Ideal packaging characteristics

1. Ideal Requirements for Different Packaging
Materials

2. • Ideal requirements of different types of PM-Glass, Plastic, Metals and Paper materials
• Essential qualities of different pharmaceutical packing material
• Regulatory compliance
• Glass-
• Type of glass materials and its evaluation
• Handling of glass containers and evaluation in line production, filling and sealing
• Plastics-
• Thermosets: Urea formaldehyde, Phenol formaldehyde, Epoxy resins, Polyurethrane
• Thermoplastics: Acetylnitrile butadiene styrene (ABS), Cellulose and Liquid Crystal Polymers (LCP)
• Polyolifines and Polyimides
• Metals-
• Tin, Aluminum, Iron and Lead
• Coating:
• Water based, Solvent based, Molten based and Vapor based
Contents

3. • Understanding the distinct properties and ideal requirements of various packaging
materials is essential to optimize protection, cost, and sustainability.
• Some major types of Pharmaceutical packaging materials are-Glass, Plastic, Metals, and
Paper
• Each material type offers unique benefits and challenges that impact product stability,
shelf life, and environmental footprint.
• We will explore critical factors such as chemical inertness, barrier properties, strength,
recyclability, and regulatory compliance for each material.

4. CHARACTERSTICS OF PMs
 Protection and safety of the contents preparation from
environmental conditions (barrier, tamper-resistance).
 Inert-not be reactive with the product.
 Nontoxic/ must not impart to the product tastes or odors.
 Maintain sterility of products
 Child resistant
 Supply Chain Compliance-adaptable to high speed packaging
equipment.
 Sustainable, durable and functional (physical durability and
mechanical strength)
 Economical and easy to handle
 Recyclable
 Meet regulatory requirements, Compliance (FDA/USP EMA/
ISO approved).

5. Ideal Material Selection Factors
Product Compatibility &
Stability
Ensuring material does not interact with
contents and maintains product integrity
throughout shelf life.
1
Shelf Life & Distribution
Conditions
Material must withstand transport stresses,
storage conditions, and environmental
factors to protect product quality.
2
Cost & Sustainability
Balancing affordability with environmental
impact and regulatory mandates to enhance
brand value.
3
Regulatory Compliance &
Manufacturing
Meeting global safety standards and
integrating seamlessly into existing filling
and packaging processes.
4

6. Pharmaceutical-Medical Glass Requirements
Chemical Inertness
• Essential to prevent leaching of
contaminants or interaction with
drugs.
• USP Type I borosilicate glass is
preferred for its exceptional
inertness & hydrolytic resistance
to maintain drug stability.
Dimensional Tolerance
& Light Protection
• Tight tolerances ensure consistent
filling & sealing accuracy.
• Amber glass offers protection from
UV and visible light for light-
sensitive pharmaceuticals, reducing
degradation risks.
Low Extractable &
Leachables
PPB leachables levels required to
ensure drug safety.
Glass such as plasma & ion exchange
treatment (P-IET) is optimized for
injectables with minimal chemical
release, preserving drug purity.

7. Ideal of properties of glass as PM -chemical inertness, resistance to atmosphere &
suitability for sterilization.
The specific type of glass used depends on the formulation and uses (e.g., injectable
vs. non-injectable). Key Requirements for Pharmaceutical Glass:
•Chemical Inertness:-No reactions with formulation, potentially altering its stability.
•Moisture & Air Barrier:-maintain the drug's integrity & stability.
•Sterilization Compatibility:-withstand autoclaving (crucial for sterile products).
•Visual Inspection:-to allow for visual inspection of the contents, (color changes or
foreign matter).
•Strength & Durability:-to withstand handling, transportation, and potential abuse.
• Extractable & Leachable: Substances that migrate into the drug product from
PM & reverse.
Ideal requirements of different types of PM-Glass:-

8. Glass Type & Product Compatibility
• The type of glass used (Type I, Type II, Type III, etc.) must be appropriate for the specific drug formulation
and intended use.
• Type I (Borosilicate):
• Highly chemically resistant and inertness (Vials and ampoules)
• Ideal for injectable drugs and sensitive formulations. (biological formulations and natural extracts)
• Type II (Treated Soda-Lime):
• Surface-treated for enhanced chemical resistance,
• Suitable for aqueous solutions.
• Type III (Soda-Lime):
• Suitable for non-aqueous and dry formulations.
• Type NP (General-Purpose Soda-Lime):
• For non-parenteral drugs.

9. Type of glass Main Constituents Properties Uses
Type-1
Borosilicate glass
e.g. Pyrex, Borosil
SiO2 -80%
B2O3 - 12
Al2O3 - 2%
Na2O+CaO - 6%
• Has high melting point so can
withstand high temperature
• Resistant to chemical substances
• Reduced leaching action
• Laboratory glass apparatus
• For injections and for
water for injection.
Type-II
Treated soda-lime
glass
Made of soda lime glass. The
surface of which is treated with
acidic gas like SO2 (i.e. de-
alkalised) at elevated
temperature (5000C) and
moisture.
• The surface is fairly resistant to
attack by water for a period of time.
• Sulfur treatment neutralizes the
alkaline oxides on the surface,
thereby rendering the glass more
chemically resistant.
• Used for alkali sensitive
products
• Infusion fluids, blood &
plasma.
• Large volume container
Type-III
Regular soda-lime
glass
SiO2
Na2O
CaO
• It contains high concentration of
alkaline oxides and imparts
alkalinity to aqueous substances
• Flakes separate easily.
• May crack due to sudden change of
temperature.
• For all solid dosage forms
(e.g. tablets, powders)
• For oily injections
• Not to be used for aqueous
injection
• Not to be used for alkali-
sensitive drugs.

10. Type NP
Non-parenteral glass
or General purpose
soda-lime glass.
• For oral and topical purpose
• Not for ampoules.
Neutral Glass
SiO2 - 72-75%
B2O3 - 7-10%
Al2O3 - 6%
Na2O - 6-8%
K2O -0.5 -2%
BaO - 2-4%
• They are softer and can easily be
moulded
• Good resistance to autoclaving
• Resistant to alkali preparations (with pH
up to 8)
• Lower cost than borosilicate
• Small vials (<25 ml)
• Large transfusion bottles
Neutral Tubing for
Ampoules
SiO2 67%
B2O3 7.5%
Al2O3 8.5%
Na2O 8.7%
K2O 4%
CaO 4%
MgO 0.3%
• In comparison to neutral glass its
melting point is less.
• After filling the glass ampoules are
sealed by fusion and therefore the glass
must be easy to melt.
• Ampoules for injection.
Coloured glass
Glass + iron oxide • Produce amber colour glass
• Can resist radiation from
290 to 400 to 450nm
(UV to Visible )
• For photosensitive products.

11. Product & Glass Type
Package Type Type Of Formulation Can Be Packed
Minimum Quality Of Glass That Can
Be Used
Ampoule
Aqueous Injectables of Any pH Type I
Aqueous Injectables of pH Less Than 7 Type II
Non-Aqueous Injectables Type III
Vial
Aqueous Injectables of Any pH Type I
Aqueous Injectables of pH Less Than 7 Type II
Non-Aqueous Injectables Type III
Dry Powders for Parenteral Use
(Need To Be Reconstituted Before Use)
Type IV
Bottles and
Jars
Tablets, Capsules, Oral Solids & Other Solids for Reconstitution Type IV
Oral Liquids
(Solutions, Suspensions, Emulsions)
Type IV
Nasal & Ear Drops Type IV
Certain Types Of External Semisolids (Rubeficients, Local Irritants) Type IV
Blood & Related Products Type I
Dropper Auxiliary packaging device with certain kind of products Type IV
Aerosol container Aerosol product (solution, suspension, emulsion or semisolid type) Type I

12. Stage Activity Evaluation Criteria Action/Tools Used
Receipt & Storage Unpacking and storing glass
containers
No visible damage to cartons or inner packs Visual inspection, designated clean
storage area
Pre-Use Inspection Visual and physical check of
containers
No cracks, chips, dirt, deformation, or foreign
particles
Visual inspection, black
background, white light
Cleaning (if needed) Rinsing or depyrogenation Containers meet sterility and particulate
standards
Sterile water rinse, tunnel sterilizer,
laminar airflow
Loading to Line Feeding containers onto
conveyor
Smooth transfer, no jams or collisions Unscrambler, protective guides,
cushioned conveyors
Filling Filling containers with
product
Correct volume, no spillage or foaming Fill volume sensors, balance check,
automated nozzles
In-Line Inspection Monitoring containers post-
fill
No underfill, overfill, or contamination Camera vision systems, level
sensors, sampling
Sealing/Capping Crimping/capping/glass
fusion sealing
Proper torque/crimp, no loose caps, no defects Torque testers, crimp testers,
automated sealers
Post-Seal Inspection Integrity and quality check of
sealed container
Seal integrity, cap alignment, no leaks or
misalignments
Leak test (vacuum/dye), visual
check, pull test
Reject Handling Removing defective units Defects logged, broken glass safely handled Rejection bins, breakage protocol,
sharp disposal containers
Documentation Recording inspection and test
results
Batch records completed, deviations logged Inspection logs, electronic batch
record (EBR) system
Handling and Evaluation for Glass Containers in Filling and Sealing Line

13. Plastics Requirements for Packaging
Material Types &
Barrier Properties
Common plastics include
HDPE, LDPE, PET, PP,
PVC, and bio-based PLA.
Their barrier effectiveness
against oxygen, carbon
dioxide, and moisture
influences product shelf
life.
Mechanical & Chemical
Properties
Tensile strength and
impact resistance (ASTM
standards) ensure
durability.
Chemical compatibility
with product components
like acids or solvents is
crucial for package
integrity.
Temperature &
Sustainability
Temperature resistance
supports hot-fill and
autoclave sterilization
processes.
Recyclability is indicated
by SPI codes, with an
increasing shift toward
bio-based, eco-friendly
materials.
ASTM-American Society for Testing and Materials SPI - Society of the Plastics Industry

14. The plastic recycling symbols (1-7) inside the chasing arrows symbol indicate the type of resin used in the plastic
product, not necessarily its recyclability. These codes are primarily used by recyclers to sort plastics for processing, not
by consumers.

15. High density polyethylene
(HDPE) = 0.955 g/cc
Inert, low cost, low water vapour
transmission, tough.
Semi-opaque, transfer of taste
ingredients, absorb dilute solutions.
Detergents, bleaches, milk, foods,
cleansing powders, drugs &
cosmetics.
Low density polyethylene
(LDPE) = 0.920 g/cc.
Squeeze property, inertness, low cost. Relatively poor barrier to non-polar
molecules and high water vapour
transmission.
Cosmetics, personal products, foods.
Polystyrene = 1.05 g/cc. Clarity, stiffness, low cost. High water vapor transmission,
susceptibility to cracking, poor
impact.
Dry drugs, petroleum jelly.
Rigid (PVC)
= 1.35 g/cc.
Clarity, stiffness, O2barrier, retention of
non-polar molecules.
10-12 additives may be present,
difficult to process, susceptible to
organic solvent.
Shampoo, bath oil, detergent.
Polypropylene = 0.90 g/cc. Inert, low cost. Low temperature brittleness, high
concentration of stabilizer is
present.
Drugs, cosmetics, syrups, juices.
Polyamide (Nylon6,10) =
1.10 g/cc.
Good barrier for nonpolar molecules,
tough, good O2-barrier, sterilizable.
High cost, water absorption Foods, drugs, cosmetics, aerosols
Polycarbonate = 1.20 g/cc. Very tough, clear, sterilizable Cost, susceptibility to solvent
cracking, poor barrier for water and
O2.
Drugs, cosmetics.
Acrylic polymers
(PMMA =Polymethyl
methacrylate)
= 1.10 g/cc.
Clarity, good for oils Poor water vapor transmission, poor
barrier for O2.
Drug cosmetics.
Polyethylene terephthlate
(PET)
Excellent strength, good barrier for gas
and aroma.
Bottle for carbonated waters, mineral
waters, mouth washes, cosmetics.

16. Properties
Polyethylene
LDPE HDPE
Poly
Propylene
PVC
Poly
Styrene
Acrylic
Multi- Polymer
Nitrile
Polymer
Clarity
Hazy,
Translucent
Hazy,
Translucent
Clear Clear Clear Clear Clear
Water Abs - - - - +, ++ + +, ++
Permeability To
Water Vapor – – – – – – + ++ ++ +
Oxygen ++ +, ++ +, ++ - ++ - --
CO2 ++ +, ++ +, ++ - ++ + --
Resistance To
Acids +, +++ +, +++ +, +++ +++ +, ++ -, ++ -, ++
Alcohol ++ ++ ++ +++ - + +
Alkalis ++ ++ +++ ++ ++ -, ++ ++
Mineral Oil - + + ++ + ++ +++
Heat - + ++ +, - + ++ +
Cold ++++ ++++ -, + -- - - -
Sunlight + + + ++ +, - ++ ++
Humidity ++++ ++++ ++++ ++++ ++++ + ++++
Stiffness - + +, ++ +, ++ +, ++ +, ++ +, ++
Cost Low Low Low Mod Low Mod High
Typical
Uses
Cosmetics, Personal
Products, Foods
Detergents, Bleaches
Milk , Foods
Industrial
Cleansing, Powders
Drugs, Cosmetics
Drugs
Cosmetics
Syrups
Juices
Shampoos, Bath
Oils, Detergents,
Floor Waxes
Vinegar, Salad
Oil
Dry
Drugs
Petroleum
Jellies
Foods
Drugs
Cosmetics
Foods, Drugs
Cosmetics
Chemicals,
Aerosols
Carbonated
Beverages
Signs: [- - : very poor, very low] [- : poor, low] [+: fair, moderate] [++: good, high] [+++: very good] [++++: excellent]

17. PACKAGE TYPE FORMULATION REMARKS
Strip, blister Tablets, capsules
Polymer coated aluminum with various thickness are
available to improve the sealability of the pack and
stability of the product.
Collapsible tubes
Ointments, creams, gels &
other semisolids
The tubes with internal protective coating of polymers
with spike & without spike are available.
Cans
Aerosols, inhalers, sprays
etc.
Pressure resistant and internal polymer coated
aluminum containers are available.
Drug-plastic Consideration:
A packaging must protect the drug without altering the composition of the product until the last dose is removed.
Drug plastic consideration have been divided into five separate categories:-
(1) permeation, (2) leaching,
(3) sorption, (4) chemical reaction, and
(5) alteration in the physical properties of plastics or products.
Other Plastic Packaging:

18. Metals: Key Packaging Requirements
Materials
Includes aluminum,
tinplate, and stainless steel
(304/316 grades),
commonly used in food
and pharmaceutical
packaging for strength and
protection.
Durability & Protection
Corrosion resistance
verified by salt spray
testing (ASTM B117),
puncture and burst
strength ensure package
integrity under stress,
preserving shelf life.
Safety & Sterilization Compatibility
Packages must be hermetically sealed and compatible with
retort sterilization at 121°C. Metal migration must remain
below regulatory ppm limits to ensure safety.
ASTM-American Society for Testing and Materials

19. Metal Advantages Disadvantages Uses
Tin
- Chemically inert- Coats other metals
for added protection
- Most expensive of the four
metals
- Food containers- Eye
ointment tubes
Aluminium
- Lightweight- Attractive- Forms
protective oxide layer
- Corrosion with reactive
substances- H₂ evolution
- Ointment tubes- Screw
caps- Strip packaging
Iron
- Tin-coated steel combines strength
and corrosion resistance
- Corrosion if tin layer
damaged- Needs lacquer
coating
- Milk containers- Screw
caps- Aerosol cans
Lead - Cheapest- Soft and formable - Toxic; needs inert lining
- Fluoride toothpaste tubes
(lined)
Package Type Formulation Remarks
Strip, blister Tablets, capsules
Polymer coated aluminum with various thickness are
available to
improve the sealability of the pack and stability of the
product.
Collapsible tubes
Ointments, creams, gels & other
semisolids
The tubes with internal protective coating of polymers with
spike & without spike are available.
Cans Aerosols, inhalers, sprays etc.
Pressure resistant and internal polymer coated aluminum
containers are available.

20. PAPER & BOARD:
Category Examples Applications / Advantages
Paper-Based Materials
Labels, Cartons, Bags, Trays for Shrink Wraps,
Layer Boards on Pallets, Outers
- Essential components in primary and secondary
packaging
Cartons Folding boxes, printed packaging
- Increases display area- Enhances shelf
presentation and stacking-
- Allows inclusion of leaflets- Provides
protection for delicate items (e.g., tubes)
Fiber board Outers Solid or corrugated boards
- Used for bulk shipping-
- Adds durability, cushioning-
- Cost-effective for large-scale transport
Regenerated Cellulose Film Cellophane, Rayophane
- Used for wrapping individual cartons-
- Useful in bundling multiple cartons together
- Offers transparency and moisture barrier

21. Paper Materials: Specifications and Performance
Parameter Details
Material Type Kraft paper, Cardboard, Paperboard
Basis Weight Measured in grams per square meter (GSM); affects strength and thickness
Strength Metrics Bursting strength (kPa) and tear resistance (mN) define package durability
Resistance Properties Water resistance (Cobb test) and grease resistance protect content
Printability & Sustainability
High-quality graphics via TAPPI standards; recycled content and FSC
certification ensure environmental responsibility

22. Coating Type Description Advantages Disadvantages Common Applications
Water-Based Coating is applied using a
water-dispersible or water-
soluble polymer system.
- Environmentally
friendly
- Low toxicity
- Easy cleanup
- Long drying time
- Sensitive to humidity
Blister packs, films,
paperboard, bottles
Solvent-Based Organic solvents dissolve the
coating material before
application.
- Fast drying
- Good film formation
- Suitable for
hydrophobic materials
- Flammable
- VOC emissions
- Health/environmental
concerns
Labels, flexible packaging,
overwraps
Molten-Based Coating materials (e.g., waxes,
hot-melt polymers) are
melted and applied hot.
- Solvent-free
- Fast solidification
- Good barrier properties
- High process
temperatures
- May affect heat-sensitive
materials
Foils, laminates, inner
seals
Vapor-Based Materials (e.g., metal or
polymer vapor) condense on
the substrate.
- Uniform thin layers
- Excellent barrier and
surface properties
- High capital cost
- Complex process
- Limited to certain
substrates
Aluminum foils, barrier
films, high-end
pharmaceutical packaging
Coating Techniques for Pharmaceutical Packaging Materials

24. Material Key Regulatory Guidelines / Standards Compliance Focus
Glass
- USP <660>- Ph. Eur. 3.2.1- FDA 21 CFR Part
211
- Type classification (I, II, III)-
Hydrolytic resistance-
Leachables/Extractables
Metal
- FDA 21 CFR Part 175/177- EU Regulations (EC
1935/2004)- ASTM standards (e.g., B117)
- Coating integrity- Corrosion
resistance- Toxicity (e.g., lead content)
Plastic
- USP <661>, <661.1>, <661.2>- FDA 21 CFR
177- Ph. Eur. 3.1.x series
- Biocompatibility- Additive migration-
Extractables/Leachables
Others (Paper, Rubber,
Films)
- USP <87>, <88> (Biological reactivity)- Ph. Eur.
3.1.3 (Rubber)- ISO 10993 series
- Biological safety- Functional
performance- Compatibility with drug
product
Regulatory Compliance Requirements

25. Comparing Key Material Properties
PM-Glass
Inert, rigid, fragile, and highly
recyclable. Best for chemically
sensitive products requiring
light protection.
Plastics
Lightweight and versatile with
variable barrier properties.
Growing focus on recyclability
and bio-based polymers.
Metals
Strong, impermeable, and
conductive materials offering
excellent protection for long
shelf-life applications.
Paper
Renewable, printable,
biodegradable, but with lower
barrier and moisture resistance
compared to other materials.