pharmaceutical packaging

Pulse pharmaceuticals pvt ltd

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

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.

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

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 and Plastic) and Caps

4. Pouch and Tube (Laminate and Collapsible)

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/PE/PVDC

Lidding Layer: Aluminum and Glassine Paper

Cold Forming

Forming Layer: OPA/Al/PVC

Lidding Layer: Aluminum

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, Screw, Pilfer Proof, Child Resistant)

PRIMARY PACKAGING

Injectable

1. Ampoule

Glass (Snap Off and OPC)

Plastic (FFS)

2. Vials

Glass (Tubular/Molded)

Plastic (PP/CoC)

Seals

(Rubber/Polymeric Material)

PRIMARY PACKAGING

Cream and Ointment

1. Collapsible Tube

2. Lami Tube

SECONDARY PACKAGING

Cartons1. 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 Wrapping (PVC, PE, PET)

4. Stretch Wrapping (Stretch Film)

5. Pallets (For Transport)

6. Leaflets

7. BOPP Self Adhesive Tape

QUALITY CONTROL OF PACKAGING MATERIAL

Glass ContainersGlass 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


Evaluation1. 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


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


Plastic ContainersMostly Used

1. Polyethylene (PE)

HDPELDPE

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


Drug-Plastic Consideration

1. Permeation

2. Leaching

3. Sorption

4. Chemical reaction

5. Alteration in the Physical Properties of Plastics or

Products.


Evaluation

1. Dimension and Defects

Wall Thickness

Height

Outer Diameter

Inner Diameter

Body diameter

Shape

Verticality


2. Mechanical Tests

Internal Pressure test

Leakage Test

Stack Load Test

Drop Test

3. Chemical TestsEnvironmental Stress Crack resistance Test (ESCR)

Compatibility test

Shelf Life Test

Melt Flow Index


Paper Board Cartons1. 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


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


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

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


FILM WRAPPERS

1. End-folded wrapper

2. Fin seal wrapper

3. Shrink wrapper


STRIP PACKAGE

BLISTER PACKAGE


BUBBLE PACK


SHRINK BANDING


FOIL, PAPER AND PLASTIC POUCHES

1. Vertical Form Fill Seal System

2. Horizontal Form Fill Seal System


FOIL, PAPER AND PLASTIC POUCHES


BOTTLE SEALS

1. Pressure Sensitive Inner Seal

2. Heat Sensitive/Induction Seal


TAPE SEALS

BREAKABLE CAPS


SEALED TUBES


SEALED CARTONS

AEROSOLES CONTAINERS

END OF PRESENTATION

Lets work together

Presented By

BRAJESH PATEL

(Executive Packaging & Development)

Pulse Pharmaceuticals Pvt. Ltd.

pharmaceutical packaging

Healthcare