OVERVIEW OF TABLET PRODUCTION PROCESS & TABLET COMPRESSION MACHINERY,I

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OVERVIEW OF TABLET PRODUCTION PROCESS & TABLET COMPRESSION MACHINERY,ITS MAINTENANCE :

OVERVIEW OF TABLET PRODUCTION PROCESS & TABLET COMPRESSION MACHINERY,ITS MAINTENANCE Presented to Presented bY Mr . A mit Porwal Kamalesh tripathi Faculty of pharmacy M.Pharm (2 nd sem )

OVERVIEW OF TABLET PRODUCTION PROCESS:

OVERVIEW OF TABLET PRODUCTION PROCESS

ORDERING:

ORDERING BEGINGS OF WORK ORDER OR SUPPLY PLAN. GENERATION OF APPROVED BILL OF MATERIAL (BOM). BOM AS PER MFR. ACTIVE VENDOR APPROVED PROGRAM.

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ADVANTAGES: REDUCTION IN REJECTED MATERIAL. REDUCTION IN LABOR LOSSES. PROCESS COST REDUCTION. FOLLOW-UP OF GMP AND OTHER GUIDELINES.

RECEIVING:

RECEIVING MATERIAL RECEIVED AS PER ORDER. ORDER LIST INCLUDE COMPONENT CODE,NAME,PURCHASE ORDER NUMBER,VENDOR LOT NUMBER. GENERATION OF RECEIVING NUMBER. MARKING OF ALL RECEIPT AS PER CGMP & COMPANY POLICY .

SAMPLING:

SAMPLING A SEPARATE AREA,CENTRAL TO RECEIVING AREA ,TO TAKE SAMPLES. SAMPLE MUST BE TAKEN BY QC PERSON IN PRESENCE OF QA PERSON. PROPER DOCUMENT MAINTAIN REGARDING SAMPLE,QUANTITY,PERSON,TIME. TAKEN SAMPLE MUST BE LABELLED. RM MUST BE LABELLED UNDER TEST .

WAREHOUSE:

WAREHOUSE CLEARLY MARKED QUARANTINE MATERIAL ARE STORED IN A SEPARATE AND IDENTIFIED STORAGE AREA. INVENTORY SHOULD KNOWN AT ALL TIME. PROPER STORAGE OF ALL MATERIAL AS PER SPECIFIED CONDITIONS. HANDLING OF REJECTED MATERIAL. PROPER LABELLING .

DISPENSING:

DISPENSING WELL DESIGNED WEIGHING AREA. HAVING ADEQUATE DUST COLLECTION EQUIPMENT. PROPER CLEANING & DOCUMENTATION. SEQUENTIAL WEIGHING. EQUIPMENT MUST BE CALIBRATED. GENERATION OF WEIGHING TICKETS OR CODE LABELLING. APPROVAL OF QA .

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MAINTAINENCE OF INVENTORY. PROPER RECONCILIATION. PROCESS IMPROVED BY AUTOMATED DISPENSING & WEIGHING EQUIPMENT. PROPER GOWNING IS NECESSARY FOR FOLLOW-UP OF CGMP.

GRANULATING:

GRANULATING MATERIAL VERIFICATION BY VISUAL INSPECTION. AREA MUST BE CLEANED,INSPECTED & CERTIFIED TO ASSURE NO-CROSS OVER. ALL CONTAINERS & EQUIPMENTS MUST BE CLEAN & IDENTIFIED. MAITAINENCE OF RECORD(BMR) AT EACH & EVERY STEP. RECONCILIATION AT THE END OF EACH STEP AND VERIFIED. TAGGING OF THE BLEND.

PROCESSING TECHNIQUES:

PROCESSING TECHNIQUES DIRECT COMPRESSION DRY GRANULATION WET GRANULATION COMBINATION PROCESS

TABLET COMPRESSION:

TABLET COMPRESSION IMPORTANT FACTORS: SIZE OF TABLET QUALITY OF BATCH EASE OF COMPRESSIBILITY AGRESSIVENESS OF PRODUCT COST OF PROCESS WILL DETERMINE THE TABLET PRESS USED AND TOOLING REQUIRED.

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CLEANING OF COMPRESSION AREA SUFFICIENT SIZE FOR FREE FLOW OF MATERIAL. CONTROL ON DUST PRESENCE OF IN-PROCESS CHEKING EQUIPMENT. MAINTAINENCE OF DOCUMENT. LINE CLEARENCE MUST BE TAKEN FOR COMPRESSION PROCESS. APPROVAL OF QA & PROPER SAMPLING AT APPROPRIATE TIME.

TABLET COATING:

TABLET COATING APPLICATION OF A COATING COMPOSITION TO A MOVING BED OF TABLET WITH THE CONCURRENT USE OF HEATED AIR TO FACILITATE EVAPORATION OF THE SOLVENT.

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ADVANTAGES: TO MASK TASTE,ODOUR OR COLOUR OF DRUG PHYSICAL AND CHEMICAL PROTECTION OF DRUG. CONTORL THE RELEASE OF DRUG. PROTECTION OF DRUG. IMPROVEMENT OF PHARMACEUTICAL ELEGANCE.

CONVENTIONAL PAN:

CONVENTIONAL PAN USE OF SOLID WALL COATING PAN PRESENCE OF WARM AIR INLET AND AN EXHAUST DUCT. POURING OR ATOMIZATION OF COATING SOLUTION TO TABLET BED.

PERFORATED PAN:

PERFORATED PAN REMOVE TECHNICAL PROBLEMS OF PREVIOUS ONE. PRESENCE OF WARMED DRY AIR WITH EXHAUST AIR THROUGH PERFORATION IN THE WALL OF PAN. ATOMIZATION OF COATING SOLUTION BY SPRAY GUN. MICROPROCESSOR CONTROL SYSTEM HAVE BEEN DEVELOPED.

WURSTER COLUMN COATING:

WURSTER COLUMN COATING HEAT SOURCE ANG AGITATION OF COATING BY FLUIDIZATION AIR. ATOMIZATION BY SPRAY NOZZLE. MOVEMENT OF SUBSTRACT. EFFECTIVE FOR SMALL TABLET,SPHERES. LIMITATION IS SMALLER POTENTIAL BATCH SIZE AND CAPITAL EXPENSE OF EQUIPMENTS.

VALIDATION:

VALIDATION IT IS THE ESTABLISHING DOCUMENTED EVIDENCE WHICH PROVIDE A HIGH DEGREE OF ASSURANCE THAT A SPECIFIED PROCESS WILL CONSISTENTLY PRODUCE A PRODUCT MEETING ITS PREDETERMINED SPECIFICATION AND QUALITY ATTRIBUTES.

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ADVANTAGES: CLEANICAL EFFICIENCY AND SAFETY OF DOSES FORM. CONTROL ON PHYSICAL CHARACTERISTICS OF DRUG. REPRODUCEBILITY OF PROCESS. REDUCTION IN OVERALL PROCESS COST. MINIMIZATION OF WASTAGE. FOLLOW-UP OF REGULATORY GUIDELINES & SOP.

ELEMENTS THAT SHOULD BE CONSIDERED-:

ELEMENTS THAT SHOULD BE CONSIDERED- RAW MATERIALS: PHYSICAL CHARACTERISTICS OF RM FOR CONTENT UNIFORMITY AND BIOAVAILABILITY. RM CHARACTERISTICS. MAINTAINENCE OF DOCUMENT. CONTROL ON DISSOLUTION.

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REPRODUCEBLITY OF MANUFACTURING PROCESS: FOLLOW-UP OF SOP FOR EACH & EVERY STEP OF PROCESS. TIME INTERVAL AND OTHER PROCESS PARAMETERS SHOULD BE SAME IN EVERY BATCH. EQUIPMENTS: MINIMIZATION OF ERRORS (BY PRE-SCREENING AND CONTOLLING THE TEMPERATURE AND HUMIDITY). EQUIPMENT CALIBRATION AND QUALIFICATION. MAINTAINENCE OF DOCUMENTS.

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PROCESS CONTROL TESTING: ASSURENCE OF PROCESS UNIFORMITY. IN-PROCESS SAMPLING AND TESTING. VALIDATION OF PROCESS. STABILITY PROFILE. MAKING PROPER ENTRY IN RECORD BY MEANS OF SIGNING AND ADDING TIME AS PER SOP.

TOOLING CONTROL:

TOOLING CONTROL INSPECTION OF PUNCH AND DIE. SUITABLE STORAGE OF PUNCH AND DIE. PROPER MAINTENANCE OF PUNCH AND DIE RECORD CARD.

PACKAGING:

PACKAGING SEPARATION OF PACKAGING LINES(15 Ft. BETWEEN TWO LINES BY PARTITION). AVOIDENCE OF CROSS CONTAMINATION. UNIDIRECTIONAL FLOW. SOP FOR EACH AND EVERY OPERATION. PROPER DOCUMENTATION. LINE CLEARENCE FROM QA.

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UNIDIRECTIONAL MATERIAL FLOW

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END OF PACKING PRODUCTION ORDER: RECONCILIATION OF BATCH. COLLECTION OF RECOVERABLE MATERIAL. DESTRUCTION OF REJECTED MATERIAL. PROPER STORAGE OF FINISHED PRODUCT.

TABLET COMPRESSION MACHINERY AND ITS MAINTENANCE:

TABLET COMPRESSION MACHINERY AND ITS MAINTENANCE

MACHINE TOOLING:

MACHINE TOOLING FOLLOWED BY THREE DIFFERENT STANDARDS TSM STANDARDS EURO STANDARDS JAPANEESE STANDARDS

EURO STANDARDS:

EURO STANDARDS TOOLING PUNCH DIA(IN mm) DIE DIA (IN mm) SIZE FOR ROUND( mm) SIZE FOR SHAPE (mm) TYPE STAGE M/C PRESSURE (TON) D 25.4 38.1 25 25 SR DR 16,20 27,29,37 10 B 19 30.15 16 19 DR 27,37,45,55 8 BB 19 24 13 14 DR 41,45,69,79 7-8 DB 25.4 30.15 19 19 SR 23 ……….

CHEMICAL COMPOSITION OF TOOL STEEL:

CHEMICAL COMPOSITION OF TOOL STEEL AISI CARBON MAGNESE SILICON CHROMIUM VANADIUM TUNGSTEN MOLYBDENUM NICKEL COBALT D2 1.4-1.6 .00-.60 .00-.60 11-13 .00-1.10 ----- .7-1.2 ----- .00-1 D3 2-2.35 .00-.60 .00-.60 11-13.5 .00-1.0 .00-1.O ------ ------- ------- O1 .90 1.2 .40 .50 .2 .2 ------ -------- --------

COMBINATION USED FOR PUNCH & DIE:

COMBINATION USED FOR PUNCH & DIE TOOL AISI HARDNESS (ROCKWELL “C” SCALE) PUNCH O1 (OHNS) 58-59 DIES D3 (HCHC) 61-62 HIGHLY ABRASIVE PRODUCT PUNCH D2 (HCHC) 54-60

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MATERIAL OF CONSTRUCTION RESULTS IN OHNS PUNCH + HCHC DIE= 4 MILLION TAB. HCHC PUNCH + HCHC DIE = 7.5 MILLION TAB. COMPLETE HARD CHROME PLATING PUNCH + HCHC DIES = 8.5 MILLION TAB.

MAINTENANCE:

MAINTENANCE INCOMING & ROUTINE INSPECTION INSTRUMENTS INSPECTING POINTS DIAL INDICATOR BARREL TIP,HEAD & NECK DIA OF PUNCH,HEIGHT & OUTSIDE DIA OF DIE TELESCOPE GAUGE OR PLUGGAGES DIE BORE MAGNIFYING GLASS ROUGH SPOT DETECTION IN PUNCH FACE EMBOSSING OPTICAL COMPARATOR DIMENSIONAL MEASUREMENT ROCKWELL HARDNESS CHECKER MEASURES STEEL HARDNESS MAGNAFLUX TO CHECK MINUTE CRACK OR FLAWS THAT ARE NOT READILY APPEARS

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CLEANING USE OF TEEPOL SOLUTION 0.1 % + PURIFIED WATER + PLASTIC SCRUBBER. COLLECTION OF RINSE & SWAB SAMPLE. DISINFECTION OF PUNCH WITH 70% IPA. USE OF FILTERED COMPRESSED AIR . AVOID USE OF METAL SCRUBBER TO AVOID SCRATCHES & MARK LINES ,ROUGHNESS ON PUNCHES & DIES.

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LUBRICATION LUBRICATION IS DONE BY FOOD GRADE OIL (CASTER OIL,LIQ. PARAFFINS) BUT RANCIDITY IS MAIN PROBLEM,SO GREASES & LUBRICANTS BOTH ARE USED. e.g. ET-2S GREASE ET-10S LUBRICANT ET-20SLUBRICANT ET-90S LUBRICANT ET-140S LUBRICANT HT-100G HIGH TEMPERATURE NON MELTING GREASE

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HANDLING & STORAGE OF TOOLING USE OF PUNCH HANDLING BOX (WOOD OR METAL) APPROVED CLEANING PROCEDURE INSPECTIN OF ABNORMAL WEAR USE OF RUST PROOF OIL SPECIAL ATTENTION ON RUST TO AVOID CORROSION

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TOOL & DIE CONTROL RECORDING THE HISTORY OF TOOL USED PROPER DOCUMENTATION AS PER SOP MAINTENANCE OF PUNCH AND DIE RECORD CARD

WEAR AND TEAR OF PUNCHES AND DIE:

WEAR AND TEAR OF PUNCHES AND DIE PERIODICAL CHECKING OF PUNCHES AND DIES FOR ANY CHANGE ,DAMAGE AND POLISHING IS TERMED AS WEAR AND TEAR.

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MOTORISED CHUCK FOR CLEANING ,POLISHING OF CONCAVE,PLAIN PUNCHES & CLEANING OF PUNCH TIP/BARREL/HEAD. HIGH SPEED GRINDER POLISHING PLAIN CONCAVE PUNCH & DIE BORES. MICRO-POLISHING PASTE FOR MICRO-POLISHING RADIUS GAUGES FOR CHECKING PUNCH TIP CURVATURE & POLISHING BOB FORMS. CHALK POWDER DRYING OFF POLISHING COMPOUNDS FOR PUNCH TIP. LUBRICANTS FOR LUBRICATION. COTTON WOOL FOR CLEANING.

CHECKING PARAMETERS:

CHECKING PARAMETERS PARAMETERS SPECIFICATIONS OVERALL LENGTH WITHIN LIMITS INSIDE HEAD ANGLE SHOULD BE SMOOTH,NOT TO BE WARNED OUT DUE TO FRICTION FLAT HEAD SMOOTH BODY DIAMETER WITHIN LIMITS PUNCH TIP SMOOTH,NOT TO BE WARNED OUT DUE TO FRICTION IMBOSING LETTER & BREAK LINE SHARP AND INTACT OUTER DIA WITHIN LIMITS INSIDE CAVITY FINISHING MIRROR FINISHED & SMOOTH DIE GROOVE & CHAMBER PROPER ,SMOOTH & APPROPRIATE DIE HEIGHT WITHIN LIMITS

CONCLUSION:

CONCLUSION HENCE WE CAN CONCLUDE THAT THE OVERVIEW OF TABLET PRODUCTION INVOLVES A SYSTEMATIC APPROACH TOWARDS THE PRODUCTION OF TABLET BY MINIMIZING PROCESS VARIABLES AND CONTAMINATION & REDUCE OVERALL PRODUCTION COST AND IMPROVE QUALITY OF PHARMACEUTICAL DOSAGE FORM TO AVOID ANY CONFLICTS BY FOLLOWING THE GMP.

REFERENCE:

REFERENCE LIBERMAN A. HERBERT ,LACHMAN LEON,SCHWARTZ B.JOSEPH “PHARMACEUTICAL DOSAGE FORM:TABLETS” VOL.3,2 nd EDITION ,PAGE NO.370-389. LIBERMAN A. HERBERT ,LACHMAN LEON,KANIG B.JOSEPH “THE THEORY & PRACTICE OF INDUSTRIAL PHARMACY”3 rd EDITION 1990,PAGE NO.303-308,348-354.

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QUERIES ????

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