This document discusses the selection and evaluation of pharmaceutical packaging techniques. It begins with an introduction and then discusses the characteristics, roles, selection criteria, and ideal requirements of packaging materials. The main types of packaging materials discussed are glass, metal, plastic, and rubber. Specific packaging applications and the tests used to evaluate different packaging materials are also summarized. The key points covered include characteristics of ideal packaging materials, factors that influence packaging selection, common packaging types and the tests used to establish their suitability.

1. SELECTION AND EVALUATION OF
PHARMACEUTICAL PACKAGING
TECHNIQUE
Guided By Presented By
Dr. Mithun Bandivadekar , Maind Shankar Daulat
AISSMS COP ,PUNE M .Pharm ( QA)
Date :17-03-2023

2. CONTENT
1. INTRODUCTION
2. Characteristics of Packaging materials
3. Role of Packaging
4. Selection of the Packaging materials
5. ideal Req uirements of Packaging Materials
6. Types of packaging material
7. Packaging Evaluation

3.  Packaging is the process by which the pharmaceuticals are suitably packed
so that they should retain their therapeutic effectiveness from the time of
their packaging till they are consumed. Packaging may be defined as the art
and science which involves preparing the articles for transport, storage,
display and use.
 Types of Pharmaceutical Packaging Materials:-
 Glass
 Metal
 Plastic
 Paper and board

4. Characteristics of Packaging Materials:-
✓ They must protect the preparation from environmental conditions.
✓ They must not be reactive with the product.
✓ They must not impart to the product tastes or odors.
✓ They must be nontoxic.
✓ They must be FDA approved.
✓ They must meet applicable tamper-resistance requirements.
✓ They must be adaptable to commonly employed high speed packaging
equipment.

5. Role of Packaging:-
✓ Protection - Against light
Against reactive gases
Against moisture
Against microbe
Against physical damage
Against pilferage and adulteration
✓ Presentation
✓ Identification
✓ Information
✓ Compatible
✓ Convenience

6. Selection of the Packaging Materials:-
1. On the facilities available, for example, pressurized dispenser requires
special filling equipment.
2. On the ultimate use of product. The product may be used by skilled person
in hospital or may need to be suitable for use in the home by a patient.
3. On the physical form of the product. For example, solid, semi-solid, liquids
or gaseous dosage form.
4. On the route of administration. For example, oral,parenteral, external,
etc.

7. 5. On the stability of the material. For example, moisture, oxygen,
carbon dioxide, light, trace metals, temperature or pressure or
fluctuation of these may have a deleterious effect on the product.
6.On the contents. The product may react with the package such as the
release of alkali from the glass or the corrosion of the metals and inturn
the product is affected.
7. On the cost of the product. Expensive products usually justify
expensive packaging

8. ➤ Factors affecting selection of Packaging Materials:-
1.Mechanical Factors:-
Shock
Compression
Puncture
Vibration
2. Environmental Factors:-•
• Temperature
• Pressure
• Moisture
• Gases
• Light
• Infestation
• Contamination

9. Containers:-
Container is one in which the product is placed.
A pharmaceutical container is defined as a device that holds the drugs and is or may be
in direct contact with the preparation.
Ex; Ampoule , Blister ,Bottle ,Cartridge ,Gas Cylinder, Injection Needle , Pressurised
container , Injection syringe ,single dose container , Strip ,Tube , Vial etc.
Ideal Requirements of Container:-•
• Must be neutral towards the material which stored in it.
• Must not interact with the substance which it holds.
• Help in maintaining the stability of the product
• Withstand wear and tear during normal handling.
• Dose can be drawn from it conveniently.
• Able to withstand changes in pressure and temperature..
• Must be non-toxic.
• Can be labelled easily.
• Pharmaceutically elegant appearance

10. Types of Container:-•
❑ Well-closed containers⚫
❑ Single dose containers•
❑ Multi dose containers•
❑ Light-resistant containers
❑ Air-tight containers•
❑ Aerosol containers
Materials used for Making of Containers:-
1. Glass
2. Plastic
3. Metal
4. Paper and board

11. Types Of Packaging Material
Priamary Packaging :
Primary packaging basically consists of products that directly come in contact with the actual
product- food, accessories, clothing, gadgets. This section consists of all the packaging products
included in retail packaging, food packaging, as well as void fill options, that end users have seen and
used.
Secondary packaging : This strata of packaging involve all those products that would help secure mass
quantities of primary packaging with the final product inside it. Industrial crates and trays are mostly
used in warehouses, in industrial areas, or in institutions where goods are stored or are transported in
bulk.
Tertiary Packaging : During transportation and shipping, most pallets are very commonly used. Other
than that, containers made from wood or corrugated fiberboards are quite popular too.
Ancillary Packaging ( Quaternary ) : No packaging industry will survive with tapes, adhesives, straps,
labels and printing inks. These are essential consumables for the industry that allows them to
efficiently and securely store and ship products, as well as organize and customize them.

12. Packaging Material
1) GLASS
2) METAL
3) RUBBER
4) PLASTIC

13. GLASS
TYPE OF GLASS PROPERTIES
TYPE 1
BOROSILICATE GLASS
• Highly resistant glass A substantial part of
the alkali & earth cations are replaced by
boron and/or aluminum & zinc.
• It is more chemically inert than the soda-
lime glass
• It is used to contain strong acids &
alkalies as well as all types of solvents.
TYPE 2
Treated soda lime Glass
• They are made of commercial soda- lime
glass that has been de-alkalized or
treated to remove surface alkali.
TYPE 3
Soda lime glass
• Containers are untreated & made up of
commercial soda-lime glass of average or
better-than-average chemical resistance.
TYPE 4 (NP )
Genereal purpose glass
• Containers made up of soda-lime glass
are supplied for non-parenteral products,
those intended for oral or topical use.

14. PACKAGE TYPE TYPE OF FORMULATION CAN BE PACKED MINIMUM QUALITY OF
GLASS THAT CAN BE
USED.
AMPOULE Aqueous injection of Any pH Type 1
Aqueous Injectables Of pH Less Than 7 TYPE 2
Non-Aqueous Injectables TYPE 3
VIAL Aqueous injection of Any pH TYPE 1
Aqueous Injectables Of pH Less Than 7 TYPE 2
Non-Aqueous Injectables TYPE 3
Dry Powders For Parenteral Use (Need To Be Reconstituted
Before Use)
TYPE 4
BOTTLES AND JARS Tablets, Capsules, Oral Solids & Other Solids For
Reconstitution
TYPE 4
Oral Liquids (Solutions, Suspensions, Emulsions) TYPE 4
Nasal & Ear Drops TYPE 4
Certain Types Of External Semisolids (Rubeficients, Local
Irritants
TYPE4
Blood & Related Products TYPE 1
Dropper Auxillary Packaging Device with Certain Kind OF products Type 4
Aerosol Container Aerosol product (Solution , Suspension, Emulsion ,Or Semisolid
type )
Type 1

15. METALS
▪ Metal Containers are used Solely for Medicinal Products for Non-Parenteral
Administration.
▪ Aluminum & stainless steel are the metals of choice for both primary & secondary
pharmaceutical packaging.
▪ They include Tubes, Pack made from Foil or Blisters, Cans and Aerosol and Gas
Cylinders.
▪ Form excellent tamper-evident containers.
▪ It is Resistant to High and Low Temperatures.
▪ Metal is Strong, Opaque, Impermeable to Moisture, Gases, Odors, Light, Bacteria and
Shatterproof, it is he ideal packaging material for pressurized containers.

16. 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.

17. RUBBERS
▪ Preparations for powders and for freeze-dried powders.
▪ Rubber closures for containers for aqueous parenteral.
▪ The rubber stopper is used primarily for multiple dose vials and disposable syringes.
▪ Rubber is used in the pharmaceutical industry to make closures, cap liners and bulbs
for dropper assemblies

18. PLASTICS
❑ Advantages:
❑ They have disadvantages like interaction, adsorption, lightness and hence poor physical
stability.
❑ All are permeable to some degree to moisture, oxygen, carbon dioxide, etc.
❑ They are resistant to inorganic chemicals.
❑ Freedom of design to which they lend themselves.
❑ Disadvantages:
❑ Extremely resistant to breakage.
❑ Ease of Transportation.
❑ Available in various types of quality.
❑ Ease of manufacturing.

19. PACKAGING EVALUATION
 It is performed to investigate the Physicochemical interactions that might
occur between the product and package.
 Packaging evaluation is designed to identify, characterized and monitor
interactions to achieve a safe, unadulterated, stable and efficacious
product.
 An Important step - to characterize the materials and the chemicals that
can migrate or extract from packaging components to the drug product.

20. TO Establish Suitability ,Evaluation of Four
Attributes is required : -
Attributes Concerns and Interactions Proposed Mathods
Protection Exporurs to light, moisture, microbial
ingress, and oxidation from presence of
oxygen
USP-661> Light Trammion and
Water Vapor Permeation,
Container Integrity (Microbial
Ingras, Dys Penetration, Hehum
Leak)
Compatibility Leachable-induced degradation,
absorption or adsorption of cirug
pracipitation, changes in pH.
dicalaration, brittleness of packaging
materials
Leachability Study (Migration of
chemicals into drug product) wing
LO/MS, GO/MS, ICP/AA, pH,
appearance of drug and container,
thermal analys (D3C, TCA), & IE
Safety No leached harmful undearable amounts
of substances to expose patients treated
with drug .
Extraction study (USP
Phyacochemical Tests-Plastics) USP
Elastomeric Closures for
Injections, Toxicological
Evaluation

21. TEST FOR GLASS
As per USP, Mainly Three Tests are done:
❑ Powder Glass Test
❑ Water Attack Test
❑ Hydrolytic Resistance Test
Water Attack Test
▪ The water attack test at 121C is performed on intact containers.
▪ The containers are filled up to 90% of their overflowcapacity Containers are
autoclaved for 60 min.
▪ * Then content of container are cooled & from cooled content 100m1 of the
solution.

22. STEPS
❖ Rinse 3 or more containers with high purity water Fill each container to 90%
of its overflow capacity
❖ Cap all the flasks, autoclave for 60 min
❖ Empty the contents & cool the contents in 250ml conicalflask to a volume of
100m1
❖ Add five drops of methyl red solution
❖ Titrate with 0.02N Sulphuric acid while warm
❖ Record the volume consumed
❖ Volume should not exceed limits.

23. Types Of Glass & Their Limits
TYPES OF
GLASS
GENERAL
DESCRIPTION
OF GLASS
TYPES OF TEST LIMITS SIZE
(ml)
LIMITS (ml of
0.20 N )
1 1.0Highly
resistant
borosilicate
glass2
Powdered glass All 1.0
2 Treated soda
limeglass
Water Attack 100 or less 0.7
Over 100 0.2
3 Soda-lime glass Powdered glass ALL 8.5
4 General-
purpose soda
lime glass
Powdered glass ALL 15.0

24. HYDROLYTIC TEST
TYPES OF CYLINDER TEST TO BE DONE
Type 1 & type 2 glass containers to
distinguish from type 3 glass containers
TEST 1( Surface Test )
Type 1 & type 2 glass containers where
it is necessary to determine whether
the high hydrolytic resistance is due to
the chemical composition or the
surface treatment
Test 1& 2

25. Test 1-Surface Glass test
Wash containers with carbon dioxide free water
❑ Fill the containers with CO2 free water (90%
❑ Close with aluminum foil
❑ Autoclave at 1009-1209C for 20 min
❑ Maintain at 120°C for 1 hr
❑ At lower temp for 40 min
❑ Remove containers & cool
❑ Titrate it within 1 hour
❑ Titrate with 0.01 M HCL (end point colourless)
❑ Repeat with same volume of CO2 free water

26. Volume Of Test Solution To Be Used
Sr . NO. Nominal capacity of
container (ml)
No. of containers
to be used
Volume of test
solution to be
used (ml)
1 Upto 3 At least 20 25.0
2 5 OR Less At least 50.0
3 6 to 30 At least 50.0
4 More Than 30 At least 100.0

27. Volume of 0.01M HCL Required By Test Solution
Capacity of container Correspondingto
90% avg over flow volume (ml)
Volume of 0.01M HCI for 100 ml of test
solution
Type 1 or 2 glass (ml) Type 3 glass (ml)
Not more than 1 2.0 20.0
More than 1 but not more than 2 1.8 17.6
More than 2 but not more than 5 1.3 13.2
More than 5 but not more than 10 1.0 10.2
More than 10 but not more than 20 0.80 8.1
More than 20 but not more than 50 0.60 6.1
More than 50 but not more than 100 0.50 4.8
More than 100 but not more than 200 0.40 3.8
More than 200 but not more than 500 0.30 2.9
More than 500 0.20 2.2

28. TEST 2
Rinse container twice with water and with 4%volume solution of HF
• Allow to stand for 10min
• * Empty the container
• * Rinse 5 times with water
• * Carry out test similar test 1

29. Tests For Plastic Containers
❖ Leak test:
▪ The plastic containers (non injectables and injectables):
▪ Fill 10 plastic containers with water and fit the closure.
▪ Keep them inverted at room temperature for 24 hours.
▪ *No sign of leakage should be there from any container
❖ WATER PERMEABILITY TEST :
▪ Fill 5 containers with nominal volume of water and sealed.Weigh each
container.
▪ Allow to stand for 14 days at relative humidity of 60% at 20-25 degree
Celsius.
▪ Again weigh the container.
▪ Loss of weight in each container should not be more than0.2%.

30. ❑ TEST FOR RUBBER CLOSURES
❖ COLLAPSIBILITY TEST:
▪ This test is applicable to the containers which are to besqueezed for
removing the contents.
▪ A container by collapsing inward during use, yield at least 90% of its normal
contents at the required rate of flow at ambient temperature.
Preparation Of Sample (Solution-A):
▪ Wash closures in 0.2%w/v of an surface active agentsfor 5min.
▪ Rinse 5 times with distilled water and add 200m1 water and is subjected to
autoclave at 119 to 123 °C for 20 to 30m in covering with aluminum foil.
▪ Cool and separate solution from closure (solution-A).

31. |.Sterility Test:
When treated closures are subjected to sterilization test at 64-66°C and a
pressure of about 0.7 KPa for 24hr.
II. Residue On Evaporation:
50ml of solution A is evaporated to dryness at105°CThen weigh the residue NMT
4mg.
III. Penetrability:
• This is measured to check the force required to make ahypodermic needle
penetrate easily through the closure.
• It is measured by using the piercing machine.
• The piercing force must not exceed a stated value.
• If it exceeds that stated value, the hypodermic needle can be damaged as a
result of undesirable hardness of the closures.

32. IV. Fragmentation Test:
For closures for aqueous
preparations
Place a vol of water corresponding to the
nominal vol minus 4 ml each of 12 clean vials
Close the vials with the 'prepared' closures& allow
to stand for 16 hours
Close 12 clean vials with the
prepared' closures
Using a hypodermic needle with an external diameter of o 8
mm inject 1 ml of water into the vial and remove 1 m I of air
Carty out this operation 4 times with new neede each time
Pass the liquid in the vials through a filter with a pores size of 0.5 um.
No of fragments is NMT 10 excepts In the case of butyl rubber closuresa here the total no of
fragments is NMT 15
For closures for dry
preparations

33. V. Self-Sealability Test :
This test is applicable to closures intended to be used with water.
• Close the vials with the 'Prepared' closures
• For each closure, use a new hypodermic needle with an external diameter of
0.8 mm & pierce the closure 10 times, each time at a different site.
• Immerse the vials upright in a 0.1% w/v solution of methylene blue & reduce
the external pressure by 27KPa for 10 min.
• Restore the atmospheric pressure and leave the vials immersed for
30minutes. Rinse the outside of the vials.
• None of the vials contains any trace of colored solution

34. TEST FOR METAL
1).Description:
Metallic tins having smooth inner surface. The upper surface is sealed consists a
clip to break the seal. The lower surface is open.
2).Dimension:
Height-Measure the height in mm of 10 metallic tin, individually from the lower
surface edge to the upper rim.
Limit-Specimen metallic tins with tolerance-170mm±10mm.
3). Diameter:
Inner diameter- Measure the inner diameter of 10 metallic tins.Limit- NLT
98mm.
Outer diameter: Limit-NMT 105mm.
4). Cleanliness Check:
It should not be dirty, damaged, stained or consist of any foreign particles.

35. Referance
1). Selection OF PACKAGING MATERIAL , Slideshare.net Hemant rathod
2). Evaluation of packaging material , Scribd .com , Tushar Naik .
3) . Pharmaceutical packaging technology ,H Hall D A Dean , Taylor & Francis
Publication .

36. THANK YOU
Email : shankarpatil8485@gmail.com