This document discusses packaging materials for pharmaceutical products. It begins by outlining factors to consider when selecting packaging, such as the product's characteristics, protective needs, and marketing requirements. It then describes the necessary characteristics of packaging materials, including protecting the product from environmental conditions while meeting regulations. The document categorizes packaging as primary, secondary, tertiary, or ancillary. It provides examples of materials used for different pharmaceutical dosage forms and packaging levels. Finally, it discusses quality control testing and tamper-resistant packaging options.

1. Pulse pharmaceuticals pvt ltd

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. 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. 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. AGENT RESPONSIBLE FOR DRUG DEGRADATION
1. Moisture
2. Oxygen
3. Light
4. Temperature

6. CLASSIFICATION
1. Primary
2. Secondary
3. Tertiary
4. Ancillary

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. CLASSIFICATION
Secondary Packaging Material
1. Label
2. Carton
Tertiary Packaging Material
1. Shipper and Drum
2. Pellet

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. PRIMARY PACKAGING
2. Strip Pack
Aluminum/LDPE
3. Bottle Pack
Glass/Plastic
(HDPE, PP, PET)

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. 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. PRIMARY PACKAGING
Cream and Ointment
1. Collapsible Tube
2. Lami Tube

14. SECONDARY PACKAGING
Cartons
1. Paper Board Cartons
2. Micro Fluted Corrugated Fibre Board Cartons
3. Plastic Cartons

15. TERTIARY PACKAGING
Corrugated Fibre Board Box

16. TERTIARY PACKAGING
Fibre Board Drum
Metal Drum
Plastic Drum

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. 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. 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. 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. 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. 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. QUALITY CONTROL OF PACKAGING MATERIAL
Evaluation
1. Dimension and Defects
Wall Thickness
Height
Outer Diameter
Inner Diameter
Body diameter
Shape
Verticality

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. 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. 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. 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. 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. TAMPER RESISTANT PACKAGING
FILM WRAPPERS
1. End-folded wrapper
2. Fin seal wrapper
3. Shrink wrapper

30. TAMPER RESISTANT PACKAGING
STRIP PACKAGE
BLISTER PACKAGE

31. TAMPER RESISTANT PACKAGING
BUBBLE PACK

32. TAMPER RESISTANT PACKAGING
SHRINK BANDING

33. TAMPER RESISTANT PACKAGING
FOIL, PAPER AND PLASTIC POUCHES
1. Vertical Form Fill Seal System
2. Horizontal Form Fill Seal System

34. TAMPER RESISTANT PACKAGING
FOIL, PAPER AND PLASTIC POUCHES

35. TAMPER RESISTANT PACKAGING
BOTTLE SEALS
1. Pressure Sensitive Inner Seal
2. Heat Sensitive/Induction Seal

36. TAMPER RESISTANT PACKAGING
TAPE SEALS
BREAKABLE CAPS

37. TAMPER RESISTANT PACKAGING
SEALED TUBES

38. TAMPER RESISTANT PACKAGING
SEALED CARTONS
AEROSOLES CONTAINERS

39. END OF PRESENTATION

40. Lets work together
Presented By
BRAJESH PATEL
(Executive Packaging & Development)
Pulse Pharmaceuticals Pvt. Ltd.