Packaging material

1. • PRESENTD BY :-
• PATIL PRANJAY SADASHIV.
• FIRST YEAR M.PHARM.
• DEPARTMENT OF QUALITY ASSURANCE.
H. R. Patel Institute of Pharmaceutical Education
and Research, Shirpur
Pharmaceutical Packaging Materials

2. Packaging Material:
Pharmaceutical packaging can be defined as the economical means of providing
presentation, protection , identification, information, containment, convenience,
compliance, integrity, and stability, of the product.
The material selected must have the following characteristics:
1) They must protect the preparation from environmental condition.
2) They must not be reactive with the product.
3) They must not impart to the product testes or odour.
4) They must be non-toxic .
5) They must be FDA approved.

3. Different Packaging Materials

4.  Primary packaging:
Primary packaging material used designate the layer packaging in immediate
contact with the product
Example: bottle.
 Secondary Packaging:
Secondary packaging material is intended to protect not only the product, but also
primary packaging.
Ex. Cartons, plastic.
 Tertiary Packaging:
Tertiary packaging is not typically not seen by consumer by since it is usually
removed the retailers before product are displayed for sale.
Classification

5. Type of Containers:
1) Well-Closed Containers:
A well-closed container protect the content from loss during transport action, handling,
storage, or sale.
2) Single dose container:
These container are use to supply only one medicament and hold generally parenteral
product.
Example: A ampoule and vials
3) Multi-dose container:
These container allow the withdrawal of dose at various intervals without changing the
strength, quality, or purity of remaining portion.
these containers hold more than one dose and are used for injectable.
Example: Vials

6. 4) Light resistance container:
These container protect the medicament from harmful effects of light. These container are
used to store those medicament which are photosensitive. Example: syringes
5) Air-light container:
These also called hermetic container. These container have air-light sealing or closing. These
container protect the product form dust, moisture and air. Where as air-tight container are used for
injectable, air-tight closed container are meant for the storage of other product.
6) Aerosols Container:
These container are used to hold aerosols product. These container have adequate
mechanical strength in order to bear the pressure of aerosols packing.

7. Type of Packaging Material
Packaging
material
Glass
Films,soil,a
nd
laminates
Fibrous
material
Plastic
Metals
Rubber

8. Glass:
 Glass has been widely used are a drug packaging material.
 Glass is composed , soda ash, limestone, and cullet.
 Si, Al, Na, K, Mg, and Zn, are generally used into the preparation of glass.
Advantages:
 It can be used an light speed packaging lines.
 They are transparent
 They have good protection power
 They can be easily labeled.

9. Disadvantage:
 They are break easily.
 They are heavier in comparison to plastic container.
Type of glass:
 Type-1-Borosilicate glass
 Type-2-Treated soda lime glass
 Type-3-Regular soda lime glass
 Type-4-General purpose soda lime glass
Type-1-Borosilicate glass:
 It is highly resistant glass.
 It is high melting point
 It is more chemically inert than the soda lime glass.
 Reducing leaching action.

10. Uses:
 Laboratory glass apparatus.
 For injection and water for injection.
Type-2-Treated soda lime glass:
 Treated to remove surface alkali
 The de-alkali zing process is know as sulfur treatment
 Sulfur treatment neutralizes the alkaline oxides on the surface,
rendering the glass more chemically resistant
Uses:
 Used for alkali sensitive produces
 Infusion fluid, blood and plasma
 Large volume container

11. Type-3- Regular soda lime glass:
 Flakes separate easily
 It container high concentration of alkaline oxide and impart
alkalinity to aqueous substance.
Uses: 2
 For all solid dosage forms.
 For oily injections.
Type-4-General purpose soda lime glass:
 Container are made of soda lime glass supplied for non
parentral products intended for oral or topical uses.
Uses:
 For oral use
 Topical purpose

12. QUALITY CONTROL TESTS FOR GLASSES
1) CHEMICAL RESISTANT OF GLASS CONTAINERS
A) POWDERED GLASS TEST:
Step-1: Preparation of glass specimen: Few containers are rinsed thoroughly with purified
water and dried with stream of clean air. Grind the containers in a mortar to a fine powder
and pass through sieve no.20 and 50.
Step-2: Washing the specimen: 10gm of the above specimen is taken into 250 ml conical
flask and wash it with 30 ml acetone. Repeat the washing, decant the acetone and dried
after which it is used within 48hr.

13. Procedure: 10gm sample is added with 50ml of high purity water in a 250ml flask. Place it
in an autoclave at 121⁰C±2⁰C for 30min.Cool it under running water. Decant the solution
into another flask, wash again with 15ml high purity water and again decant. Titrate
immediately with 0.02N sulphuric acid using methyl red as an indicator and record the
volume.
B) WATER ATTACK TEST:
This is only for treated soda lime glass containers under the controlled humidity
conditions which neutralize the surface alkali and glass will become chemically more
resistant.
Principle: involved is whether the alkali leached or not from the surface of the container.
Procedure: Rinse thoroughly with high purity water. Fill each container to 90%of its
overflow capacity with water and is autoclaved at 121⁰C for 30min then it is cooled and
the liquid is decanted which is titrated with 0.02N

14. sulphuric acid using methyl red as an indicator. The volume of sulphuric acid consumed is the
measure of the amount of alkaline oxides present in the glass containers
2) HYDROLYTIC RESISTANCE OF GLASS CONTAINERS:
 Rise each container at least 3 times with CO2 free water and fill with the same to their
filling volume. Also fill & Cover the vials and bottles and keep in autoclave. Heat to 100⁰C
for 10min and allow the steam to issue from the vent cork. Rise the temp from 100⁰C to
121⁰C over 20min. Maintain the temp at 121⁰C to 122⁰C for 60min.Lower the temp from
121⁰C to 100C over 40min venting to prevent vacuum.
 Remove the container from autoclave, cool and combine the liquids being examined.
Measure the volume of test solution into a conical flask and titrate with 0.01M HCl using
methyl red as an indicator. Perform blank with water and the difference between the
titration represents the volume of HClconsumed by the test solution

15. 3) THERMAL SHOCK TEST:
Place the samples in upright position in a tray. Immerse the tray into a hot
water for a given time and transfers to cold water bath, temp of both are
closely controlled. Examine cracks or breaks before and after the test. The
amount of thermal shock a bottle can withstand depends on its size, design
and glass distribution. Small bottles withstand a temp differential of 60 to
80⁰C and 1 pint bottle 30 to 40⁰C. A typical test uses 45C temp difference
between hot and cold water.
4) INTERNAL BURSTING PRESSURE TEST:
The most common instrument used is American glass research increment
pressure tester .The test bottle is filled with water and placed inside the test
chamber. A scaling head is applied and the internal pressure automatically
raised by a series of increments each of which is held for a set of time. The
bottle can be checked to a preselected pressure level and the test continues
until the container finally burst

16. 5) LEAKAGE TEST:
Drug filled container is placed in a container filled with coloured solution (due to the addition
of dye)which is at high pressure compared to the pressure inside the glass container so that the
coloured solution enters the container if any cracks or any breakage is present.
6) ANNEALING TEST:
The sample is examined by polarized light in either a polariscopeor strain viewer. The strain
pattern is compared against standard discs or limit samples.
7)VERTICAL LOAD TEST:
The bottle is placed between a fixed platform & a hydraulic ramp platform which is gradually
raised so that a vertical load is applied. The load is registered on pressure gauge.
8) AUTOCLAVING (121⁰ C for 60 min) :
Ability of a filled or empty container to withstand autoclaving may be checked.

17. Plastic Containers:
 Plastic are synthetic polymer of high molecular weight.
 Plastic as packaging have proved useful for a number of reasons, including the
ease with which they can be formed ,they are high quality and the freedom to
design.
 Plastic container are two forms:
1 ) Amorphous plastic
2) Crystalline Plastic

18. 1) Amorphous Plastic:
 They are of less inert
 They are more permeable to glass and vapour
 They give good transparency
2) Crystalline Plastic:
 They are more flexible
 They are more inert
 They are less permeable to gases and vapour

19.  Type of plastic:
1) Thermoplastic Type
2) Thermosetting type

20. 1) Thermoplastic type:
 On heating they are soften to viscous fluid which hardness again on
cooling.
Ex. Polyethylene, PVC, Polystrene, Melting point range 110
Polyamide, Polycarbonate.
2) Polyethylene: It is flexible, very light but through plastic.
 Melting point range 110⁰ to 150⁰.
 It has high melting point and can sterilized by autoclaving.
It is divided into :
1) HDPE(High density Polyethylene)
2) LDPE(Low density Polyethylene)

21. 3) Polyvinyl chloride (PVC)
 It is less flexible and more permeable to water vapour as compared with
normal polyethylene.
 It is high clarity and not effected by sunlight.
 It is used for preparation of eye ointment tubes.
4) Polymetyl Metocarylate ( PMMA)
 It is hard, strong but light, transparent plastic
 It is soften at about 100⁰c.
 It is used for preparation bottles and tubes.

22. 5) Polystrene:
 It is hard, rigid, Light material.
 It can easily molded into any shape.
 So it is used for preparation bottles, tubes, jars, boxes, and
syringes.
6) Polypropylene:
 It is similar to high density Polythene.
 It is very light and heat resistant.
 It is melting point 170⁰c.
 Used in preparation bottle, tubes etc.
7) Polycarbonate:
 It is transparent, has high impact strength and very good heat
resistance.
 It is used in preparation of surgical equipment

23.  Advantages of plastic:
 It are light in wt. and can be handled easily.
 They are transparent easily.
 They are unbreakable.
 They available in various shapes and sizes.
 Disadvantages:
 They are permeable to water vapour and atmospheric gases.
 They are poor conductor to heat.
 They absorb chemical substance, such as preservative for solution.

24. Biological TestBiological test of plastic:
A) Systemic injection Test:
 Test animal- Albino Mice
 Injection each of 5 mice in test group with sample or blank observe the animals
immediately, again after 4hr and at 24, 48, 72hrs.
 If non of animals shows significant greater biological reactivity than the blank the
sample meets the requirement.
 Limit: If abnormal behavior such as Convulsion or Prostration occurs or if body wt. loss
is greater than 2g, the sample dose not meet the requirements.

25. B) Intra Cutaneous Test:
 Test animal: Rabbit
 Examine the site of for any tissue reaction like erythema, oedema, neurosis at 24, 48,
72 hrs. after injection.
 Limit: Different between the scores of sample and blank should be lesser than 1.0.
C) Eye Irritation Test on Rabbit:
 Test animal: Albino rabbit
 Limit: Sample extract shows no significant irritation during the observation period with
blank extract.

26. Leakage test for plastic containers (non-injectable & injectable 1996 IP):
Fill 10 plastic containers with water and fit the closure
Keep them inverted at room temperature for 24 hrs
No sign of leakage should be there from any container

27. Drug- Plastic Consideration :
A packaging system must protect the drug without altering the composition of the
product until the dose is remove.
 Drug-Plastic consideration have been divided have into five categories:
1) Permeable
2) Leaching
3) Sorption
4) Chemical reaction
5) Alternation

28. 1) Permeation:
 It is the transmission of gases, vapour or liquid through plastic packaging material.
 Permeation of water vapor and oxygen through plastic wall into the drug is major
problem is the dosage form is sensitive to hydrolysis and oxidation.
2) Leaching:
 Some plastic container have one or more ingredient added to stabilize it, these may
leach into the drug product.
Fill 10 containers with water, fit with intended closures and keep them inverted at room
temperature for 24hr.The test is said to be passed if there is no signs of leakage from any
container.

29.  Sorption: The process involves the removable of from the constituent from the drug
product by packaging material
 The therapeutic efficacy of the product may be reduced due to sorption.
 Sorption may change the chemical structure, ph., solvent system, concentration of
active ingredients and temp. etc.

30. 3) Chemical Reactivity:
 Certain ingredients in plastic formulation may react chemically with one or more
components of the drug product.
 Even in micro quantities if incompatibility occurs may alter the appearance of the
plastic or the product.
4) Modification:
 The physical and chemical alteration on of the packaging material by drug product is
called modification.
 Some solvent system found to be considerable change in the mechanical properties of
the plastic.
 For example oils have a softening effect on polyethylene, hydrocarbon attack
polyethylene and PVC.

31. Reference
Leon Lachman , Herbert A. liberman ,
Joseph L. Kanig , “The Theory and
Practice of Industrial Pharmacy” , third
edition , Indian Edition VARGHESE
PUBLICATION HOUSE , Mumbai , Page no:
711-720

32. THANK YOU..!