TRANING PERIOD INVISA DRUGS & PHARMACEUTICALS BADDI (HP)

Name: Harwinder KumarRoll No. 81307421017

Address :- V.P.O Khera, pin code 146106,Dist Hoshiarpur.Contacts - 01884242575, +919464065575.

Email Id:- harwinderpandit@yahoo.comharwinderpandit@hotmail.com

Collage:- RAYAT BAHRA INSTITUTE OF PHARMACY (Hoshiarpur, PUNJAB)

Site:- http://home.rayatbahra.com/

TABLETS

TABLET PRODUCTION SECTIONInstruments-1. Paste kettle2. RMG (Rapid Mixer Granulator)3. FBD (Fluid Bed Dryer)4. Vibro Sifter5. Multimill6. Blenders ( Double Cone Blender &

octagonal blender)7. Tablet Compression Machine 8. Tablet Coating Pan

1.PASTE KETTLE

Capacity- 50 to 300 ltrs ( 65 ltrs) Set temp- 400 degrees Celsius Act temp (actual temp of liquid present in paste

kettle. It may be varies acc. to time when paste kettle is on and if set temp is 400 degree Celsius then the liquid have to reach at that temp bye the heater then heater stops.)

USE-The paste kettle, is designed for binder paste preparation.

2.RAPID MIXER GRANULATOR (RMG) PRINCIPLE- The Rapid Mixer Granulator is mixing unit with a bottom entry agitator

ad side mounted chopper for granulation. It is used for dry blending, wet mixing, preparation of dough and granulation, i.e. cutting of the wet mass into small size granules. It works on the basic principle of agitation of the contents of the bowl at moderate speed and then running a specially profiled cutter blade at high speeds into the wet mass.

Total capacity – 250 ltrs Working capacity- 200ltrs Working time 20 to 30mins (for one lot) Speed – 100rpm USE- Homogenous mixing of dry & wet powders, deaglomeration of wet

mass and fast dispersion of binding agent.

3.FLUID BED DRYER (FBD) PRINCIPLE – In FBD , hot air is passed at

high pressure through a perforated bottom of the container containing granules to be dried. The granules are lifted from the bottom and suspended in the stream of air . This condition is called fluidized state . The air is surrounding every granules to completely dry them.

Capacity- 60kg & 120kg Working time – 20 to 40mins USES- FBD is popularly used for drying of

granules in the production of tablets. It can also used for three operations such as mixing , granulations, and drying. It is modified for coating of granules.

4.VIBRO SIFTER PRINCIPLE- Vibro Sifter consists of Specially Designed Motor mounted

vertically at the center of the base plate of the Screen. The Screen is in between feeding hopper and bowl. The material is fed on to the centre of top screen. The undersize material passes rapidly through the screen during its travel to the periphery. The over size material get continuously discharged through a tangential outlet.

Mesh size - 4 to 300 Mesh(acc. to granules) Capacity - 50 Kg/Hr  to 300 Kg/Hr USES- Vibro Sifter is a versatile screening, sieving, grading for separation

of solid from solid and liquid from solid.

5.MULTI MILL Mesh size – 2, 4, 6, 8, 10, 12, 14, 16, 20,

24, 30, 40, 50. Rotor RPM : 750 / 1400 / 2200 / 2800 Out Put : 50 kg to 200 kg/hour(depending

upon the product   and the reduction required In   size.)

Beaters : 12 nos. with knife and   impact edges.and 2 scraper   blades

USES- ulti Mill is widely used for wet and dry granulation, pulverisation etc., in Pharmaceuticals, Chemicals, Cosmetics, Ceramics, Colours, Dyestuff, Food products etc. It also finds application in Pesticides, Fertilizers, Spices, Detergents, Insecticides, Plastics and Resins Industries.

Multi Mill

Beatersmesh

6. BLENDERS 1. DOUBLE CONE BLENDER Volume capacity – 320ltrs Working capacity – 100kg Speed – 9-10rpm USES- The Double Cone Blender is efficient and

versatile equipment for homogeneous mixing of dry powder and granules. This is also used for lubrication.

2. OCTAGONAL BLENDER Volume capacity – 650ltrs Working capacity – 500kg Speed – 10rpm USES - Octagonal Blender is widely used for blending,

mixing and homogenizing in Pharmaceuticals, Chemicals, Cosmetics, Ceramics, Colours, Dyestuff, Food products etc

7.TABLET COMPRESSION MACHINE

Hopper for holding and feeding granulation to be compressed.

Dies that define the size and shape of the tablet. Punches for compressing the granulation within the dies. Cam tracks for guiding the movement of the punches. Feeding mechanisms for moving granulation from the

hopper into the dies. Maximum speed- 100rpm Working speed- 26rpm

PUNCHES AND DIES

COMPRESSION CYCLE

8. COATING PAN

Capacity – 60-100kg Blower temp. – 40°to 80°C (controlled by thermostat)

Spray rate – 100ml/min (coating material)

Working time- 2-3hrs(for one lot)

Speed of pan- 10rpm USES- Coating pans are used to form an aqueous or organic

film around any kind of pellets and tablets or micro granules. These pans are also widely used to sugar-coat tablets

PRODUCT PROFILE OF TABLETS Beta Lactum Tablets Con pod 200mg (Cefpodoxine proxetil) Cefnat-o-50-DT(Cefexine)

Non Beta Lactum Tablets Ulticept 500 (ciprofloxacin 500mg) Diazacid- MPS (antacid) Dexacona Embenor 400 (Norfloxacin)

FLOW CHART FOR PRODUCTION OF TABLETS

Harwinder kumar

CAPSULES

CAPSULE FILLING & SEALING SECTION CONDITIONS FOR BETA LACTUM

POWDER FILLING Temperature – 23°to 27°C Humidity - below 23% CONDITIONS FOR NON BETA LACTUM

POWDER FILLING Temperature – 23°to 27°C Humidity - 45 to 55%

CAPSULE FILLING & SEALING MACHINE

THE FIRST STATION:ORIENTATION OF CAPSULE

The functions of first station include capsule feeding, aligning and insertion into bores of holding ring .

Also, vacuum is used for separating capsule cap and body in first station.

After orientation of capsule, capsule cap can stay in upper holding ring and capsule body can stay in lower holding ring.

THE SECOND STATION:POWDER FILLING

Separate the holding ring,put the lower (body) holding ring on the rotary table, pull the powder hopper over the lower (body) holding ring, then auger inside powder hopper starts to run and fill powder into the capsule body. While Iower holding ring turns one circle, push powder hopper to its original position.

THE THIRD STATION:CAPSULE CLOSING

Put upper holding ring and lower holding ring together, then take the holding ring ahead of ejector and aim ejector at the bores of holding ring . Use hydraulic cylinder to push ejector and let it press capsules for closing. Finally push capsules inside the bores of holding ring out, the finished capsules will be collected into the container.

CAPSULE POLISHING MACHINE

Polishing machine is used after capsules are filled for cleaning the powder attached on the capsules surface.

APPLICABILITY:   Applicable to all size of capsules (#) 000, 00, 0, 1, 2, 3, 4, 5. 

PRODUCT PROFILE OF CAPSULES Beta Lactum Capsules Cepmox 250 (Amoxycillin) Natcocillin 250 (Ampicillin) Non Beta Lactum Capsules Panta con DSR ( Pantaprozole &

domparidone) Tetralin 250 (Tetracycline hydrochloride) Omec 20 (Omeprazole)

PACKAGING

BLISTER PACKAGING

In this packing one side of tablet stripes is PVC (Poly vinyl Chloride) and another side is alumininum foil is used.

1.PVC FOILS- 1. PVC (Poly vinyl Chloride) foil 2. PVDC(poly vinyl dichloride foil) foil.

Thickness of PVC foil – 0.250mm. 2. ALUMINIUM FOIL Thickness of aluminum foil – 0.075mm.

BLISTER PACKING MACHINE PVC forming temp. - 180°C Sealing heater temp. - 202°C (PVC & alum.

Foil)

Air required - 4kg (for start the machine)

Max. Speed – 100rpm Working speed - 70rpm

ALU-ALU PACKAGING In which both side of tablet/capsule

strips aluminium foil is used. Thickness of alu. Foil - 0.020mm to

0.045mm

ALU ALU PACKING MACHINE Forming temp. - 180°C Sealing temp. - 200°C Max. Speed – 35rpm Working speed – 20rpm

IMPORTANCE OF PACKAGING Protect against all adverse external

influences that can alter the properties of product.

Protect against biological contamination. Protect against physical damage. Carry the correct information and

identification of product.

INJECTIONS

VIALS

AMPOULES

WASHING AREA 1.MULTI JET WASHING

MACHINE- Capacity – 190 (ampoules

washed at one time) WASHING CYCLE TIME  :     60

Seconds(Approximately- Can Be Customize)

NO. OF CYCLES/ HOUR  :      25 to 30 ( Depend Upon the Speed of Operator or Method Of Loading & Un-Loading) 

USES- The machine is flexible to wash 1ml to25ml Ampoule & 2ml to 10ml Vial with the help of suitable individual trays.

2. LINEAR VIAL WASHING MACHINE Suitable for – 2ml to 30ml vials. Washing by – Air , DM Water, WFI. Speed – 150 to 200 rpm.

STERILIZATION 1.DHS (Dry Heat Sterilization)

2. MHS (Moist heat sterilization)

DRY HEAT STERILIZATION (DHS) DHS done by hot air oven . Temp required - 250°C Time – 2hrs Capacity of hot air oven – 90 trays

(24000 vials ) Used for ampoules , vials ,glass

instruments

MOIST HEAT STERILIZATION (MHS)

It is done by AUTOCLAVE. Steam inlet – 15lb/cm2. Temp - 121°C Time – 30mins. Used for production machine parts ,

rubber plugs, dresses etc.

INJECTION FILLING & SEALING SECTION CONDITIONS FOR BETA LACTUM DRY

POWDER FILLING Temperature – 23°to 27°C Humidity - below 23% CONDITIONS FOR NON BETA LACTUM

LIQUID FILLING Temperature – 23°to 27°C Humidity - 45 to 55%

AMPOULE FILLING AND SEALING MACHINE Filling of liquid into ampoules by 6

nozzles. Sealing is done by LPG + oxygen. Output – 6000/hr USeful For 2 ml to 10ml ampoules

LIQUID FILLING MACHINE (VIALS) Speed – 100rpm Useful for 2ml to 100ml vials. Nozzles – 6 ( for filling of liquid into

vials)

DRY POWDER FILLING MACHINE It contain different size of pot wheels

according to vials capacity & piston which transfer the powder into vials by the help of pressure and nitrogen gas.

Machine speed – 140rpm.

FILLING SECTION AREA 100 class A – filling area under LAF

(laminar air flow). 1000 class B – surrounding of filling area

not under LAF. 10000 class C – collider , batch room, air

lock 2nd and 3rd . 100000 class D – packing area ,

washing area, air lock 1st .

PRODUCT PROFILE OF INJECTIONS Beta Lactum Injections Cefx-500 and 1000 (Ceftriaxonal

sodium) Ampicillin Non Beta Lactum Injection Pantaprozole Diclofam

Harwinder kumar

GLASS USED

Glass is composed of sand, soda ash, limestone,& cullet.

Si, Al, B, Na, K, Ca, Mg, Zn & Ba are generally used into preparation of glass ADVANTAGE:

They are transparent. They have good protection power. They can be easily labelled.

DISADVANTAGE:

Glass is fragile so easily broken. Release alkali to aqueous prerparation.

44Harwinder kumar

TYPE OF GLASS:

I. COLOURED GLASS OR AMBER GLASS

II. SULPHURED GLASS

III. BOROSILICATE GLASS

IV. TREATED SODALIME GLASS

V. REGULAR SODALIME GLASS

VI. GENERAL PURPOSE SODALIME GLASS

MERRITS1. All staff members are highly educated.2. All types of pharmaceutical machines

are available.3. Machine Operators are very

experienced.4. All departments are present i.e.

QA,QC, Tablet , capsule , ointment , jelly & injection production area.

DEMERRITS Drinking water is not good. Water is filled beside the industry. No place for waste material storage.