PRESENTATIONON

TABLET MANUFACTURING

SUMMER TRAINING CONDUCTED ATSOLREX PHARMACEUTICALS

(GROUP OF RANBAXY LABORATORIES)Baddi,Himachal Pradesh,Under the supervision of

MR.ASHISH KUMAR SITE

By: To: GAUTAM AHUJA Mrs.JYOTI

Chem Engg,3rd year HOD CHEM

SETH JAI PARKASH MUKAND LAL INSTITUTE OF ENGINEERING & TECHNOLOGY,Radaur,distt-Yamunanagar,Haryana

ACKNOWLEDGEMENT

It is really a matter of great pleasure and pride for me to present this training report on tablet manufacturing undergone at Solrex Pharmaceuticals,unit of Ranbaxy Ltd, Baddi.I,Gautam Ahuja,student of B.tech Chemical Engg. 3rd year,Seth Jai Parkash Mukand Lal Institute of Engineering & Technology,would like to express my deep gratitude to Mr.R.P.Singh,HR Manager,for giving me the opportunity to pursue summer training at their organization and acquire industrial knowledge.I express my grateful thanks to Mr.Ashish Kumar Site,Production Manager, for his continuous support and encouragement.I owe my heartiest gratitude to Mr.Dinesh Yadav(Chemist), Mr.Amit,Mr.Chandramohan,Mr.Venktesh for their kind cooperation for making this venture aesthetically so satisfying. I would like to thank all the operators and workers for providing me with various aspects of machinery and its working.I express my sincere thanks to Dr.S.C.Jain,Chairperson-Chemical dept.,Mrs.Jyoti, HOD-Chemical deptt,Miss.Sudha Minz and all other dignified faculty members for their assistance throughout the training tenure. Above all i am thankful to God for endowing me with inevitable strength & patience.

TABLETS

INTRODUCTIONTablets are solid unit dosage form of medicaments with or without suitable diluents and prepared either by moulding or compression. They are solid, flat or biconvex disc in shape. They vary greatly in shape, size and weight which depend upon amount of medicament used and mode of administration. They also vary in hardness, thickness, disintegration and dissolution characteristics and in other aspects depending upon their intended use and method of manufacture. Tablets are the most widely used solid dosage form of medicament. Because of their advantages their popularity is continuously increasing day by day

PROPERTIES OF AN IDEAL TABLET:-

1. Tablet should be elegant having its own identity and free from defects such as cracks, chips, contamination, discoloration etc.2. It should have chemical and physical stability to maintain its physical integrity over time.3. It should be capable to prevent any alteration in the chemical and physical properties of medicinal agent(s).4. It should be capable of withstanding the rigors of mechanical shocks encountered in its production, packaging, shipping and dispensing.5. An ideal tablet should be able to release the medicament(s) in body in predictable and reproducible manner..

TABLET MANUFACTURING TABLET MANUFACTURING PROCESSPROCESS

1. DISPENSING (WEIGHING AND MEASURING) Dispensing is the first step in any pharmaceutical manufacturing process. Dispensing is one of the mostcritical steps in pharmaceutical manufacturing; as during this step, the weight of each ingredient in themixture is determined according to dose. 2. SCREENING Screener is an essential part of every pharmaceutical production process, particularly as product quality &integrity are so important. The use of a sieve gets rid of oversized contamination to ensure that ingredients & finished products are quality assured during production and before use or despatch. 3. GRANULATION Granulation may be defined as a size enlargement process which converts small particles into physically stronger & larger agglomerates.Granulation method can be broadly classified into two types:-A. WET GRANULATION--Wet granulation process simply involves wet massing of the powder blend with a granulating liquid, wet

sizing and drying. B. DRY GRANULATION--In dry granulation process the powder mixture is compressed without the use of heat and solvent. It is the

least desirable of all methods of granulation. The two basic procedures are to form a compact of material by compression and then to mill the compact to obtain a granules.

4. DRYING After the process of granulation,product exists as a wet mass from which liquid must be removed,since the presence of water leads toimpairment of flow properties.The essential constituents of an effective piece of drying equipment are a heat supply to increase thetemperature & thereby reduce relative humidity, a device for removal of evaporated water.The fluidized bed dryer is the most commonly useddevice for drying tablet granules.5. MILLINGMilling process is not an easily contained unit operation because of the high possibility of cross contamination.Whether used to reduce size ordistribute colour or active ingredients,milling process is an integral part of the successful development & mass production of formulae ofparticulates,which are compressed to yield tablets that are reproducible & are physically & chemically stable.6. BLENDINGThe successful mixing of powder is acknowledged to be more difficult unit operation because,unlike the situation with liquid,perfect homogeneity is practicallyunattainableThe powder/granules blending are involved at stage of pre granulation and/or post granulation stage of tablet manufacturing. The optimum mixing timeand mixing speed are to be evaluated. Blending step prior to compression is normally achieved in a simple tumble blender. The blender may be a fixed blender intowhich the powders are charged, blended and discharged.

7. COMPRESSIONAfter the preparation of granules (in case of wetgranulation) or sized slugs (in case of dry granulation), they are compressed to get final product. The compression is done either by single punch machine (stamping press) or by multi station machine (rotary press).The tablet press is a high-speed mechanical device. It 'squeezes' the ingredients into the required tablet shape with extreme precision. It can make the tablet in many shapes, although they are usually round or oval. Also, it can

press the name of the manufacturer or the product into the top of the tablet.

8. COATINGCoated tablets are defined as “tablets covered with one or more layers of mixture of various substances such as natural or synthetic resins ,gums ,inactive and insoluble filler, sugar, plasticizer, polyhydric alcohol ,waxes ,authorized colouring material and some times flavoring material .Coating may also contain active ingredient. Substances used for coating are usually applied as solution or suspension.

TYPE OF TABLET COATING PROCESS:-A.SUGAR COATING --Compressed tablets may be coated with coloured or uncoloured sugar layer. The coating is water soluble and quickly dissolves after

swallowing. The sugarcoat protects the enclosed drug from the environment and provides a barrier to objectionable taste or order. B. FILM COATING --Film coating is deposition of a thin film of polymer surrounding the tablet core.Film coating is more favored over sugar coating. C. ENTERIC COATING --This type of coating is used to protect tablet core from disintegration in the acid environment of the stomach.

9. QUALITY CONTROL & QUALITY ASSURANCE Quality of any goods is the essence which characterizes its usefulness & which distinguishes its image.The criticality of quality in case of drugs is almost of immense significance since theses are used for mitigation of disease in human beings & therefore,it assumes indispensable role in the service of humanity & consumer in general.QUALITY ASSURANCE : It is the sum total of the organized arrangement made with the objective of ensuring that product will be of quality required for its intended use.The quality assurance is the most vital organization of any pharmaceutical industry.

10. PACKAGING Pharmaceutical manufacturers have to pack their medicines before they can be sent out for distribution. The type of packaging will depend on the formulation of the medicine.There are generally two types of packing:-1.Strip sealing2.Blister packing'Blister packs' are a common form of packaging used for a wide variety of products. They are safe and easy to use and they allow the consumer to see the contents without opening the pack. Many pharmaceutical companies use a standard size of blister pack. This saves the cost of different tools and to change the production machinery between products. The blister pack itself must remain absolutely flat as it travels through the packaging processes, especially when it is inserted into a

carton.

EQUIPMENTS USEDEQUIPMENTS USED 1. 1. VIBRO SIFTERVIBRO SIFTER Vibro separators are circular gyratory screens Vibro separators are circular gyratory screens

used to separate solids from solids and liquid used to separate solids from solids and liquid from solid. from solid.

The material is fed on to the centre of top The material is fed on to the centre of top screen. The undersize material passes rapidly screen. The undersize material passes rapidly through the screen during its travel to the through the screen during its travel to the periphery. The over size material get periphery. The over size material get continuously discharged through a tangential continuously discharged through a tangential outlet. This is achieved by specially designed outlet. This is achieved by specially designed Vibratory MotorVibratory Motor

FEATURES FEATURES :: Faster Separation.Faster Separation. Lesser Maintenance and Power Consumption Lesser Maintenance and Power Consumption

than the Conventional Sifter.than the Conventional Sifter. Simple & Compact constructionSimple & Compact construction Easy dismantling and cleaning. Easy dismantling and cleaning. High degree of surface finish. . High degree of surface finish. . MOC: SS 304 / 316.MOC: SS 304 / 316.

2. 2. RAPID MIXER GRANULATORRAPID MIXER GRANULATOR The rapid mixer granulator is a mixing unit The rapid mixer granulator is a mixing unit

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

FEATURESFEATURES • • As far as possible paint free As far as possible paint free

construction. construction. • Flame proof motors / controls. • Flame proof motors / controls. • Powder loading system / bin hoist • Powder loading system / bin hoist • anti vibration mounting. • anti vibration mounting. • Material of construction can be from • Material of construction can be from 100% SS 316 to various combinations of 100% SS 316 to various combinations of SS 316 and SS 304. SS 316 and SS 304.

3. 3. FLUID BED DRYERFLUID BED DRYER In the pharmaceutical industry, fluid bed In the pharmaceutical industry, fluid bed

dryers are commonly used to dry batches of dryers are commonly used to dry batches of wet granules produced in a high shear mixer wet granules produced in a high shear mixer granulator.granulator.

Fluid bed dryers remove the moisture from Fluid bed dryers remove the moisture from the granules by suspending the granules in a the granules by suspending the granules in a heated air stream until dry. The movement of heated air stream until dry. The movement of the granules in the heated air stream provides the granules in the heated air stream provides a relatively quick, efficient and uniform a relatively quick, efficient and uniform method of removing the liquids introduced in method of removing the liquids introduced in the previous wet mixing-granulation step. This the previous wet mixing-granulation step. This process is called fluid bed drying (or fluidized process is called fluid bed drying (or fluidized bed drying) because the bed of granules bed drying) because the bed of granules suspended in the airflow is said to be suspended in the airflow is said to be fluidized.fluidized.

FEATURES:-FEATURES:- Very versatile process equipment. Very versatile process equipment. Fully automatic operation based on PLC Fully automatic operation based on PLC

control / without PLC control. control / without PLC control. Minimum handling and hygienic. Minimum handling and hygienic. Tilting & lifting device for product container for Tilting & lifting device for product container for

easy handling. easy handling. Capacity available from 2.5kg to 500kg. Capacity available from 2.5kg to 500kg. FLP models available. FLP models available. MOC SS 304/ 316.MOC SS 304/ 316.

4.4. MULTIMILL MULTIMILL Multimill is a stand-alone unit for particle size Multimill is a stand-alone unit for particle size

reduction through impact in air, on material by reduction through impact in air, on material by blades moving at high speeds, inside a blades moving at high speeds, inside a cylindrical hopper. The particles of the desired cylindrical hopper. The particles of the desired size pass out through the screen placed inside size pass out through the screen placed inside the hopper. the hopper. The feed to the machine is through a charging The feed to the machine is through a charging hopper. The beaters mounted on rotor impart hopper. The beaters mounted on rotor impart impact to the material in air. The particles of impact to the material in air. The particles of desired size are obtained by providing sieve of desired size are obtained by providing sieve of desired meshdesired mesh

FEATURESFEATURES Multispeed drive for various product grading.Multispeed drive for various product grading. Easy dismantling and cleaning. Easy dismantling and cleaning. Low energy consumption. Low energy consumption. High degree of surface finish. High degree of surface finish. Easy portability Easy portability MOC: SS 304 / 316 MOC: SS 304 / 316

5. 5. OCTAGONAL BLENDEROCTAGONAL BLENDER The Octagonal Blender is an efficient and The Octagonal Blender is an efficient and

versatile blending machine for mixing and versatile blending machine for mixing and lubrication process.It consists of octagon lubrication process.It consists of octagon shaped body, rectangular central portion and shaped body, rectangular central portion and top and bottom polygonal frustum. It is provided top and bottom polygonal frustum. It is provided with baffles for fast and efficient mixing. It is with baffles for fast and efficient mixing. It is very useful machinery for pharmaceutical very useful machinery for pharmaceutical industry where in gentle blending of dry industry where in gentle blending of dry granules or powder is to be done.The bin granules or powder is to be done.The bin charging system can also be incorporated in it charging system can also be incorporated in it which is a dust free closed system for charging which is a dust free closed system for charging and discharging of powders or granules. The and discharging of powders or granules. The powder consumption is comparatively lower powder consumption is comparatively lower than the other similar type of blender.than the other similar type of blender.

FEATURESFEATURES The Octagonal blender gives best result for The Octagonal blender gives best result for

granules due to very slow speed and granules due to very slow speed and octagon shape of container.octagon shape of container.

Suitable mainly for Crystalline & Granular type Suitable mainly for Crystalline & Granular type material. This type of material gets sufficient material. This type of material gets sufficient continuous movement due to their shape if continuous movement due to their shape if container has only slow movement and will container has only slow movement and will results in good quality of blending / lubrication results in good quality of blending / lubrication of granulesof granules

Dust free, dry blending and lubrication of Dust free, dry blending and lubrication of powder and granulespowder and granules

6. TABLET COMPRESSION MACHINE6. TABLET COMPRESSION MACHINE The tablet compression machine performs the The tablet compression machine performs the

task of compressing the granules to get the task of compressing the granules to get the tablet form.It is a high speed mechanical device tablet form.It is a high speed mechanical device which squeezes the ingredients into the which squeezes the ingredients into the required tablet shape with extreme precision.required tablet shape with extreme precision.

FEATURESFEATURES Auto Lubrication System. Auto Lubrication System. Combination tooling with ''D'' & ''B'' tooling on Combination tooling with ''D'' & ''B'' tooling on

same turret. same turret. Power level monitoring device at feed hopper. Power level monitoring device at feed hopper. Spray lubrication system for effervescent tablet Spray lubrication system for effervescent tablet

production. production. Robust design with quality engineering.Robust design with quality engineering. Double Rotary Machine for medium batch Double Rotary Machine for medium batch

production.production. Simple and convenient operations,easy to Simple and convenient operations,easy to

maintain.maintain. Ensures hygienic production condition and Ensures hygienic production condition and

operator safety. operator safety. MOC: SS 304/316.MOC: SS 304/316.

7. 7. TABLET COATING MACHINETABLET COATING MACHINE A fully automatic tablet coating machine is used A fully automatic tablet coating machine is used

to coat the prepared solution on the tablets.to coat the prepared solution on the tablets.

FEATURESFEATURES:: The coating machine has sturdy structure of The coating machine has sturdy structure of

square SS square pipes. Base plate is of MS square SS square pipes. Base plate is of MS having SS cladding. having SS cladding.

It is very much easy for cleaning. It is very much easy for cleaning. Electric motor & gear box are directly coupled. Electric motor & gear box are directly coupled. Fixed Baffles or detachable baffles are provided Fixed Baffles or detachable baffles are provided

in coating pan to facilitate the tablet in coating pan to facilitate the tablet mixing during the coating operation which helps mixing during the coating operation which helps in achieving uniform tablet finish. in achieving uniform tablet finish.

Separate hot air blower unit of adequate Separate hot air blower unit of adequate heating element is provided with temperature heating element is provided with temperature controller. controller.

The coating machine has separate electric The coating machine has separate electric control panel. control panel.

Separate polishing pan can also be provided. Separate polishing pan can also be provided.

8. 8. TABLET PACKAGING MACHINETABLET PACKAGING MACHINE A. A. BLISTER PACKAGING MACHINEBLISTER PACKAGING MACHINE Blister packing machine is a Blister packing machine is a

thermoforming machine with automatic thermoforming machine with automatic forming,sealing and trimming operations. forming,sealing and trimming operations. The machine is available for both rigid and The machine is available for both rigid and flexible packing.flexible packing.

FEATURES:FEATURES: Ideal for packing tablets, capsules and Ideal for packing tablets, capsules and

other solid objects. other solid objects. Suitable for alu-alu/alu-pvc blisters. Suitable for alu-alu/alu-pvc blisters. Available in single/double track and with Available in single/double track and with

rotary/flat bed models. rotary/flat bed models. PLC based control with touch screen PLC based control with touch screen

application. application. Add-on imported tablet feeding, detection Add-on imported tablet feeding, detection

and rejection system.and rejection system.

B. STRIP SEALING MACHINEB. STRIP SEALING MACHINE Industry strip sealing machine gives high Industry strip sealing machine gives high

speed and uninterrupted performance at speed and uninterrupted performance at low maintenance cost. They are ideal for low maintenance cost. They are ideal for high speed sealing of coated or uncoated high speed sealing of coated or uncoated tablets, capsules of any shape or size in tablets, capsules of any shape or size in aluminium foil, polythene, cellophane or aluminium foil, polythene, cellophane or any other heat sealing material.any other heat sealing material.

High quality sealing is achieved with High quality sealing is achieved with features such as proportional temperature features such as proportional temperature controls, variable sealing roller pressure controls, variable sealing roller pressure and rugged and precision construction.and rugged and precision construction.

FEATURES: FEATURES: Adjustable cutting arrangementsAdjustable cutting arrangements Noiseless, trouble free operations.Noiseless, trouble free operations. Heavy duty electrically vibrating feeding Heavy duty electrically vibrating feeding

system.system. Easy change over of parts for different Easy change over of parts for different

products.products. Standard interchangeable parts.Standard interchangeable parts. Sealing rolls with precise knurling.Sealing rolls with precise knurling.

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