In-Plant Training Program At SK+F Eskayef Bangladesh Ltd.

In-Plant Training Program

At

SK+F Eskayef Bangladesh Ltd.

Introduction

SK+F symbolizes a name-a state of mind. From the inception in 1990, it has today burgeoned into one of the top line conglomerates in Bangladesh. Eskayef Bangladesh Limited, the flagship company, is holding the strong leadership position in the pharmaceutical industry of Bangladesh since 1990 and is now on its way to becoming a high performance global player. Eskayef Bangladesh Limited is an organization with equal emphasis on Leadership, Technology, Quality & Passion.

Eskayef Bangladesh Limited is the leading generic pharmaceutical manufacturer in Bangladesh producing quality essential and other ethical drugs & medicines. Eskayef Bangladesh Limited has three GMP compliant formulation plants. The Tongi unit plant started its operation to meet challenges of globalization & to expand export horizon.

Tongi plant is situated at Tongi, Gazipur. It is constructed as per the requirement of the UK MHRA. All the facilities and equipment have been designed and built to ensure cGMP compliance.

All facility is an excellent blend of modern architecture, advanced technology, quality assurance and professionalism. It enjoys its brilliant is the prominent Drag manufacturing company in Bangladesh. It has started its production & Drag delivery from 1990. Eskayef Bangladesh Limited Tongi Plant is especially established for achieving the MHRA approval. For this reason, this unit provides the products with high quality.

According to the training schedule we have visited all the departments of Eskayef Bangladesh Limited. The process of manufacturing & of maintaining qualities according to the cGMP guidelines were observed & in this light standard operating procedure (SOP) has been developed. All performances in the factory are highly documented.

Besides, Eskayef Bangladesh Limited providing local pharmaceutical needs & has been exporting its products to the many countries. It has been also receiving the order from the many Pharmaceutical Industry ( Tole Manufacturing ).

Eskayef Bangladesh Limited not only provide the high quality Drugs but also prevent the nature from its wastage affect. For this reason, it has established ETP plant which destroys the harmful effect of various toxic chemicals.

As a result of completing in-plant training in a well organized & well reputed company such as Eskayef Bangladesh Limited, our theoretical concept has become developed on the basis of practical view.

About Tongi Plant :

Area (Infrastructure):

Total area of Tongi Plant is 39,000 square feet (approximate) and the capacity of Warehouse 7,34,000 square feet.

Manufacturing Dosage Facilities:

Tablet (Uncoated, Film Coated, Enteric Coated Tablet)

Capsule

Liquid

Sachet

Topical Preparation

HVAC System:

Total manufacturing area is under HVAC System.

Power Back up System:

Normally Electricity supplied from Dhaka Electric Supply Company (DESCO) & 24 hours back up power supply available through 03 Generators having capacity of 1250 KVA.

Purified Water System:

Water treatment plant have the capacity of 1000 Ltr./hr following Reverse Osmosis & UV Radiation Technology.

Current Plant Capacity:

Present production capacity in value is 120 Crore Taka & in unit packs 1.61 Crore Packs per year.

Waste Management System:

Have separate area for waste disposal under the supervision of the authorized person according to the standard operating procedure (SOP) following the direction of WHO guideline.

Manufacturing Dosage Facilities:

Tablet

Capsule

Eye drop

Vial

Dry Syrup

HVAC System:

Total manufacturing area is under HVAC System.

Power Back up System:

Captive own power supply from gas generator of 2.2 MW capacity which is back

up by 800 KW diesel generator.

Purified Water System:

Water treatment plant has the capacity of 1000 Ltr./hr following Reverse Osmosis Technology and the capacity of WFI 800 kg / hr.

Distribution channel :

Transcom Distribution Co. Ltd. (TDLC) is the sole distributor of Eskayef products throughout Bangladesh.

Eskayef at a glance

Company name	:	Eskayef Bangladesh Limited
Company logo	:
Company slogan	:	Excellence through quality
Company type	:	Private limited company
Acquisition from	:	SmithKline & French
Company started	:	1990
Ownership	:	Transcom group
Factories	:	Mirpur (generic), Tongi (generic & cepha)
Marketing office	:	Taneem Square, Banani, Dhaka
Commercial Dept.	:	Taneem Square, Banani, Dhaka
International Business	:	Taneem Square, Banani, Dhaka
Finance & Accounts	:	Gulshan Tower, Gulshan 2, Dhaka
AHND office	:	Motijheel C/A, Dhaka
Annual turnover	:	BDT 3000 million , US$ 44 million
Web address	:	www.skfbd.com
E-mail	:	info@skf.transcombd.com
Managing Director	:	Mr. A M Faruque
Employees	:	1500
IMS ranking	:	5th largest in Bangladesh Pharma Industry
Prime brand	:	Losectil (omeprazole)
Business	:	Formulation, Consumer, Bulk Pellets, AHND
Distribution	:	Transcom Distribution Company Limited, TDCL
Depots	:	20 Depots
Regions	:	20 Regions

Vision & mission :

Eskayef envisions a leading role for itself as a catalyst for improvement of the healthcare environment.

The company’s mission is to maintain people’s health and combat disease to enhance the quality of human life so that people may live longer, healthier and more meaningful lives.

Business :

Eskayef Bangladesh Ltd. started its operation with pharmaceutical finished products for the home market. Over time we have diversified our operations into bulk products as well as animal health and nutrition products.

Finished Products :

Backed by our strong technical and marketing teams we offer 149 products in 55 therapeutic segments.

Bulk Products :

We produce Timed Release Blended Pellets. Eskayef is the first and only pellet manufacturer in Bangladesh.

Animal Health and Nutrition Products :

We manufacture 28 animal health and nutrition products in 57 dosage forms and market them throughout Bangladesh.

Export :

Eskayef Bangladesh Ltd. has been showing a significant outcome in exporting medicines to many countries. Eskayef Bangladesh Ltd. has started supplying medicines in 16 countries like Germany, UAE, Nepal, Bhutan, Sri Lanka, Myanmar, Vietnam, Ghana, Iraq, Indonesia, Kenya, Guatemala, Belize, Yemen, Macau and Somalia.

Marketing of International Brands :

We are the sole agent in Bangladesh for marketing the ophthalmic products of Allergan Pharmaceuticals Ltd., Ireland in Bangladesh.

People :

The workforce of Eskayef consists of more than 1200 to 1500 appropriately qualified, trained and skilled personnel who are drawn from different disciplines that have a bearing on the pharmaceutical industry. Our team of dedicated professionals includes a panoply of pharmacists, medical graduates, microbiologists, chemists, engineers and business management experts. Their competencies, experience and strict adherence to the work ethic go into the manufacturing and marketing of each of the company’s products.

Quality Approach

Our Total Quality System is our key strength. We have inherited the Standard Operating Procedures and Quality-Approach of SmithKline & French. Our WHO audited plants produce the products conforming to the highest international standards. And to maintain the excellence that we strive to achieve we use the most advanced technology for quality control and at each and every stage of the manufacturing process.

History:

The chairman of Transcom group planted a seed of dream in 1885. As the years went by the seed began to grow and soon turned into a full-grown tree with its leaves branching out in innumerable ventures. The company which started its business in the jute and tea sectors gradually diversified its operations into:

Health care sector

Household electronic products

Beverage

Print media

Restaurant franchise

Software, and

Distribution Channel

Today, TRANSCOM is one of the leading conglomerate companies of the country. The dream has turned into reality by the pragmatic vision of Mr. Latifur Rahman, the Chairman of TRANSCOM GROUP and Eskayef Bangladesh Limited and the company proudly stands symbolizing the epic tree of the seed that was planted 120 years ago.

Continuing its journey towards diversification, TRANSCOM entered the health care sector and acquired ownership of the world-renowned multinational pharmaceutical company SmithKline & French in the wake of the merger between SmithKline & French, USA and Beecham, UK in 1990. After the acquisition, the new company was styled – Eskayef Bangladesh Ltd and that has subsequently culminated under the bold and dynamic leadership of Mr. A M Faruque, the driving force and the Managing Director of Eskayef Bangladesh Limited.

Profile of MD

Mr. A M Faruque is the Managing Director of Eskayef Bangladesh Ltd., one of the top five pharmaceutical companies in Bangladesh. He started his pharmaceuticals career with Fisons Bangladesh Ltd. in 1974. In his long and illustrious career, he has also served in different positions in ICI, Hoechst, Smith Kline & French and Gulf Pharmaceuticals Industries, UAE. Mr. Faruque rejoined SK&F as Marketing Manager in the United Kingdom Overseas Group (UKOG), based at Welwyn Garden city, Hertfordshire, UK. After that he was relocated to the Bangladesh Smith Kline & French operation as their Marketing Manager till 1990, prior acquisition of the company by Transcom group, one of the leading conglomerate companies of Bangladesh.

Mr. Faruque started working at Eskayef Bangladesh Limited as a Plant Manager. Later on he served as the General Manager and then the Executive Director of the company from till July 2004. Since July 15, 2004 he has been assigned with the responsibility of Managing Director of Eskayef Bangladesh Ltd. It is to be mentioned here that in the history of Bangladesh pharma market this is the first instance, where a private limited company, Eskayef, has appointed a Managing Director from the professional stratum.

Having started with a modest business of 1.20 crore taka in 1990, Eskayef Bangladesh Ltd. has now an annual turnover of 350 crore taka. This phenomenal growth was achieved under the bold and dynamic leadership of Mr. A M Faruque, the driving force and the navigator of Eskayef Bangladesh Limited. Keen to explore newer horizon, Mr. Faruque also has turned its focus on exporting the products. With its pioneering venture in international market with Nepal, Eskayef has expanded its business to Germany, UAE, Sri Lanka, Belize, Vietnam, Yemen and some other Central American countries.

True to his vision of offering world-class healthcare products, Mr. Faruque has undertaken a new project to expand its state-of-the-art pharmaceutical operations under the exclusive technical supervision of an UK pharmaceutical consultant. The new facility is being designed to conform to international cGMP with particular emphasis on meeting MHRA standards of the UK in order to facilitate exports to overseas markets.

Mr Faruque has obtained BSc (Hons) and MSc in Chemistry from Dhaka University. He has undergone an extensive training on marketing and sales force management in Ashridge Management College, UK.

Backed by our strong technical and marketing teams we offer 160 products in 59 therapeutic segments.

TOTAL PRODUCT LIST
	BRAND	GENERIC NAME
	AMBOTEN	Ambroxol HCl
	ANAPRIL	Enalapril maleate
	AROCEF	Cefadroxil monohydrate
	AROTIDE	Salmeterol and fluticasone
	BONFLEX	Glucosamine sulfate 250 mg & chondroitin sulfate 200 mg
	BRIZY	Levosalbbutamol
	BROMID	Hyoscine butylbromide
	CARBAZIN	Carbamazepine
	CARBAZIN CR	Carbamazepine
	CARBOLIN	Carbocisteine
	CARDON	Losartan potassium
	CARDOPLUS	Losartan potassium + Hydrochlorothiazide
	CEDNIR	Cefdinir
	CEFLON	Cefaclor
	CELIPRESS	Celiprolol hydrochloride
	CLORON	Clonazepam
	CORTIDER	Hydrocortisone acetate
	COSAT	Co-trimoxazole
	CRESTON	Rosuvastatin
	DANAMET	Danazol
	DAYPROX	Oxaprozin
	DELOXI	Duloxetine HCl
	DESODIN	Desloratadine
	DEXPOTEN	Dextromethorphan HBr + Pseudoephedrine + Triprolidine HCl
	DEZIDE	Hydrochlorothiazide + Triamterene
	DIALON	Glimepiride
	DIETIL	Orlistat
	DILATOR	Bambuterol
	DORENTA	Diphenhydramine hydrochloride
	EDENIL	Furosemide + Spironolactone
	EFOPAM	Nefopam hydrochloride
	EMEZIN	Meclizine hydrochloride
	EMEZIN PLUS	Meclizine HCl and Pyridoxine HCl
	ESORAL	Esomeprazole
	ETORIX	Etoricoxib
	EXPOTEN	Guaiphenesin+ Pseudoephedrine HCl+ Triprolidine HCl
	EZY XINC	Zinc sulfate monohydrate USP
	FACID	Fusidic acid / Sodium fusidate
	FACID-HC	2% fusidic acid with 1% hydrocortisone acetate
	FENOBAC	Baclofen
	FEOFOL	Ferrous sulfate + Folic acid
	FEOFOL-CI	Carbonyl iron and folic acid
	FEOZIN	Falic Acid USP and Zinc Sulfata Monohydarate USP
	FLUCLOXIN	Flucloxacillin
	FLUCODER	Fluconazole
	FOLVIT	Ferrous sulfate , folic acid, vitamin B-complex and vitamin C
	FOLVIT CI	Carbonyl iron, folic acid, vitamin C, vitamin B complex
	GASNIL	Simethicone USP Paediatric Drops
	GATINOX	Gatifloxacin
	GELICON	Gemfibrozil
	GLUNOR	Metformin hydrochloride
	GLUNOR XR	Metformin hydrochloride
	GTN 2.6 SR	Nitroglycerin
	HANDIRUB	Chlorhexidine Gluconate & Isopropyl Alcohol solution
	HUNNY	Glycerol & Liquid sucrose
	Hi-C	Ascorbic Acid USP
	IRBES	Irbesartan
	KETONIC	Ketorolac tromethamine
	KILMAX	Cefuroxime
	KYNOL	Ketoprofen
	KYNOL D	Dexketoprofen trometamol
	LAMIDIN	Lamivudine
	LAXITOL	Lactitol monohydrate
	LIPICON	Atorvastatin calcium
	LODIBEN	Amlodipine +Benazepril
	LOSECTIL	Omeprazole
	LOSECTIL DR	Omeprazole
	LOSECTIL PFS	Omeprazole
	LOSITA	Escitalopram
	LUMONA	Montelukast
	MEBIDAL	Mebhydroline
	MECOPEN	Mecobalamin
	METCO	Metronidazole
	METOPA	Metformin hydrochloride and Pioglitazone hydrochloride
	MILAM	Midazolam
	MIXAVIT	Cod liver oil with multivitamin
	MUPIRON	Mupirocin
	MYCOFIN CREAM	Terbinafine hydrochloride
	MYCOFIN TABLET	Terbinafine
	NAPROX	Naproxen
	NEOREX	Cefalexin
	NEORICE	Rice Based ORs
	NEOSALINE	Sodium chloride, potassium chloride, trisodium citrate as dihydrate and anhydrous glucose
	NIMODI	Nimodipine
	NOCLOG	Clopidogrel
	NOFICON	Fenofibrate BP Capsula
	NORIUM	Flunarizine
	NRG	Glucose
	ONTIN	Cetirizine
	ORADIN	Loratadine
	ORADIN PLUS
	OSTOCAL	Calcium carbonate
	OSTOCAL D	Calcium carbonate + vitamin D3
	OSTOCAL M	Calcium carbonate + Magnesium + Manganese+ Boron + Zinc + Vitamin-D3 + Copper
	OSTOCAL-C	Calcium Lactate Gluconate INN, Calcium Carbonate USP and Ascorbic Acid (Vitamin-C)
	PANORAL	Pantoprazole
	PARLOX	Sparfloxacin
	PEPTIL-H	Ranitidine
	PEROSA	Permethrin 5% (w/w) creame
	PRIOCIN	Erythromycin
	PRIOVIT	Vit.A + Vit.E + Vit.C
	PROACTIN	Cyproheptadine
	Parisii@osoud.net	parisii
	Parisii@osoud.net	hacker
	QUINOX	Ciprofloxacin
	Quinox DS	Ciprofloxacin
	Quinox XR 1000	Ciprofloxacin
	REOMEN	Clomiphene citrate
	RESTOL	Bromazepam
	RIDON	Domperidone
	ROXIM	Cefixime
	SALOMAX	Salbutamol 100 mcg
	SENSIT	Flupentixol dihydrochloride and melitracen hydrochloride
	SENTIX	Flupentixol dihydrochloride
	SIDOPIN	Amlodipine
	SIDOPLUS	Amlodipine + Atenolol
	SK-CEF	Cephradine
	SK-FLU	Oseltamivir Phosphate
	SK-MOX	Amoxicillin
	SOFTI	Zinc and castor oil
	SOLBION	Vitamin B₁, B₆ & B₁₂
	SOLVITONE	Vitamin B-complex
	SOMINEX	Eszopiclone
	STARIN	Cefpodoxime proxetil
	STOMA	Aluminium hydrox. + Magnesium hydrox.
	SULIDAC	Sulindac
	TAMEN	Paracetamol
	TAMEN-X	Paracetamol and Caffeine
	TELABID	Trifluoperazine +Isopropamide
	TELAZINE	Trifluoperazine
	TIMOTHY	Tiemonium methylsulfate film coated tablet / syrup / injection
	TOPERIN	Tolperisone hydrochloride
	TOPRESS	Metoprolol tartrate
	TOTI	Ketotifen fumarate
	TOZA	Nitazoxanide
	TRIJECT	Ceftriaxone sodium injection
	TUFFOX	Aceclofenac
	TUFNIL	Tolfenamic acid
	TULAC	Lactulose oral solution
	TUMY	Calcium carbonate
	URITOL	Tolterodine tartrate
	UROKIT	Potassium citrate
	UROSIN	Tamsulosin hydrochloride
	VEDILOL	Carvedilol BP Coated Tablet
	VERON	Mebeverine HCl
	VINCET	Vinpocetine
	VIROXI	Aciclovir
	VITRUM GOLD	Multivitamin and multimineral Supplement
	VITRUM SILVER	Multivitamins and Multimineralsl
	VOLMAX	Diclofenac sodium
	XENOXIN	Levofloxacin
	XENTHOL 30	Methyl salicylate 30% & Menthol 8% cream
	XINC	Zinc sulfate
	XINC B	Zinc and vitamin B complex
	ZATRAL	Alfuzosine hydrochloride
	ZEEFOL	Iron+Folic acid+Zinc
	ZEEFOL-CI	Carbonyl iron, folic acid and zinc
	ZILVIT	Zinc,carbonyl iron, folic acid, vitamin B complex and vitamin C
	ZITHROX	Azithromycin dihydrate
	ZOFRA ODT	Ondansetron

Warehouse : Generic

Date :21.06.2010

Instructor : Shujib Biswas, Warehous Officer.

Key Service Benefits Of Warehouse :

Compliance

Fit for purpose facilitiesWritten Standard Operating ProceduresWarehouse personnel are trained in GWP Matters (hygiene, Protective clothing,handling Of Goods, computersystems And Preventativemaintenance Interface and computer systems validation

Increase productivity and efficiency

With an outsourced warehouse, we let you focus on your core business activities and reduce or eliminate your capital investment in non-core areas such as equipment and facilities.

Certainty and reliability

With a proven track record and an impressive customer portfolio, we will work to defined service levels to improve your entire supply chain.

Fast, accurate, detailed

A professional and progressive company, with the added partner resources of POD, Couriers Please, Star Track, Toll, Australia Post, Jet Express and more.

A complete, integrated solution

Supply chain management, leading edge technology and the most comprehensive distribution network available.

Responsive

Dedicated support personnel and regular service reviews ensure that our services continue to provide the best solution for your business needs. We’ll adapt as you grow.

Materials that are stored :

Raw materials ( RM )

Packaging materials ( PM )

Finished goods ( FG )

Functions :

1.Receiving Raw Materials : Receiving raw materials from approved source according to SOP.

2. Storing Materials : Storing raw materials, finished goods and packaging materials.

3. Dispensing : Dispensing raw materials, distributing packaging materials and loading finished products to the booth for marketing.

Central warehouse : warehouse-1 and warehouse-2

Source of RM :

Remo – Big Source

Ganashasthya and Square Pharmaceuticals.

Dealing Documents :

Receiving Record :

Receiving Record No.

Materials Name

Batch No.

Manufacturer

Supplier

Quantity

Remarks

BMR request form

Manufacturing Order

Finished Order

Central Warehouse : Unit- 01

Temperature : CRT ( 15-25 degree celcius )

Observation :

1.Sampling Booth : In Which sampling of raw materials is done.The following raw materials are available that were observed…

Active :161

Excipients : 160

2.Narcotic Station :

Stored according to govt. Regulations. The drugs that are stored in narcotic station are very much potent CNS stimulant and sometimes called controlled drugs.

Stored in a locking system.

Example : Dexpoten , Clonazepam, Pseudoephedrin ( Max. 3000 kg every year )

3. Capsule shell storing ( RH – 25-65% )

Raw Materials Room Ext – 01: Active materials at CRT condition

Raw Materials Room Ext – 02: Active materials at CRT condition

Raw Materials Room Ext – 03: Active materials at CRT condition

4. Packing Materials Ext-01 :

Bottle label

Leaflet

Zinc syrup

Dexpoten

5. Packaging Material Ext-02 :

Cap Storing -22, 25, 28

Color : White , Blue, Gold, Brown

Pet bottle

Central Warehouse : Unit -02

Temperature : Ambient ( below 40 degree celcius )

Observation :

Maximum-Minimum thermometer

Log book

Cold room

Temperature range : 2-8 degree celcius.

Observed temperature : 5 degree celcius.

Stored materials : Na frusitate, Benzyl alcohol, Injectables.

Cool room

Temperature range : 8-15 degree celcius.

Observed temperature : 12 degree celcius.

Stored Materials : Omeprazol E.C Pellates, Mg powder, Flavor’s, orange flavor powder, Essence, etc.

Shelf block

Contains : Glass bottle, Plastic bottle, Raw materials that are not degraded in ambient conditions.

Solvent Room ( SR ) :

Temperature : Ambient

Stored Solvent :

Methanol , Ethanol, Nitric Acid, HCl, isopropile alcohol, carbon tetrachloride, etc.

Miscellaneous bottle Stored -1 :

Bottle ( Bengal bottle from Hindustan )

EGC shell Room.

Warehouse : Cepha Block

21.06.2010

Entering the Cepha block :

Instructor : Nazir , Warehouse Officer , Cepha block

Cephalosporine Collection :

Active materials : Various generations of cephalosporin

Excipients :

Methyl hydroxy benzoate

Propylene glycol

Arocef – 500

Etc

Cold room

Temperature range : 2-8 degree celcius.

Observed temperature : 5 degree celcius.

Stored materials : Benzyl alcohol, Injectables.

Cool room

Temperature range : 8-15 degree celcius.

Observed temperature : 12 degree celcius.

Stored Materials : Cefradin with l-Arginine, Flavor’s, orange flavor powder, Essence, etc.

Room – 2003 :

Flip off Seal. Eg- Triject 500

Cap Color : Golden, Pink, Sky.

Cap Size : 22, 25, 26, 28

Bottle Size : 70, 75, 100 ml

Room – 2005 :

Engineering work shop : Change Part.

Room -2007 :

Master Carton size : 48-130

Syringe disposable

Master Carton specifications : Tablet, Capsule, PFS, Injections.

Room – 2008 :

Vial : 7.5, 15, 30 ml

Rubber Stopper – Blue color

Flip off seal

Carton

Leaflet

Room – 2013 :

Simplification : Finished Goods ( FG )

Eg : SK-Cef ( Cefixim 500mg )

Master Carton : 24*100

Shelf-Life : PFS -2 years, Injectable-3 years.

Room- 2125 :

Simplifications : Buffer Room

Utilization : Mainly for finished goods delivery.

Room – 2126 :

Simplifications : Waste disposal room

Utilization : For storing waste products with waste packaging materials

Production : Solid Dosage Form

Unit : Manufacturing Unit – 02

Date : 02.02.2010

Entering Procedure :

Instructor : Ishtiaq Ahmed, Asst. Manager, MU – 2

Wet granulation :

Wet granulation is a process of using a liquid binder to lightly agglomerate the powder mixture. The amount of liquid has to be properly controlled, as over-wetting will cause the granules to be too hard and under-wetting will cause them to be too soft and friable. Aqueous solutions have the advantage of being safer to deal with than solvent-based systems.

Procedure

Step 1: The active ingredient and excipients are weighed and mixed.

Step 2: The wet granulate is prepared by adding the liquid binder–adhesive to the powder blend and mixing thoroughly. Examples of binders/adhesives include aqueous preparations of cornstarch, natural gums such as acacia, cellulose derivatives such as methyl cellulose, gelatin, and povidone.

Step 3: Screening the damp mass through a mesh to form pellets or granules.

Step 4: Drying the granulation. A conventional tray-dryer or fluid-bed dryer are most commonly used.

Step 5: After the granules are dried, they are passed through a screen of smaller size than the one used for the wet mass to create granules of uniform size.

Low shear wet granulation processes use very simple mixing equipment, and can take a considerable time to achieve a uniformly mixed state. High shear wet granulation processes use equipment that mixes the powder and liquid at a very fast rate, and thus speeds up the manufacturing process. Fluid bed granulation is a multiple-step wet granulation process performed in the same vessel to pre-heat, granulate, and dry the powders. It is used because it allows close control of the granulation process.

Dry granulation :

Dry granulation processes create granules by light compaction of the powder blend under low pressures. The compacts so-formed are broken up gently to produce granules (agglomerates). This process is often used when the product to be granulated is sensitive to moisture and heat. Dry granulation can be conducted on a tablet press using slugging tooling or on a roll press called a roller compactor. Dry granulation equipment offers a wide range of pressures to attain proper densification and granule formation. Dry granulation is simpler than wet granulation, therefore the cost is reduced. However, dry granulation often produces a higher percentage of fine granules, which can compromise the quality or create yield problems for the tablet. Dry granulation requires drugs or excipients with cohesive properties, and a ‘dry binder’ may need to be added to the formulation to facilitate the formation of granules.

Direct Compression :

The term “direct compression” is defined as the process by which tablets are compressed directly from powder mixture of API and suitable excipients. No pretreatment of the powder blend by wet or dry granulation procedure is required.

The events that motivates the industry people to use direct compression technique

I.Commercial availability of the directly compressible excipients possessing both good compressibility and good flowability.

SorbitolÒFor example, Spray dried lactose, Anhydrous lactose, Starch-1500, microcrystalline cellulose, Di-Pac

II. Major advances in tablet compression machinery,

i) Improved positive die feeding

ii) Precompression of powder blend

Merits

i)Direct compression is more efficient and economical process as compared to other processes, because it involves only dry blending and compaction of API and necessary excipients.

ii)The most important advantage of direct compression is economical process.Reduced processing time, reduced labor costs, fewer manufacturing steps, and less number of equipments are required, less process validation, reduced consumption of power.

iii)Elimination of heat and moisture, thus increasing not only the stability but also the suitability of the process for thermolabile and moisture sensitive API’s.

iv)Particle size uniformity.

v)Prime particle dissolution.

In case of directly compressed tablets after disintegration, each primary drug particle is liberated. While in the case of tablets prepared by compression of granules, small drug particles with a larger surface area adhere together into larger agglomerates; thus decreasing the surface area available for dissolution.

vi)The chances of batch-to-batch variation are negligible, because the unit operations required for manufacturing processes is fewer.

vii)Chemical stability problems for API and excipient would be avoided.

viii)Provides stability against the effect of aging which affects the dissolution rates.

Merits over wet granulation process

The variables faced in the processing of the granules can lead to significant tableting problems. Properties of granules formed can be affected by viscosity of granulating solution, the rate of addition of granulating solution, type of mixer used and duration of mixing, method and rate of dry and wet blending. The above variables can change the density and the particle size of the resulting granules and may have a major influence on fill weight and compaction qualities. Drying can lead to unblending as soluble API migrates to the surface of the drying granules.

Pharmaceutical Manufacturing

Containment Interfaces (Hicoflex®)

Tablet Coating

Room : P- 23

Specifications : Wash Bay -2

Pressure Difference : 10-30 pas ( between corridor and room )

Instrument and materials :