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Pulse pharmaceuticals pvt ltd
SELECTION OF A PACKAGING MATERIALS
1. Begins with a determination of the product’s Physical and
Chemical characteristics.
...
PM MUST HAVE FOLLOWING CHARACTERISTICS
1. Must protect the preparation from environmental condition.
2. Must not be reacti...
FUNCTION OF A DRUG PACKAGE
Fundamental Functions:
1. Containment
2. Protection
Other functions:
1. Inform
2. Dispense
3. M...
AGENT RESPONSIBLE FOR DRUG DEGRADATION
1. Moisture
2. Oxygen
3. Light
4. Temperature
CLASSIFICATION
1. Primary
2. Secondary
3. Tertiary
4. Ancillary
CLASSIFICATION
Primary Packaging Material
1. Blister and Strip
2. Ampoules, Vials and Prefilled Syringes
3. Bottles (Glass...
CLASSIFICATION
Secondary Packaging Material
1. Label
2. Carton
Tertiary Packaging Material
1. Shipper and Drum
2. Pellet
PRIMARY PACKAGING
Solid Oral Dosage Form
1. Blister
Thermoforming
Forming Layer: PVC, PVC/PVDC, PP, CoC,
PVC/ACLAR and PVC...
PRIMARY PACKAGING
2. Strip Pack
Aluminum/LDPE
3. Bottle Pack
Glass/Plastic
(HDPE, PP, PET)
PRIMARY PACKAGING
Liquid/Powder For OS
Bottle
Plastic (HDPE, PP, PET)
Glass
Sachet (Laminate)
Caps and Closure (ROPP, Scre...
PRIMARY PACKAGING
Injectable
1. Ampoule
Glass (Snap Off and OPC)
Plastic (FFS)
2. Vials
Glass (Tubular/Molded)
Plastic (PP...
PRIMARY PACKAGING
Cream and Ointment
1. Collapsible Tube
2. Lami Tube
SECONDARY PACKAGING
Cartons
1. Paper Board Cartons
2. Micro Fluted Corrugated Fibre Board Cartons
3. Plastic Cartons
TERTIARY PACKAGING
Corrugated Fibre Board Box
TERTIARY PACKAGING
Fibre Board Drum
Metal Drum
Plastic Drum
ANCILLARY PACKAGING MATERIAL
1. Labels (Pressure Sensitive and Adhesive Coated Label)
2. Plastic Strapping
3. Shrink Wrapp...
QUALITY CONTROL OF PACKAGING MATERIAL
Glass Containers
Glass for Drugs
(Evaluated by Powdered Glass & Water Attack Test)
1...
QUALITY CONTROL OF PACKAGING MATERIAL
Evaluation
1. Dimension and Defects
Shape
Wall Thickness
Inner Diameter
Outer Diamet...
QUALITY CONTROL OF PACKAGING MATERIAL
2. Mechanical Strength Test
Internal Pressure Test
Thermal Shock Test
Vertical Load ...
QUALITY CONTROL OF PACKAGING MATERIAL
Plastic Containers
Mostly Used
1. Polyethylene (PE)
HDPE
LDPE
2. Polypropylene (PP)
...
QUALITY CONTROL OF PACKAGING MATERIAL
Drug-Plastic Consideration
1. Permeation
2. Leaching
3. Sorption
4. Chemical reactio...
QUALITY CONTROL OF PACKAGING MATERIAL
Evaluation
1. Dimension and Defects
Wall Thickness
Height
Outer Diameter
Inner Diame...
QUALITY CONTROL OF PACKAGING MATERIAL
2. Mechanical Tests
Internal Pressure test
Leakage Test
Stack Load Test
Drop Test
3....
QUALITY CONTROL OF PACKAGING MATERIAL
Paper Board Cartons
1. Substance of Paper Board or GSM
2. Stiffness of Board
3. Grai...
QUALITY CONTROL OF PACKAGING MATERIAL
Corrugated fiber board box
1. Internal Dimensions
2. Substance of Each Ply
3. Bursti...
QUALITY CONTROL OF PACKAGING MATERIAL
LAMINATE, FOIL, BLISTER PACKAGING AND STRIP PACKAGING
1. Oxygen Permeability
2. Wate...
TAMPER RESISTANT PACKAGING
1. Film Wrappers
2. Blister Pack
3. Strip Pack
4. Bubble Pack
5. Shrink Seal and Bands
6. Foil,...
TAMPER RESISTANT PACKAGING
FILM WRAPPERS
1. End-folded wrapper
2. Fin seal wrapper
3. Shrink wrapper
TAMPER RESISTANT PACKAGING
STRIP PACKAGE
BLISTER PACKAGE
TAMPER RESISTANT PACKAGING
BUBBLE PACK
TAMPER RESISTANT PACKAGING
SHRINK BANDING
TAMPER RESISTANT PACKAGING
FOIL, PAPER AND PLASTIC POUCHES
1. Vertical Form Fill Seal System
2. Horizontal Form Fill Seal ...
TAMPER RESISTANT PACKAGING
FOIL, PAPER AND PLASTIC POUCHES
TAMPER RESISTANT PACKAGING
BOTTLE SEALS
1. Pressure Sensitive Inner Seal
2. Heat Sensitive/Induction Seal
TAMPER RESISTANT PACKAGING
TAPE SEALS
BREAKABLE CAPS
TAMPER RESISTANT PACKAGING
SEALED TUBES
TAMPER RESISTANT PACKAGING
SEALED CARTONS
AEROSOLES CONTAINERS
END OF PRESENTATION
Lets work together
Presented By
BRAJESH PATEL
(Executive Packaging & Development)
Pulse Pharmaceuticals Pvt. Ltd.
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Pharmaceutical Packaging

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Pharmaceutical Packaging

  1. 1. Pulse pharmaceuticals pvt ltd
  2. 2. SELECTION OF A PACKAGING MATERIALS 1. Begins with a determination of the product’s Physical and Chemical characteristics. 2. Its protective needs 3. Marketing requirements
  3. 3. PM MUST HAVE FOLLOWING CHARACTERISTICS 1. Must protect the preparation from environmental condition. 2. Must not be reactive with the product 3. Must not impart to the product tastes and odour 4. Must be nontoxic 5. Must be FDA approved 6. Must meet applicable tamper resistance requirement 7. Must be adaptable to commonly employed high speed packaging equipment.
  4. 4. FUNCTION OF A DRUG PACKAGE Fundamental Functions: 1. Containment 2. Protection Other functions: 1. Inform 2. Dispense 3. Maintain Sterility 4. Child Resistant 5. Temper Evident 6. Sell 7. Transport
  5. 5. AGENT RESPONSIBLE FOR DRUG DEGRADATION 1. Moisture 2. Oxygen 3. Light 4. Temperature
  6. 6. CLASSIFICATION 1. Primary 2. Secondary 3. Tertiary 4. Ancillary
  7. 7. CLASSIFICATION Primary Packaging Material 1. Blister and Strip 2. Ampoules, Vials and Prefilled Syringes 3. Bottles (Glass and Plastic) and Caps 4. Pouch and Tube (Laminate and Collapsible)
  8. 8. CLASSIFICATION Secondary Packaging Material 1. Label 2. Carton Tertiary Packaging Material 1. Shipper and Drum 2. Pellet
  9. 9. PRIMARY PACKAGING Solid Oral Dosage Form 1. Blister Thermoforming Forming Layer: PVC, PVC/PVDC, PP, CoC, PVC/ACLAR and PVC/PE/PVDC Lidding Layer: Aluminum and Glassine Paper Cold Forming Forming Layer: OPA/Al/PVC Lidding Layer: Aluminum
  10. 10. PRIMARY PACKAGING 2. Strip Pack Aluminum/LDPE 3. Bottle Pack Glass/Plastic (HDPE, PP, PET)
  11. 11. PRIMARY PACKAGING Liquid/Powder For OS Bottle Plastic (HDPE, PP, PET) Glass Sachet (Laminate) Caps and Closure (ROPP, Screw, Pilfer Proof, Child Resistant)
  12. 12. PRIMARY PACKAGING Injectable 1. Ampoule Glass (Snap Off and OPC) Plastic (FFS) 2. Vials Glass (Tubular/Molded) Plastic (PP/CoC) Seals (Rubber/Polymeric Material)
  13. 13. PRIMARY PACKAGING Cream and Ointment 1. Collapsible Tube 2. Lami Tube
  14. 14. SECONDARY PACKAGING Cartons 1. Paper Board Cartons 2. Micro Fluted Corrugated Fibre Board Cartons 3. Plastic Cartons
  15. 15. TERTIARY PACKAGING Corrugated Fibre Board Box
  16. 16. TERTIARY PACKAGING Fibre Board Drum Metal Drum Plastic Drum
  17. 17. ANCILLARY PACKAGING MATERIAL 1. Labels (Pressure Sensitive and Adhesive Coated Label) 2. Plastic Strapping 3. Shrink Wrapping (PVC, PE, PET) 4. Stretch Wrapping (Stretch Film) 5. Pallets (For Transport) 6. Leaflets 7. BOPP Self Adhesive Tape
  18. 18. QUALITY CONTROL OF PACKAGING MATERIAL Glass Containers Glass for Drugs (Evaluated by Powdered Glass & Water Attack Test) 1. Type I- Borosilicate Glass 2. Type II- Treated Soda Lime Glass 3. Type III- Regular Soda Lime Glass 4. Type NP- General Purpose Soda Lime Glass
  19. 19. QUALITY CONTROL OF PACKAGING MATERIAL Evaluation 1. Dimension and Defects Shape Wall Thickness Inner Diameter Outer Diameter Height Body Diameter Vertically Warp and Broken Finish (Cap Sealing Ability) Checks (Finish, Neck and Bottom) Annealing Defects Stones and Seeds
  20. 20. QUALITY CONTROL OF PACKAGING MATERIAL 2. Mechanical Strength Test Internal Pressure Test Thermal Shock Test Vertical Load Test Hammering Test 3. Chemical Test Alkalinity Test for USP I, USP II and USP III 4. Other Test Capability Weight
  21. 21. QUALITY CONTROL OF PACKAGING MATERIAL Plastic Containers Mostly Used 1. Polyethylene (PE) HDPE LDPE 2. Polypropylene (PP) 3. PVC and PVDC 4. Polystyrene (PS) Lesser Used 1. Polymethyl Methacrylate (PMMA) 2. Polyethylene Terepthalate (PET) 3. Polytrifluoroethylene 4. Nylon (Polyamides) 5. Amino Formaldehydes
  22. 22. QUALITY CONTROL OF PACKAGING MATERIAL Drug-Plastic Consideration 1. Permeation 2. Leaching 3. Sorption 4. Chemical reaction 5. Alteration in the Physical Properties of Plastics or Products.
  23. 23. QUALITY CONTROL OF PACKAGING MATERIAL Evaluation 1. Dimension and Defects Wall Thickness Height Outer Diameter Inner Diameter Body diameter Shape Verticality
  24. 24. QUALITY CONTROL OF PACKAGING MATERIAL 2. Mechanical Tests Internal Pressure test Leakage Test Stack Load Test Drop Test 3. Chemical Tests Environmental Stress Crack resistance Test (ESCR) Compatibility test Shelf Life Test Melt Flow Index
  25. 25. QUALITY CONTROL OF PACKAGING MATERIAL Paper Board Cartons 1. Substance of Paper Board or GSM 2. Stiffness of Board 3. Grain Direction 4. Type of Paper Board 5. Moisture Content 6. Compression Strength 7. Print Quality 8. Scuff Proofness 9. Porosity and Smoothness of Paper Board 10.Dimensions 11.Style of Carton 12.Checking of Printing Matters
  26. 26. QUALITY CONTROL OF PACKAGING MATERIAL Corrugated fiber board box 1. Internal Dimensions 2. Substance of Each Ply 3. Bursting Strength 4. Cobb Value (Water Absorption Test) 5. Moisture Content 6. Style of Box 7. Type of Flutes 8. Compression strength
  27. 27. QUALITY CONTROL OF PACKAGING MATERIAL LAMINATE, FOIL, BLISTER PACKAGING AND STRIP PACKAGING 1. Oxygen Permeability 2. Water vapour Transmission rate (WVTR) 3. Compatibility ALUMINIUM FOIL 4. Printing Cello Tape Test Rub Resistance Test 5. Pin Hole
  28. 28. TAMPER RESISTANT PACKAGING 1. Film Wrappers 2. Blister Pack 3. Strip Pack 4. Bubble Pack 5. Shrink Seal and Bands 6. Foil, Paper and Plastic pouches 7. Bottle Seals 8. Tape Seals 9. Breakable Seals 10.Sealed Tubes 11.Aerosol containers 12.Sealed cartons
  29. 29. TAMPER RESISTANT PACKAGING FILM WRAPPERS 1. End-folded wrapper 2. Fin seal wrapper 3. Shrink wrapper
  30. 30. TAMPER RESISTANT PACKAGING STRIP PACKAGE BLISTER PACKAGE
  31. 31. TAMPER RESISTANT PACKAGING BUBBLE PACK
  32. 32. TAMPER RESISTANT PACKAGING SHRINK BANDING
  33. 33. TAMPER RESISTANT PACKAGING FOIL, PAPER AND PLASTIC POUCHES 1. Vertical Form Fill Seal System 2. Horizontal Form Fill Seal System
  34. 34. TAMPER RESISTANT PACKAGING FOIL, PAPER AND PLASTIC POUCHES
  35. 35. TAMPER RESISTANT PACKAGING BOTTLE SEALS 1. Pressure Sensitive Inner Seal 2. Heat Sensitive/Induction Seal
  36. 36. TAMPER RESISTANT PACKAGING TAPE SEALS BREAKABLE CAPS
  37. 37. TAMPER RESISTANT PACKAGING SEALED TUBES
  38. 38. TAMPER RESISTANT PACKAGING SEALED CARTONS AEROSOLES CONTAINERS
  39. 39. END OF PRESENTATION
  40. 40. Lets work together Presented By BRAJESH PATEL (Executive Packaging & Development) Pulse Pharmaceuticals Pvt. Ltd.

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