logging in or signing up packaging in pharmaceuticals-jayprakash nogaja jpnogja Download Post to : URL : Related Presentations : Share Add to Flag Embed Email Send to Blogs and Networks Add to Channel Uploaded from authorPOINT lite Insert YouTube videos in PowerPont slides with aS Desktop Copy embed code: (To copy code, click on the text box) Embed: URL: Thumbnail: WordPress Embed Customize Embed The presentation is successfully added In Your Favorites. Views: 757 Category: Education License: All Rights Reserved Like it (4) Dislike it (0) Added: May 30, 2011 This Presentation is Public Favorites: 4 Presentation Description Packaging in pharmaceuticals ,types,materials,evaluation ,QC Test ,etc Comments Posting comment... By: mahankrishna (7 month(s) ago) hello sir.. plz can u send me a copy of the presentation on deepak0588@gmail.com.. thank you sir. Saving..... Post Reply Close Saving..... 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Slide 2: Contains General introduction to pharmaceutical packaging Types of packaging Importance of packaging Materials of packaging (Primary packaging) Container and closure Selection of packaging material Types of primary packaging Quality control test for container Quality control test for rubber closure Conclusion Reference 2 Slide 3: “Packaging can also be defined as the collection of different components which surround the pharmaceutical product from the time of production until its use .” It is the means economically providing :- Presentation . Identification . Protection . Convenience . Stability during storage . Dose defining . Ease to Transportation . PACKAGING 3 Slide 4: Primary packaging Is the material that envelopes the product and holds it. This usually is the smallest unit of distribution or use and is the package which is in direct contact with the contents Types of Packaging : 4 Slide 5: Secondary packaging Is outside the primary packaging-perhaps used to group primary packages together. 5 Slide 6: Tertiary packages Is used for bulk handling, warehouse storage and transport shipping. The most common form is a palletized unit load that packs tightly into the container. 6 Slide 7: Importance of packaging Protect against all adverse external influences (Light ,Moisture, Oxygen ,Mechanical damage) that can alter the properties of the product. Protect against biological contamination. Protect against physical damage. Carry the correct information and identification Tamper evident / Child resistance . 7 Slide 8: MATERIALS OF PACKAGING Glass Metals Rubber Plastics Fibrous materials Foil, Film, & Laminates 8 Slide 9: Glass is composed of sand (silica), soda ash, limestone & cullet. Si, Al, B, Na, K, Ca, Mg, Zn, Ba and oxides are generally used for the preparation of glass. Advantage : Disadvantage : GLASS AS PACKAGING MATERIAL (Bottles ,Ampoules ,Vials ,Prefilled injection) 9 Pharmaceutical classification of Glass : Pharmaceutical classification of Glass 10 Slide 11: They are synthetic polymers of high molecular weight. PLASTICS AS PACKAGING MATERIAL Thermoplastic type :- polyethylene ,PVC ,Polystyrene ,polypropylene ,Polyamide ,Polycarbonate ,PMMA Thermosetting type :- Phenol formaldehyde ,urea formaldehyde, malamine formaldehyde 11 Slide 12: METALS AS PACKAGING MATERIAL The thickest Aluminium ,Tin are rigid e.g. Aerosol Can. Intermediate thickness steel important but the pack should be capable of being deformed under a resonable force. e.g. Collapsible tube for semisolid preparations. Thinnest Aluminium is used in the flexible fills. (blister package) Closure Crimping & Screw caps of container 12 Slide 13: RUBBER AS PACKAGING MATERIAL Rubbers are excellent material for forming seal ,so they are used almost exclusively to form closures such as bungs for vials or as gasket in aerosol can. Those are consist of two types :- Natural. Synthetic. 13 Slide 14: FIBROUS PACKGING MATERIALS Paper and board are used in Secondary & Tertiary packaging mainly They are used for preparing outer containers such as cartons, boxes, envelopes. Lable printing material . 14 Slide 15: FOILS, FILMS & LAMINATES AS PAKAGING MATERIAL Foil :- The most important metal for application is Aluminium. Films :- Cellophane is an attractive transparent film which can be coloured & printed upon so it is useful as outer wrap. Laminates :- Laminates are used to combine the properties of individual foil & films & strictly are made by bonding the layer with adhesive. 15 Slide 16: CONTAINERS & CLOSURES CONTAINERS : Pharmaceutical containers has been defined as a device that holds the drugs or it may or may not be indirect contact with the pharmaceutical preparation. TYPES OF CONTAINERS : Well closed containers. Single dose containers. Multiple dose containers. Light resistance containers. Airtight containers. Aerosol containers. Hermetically Sealed 16 Slide 17: CLOSURES : An effective closure must prevent the contents from escaping the products from the container and avoid entry of external environment . TYPES OF CLOSURES : Plug Type. Crown Type. Push Type. Screw Type. 17 Slide 18: Choosing appropriate primary pack : Hygroscopicity Physical degradation Chemical degradation Drug release properties Mechanical properties Photosensitivity Gas liberation tendency Dimensional aspects Product characteristics / Sensitivity Selection of Packaging Material Light barrier requirements. Gas barrier requirements. Chemical properties. Moisture barrier requirements. 18 Slide 19: Choosing The Most Appropriate Pack 19 Slide 20: TYPES OF PRIMARY PACKAGING Solid Products Semi-solid Products Liquid Products Unit packs Child resistance packaging Tamper resistance packaging 20 Slide 21: SOLID PRODUCTS : Tablets ,Capsules ,Powder or granules (packed as a dosage form in flexible sachets.) 21 Slide 22: SEMI-SOLID PRODUCTS : They are often too viscous to flow but contain a sufficient amount of water to be classified as “wet” products. Include creams, emulsions, gels, or ointments. Flexible tubes are frequently used 22 Slide 23: LIQUID PRODUCTS : Traditionally glass and a variety of plastics are used Oral liquids ,parenteral liquids. UNIT PACKS : Unit Packs in which individual dosage are separated from each 23 Slide 24: CHILD RESISTANCE PACKAGING : Work on one of the two principles : Certain degree of strength will be required to open the product. High degree of manual co-ordination is required. TAMPER RESISTANCE PACKAGING : Tamper resistance can be conferred on a pack by using a roll on closure which has a perforated collar which grips on to a lip on the bottle neck & these perforations must be broken before the cap can be unscrewed. 24 Slide 25: QC TEST FOR CONTAINERS 1) Material Quality - Arsenic ,Zinc ,Tin ,Barium ,Heavy metal contain ,Non volatile residue / Residue on ignition ,Sulphated ash ,Chemical composition 2 )Dimensional Conformity – Height ,Diameter ,Wall thickness Variation ,Concentricity of opening , finish Shape ,Internal neck diameter ,Over flow capacity 3) Surface integrity - Absence of irregularities ,scraches , Blisters Chipped edges . 25 Slide 26: 4 ) Chemical / Hydrolytic resistance / limit of alkalinity - Powdered / Crushed Glass test. Water attach /Whole container test . 5 ) Thermal shock resistance test . 6 )Vapors permeability test . 7 ) Light permeability /Transparency /Protection from light test. 8 ) Collapsibility Test . 9) Test for clarity of aqueous extract 10 ) Organic extracts 26 Hydrolytic resistance Test Water attach test /alkali leach test/ : Hydrolytic resistance Test Water attach test /alkali leach test/ Powdered / Crushed Glass test. (Intrinsic chemical durability test) 27 Slide 28: Water attach / Whole container test . 28 Standards : : Standards : Volume of extract to be used for titration : 29 Slide 30: Water vapor permeability test : Take 5 container filled with distilled water and sealed properly either by fusion or covering with aluminumfoil Weigh accurately and note it Allow to stand for 14 days At 60±5 % relative humidity and temp.20 to 25ºc Light permeability /Transparency /Protection from light test : By using Spectrophotometer Transmittance of wave length between 290 to 450 nm Is determined continuously or at the interval of about 2nm Standard-The loss in the weight in each container is NMT0.2 % 30 Slide 31: Collapsibility test : This test is applicable container which are squeezed in order to remove contains. Standard -A container by collapsing inward during use yield at least 90% of it nominal mentioned at ambient temp. Clarity of Aqueous extract : Select suitable no .of unmarked ,unlabeled container Sufficient to yield 1250 cm²transfer to the flask previously cleaned add 250 ml distilled water Cover flask with beaker and autoclaved at 121º C Carry out blank examining for free from turbidity 31 Slide 32: Test on residue on ignition Take 5 gm of container cut in to pieces transferred to tared crucible and ignited to constant weight in muffle furnace at 800± 25ºc Allow crucible to cool in desicater Standard-NMT 0.1 % residue . Leakage Test Fill 10 container with distilled water closed with closure Keep them inverted for 24 hrs Standard –There is not a single drop will come out. 32 Slide 33: QC TEST FOR RUBBER CLOSURE 1 ) Physical dimension ( treated & untreated ) 2 ) Particulate matter /Clarity of aq.extract 3 ) Sterilization test 4 ) pH of aq. Extract (after and before sterilisation) 5 ) Compatibility 6 ) Fragmentation test 7 ) Self sealability 8 ) Residue on evaporation 9 ) Chemical composition 33 Slide 34: Sterilization test After sterilisation the closures are checked versus untreatde samples to detect swelling colour change and hardness … Particulate matter /Clarity of aq.extract Pretreatment to closure washing ,autoclaving at 121̊c for 30 min. Place 400ml in 1 lit. flask. Add sufficient no .of closure to provide a total exposed surface area appximately 200cm² shake the flask and quickly withdrow 50 ml of aliquit .Transferred onto a prewashed ,preweighed 0.45um membrane filter . Partials is washed with 10 ml fresh distill water . Dried to constant weight & membrane is weighed and viewed under microscope at a10X magnification 34 Slide 35: Conclusion : Packaging is one of the most important part of pharmaceutical industries . Product produced is might be of vary good quality at the time production but it is useless if is not able to reach as it is up to end user. Quality Maintenance is the major role played by packaging material .Along with that it gives pharmaceutical elegance and convenience to user to product . Many times the Packaging is may become a ideal unique identification for some of brand in market .Quality control of such important part is also a vary valuable work. 35 Slide 36: References 1 ) Lion Lachman ,Harbert A. Libeberman ,Joseph L.Kanig “The Theory andPractice of Industrial Pharmacy “ ,Varghese puplishing house ,Thied edition 1991,Pg-644-651 2) Pharmaceutical Dosage Forms: parenteral medications, 2nd edition, Edited by K. E. Avis, H.A. Lieberman, Leon Lachman, vol.1, Page no.249-282, vol.2, Page no. 1-92. 3) Remington, The Science & Practice of pharmacy, 21st edition, Vol.1, Page no.780-806. 4) Indian pharmacopoeia 1996,vol-2 ,page no - 36 You do not have the permission to view this presentation. In order to view it, please contact the author of the presentation.
packaging in pharmaceuticals-jayprakash nogaja jpnogja Download Post to : URL : Related Presentations : Share Add to Flag Embed Email Send to Blogs and Networks Add to Channel Uploaded from authorPOINT lite Insert YouTube videos in PowerPont slides with aS Desktop Copy embed code: (To copy code, click on the text box) Embed: URL: Thumbnail: WordPress Embed Customize Embed The presentation is successfully added In Your Favorites. Views: 757 Category: Education License: All Rights Reserved Like it (4) Dislike it (0) Added: May 30, 2011 This Presentation is Public Favorites: 4 Presentation Description Packaging in pharmaceuticals ,types,materials,evaluation ,QC Test ,etc Comments Posting comment... By: mahankrishna (7 month(s) ago) hello sir.. plz can u send me a copy of the presentation on deepak0588@gmail.com.. thank you sir. Saving..... Post Reply Close Saving..... Edit Comment Close By: jignesh979 (10 month(s) ago) hello sir.. plz can u send me a copy of the presentation on jignesh979@gmail.com.. thank you sir... Saving..... Post Reply Close Saving..... Edit Comment Close By: SunnyXav (11 month(s) ago) SIR PLZ SEND ME THIS PPT ON MY ID shrutigangwar10@gmail.com Saving..... Post Reply Close Saving..... Edit Comment Close Premium member Presentation Transcript Slide 1: PACKAGING OF PHARMACEUTICAL PRODUCTS 1 (Major Emphasis On Parenteral Dosage Form Packaging ) A Seminar By, Mr. Jayprakash S.Nogaja M. Pharm-I (PHARMACEUTICS) SVERI’s College Of Pharmacy,Pandharpur. Slide 2: Contains General introduction to pharmaceutical packaging Types of packaging Importance of packaging Materials of packaging (Primary packaging) Container and closure Selection of packaging material Types of primary packaging Quality control test for container Quality control test for rubber closure Conclusion Reference 2 Slide 3: “Packaging can also be defined as the collection of different components which surround the pharmaceutical product from the time of production until its use .” It is the means economically providing :- Presentation . Identification . Protection . Convenience . Stability during storage . Dose defining . Ease to Transportation . PACKAGING 3 Slide 4: Primary packaging Is the material that envelopes the product and holds it. This usually is the smallest unit of distribution or use and is the package which is in direct contact with the contents Types of Packaging : 4 Slide 5: Secondary packaging Is outside the primary packaging-perhaps used to group primary packages together. 5 Slide 6: Tertiary packages Is used for bulk handling, warehouse storage and transport shipping. The most common form is a palletized unit load that packs tightly into the container. 6 Slide 7: Importance of packaging Protect against all adverse external influences (Light ,Moisture, Oxygen ,Mechanical damage) that can alter the properties of the product. Protect against biological contamination. Protect against physical damage. Carry the correct information and identification Tamper evident / Child resistance . 7 Slide 8: MATERIALS OF PACKAGING Glass Metals Rubber Plastics Fibrous materials Foil, Film, & Laminates 8 Slide 9: Glass is composed of sand (silica), soda ash, limestone & cullet. Si, Al, B, Na, K, Ca, Mg, Zn, Ba and oxides are generally used for the preparation of glass. Advantage : Disadvantage : GLASS AS PACKAGING MATERIAL (Bottles ,Ampoules ,Vials ,Prefilled injection) 9 Pharmaceutical classification of Glass : Pharmaceutical classification of Glass 10 Slide 11: They are synthetic polymers of high molecular weight. PLASTICS AS PACKAGING MATERIAL Thermoplastic type :- polyethylene ,PVC ,Polystyrene ,polypropylene ,Polyamide ,Polycarbonate ,PMMA Thermosetting type :- Phenol formaldehyde ,urea formaldehyde, malamine formaldehyde 11 Slide 12: METALS AS PACKAGING MATERIAL The thickest Aluminium ,Tin are rigid e.g. Aerosol Can. Intermediate thickness steel important but the pack should be capable of being deformed under a resonable force. e.g. Collapsible tube for semisolid preparations. Thinnest Aluminium is used in the flexible fills. (blister package) Closure Crimping & Screw caps of container 12 Slide 13: RUBBER AS PACKAGING MATERIAL Rubbers are excellent material for forming seal ,so they are used almost exclusively to form closures such as bungs for vials or as gasket in aerosol can. Those are consist of two types :- Natural. Synthetic. 13 Slide 14: FIBROUS PACKGING MATERIALS Paper and board are used in Secondary & Tertiary packaging mainly They are used for preparing outer containers such as cartons, boxes, envelopes. Lable printing material . 14 Slide 15: FOILS, FILMS & LAMINATES AS PAKAGING MATERIAL Foil :- The most important metal for application is Aluminium. Films :- Cellophane is an attractive transparent film which can be coloured & printed upon so it is useful as outer wrap. Laminates :- Laminates are used to combine the properties of individual foil & films & strictly are made by bonding the layer with adhesive. 15 Slide 16: CONTAINERS & CLOSURES CONTAINERS : Pharmaceutical containers has been defined as a device that holds the drugs or it may or may not be indirect contact with the pharmaceutical preparation. TYPES OF CONTAINERS : Well closed containers. Single dose containers. Multiple dose containers. Light resistance containers. Airtight containers. Aerosol containers. Hermetically Sealed 16 Slide 17: CLOSURES : An effective closure must prevent the contents from escaping the products from the container and avoid entry of external environment . TYPES OF CLOSURES : Plug Type. Crown Type. Push Type. Screw Type. 17 Slide 18: Choosing appropriate primary pack : Hygroscopicity Physical degradation Chemical degradation Drug release properties Mechanical properties Photosensitivity Gas liberation tendency Dimensional aspects Product characteristics / Sensitivity Selection of Packaging Material Light barrier requirements. Gas barrier requirements. Chemical properties. Moisture barrier requirements. 18 Slide 19: Choosing The Most Appropriate Pack 19 Slide 20: TYPES OF PRIMARY PACKAGING Solid Products Semi-solid Products Liquid Products Unit packs Child resistance packaging Tamper resistance packaging 20 Slide 21: SOLID PRODUCTS : Tablets ,Capsules ,Powder or granules (packed as a dosage form in flexible sachets.) 21 Slide 22: SEMI-SOLID PRODUCTS : They are often too viscous to flow but contain a sufficient amount of water to be classified as “wet” products. Include creams, emulsions, gels, or ointments. Flexible tubes are frequently used 22 Slide 23: LIQUID PRODUCTS : Traditionally glass and a variety of plastics are used Oral liquids ,parenteral liquids. UNIT PACKS : Unit Packs in which individual dosage are separated from each 23 Slide 24: CHILD RESISTANCE PACKAGING : Work on one of the two principles : Certain degree of strength will be required to open the product. High degree of manual co-ordination is required. TAMPER RESISTANCE PACKAGING : Tamper resistance can be conferred on a pack by using a roll on closure which has a perforated collar which grips on to a lip on the bottle neck & these perforations must be broken before the cap can be unscrewed. 24 Slide 25: QC TEST FOR CONTAINERS 1) Material Quality - Arsenic ,Zinc ,Tin ,Barium ,Heavy metal contain ,Non volatile residue / Residue on ignition ,Sulphated ash ,Chemical composition 2 )Dimensional Conformity – Height ,Diameter ,Wall thickness Variation ,Concentricity of opening , finish Shape ,Internal neck diameter ,Over flow capacity 3) Surface integrity - Absence of irregularities ,scraches , Blisters Chipped edges . 25 Slide 26: 4 ) Chemical / Hydrolytic resistance / limit of alkalinity - Powdered / Crushed Glass test. Water attach /Whole container test . 5 ) Thermal shock resistance test . 6 )Vapors permeability test . 7 ) Light permeability /Transparency /Protection from light test. 8 ) Collapsibility Test . 9) Test for clarity of aqueous extract 10 ) Organic extracts 26 Hydrolytic resistance Test Water attach test /alkali leach test/ : Hydrolytic resistance Test Water attach test /alkali leach test/ Powdered / Crushed Glass test. (Intrinsic chemical durability test) 27 Slide 28: Water attach / Whole container test . 28 Standards : : Standards : Volume of extract to be used for titration : 29 Slide 30: Water vapor permeability test : Take 5 container filled with distilled water and sealed properly either by fusion or covering with aluminumfoil Weigh accurately and note it Allow to stand for 14 days At 60±5 % relative humidity and temp.20 to 25ºc Light permeability /Transparency /Protection from light test : By using Spectrophotometer Transmittance of wave length between 290 to 450 nm Is determined continuously or at the interval of about 2nm Standard-The loss in the weight in each container is NMT0.2 % 30 Slide 31: Collapsibility test : This test is applicable container which are squeezed in order to remove contains. Standard -A container by collapsing inward during use yield at least 90% of it nominal mentioned at ambient temp. Clarity of Aqueous extract : Select suitable no .of unmarked ,unlabeled container Sufficient to yield 1250 cm²transfer to the flask previously cleaned add 250 ml distilled water Cover flask with beaker and autoclaved at 121º C Carry out blank examining for free from turbidity 31 Slide 32: Test on residue on ignition Take 5 gm of container cut in to pieces transferred to tared crucible and ignited to constant weight in muffle furnace at 800± 25ºc Allow crucible to cool in desicater Standard-NMT 0.1 % residue . Leakage Test Fill 10 container with distilled water closed with closure Keep them inverted for 24 hrs Standard –There is not a single drop will come out. 32 Slide 33: QC TEST FOR RUBBER CLOSURE 1 ) Physical dimension ( treated & untreated ) 2 ) Particulate matter /Clarity of aq.extract 3 ) Sterilization test 4 ) pH of aq. Extract (after and before sterilisation) 5 ) Compatibility 6 ) Fragmentation test 7 ) Self sealability 8 ) Residue on evaporation 9 ) Chemical composition 33 Slide 34: Sterilization test After sterilisation the closures are checked versus untreatde samples to detect swelling colour change and hardness … Particulate matter /Clarity of aq.extract Pretreatment to closure washing ,autoclaving at 121̊c for 30 min. Place 400ml in 1 lit. flask. Add sufficient no .of closure to provide a total exposed surface area appximately 200cm² shake the flask and quickly withdrow 50 ml of aliquit .Transferred onto a prewashed ,preweighed 0.45um membrane filter . Partials is washed with 10 ml fresh distill water . Dried to constant weight & membrane is weighed and viewed under microscope at a10X magnification 34 Slide 35: Conclusion : Packaging is one of the most important part of pharmaceutical industries . Product produced is might be of vary good quality at the time production but it is useless if is not able to reach as it is up to end user. Quality Maintenance is the major role played by packaging material .Along with that it gives pharmaceutical elegance and convenience to user to product . Many times the Packaging is may become a ideal unique identification for some of brand in market .Quality control of such important part is also a vary valuable work. 35 Slide 36: References 1 ) Lion Lachman ,Harbert A. Libeberman ,Joseph L.Kanig “The Theory andPractice of Industrial Pharmacy “ ,Varghese puplishing house ,Thied edition 1991,Pg-644-651 2) Pharmaceutical Dosage Forms: parenteral medications, 2nd edition, Edited by K. E. Avis, H.A. Lieberman, Leon Lachman, vol.1, Page no.249-282, vol.2, Page no. 1-92. 3) Remington, The Science & Practice of pharmacy, 21st edition, Vol.1, Page no.780-806. 4) Indian pharmacopoeia 1996,vol-2 ,page no - 36