creates in washing room.
Arrange these ampoules in S.S. trays.
Load tray in ampoules washing machine.
Put on the cycle.
Ampoules are washed through unit with 5 micron filtered D.M. water with alternate the flushing with filtered compressed air.
Unload the machine and arrange.
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° 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 2.0 to 2.30 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 :
The arranged ampoules on the jolley are autoclaved by steam sterilization at 115 0 C for 30 minutes. After the cycle is completed the ampoules are allowed to cool in the sterilizers. After some time the ampoules are taken out and are kept in hold area and precaution were taken to avoid any accident . After they are completely cooled taken out to quarantine . In the sterilization area special precautions are taken for the worker because temperature is variate in these areas there to avoid any type of accidents. Worker wear helmets and their body is kept covered by a protective covering.

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 paintedwith 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 contects 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 : Dicyclomine Hydrochloride injection 2 ml ampoule

Self life : 2 Years

Colour : Clear, colourless solution.

Contents : 2.15 ml

pH : 4.5 to 5.5

Assay : Dicyclomine Hydrochloride I.P. 10.0 mg

Limit 95.0 % to 105.0%

Theoretical yield at different stages :

Scheduled fill : 46511 yield permissible limit

Filling rejection 1.5 % : 697 45814 0 to 2.5%

Optical checking rejection 6% : 2790 43721 0 to 8.0 %

Total rejection : 3487

Normal yield : 43024

After optical inspection ampoules are kept on labeling machine .

PACKING DETAILS : Box of 50 x 2 ml

Outer of 10 x 50 x 2 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.

Sr. No.	Packaging Material	Unit	Quantity
01.	Label
02.	Label Big size
03.	Inner Box
04.	Outer Box

Additional material if required may be drawn giving additional requisition slip duly authorised. Material if in excess may be returned to stores after taking authorization.

CODING :

Ampoule labels are overprinted in label printing machine / by hand stamping with batch no. ,Mfg. date, Exp. Date,Retail price and any specific instruction.

PROCEDURE :

Ampoules are labeled on labeling machine after getting line clearance . The capacity of the

machine is 120 ampoules per minutes.The ampoules are checked for authentic appearance and any

cross labeled / dirty labeled ampoules are delabelled and labeled again . After labeling ampoules

are kept in cartons, inner boxes and then kept in outer boxes.Outer boxes are passed for taping with

printed BOPP tape by taping machine. After packing

is over left out labels are counted and destroyed .

FINISHED PRODUCT :

After final packing store in a segregated storage area .Finished products which

are “ UNDER TEST ’’ must be quarantined and segregated by fixed printed labels.

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