UNIT-5 INDUSTRIAL PHARMACY-I PART-3

PACKAGING MATERIALS SCIENCE

The packaging process is employed to maintain the therapeutic effectiveness of
pharmaceuticals as the packed products retain their potency till their consumption. The art
and science of preparing the articles for their transport, storage, display, and use is termed
packaging. A preparation which has been formulated with proper care but its packaging has
been done inappropriately, fails to fulfil the purpose. Different formulations are packed in
containers of different materials and of various shapes and sizes.
A package comprises of the following components:
1) Container: It encloses the drug, thereby remains in direct contact with the drug. Such
a container which is always in direct contact with the drug is an immediate
container.

2) Closure: It seals the container to eliminate oxygen, carbon dioxide, moisture, and
microorganisms. A closure prevents the loss of volatile substances, and also the loss
of medicament during transport and handling. I t is a component of container system,
and has no direct contact with the drug.

3) Carton: It is made up of cardboard, moulded wood pulp, or expanded polystyrene,

and provides secondary protection. It is an outer covering and protects against
mechanical and other environmental hazards.

4) Box: It is made up of thick cardboard, wood, or any other suitable material, and
carries multiples of a product. It provides primary protection against external hazards
during transportation and handling.

The characteristics of packaging materials are:

1) They should provide protection to the materials against environmental conditions (e.g.,
temperature, humidity, oxygen, and light).
2) They should neither react with the product nor with its ingredients.
3) They should not impart to the product any odour or taste (e.g., certain plastics impart
odour to the product).
4) They should bear no toxic property.
5) They should be Food and Drugs Administration approved.
6) They should be tamper-resistant so that the package integrity is protected, thus
preventing adulteration, substitution, or any such negligence.
7) They should be useful for packaging equipments and machines.

Objectives of Packaging
The packaging and package labelling have the following objectives:
1) Physical Protection: The package provides protection to the product against
mechanical shock, vibration, electrostatic discharge, compression, temperature, etc.
2) Barrier Protection: A barrier is required to protect the product from oxygen, water
vapour, dust, et c. The critical factor in the designing of such package is permeation.
To extend the product shelf -life, some packages contain desiccants or oxygen
absorbers. In some food packages, atmosphere maintenance is done with respect to
modified or controlled atmospheres. Major aim is to sustain the contents clean, fresh,
sterile, and safe throughout the shelf-life.
3) Containment or Agglomeration: Small objects are kept collectively in a package to
sustain efficiency. For example, 100 syrups packed in a single box need a less

Mr. VIVEKANAND PRAJAPATI, ASST. PROFESSOR, HCOP, LUCKNOW.

UNIT-5 INDUSTRIAL PHARMACY-I PART-3

physical effort in handling than 100 single syrups. Liquids, powders, and granular
materials require containment.
4) Information Transmission: Packages and labels provide information about the
usage, transport, recycling, or disposing of the package or product. Pharmaceuticals,
food, medical and chemical products need special information stated by the
governments. Some packages and labels have track and trace purposes.
5) Marketing: Marketers use the packaging and labels of a particular product for
convincing the buyers to purchase it. Package graphic designing and physical
designing phenomenon are progressing since many years. Marketing communications
and graphic design are placed on the package surface and many times at the point of
sale display.
6) Security: The security risks of shipment are minimised by packaging. Packages with
improved tamper resistance prevents tampering. Such packages also bear tamper-
evident features to indicate tampering. Packages are designed such that the risks of
package pilferage are reduced. Some packages can resist pilferage and can bear seals
indicating pilferage. Packages bear authentic seals and security printing indicating
that the package contents are not fake. Some packages are fitted with anti -theft
devices (e.g., dye packs, electronic article surveillance tags), which get activated and
detected at the exit points. These devices can be deactivated only with specialised
tools. This type of packaging minimises loss.
7) Convenience: Packages exhibit features aiding in distribution, handling, stacking,
display, sale, opening, reclosing, use, dispensing, and reuse.
8) Portion Control: Single serving or single dosage packages carry precise quantity of
contents to manage usage. Bulk possessions (like salt) are placed in packages of
suitable size for individual households. It also supports the inventory control, e.g., by
selling one -litre sealed milk bottles, individuals can stop bringing their individual
bottles to fill.

Materials Used for Packaging of Pharmaceutical Products

The packaging materials selected should have the following properties:
1) They should protect the preparation from environmental conditions.
2) They should not react with the products.
3) They should be non-toxic.
4) They should not impart any taste or odour to the product.
5) They should not be influenced by adverse manufacturing conditions.
6) They should protect the light-sensitive drugs.
7) They should be easily available, feasible, and economical.
**
The various types of materials used for packaging of pharmaceutical products are:
1) Glass,
2) Plastic,
3) Rubber,
4) Metals,
5) Fibrous materials, and
6) Foils, films and laminates.

Glass
Glass is economical, chemically inert, impermeable, strong, rigid, has FDA clearance, and
possesses superior protective qualities; thus, is used for packaging pharmaceuticals. Glass
containers are available in various sizes and shapes.

Mr. VIVEKANAND PRAJAPATI, ASST. PROFESSOR, HCOP, LUCKNOW.

UNIT-5 INDUSTRIAL PHARMACY-I PART-3

Glass does not get depreciated with time. If a proper closure system is provided, glass serves
as an efficient barrier against every element; however, only amber -coloured glass can
provide protection against light. The fragile nature and weight of glass are its major
limitations when used for packaging.

Composition
Glass is composed of sand, soda-ash, limestone, and cullet. Sand is pure silica, soda –ash is
sodium carbonate, limestone is calcium carbonate, and cullet is broken glass mixed with the
batch and serves as a fusion agent for the entire mixture. Glass composition varies and needs
to be adjusted specifically for different purposes. Silicon, aluminium, boron, sodium,
potassium, calcium, magnesium, zinc, and barium are the cations commonly found in
pharmaceutical glassware; while oxygen is the only anion.

Types, Properties, and Applications:

Type I – Borosilicate Glass

Borosilicate glass is highly resistant, and a large part of the alkali and earth cations are
replaced with boron and/or aluminium and zinc. This glass is more chemically inert in
comparison to the soda -lime glass that contains either an insignificant amount or none of
these cations. Since glass is a practically inert material, it is used for storing strong acids and
alkalis, and all types of solvents. It undergoes a definite and measurable chemical reaction
with some substances, especially water.

Type II – Treated Soda-Lime Glass

On storing the glassware in a damp atmosphere or under extreme temperature variations for a
few months, the condensed moisture makes the glass surface wet and the salts dissolve out of
the glass; this phenomenon is termed blooming or weathering. In the early stages of this
process, fine crystals appear on the glass. The salts that dissolve out of the glass can be
washed with water or acid.
Treated soda -lime glass has been de -alkalised or treated to remove their surface alkali and
prevent the weathering of empty bottles; this de -alkalising process is termed sulphur
treatment.

Type III – Regular Soda-Lime Glass

Regular soda-lime glass is untreated and exhibits average or better -than-average chemical
resistance.

Type NP – General-Purpose Soda-Lime Glass

General-purpose soda -lime glass is used for non -parenteral products that are meant for
oral or topical use.

Mr. VIVEKANAND PRAJAPATI, ASST. PROFESSOR, HCOP, LUCKNOW.

UNIT-5 INDUSTRIAL PHARMACY-I PART-3

Different types of glass, their constituents, properties, and uses are enlisted in table:

Table: Types of Glass, their Composition, Properties and Uses

Types of Main Constituents Properties Uses

Glass
Type-1: SiO2 (80%), B 2O3 High melting point to For laboratory
Borosilicate (12%), Al 2O3 (2%), withstand high glass
glass, and Na2O + CaO (6%) temperature; resistant apparatus,
e.g., Pyrex, to chemical substances, injections,
Borosil reduced leaching and water for
action. injection.

Type-II: Made up of soda lime Glass surface is For alkali sensitive

Treated soda glass whose surface is resistant products, infusion
-lime de-alkalised or treated to water attack for a fluids, blood and
glass with an acidic gas definite time period; plasma, and large
(SO2) at 500°C and sulphur treatment volume containers.
moisture. neutralises the alkaline
oxides on the surface,
thus the glass is
chemically resistant.

Type-III: SiO2 (73%), Na2O (15%), - For oral and topical

Regular CaO (7%), MgO (4%), Purpose; not for
soda-lime Al2O3 (1%) ampoules.
glass
Softer and can be For small vials
Neutral SiO2 (72-75%), B 2O3 moulded; good (<25ml) and large
Glass (7-10%), Al 2O3 (6%), resistance transfusion bottles.
Na2O (6 -8%), K 2O to autoclaving; resistant
(0.5-2%), and BaO (2 - to alkali -preparations
4%) (with pH up to 8);
lower
Cost than borosilicate.

Neutral SiO2 (67%), B 2O3 Melting point is less; Ampoules for

Tubing (7.5%), A1 2O3 (8.5%), after filling the glass injection
for Na2O (8.7%), K 2O (4%), ampoules are sealed by
Ampoules CaO (4%), and MgO (0.3%) fusion, therefore the
glass is easy to melt.

Coloured Glass + iron oxide Amber coloured glass; For photosensitive

Glass resist radiation from Products.
290
to 400 to 450nm UV
Visible.

Mr. VIVEKANAND PRAJAPATI, ASST. PROFESSOR, HCOP, LUCKNOW.

UNIT-5 INDUSTRIAL PHARMACY-I PART-3

Merits
1) It has superior protective qualities.
2) It is available in various colours (e.g., amber, red, blue, emerald, green, and opal), and
most of them are used for ornamental purposes.
3)Amber-coloured glass provides protection against light to those ingredients of a
pharmaceutical product which gets chemically deteriorated by UV rays.
4) Red an d yellow -green coloured glasses also provide protection to light-sensitive products.
5) Green-coloured glass provides protection against IR rays.
6) Transparent glass allows visual inspection of the products.
7) It does not deteriorate with age.
8) It is heat resistant, thus can undergo heat sterilisation.
9) It can be easily cleaned.
10) It is impermeable.
11) It provides clarity to products.
12) It enables identification of products.
13) It is economical.
14) Glass containers are available in various shapes and sizes.

Demerits
1) It is of fragile and brittle nature.
2) It is heavy in weight and occupies more volume.
3) Its tensile strength is 1/20th that of steel.
4) It cannot undergo operations involving pressure and vacuum.
5) Alkaline glasses impart alkalinity and flakes to the products.
6) Once broken, it cannot be joined back.

Mr. VIVEKANAND PRAJAPATI, ASST. PROFESSOR, HCOP, LUCKNOW.

UNIT-5 INDUSTRIAL PHARMACY-I PART-3

Plastic
Plastic used as a material for container is composed of thermoplastic polymer. This polymer
forms the basic organic structural unit for each plastic type, and is commonly used in medical
field. The plastic materials used in medical field are added with a less amount of ingredients;
however, plasticisers, fillers, antistatic agents, antioxidants, and other ingredients are added in
large amounts to some plastic materials used for special purposes. Plastic containers are used
because of their light weight, non -breakable nature, low toxicity, and low reactivity with the
products (provided they contain fewer amounts of additives).
Materials
Nowadays, there are many plastic resins available to be used for packaging drug products.
Some commonly used plastic materials are discussed below:

1) Polyethylene: This material, having high density, is used in pharmaceutical industries for
making containers. Polyethylene serves as an efficient barrier against moisture; however, it
provides poor protection against oxygen and other gases. It remains unaffected by most of
the solvents, strong acids and alkalis. Polyethylene has the drawbacks of lack of clarity and
high permeation rate of essential odours, flavours, and oxygen; thus its use as a material for
container of pharmaceutical preparations is limited. Polyethylene’s density ranging from
0.91-0.96, directly determines the following
physical characteristics of blow-moulded containers:
i) Stiffness, ii) Moisture-vapour transmission, iii) Stress cracking, and iv) Clarity or
translucency. With increasing density, polyethylene becomes stiffer, less permeable to gases
and vapours, less resistant to stress cracking, and has a higher distortion and melting
temperature.

2) Polypropylene: This polymer material possesses many good properties of polyethylene,

thus its use at the current time has increased. Only hot aromatic or halogenated solvents can
soften polypropylene, otherwise it does not stress –crack under any conditions. It is resistant
to strong acids, alkalis, and most organic materials. It has a high melting point, thus can
be used for boilable packages and for sterilisable products. It serves as an efficient barrier
against gas and vapour. Polypropylene has a drawback of lack of clarity; however, this can
be improved by making its walls comparatively thinner.

3) Polyvinyl Chloride (PVC): Natural PVC is inexpensive, clear, and stiff; however, it can
be made soft by adding plasticisers. Stabilisers, anti -oxidants, lubricants, and colourants can
also be added. Pure form of PVC is used rarely. PVC can be easily processed. Containers of
PVC have extreme clarity, are rigid, serve as an efficient barrier against oxygen, and thus
overcome the drawbacks of polyethylene. The major disadvantages of PVC are that it has
poor impact resistance; on overheating it starts degrading at 280°F, giving highly corrosive
degradation products; and on exposure to heat or UV rays, it turns yellow, which can be
prevented by adding a stabiliser.
4) Polystyrene: It is an inexpensive, clear, and rigid plastic material. Polystyrene containers
are in use since many years by the pharmacists for dispensing solid dosage forms. It is not
suitable for dispensing liquid products. Its water vapour transmission is higher than that of
high -density polyethylene; its oxygen permeability is also high; and it is resistant to acids
(except the strong oxidising acids) and alkalis. The disadvantage of polystyrene is that on
exposure to certain chemicals, it gets cracked, thus is preferred only for packaging dry
products.

Mr. VIVEKANAND PRAJAPATI, ASST. PROFESSOR, HCOP, LUCKNOW.

UNIT-5 INDUSTRIAL PHARMACY-I PART-3

5) Polyethylene Terephthalate (PET): It is a condensation polymer, formed when

terephthalic acid or dimethyl terephthalate reacts with ethylene glycol in the presence of a
catalyst. It has exceptional impact strength, and also serves as a barrier against gas and
aroma; thus it is preferred for packaging cosmetics and mouth washes, and other products
which consider strength, toughness, and barrier important.
Properties
1) It can be remoulded.
2) It has flexibility.
3) It provides transparency.
4) It provides elasticity.
5) It has permeability.
Applications
1) It is used as a lining for tanks and vessels and as coatings on stirrers and fans.
2) Plastic cements are used for spaces between acid-resistant tiles and bricks.
3) Transparent plastic guards are used for moving parts of machinery and asepsis screens.
4) Nylon and PVC fibres are woven into filter clothes.
5) Rigid or semi -rigid mouldings are used for tanks, pipes, ducts, and other similar items.
6) Unbreakable plastics are used for slightly flexible funnels, buckets, and jugs.
Merits
1) It has a low thermal and electrical resistance.
2) It is resistant to weak mineral acids.
3) It remains unaffected by inorganic salts.
4) It is resistant to slight pH changes.
Demerits
1) It has a low mechanical strength.
2) Its expansion rate is high.

Mr. VIVEKANAND PRAJAPATI, ASST. PROFESSOR, HCOP, LUCKNOW.

UNIT-5 INDUSTRIAL PHARMACY-I PART-3

Rubber
Rubber is either used as such or as lining materials for plant construction. Rubbers are
categorised into:
1) Natural Rubber: This naturally occurring polymer is obtained from rubber trees in the
form of latex. It is a common example of an elastomer, which is a substance that can be
easily stretched, but quickly move to its original form on releasing. Natural rubber is further
categorised into:
i) Soft Rubber: It is also a naturally occurring polymer of monomeric isoprene (C5H8).
Thus, rubber is a polyisoprene with molecular formula (C5H8) n. Soft rubber when added
with carbon black yields hardened rubber, which is used for making tyres, tubes, and
conveyor belts. Soft rubber is also used as a lining material for plants as it gets easily bonded
to the steel.
ii) Hard Rubber: It is formed by the process of vulcanisation, in which soft rubber is mixed
and warmed with sulphur, and set into a given shape. The sulphur then combines with the
polymeric chains of rubber and cross –links between them, thus soft rubber attains the shape
in which it was set. Soft rubber with 25% or more sulphur is termed hard rubber. Hard
rubber due to its hardness and strength is used for making gloves, bands, tubes, and stoppers.
2) Synthetic Rubber: This rubber is resistant to oxidation, solvents, oils, and other
chemicals. Due to these superior properties, synthetic rubber is more important than natural
rubber. Examples of some synthetic rubber s, their properties, and applications are given in

Table: Types of Synthetic Rubber

Applications
1) Rubber is used in pharmaceutical industries for making stoppers, cap liners, and bulbs for
dropper assemblies.
2) Rubber stopper is used for multi-dose vials and disposable syringes. More commonly used
rubber polymers are natural, neoprene, and butyl rubber. *
Merit: Soft rubber provides resistance against dilute mineral acids, dilute alkalis, and salts.
Demerit: Soft rubber can be attacked by oxidising media, oils, and organic solvents.

Mr. VIVEKANAND PRAJAPATI, ASST. PROFESSOR, HCOP, LUCKNOW.

UNIT-5 INDUSTRIAL PHARMACY-I PART-3

Metals
Tin
It is a malleable, ductile, highly crystalline, silvery white coloured, and a non-reactive
metal. Tin acts as a catalyst when oxygen is in solution.
Advantages
1) It is highly resistant to chemical attack.
2) It readily coats several metals, e.g., tin-coated lead tubes combine the softness of lead with
the inertness of tin and so it was earlier used for packaging fluoride toothpastes.
Disadvantages
It is the most expensive metal among lead, aluminium, and iron.
Uses
1) Tin containers are used for storing food materials, e.g., tin-coated milk powder containers.
2) Pure tin ointment tubes are used for packaging some eye ointments.

Aluminium
Advantages
1) It is a light metal; thus its shipment cost is less.
2) It provides attractiveness of tin at a lower cost.
3) Its surface reacts with atmospheric oxygen to form a thin, tough, coherent, and transparent
coating of oxide to prevent the oxidation of metal.
Disadvantages
If any substance reacts with this oxide coating, corrosion occurs, e.g., products of high or low
pH and some complexing agents can cause corrosion by reacting with the oxide coating. This
corrosion process leads to evolution of hydrogen.
Uses
1) It is used for making ointment tubes and screw caps.
2) Aluminium strips are used for strip-packaging of tablets, capsules, etc.
3) Aluminium containers are lacquered from inside to prevent its reaction with the contents.

Iron
Advantages
Iron as such is not used for pharmaceutical packaging, but large qualities of tin -coated
steel called „tin‟, combines the strength of steel with the corrosion resistance of tin.
Disadvantages
If an aqueous liquid penetrates a pinhole or other fault in the tin layer, a short -circuited
galvanic cell is set -up; and the resultant intense chemical reaction causes rapid corrosion
of underlying steel. Thus, the tin surface is lacquered.
Uses
Iron is used for fabrication of milk containers, screw caps, and aerosol cans.
Lead
Advantages
1) It is of lowest cost of all the metals used in pharmaceutical containers.
2) It is a soft metal.
Disadvantages
If taken internally, lead poisoning may occur; thus, the lead containers and tubes should
have an internal lining of inert metal or polymer.
Uses
The lining lead tubes are used for fluoride toothpastes.

Mr. VIVEKANAND PRAJAPATI, ASST. PROFESSOR, HCOP, LUCKNOW.

UNIT-5 INDUSTRIAL PHARMACY-I PART-3

Fibrous Materials
Paper and cardboard are materials of cellulose fibres. They are used in primary as well as
secondary packaging of pharmaceutical products. Cardboard carton s are used to provide
protection to the primary pack and also a suitable area for decorative design and mentioning
the information required by regulatory authorities. Cartons are convenient for stacking and
can bear information leaflets. Cards can also be used as dividers or trays inside secondary
packs. Thicker, corrugated cardboard and fibreboard are used for shipping cartons as they
are subjected to greater mechanical stresses than the ordinary cartons.
Paper is used in most of the packs as the label on the container and as the patient information
leaflet. The paper is usually printed and coated as a part of a laminate or adhesive backed. In
sterile sachets for syringes and dressings, paper is a constituent of the primary pack. Sacks
made from thick paper and lined with polyethylene are used as the primary pack for some
bulk powders.

Foils, Films, and Laminates

Foils, films, and laminates are the major types of thin and flexible packaging. Foils are thin
metal sheets of less than 100 um thickness; films are non -fibrous and non –metallic sheets of
less than 250 um thickness; and laminates are formed by bonding two or more film or foil
webs together.
These are described as follows:

1) Foils: Aluminium is more commonly used as foils. Foils have excellent barrier properties.
With the help of modern technology, they are produced to 10um thickness; however, pinholes
may form and deteriorate the barrier properties of foils, if their thickness is below 25 um.
Foils are either used alone or in combi nation with other materials in laminates to provide an
attractive and reflective surface. Thicker aluminium sheets are used in rigid packaging, such
as the trays of blister packs (where they are formed by cold-moulding) that are becoming an
alternative to plastic trays.
Another development, in which aluminium is used as part of a thin film, is vacuum dis-
positioning wherein a thin aluminium film is sprayed on a polymer substrate (like polyester).
This imparts some barrier properties on the polymer, although not as good as a proper
aluminium foil. This film has a shiny aluminium coating on one side and can be printed on
the other.
**
2) Films: The packaging films used before were of regenerated cellulose and are now called
cellophane, which is an attractive, transparent film that can be coloured and printed, and is
used as an outer wrap. Cellophane provides an efficient barrier against vapours, but not
against moisture, so the cellophane is coated with various substances. This coated cellophane
is used for heat -sealing purposes. The coated and non –coated cellophane is widely used in
pharmaceutical, food, and other types of packaging.
At the present time, many other plastics (e.g., PVC, LDPE, polypropylene, and polyester) are
used to make films that can be used as outer wraps for other packs. Plastics like thicker
grades of PVC are suitable for thermo -moulding into trays which can be used as part of a
blister pack or to hold primary packs within a secondary pack (e.g., a tray holding several
glass ampoules inside a cardboard carton). Plastic films have limited beneficial properties,
thus their use as the sole packaging material is still restricted. Films with desired properties
can be selected and combined in a laminate to provide multiple functions.

Mr. VIVEKANAND PRAJAPATI, ASST. PROFESSOR, HCOP, LUCKNOW.

UNIT-5 INDUSTRIAL PHARMACY-I PART-3

3) Laminates: They are made by bonding the layers with adhesive; but if the product is a
liquid or semi-solid and is in close contact with the laminated walls of a sachet, the adhesive
can migrate into the product through the inner layers of the laminate. Laminates are used to
combine the properties of individual foils and films. To fulfil all the pack requirements, a
laminate may have many layers, thus a sachet for a tablet may also have multiple layers (from
the outside in), i.e., a layer f or decoration and information, a layer for mechanical protection,
a layer for light and moisture barrier, and a heat sealer layer. Laminates are widely used in
blister packs, bubble packs, strip packs, pouches, sachets, and other types of flexible packs.

Types of Packaging
Packaging comes in many different types. For example, a transport package or
distribution package are the shipping containers used for transporting, storing, and handling
product or inner packages. A consumer package is the one that reaches a consumer or
household directly. Packaging depends on the type of product being packaged (medical
device packaging, bulk chemical packaging, over -the-counter drug packaging, retail food
packaging, military material packaging, pharmaceutical packaging, etc.). Packages are
categorised as follows by layer or function:
1) Primary packaging,
2) Secondary packaging, and
3) Tertiary packaging.
A product requires all the three packaging types as per the intended purpose.
Primary Packaging
The material used in primary packaging is the first to surround the product and hold it. This
type of packaging is the smallest unit of distribution or use. It is always in direct contact with
the product.
Materials Used in Primary Packaging
Glass is the major primary packaging material. The different types of materials used for
primary packaging are discussed below:

1) Type-I Glass: It is employed as glass ampoules and vials for fluids for injection:
i) Ampoules
a) One point cut ampoules,
b) Flat based and constricted neck ampoules,
c) Flame cut ampoules,
d) Closed ampoules, and
e) Ampoules with colour break band and identification bands.

ii) Tubular Vials: These are clear or amber-coloured, neutral, type I glass vials.

Types of Glass Containers

i) Bottles: Amber metric medical bottles or ribbed (fluted) oval bottles are used in the
dispensaries. Their size ranges from 50 -500ml. Various oral medications are packed in
amber metric medical bottles; while liniments, lotions, inhalations, and antiseptic solutions
are packed in ribbed oval bottles.
ii) Dropper Bottles: These bottles used for packaging ear, nasal, and eye drops are
hexagonal-shaped, amber -coloured, and fluted on three sides. These are additionally fitted
with a closure kit comprising of a cap, rubber teat, and a dropper. Dropper bottles are
available in capacity of 10-20ml.

Mr. VIVEKANAND PRAJAPATI, ASST. PROFESSOR, HCOP, LUCKNOW.

UNIT-5 INDUSTRIAL PHARMACY-I PART-3

iii) Jars: These are used for packaging powders and semi -solid preparations (like ointments
and pastes). Jars are cylindrical -shaped, have a wide mouth, and are made up of clear or
amber-coloured glass. The size of jars ranges from 15-500ml.

2) Plastics: These materials are preferred for product container and also as a secondary
packaging. These are classified into thermosets and thermoplastics. Plastics can be used for
making several types of pack like rigid bottles for tablets and capsules, squeezable bottles for
eye drops and nasal sprays, jars, flexible tubes, and strip and blister packs.
Merits
i) They are flexible and hard to break.
ii) They have a low density and are light weighted.
iii) They are inexpensive.
Demerits
i) They are chemically less inert than Type-I glass.
ii) They are less impermeable to gas and vapour than glass.
iii) They carry electrostatic charge which attracts particles.
Examples
i) Polyethylene: It is available as high and low density polyethylene. Low Density Poly
Ethylene (LDPE) is used for making squeeze bottles, while High Density Poly Ethylene
(HDPE) is used for making bottles for solid dosage forms. HDPE shows less permeability to
gases and greater resistant to oils, chemicals, and solvents.
ii) Polyvinylchloride (PVC): It is a rigid packaging material that forms the major component
of intravenous bags.
iii) Polypropylene: It does not crack when flexed. It is used for making closures, tablet
containers, and intravenous bottles.
iv) Polystyrene: It is used for making jars to pack ointments and creams having low water
content.

3) Metals: Various metals, e.g., tin-plated steel, mild steel, stainless steel, tin -free steel, and
aluminium and its various alloys are used as packaging material. Metal has properties of
being strong, opaque, impermeable to moisture, gases, odours, light, bacteria, etc., and
resistant to high and low temperatures. The metals used for packaging purpose are as follows:
i) Tin: It has the most chemically inert nature. Tin as a packaging material for many products
is reliable, compatible, and provides a good appearance to the product.
ii) Tinplate: It is a steel structure on one or both sides of which a thin layer of tin is
deposited. This layer prevents the product from getting corroded.
iii) Aluminium: It is a light -weighed metal, which can be easily casted in any shape. The
thick, rigid closures are used for making cans or aerosol containers, whereas the thin flexible
material is used for making closure of bottles or thermoforms. Blister packaging is done
using a hard tamper (where tablet is pushed through the material). Tubes are internally
lacquered, wax coated, and latex lined.

4) Plastic Tubes: The size of flexible plastic tubes ranges between 19 -50mm in diameter, up
to 300ml in volume, 2 -8mm orifice (3mm is considered standard), and around 400-500μ of
tube wall thickness.

5) Laminated Tubes: These tubes have multiple layers of aluminium foil or nylon or
polyester which provides protection against oxygen and moisture, prevents loss of odour, and
makes the surface glossy that improves printing quality. These are transparent and stretched

Mr. VIVEKANAND PRAJAPATI, ASST. PROFESSOR, HCOP, LUCKNOW.

UNIT-5 INDUSTRIAL PHARMACY-I PART-3

polypropylene. PET tubes with dispenser caps are available. Caps are available in variety of
designs (like conical or flip-top) for an appealing look.

6) Bulk Containers: These hold the bulk drug and active pharmaceutical ingredients. They
are available as packages, bags, and drum liners manufactured by following c GMP (Current
Good Manufacturing Practices). c GMP compliance in terms of quality systems, complete
traceability, change control, SOPs, and pharmaceutical grade housekeeping are recorded in
the drug master file. LDPE, foil laminate bags, and drum liners come in many sizes and
designs.

7) Blister Packs: These are unit dos e packs for pharmaceutical tablets, capsules, or
lozenges. The two principal components of blister packs are:
i) A base-like web that creates a cavity to fit the product inside, and
ii) The lidding foil that dispenses the product out of the pack.
*
Types of cavity forming into a base web sheet are:
i) Thermoforming: In this type, a plastic film or sheet from the reel is unwound, and
directed towards the blister line by passing through the pre -heating station. These pre -
heating upper and lower plates have a temperature sufficient enough to soften the plastic and
make it mouldable.
ii) Cold Forming: In this type, an aluminium -based laminate film is pressed through a
mould using a stamp. Thus, the aluminium film gets stretched and takes the desired shape.
The cold form foil blisters have the advantage that aluminium provides almost complete
protection against water and oxygen, thus prolonging the product expiry date. The cold form
foil blisters have the disadvantages that their production speed is slower than
thermoforming, the package is non-transparent, and the blister card is larger in size.
Examples
a) Aluminium foils for blister packing.
b) Aluminium foils used for blister packing of pharmaceutical products like
tablet, capsules, etc.

8) Strip Package: It is use d for packing tablets and capsules. It is made up of cellophane,
polyester, polyethylene, polypropylene, and polyvinyl chloride. A strip package is produced
by feeding two webs of films (which are flexible and heat sealable) through a heated
crimping roller. The product is allowed to reach the pocket formed prior to the formation of
the final set of seals. The obtained continuous strips of packets are cut into desired number
and length.

9) Closures: These are used for facilitating the opening and closing of containers. Container
should be closed properly to prevent:
i) Spilling or volatilisation of components,
ii) Product contamination from dirt, microbes, or insects, and
iii) Product deterioration by the environmental factors like moisture, oxygen, or carbon
dioxide.

Materials Used for Making Closures: Cork, glass, plastic, metal, and rubber are used to
make closures of containers used to pack pharmaceutical products.

Mr. VIVEKANAND PRAJAPATI, ASST. PROFESSOR, HCOP, LUCKNOW.

UNIT-5 INDUSTRIAL PHARMACY-I PART-3

Secondary Packaging
The materials employed in secondary packaging covers the primary package. This type of
packaging forms an outer wrapping to store, transport, inform, display, and protect the
product. An example of a secondary package is decorated cartons. * *

Materials Used
1) Paper: This is use d as a flexible wrap for products and sometimes as a closure material
for jars. Generally, the paper materials are applied with a liner either as a laminate or coating.
2) Pharmaceutical Corrugated Fibreboard: This paper -based material having fluted
corrugated sheet and one or two flat linerboards is used for manufacturing corrugated boxes.
3) Carton: This is used for packing food, pharmaceuticals, hardware, and other products.
Folding cartons are combined into a tube at the manufacturer and shipped flat (knocked
down) to the packager.

Symbols on Packages and Labels

Several symbols used nationally and internationally for package labelling have been
standardised for product certifications, trademarks, proof of purchase, etc., identification
code.

Fragile This way-up Keep away from Sunlight

Keep away from Water Do not use Hand Hooks Do not clamp as indicated

Tertiary Packaging
Tertiary packaging is suitable for bulk product handling, warehouse storage, and transport
shipping. These are commonly available as palletised unit load for tightly packing into
containers.

Factors Influencing Choice of Containers

The choice of containers is affected by the following factors:

1) Compatibility and Safety Concerns: The administration route of drug product and the
dosage form nature (e.g., solid, semi -solid or li quid based) influences the compatibility and
safety of packaging materials. The drug samples selected for stability studies should be
packaged in the same manner as they will be for marketing and distribution.

Mr. VIVEKANAND PRAJAPATI, ASST. PROFESSOR, HCOP, LUCKNOW.

UNIT-5 INDUSTRIAL PHARMACY-I PART-3

i) Compatibility of the Packaging Material with the Formulation: The packaging material
should not produce any adverse effect on the formulation by undergoing chemical reactions,
by leaching of packaging materials, by absorption or adsorption.
ii) Compatibility of the Formulation with the Packaging Material: The formulation
should not affect the properties and/or the protective functions of the packaging materials.

2) Degree of Protection Required: Since the stability of active pharmaceutical ingredients

are lowered when they are formulated into dosage forms, they may decompose under the
influence of excipients, moisture, oxygen, light, temperature, the formulation process, etc.
The degree of protection required depends on the formulation; for example, the packaging
materials used for photosensitive products should provide protection against light. The same
is also applicable to hygroscopic, easily oxidised drug products and so on.

3) Cost: To make the drugs affordable, cost effectiveness of the packaging materials should
be considered. However, the manufactures should not compromise with the formulation
integrity while reducing its cost. Instead, they should find a better way to reduce cost which
can also reduce the wastage of packaging materials.

4) Convenience: The packaging materials for a dosage form should be selected by

considering its size, weight, method of opening or reclosing during administration for patient
convenience.

5) Legibility: The legibility of printing should be considered while choosing and designing a
package as it serves as a source of information and identification of the formulation.

Legal & Other Official Requirements for Containers

Different specifications are required for parenteral, non -parenteral, pressurised and bulk
containers and for those made of glass, plastic, and metal. In each case, the package and
closure system should be effective for the particular product for which it is intended. The
packaging materials should neither physically nor chemically interact with the finished
product to alter its strength, quality, or purity beyond the specified standards.
Specifications and test methods for light resistant, tightly closed, and four types of glass
containers are provided in the compendium. These specifications and test methods are
designed for containers based on the tests performed on the product in the container. The
following features should be considered while developing container specifications:
1) The properties of container tightness,
2) Moisture and vapour tightness regardless of container construction,
3) Toxicity and chemical/physical characteristics of materials to be used in container
construction,
4) Physical or chemical changes of container when kept in prolonged contact with the
product, and
5) Compatibility between the container and product. As per the Good Manufacturing
Practices, stability data should be submitted for the finished dosage forms in the container
closure system in which it is to be marketed.

Label Control
The production control issues a packaging form bearing the product name, item number, lot
number, number of labels, inserts, packaging materials to be used, operations to be
performed, and the quantity to be packaged. The supervisor of label control receives a copy
of this form, and counts out the required number of labels. The labels during the packaging

Mr. VIVEKANAND PRAJAPATI, ASST. PROFESSOR, HCOP, LUCKNOW.

UNIT-5 INDUSTRIAL PHARMACY-I PART-3

operation may get damaged, thus they are being used in numbers more than actually required;
however, all the labels should be accounted for at the end of the operation, and unused labels
should be accounted for before their destruction.

Closures
A containers most vulnerable and critical component is the closure with respect to the
stability and compatibility with the product. A closure should effectively prevent the contents
from escaping and the access of substances into the container. A simplest closure system
should retain or contain the contents.
Safety and security concerns should be considered to prevent hazards due to leakage,
seepage, spillage, pilferage, exposure to wrong persons (e.g., children), or loss of quality,
purity, etc., by some source of contamination, impurity, etc.
Closures form a part of the overall design of the package, enhance the product appearance,
act in a functional role during use (e.g., reclosables), or assist in the product administration
(e.g., aerosol valve). They also play a protective/preventive role by controlling ingress
(odours, taints, moisture, oxygen, carbon dioxide, mould, bacteria, etc.) and egress (loss by
evaporation, loss of moisture, perfume, flavourings, volatiles, etc.).
Closures should be clean and inert so that they do not affect the product by
absorption/adsorption, prevent the interaction or migration of substances into the product, and
provide protection against any hazard during the product shelf -life, e.g., climatic, chemical,
biological, and mechanical hazards. Not only the closures cover the primary or immediate
pack, they are also important to the secondary pack.
For example, a fully taped (H -seal) and glued case is more robust than a partially taped
case, thus a better closuring system makes a more rigid unit that more effectively withstands
transit and stacking.

Basis of Closure Systems

Closures may be achieved by the following basic means either alone or by the combination of
two or more:
1) Pressure
i) Mechanical Pressure: For example, the top an d side internal pressure on a container
finishes ideally involving a seal between a fairly rigid and a more resilient material. It
includes screw closures, plug seals, lever lids, etc., to create an interference fit between the
two materials.
ii) Atmospheric Pressure (Pressure and Vacuum): A similar mechanical seal occurs, but
this is initially achieved by a differential pressure (e.g., vacuum sealed tin).

2) Temperature
i) Welding/Heat Sealing: It involves direct and indirect application of heat, under pressure,
for a given time (dwell) followed by a cooling period, so that two materials bound together.
ii) Electrical: For example, ultrasonic, high -frequency/radio frequency, impulse, and
induction sealing; basically a modification of the heat seal process.

3) Adhesion: This is achieved by aqueous solvent, hot melt, etc., adhesives or self -
adhesives, cold seal materials.
**
Closure Designs
1)Threaded Screw Cap: It is made up of metal (tinplate or aluminium) or plastics (both
thermoplastic and thermosetting materials). The threads of the screw cap (when applied on
the bottle) engage with the corresponding threads moulded on the bottle neck. When the

Mr. VIVEKANAND PRAJAPATI, ASST. PROFESSOR, HCOP, LUCKNOW.

UNIT-5 INDUSTRIAL PHARMACY-I PART-3

screw cap is applied, it overcomes the sealing surface irregularities and provides physical and
chemical protection to the contents.

Figure: Threaded Screw Cap Figure: Threaded Screw Cap Bottle

2) Lug Cap: It is used for both normal atmospheric -pressure and vacuum –pressure closing.
Lug cap is similar to the threaded screw cap and operates on the same principle. It is an
interrupted thread (and not a continuous thread) on the glass finish. A lug on the cap sidewall
is engaged and the cap is drawn down to the sealing surface of the container. Unlike the
threaded closure, it requires only a quarter turn.

Figure: Lug Cap Figure: Crown Caps

2) Crimp-on/Crown Cap: This cap is used as a crimped closure for beverage bottles and has
remained unchanged for more than 50 years.
3) Roll-on Cap: It can be sealed securely, opened easily, and resealed effectively. The roll-
on closure requires an easy -to-form material, such as aluminium or other light -gauge metal.
Re -sealable, non -re-sealable, and pilfer proof types of the roll –on closure is available for
use in glass or plastic bottles and jars.

Figure: Roll-On Closures Figure: Pilfer Proof Closures

4) Pilfer-Proof Screw Cap: It is similar to the standard roll -on closure except that it has a
greater skirt length that extends below the threaded portion to form a bank fastened to the
basic cap by a series of narrow metal bridges. On removing the pilfer - proof closure, the
bridges break and the bank remains in place on the container neck. The closure can be easily
re-sealed. The detached band indicates that the package has been opened. The torque is
necessary to remove the cap.* *
5) Rubber Stopper: Rubber polymers (like natural, neoprene, and butyl rubber) are used for
making stoppers, cap liners, and bulbs for droppers. Rubber stopper is used for multiple-dose
vials and disposable syringes.

Mr. VIVEKANAND PRAJAPATI, ASST. PROFESSOR, HCOP, LUCKNOW.

UNIT-5 INDUSTRIAL PHARMACY-I PART-3

6) Other Metal Closures for Glass and/or Plastics: The foremost metal closure in this
category is the crown closure (beer bottle), the foil heat seal (for yoghurt pots), or the
induction sealed diaphragm. The crown cork closure is a tinplate shell containing a
wad/facing. This may be conventional, polythene or a flowed –in compound. Its application
works on the principle that top pressure is applied first, followed by the application of
crimping action. Some other types of metal closures
are:
i) Metal Lever Cap (Narrow Neck Mineral Bottle): It can be resealed but is being replaced
with flavour-lock type closures.
ii) Centre Pressure Cap: It has a press cap centre for cap removal and press cap sides for
retention. It is used on glass jars but is mainly used on metal drums.
iii) Metal Vacuum Seal: It is top sealing disc plus rubber or plastic seal that is held on by a
safety band ring (as used on jars of paste). The cap is crimped under the neck ring (as in jam,
pickles, etc.). Omnia (continuous beading) and Gerda (perforated beading) are more rigid
tinplate closures applied by a side seal on the neck by a rubber ring or flowed-in compound.

Stability Aspects of Packaging Materials

Medicinal products are provided protection against moisture, oxygen, light, and chemicals.
The International Conference on Harmonisation (ICH) implemented guidelines in 1999,
which are now strictly followed during the stability testing of new drug substances. The
actual conditions used for the ICH guidelines were based on years of development work
using forced degradation studies or stress testing. These guidelines have standardised stability
testing and package determination. However, there are still some limitations to the current
ICH testing. These guidelines were developed for climatic zones I and II, thus they do not
meet the requirements of other climatic zones. Pharmaceutical customers select the
appropriate packaging based on the ICH stability studies of the packed product. Some,
however, fail to select optimum packaging as the stability becomes only a confirmatory test
for the selected packaging material.
The stability studies do not give a quantitative understanding of the cause and conditions of
tablet failure. Moreover, there are little chances that the parameters interact among
themselves.
Forced Degradation and Stress Testing
No regulatory practical and scientific guidelines are available that describe the method of
stress testing as a guide for the pharmaceutical scientists. Stress testing and accelerated
testing, although different, are often used synonymously.
The ICH has defined accelerated testing as the “studies designed to increase the rate of
chemical degradation or physical change of an active substance or drug product using
exaggerated storage conditions as part of the formal, definitive storage program”.
These data are used in long-term stability studies, to assess long -term chemical effects at
non-accelerated conditions, and to evaluate the impact of short -term excursions outside
label-storage conditions that might occur during shipping. * *
The ICH has defined stress testing as the “studies being carried out to elucidate the intrinsic
stability of the drug substance”. Such testing is a part of the development strategy and is
carried out under more severe conditions than those used for accelerated testing. From
regulatory view point, stress testing or forced degradation study is a scientific tool to
understand stability issues, and is characteristically predictive in nature; while, the
accelerated testing aims to maintain stability at a pre -set condition, identify the conditions
under which the product becomes unstable, and identify the moisture, gas, and light-barrier
properties in the protective packaging.

Mr. VIVEKANAND PRAJAPATI, ASST. PROFESSOR, HCOP, LUCKNOW.

UNIT-5 INDUSTRIAL PHARMACY-I PART-3

The actual dosage form is evaluated in an open -dish environment, instead of the solid oral
dose as part of a set of packaging materials. The dosage form is tested under different
conditions to determine the critical characteristics, which further determine the product shelf-
life. An evaluation of the test data along with a blister cavity model, results a
recommendation for the best material specific to that dosage form.
Three batches of dosage forms are studied under different environmental conditions to obtain
a more precise understanding of the following:
1) Hygroscopic tendency,
2) Dehydration tendency (if needed),
3) Degradation tendency (physical and chemical),
4) Effect on drug release properties,
5) Effect on hardness,
6) Photosensitivity as a function of RH and temperature,
7) Gas liberation tendency, and
8) Dimensional aspects.

When these properties have been evaluated, an exact determination is made to decide the oral
dose characteristic that was highly sensitive to the varying environmental conditions. Based
on this determination, the blister configuration for the solid oral dose is moulded, and the
maximum amount of moisture transmission is determined to make appropriate material
selection. All the polymers become thin on thermoforming, thus a critical understanding of
the thinning characteristics of various polymers in relation to the cavity design through a
software package using cavity -forming parameters is critical to optimise the barrier
properties of the blister structure for the specific application. Based upon the test data and the
blister cavity design work, a recommendation is made regarding the appropriate Moisture -
Vapour Transmission Rate (MVTR) and the packaging material.

Quality Control Tests

The evaluation of package helps in determining the physicochemical interactions that might
occur between the product and the package. The evaluation parameters identify, characterise,
and monitor these interactions to achieve a safe, unadulterated, stable, and efficacious
product. An ideal package should be inert and should have a maximum shelf -life. Any
defects in packaging material lead to contamination of the drug products and also reduce their
therapeutic efficacy.
The various quality control tests performed for different packaging material are discussed
below:
1) Glass Containers: The following tests are performed for glass containers:
i) Powdered Glass Test: The selected glass containers are washed, dried, crushed, sieved,
again crushed, and finally sieved through a nest of sieves. The amount retained on the sieve is
transferred to a closed container and stored in desiccators. After removing iron particles, the
glass sample is washed with acetone and dried. 10gm of this dried sample is mixed with
distilled water in a conical flask and autoclaved for 30 minutes at 121°C temperature. Water
is
decanted into another container and the washings of the sample made using distilled water are
added to the residual powdered glass. The pooled sample is titrated against 0.02N sulphuric
acid using methyl red indicator.
ii) Water Attack Test: Intact glass containers are filled with distilled water (up to 90% of its
volume) and autoclaved for 30 minutes at 121°C temperature. Within 60 minutes of
autoclaving, the contents are titrated against 0.02N sulphuric acid under warm conditions
using methyl red indicator. Blank titration is performed in the similar manner but without

Mr. VIVEKANAND PRAJAPATI, ASST. PROFESSOR, HCOP, LUCKNOW.

UNIT-5 INDUSTRIAL PHARMACY-I PART-3

autoclaving. The actual volume consumed (sample-blank) should not exceed the indicated
value mentioned in table for the glass concerned.

Table: Glass Types and Their Test Limits

iii) Arsenic Test: This test is performed on glass containers used for aqueous parenteral
products. The inner and outer surface of the containers is washed with fresh distilled water
for 5 minutes. 50ml sample is pipetted out into the flask of 10ml solution from the combined
contents of all ampoules. 10ml HNO 3 is added to dryness on the water bath.
The residue is dried in an oven for 30 minutes at 130˚C temperature. On cooling, 10ml
hydrogen molybdate reagent is added, swirled to dissolve, bath under water bath, and
refluxed for 25 minutes. The contents are cooled to room temperature and the absorbance is
determined at 840nm. The same procedure is repeated using 10ml hydrogen molybdate. The
test solution absorbance should not exceed the absorbance obtained by repeating the
determination using 0.1ml of arsenic standard solution (10ppm) in place of test solution.

iv) Thermal Shock Test: The samples are placed in upright position in a tray, which is
immersed in hot water for a specified time and then transferred to cold water bath. The
temperature difference between hot and cold water is typically 45˚C. Any cracks or breaks
before and after the test are examined carefully. The amount of thermal shock a bottle can
withstand depends on its size, design, and glass distribution. Small bottles can withstand a
temperature difference of 60 -80°C and 1pint bottle can withstand 30-40°C temperature
difference.

v) Internal Bursting Pressure Test: American glass research increment pressure tester is
used. The test bottle is filled with water and placed inside the apparatus chamber. A scaling
head is applied and the internal pressure is automatically raised by a series of increments each
held for a definite time. The bottle can be checked to a pre -selected pressure level and the
test is continued till the container burst.

vi) Leakage Test: Drug filled container is placed i n a container filled with dye coloured
solution which is at high pressure than the pressure inside the glass container; thus, the
coloured solution enters the container through any crack or breakage that might be present.

Mr. VIVEKANAND PRAJAPATI, ASST. PROFESSOR, HCOP, LUCKNOW.

UNIT-5 INDUSTRIAL PHARMACY-I PART-3

vii) Annealing Test: The sample is examined using polarised light either in a polariscope or
strain viewer. The strain pattern is compared against standard discs or limit samples.

viii) Vertical Load Test: The container is placed between a fixed platform and a hydraulic
ramp platform that is gradually raised so that a vertical load is applied. The load is registered
on pressure gauge.

2) Plastic Containers: The following tests are performed for plastic containers:
i) Leakage Test: 10 randomly selected containers are filled with distilled water, sealed, and
kept inverted for 24 hours at room temperature. The containers are considered to pass the test
if no sign of leakage from any of the containers is noticed.

ii) Collapsibility Test: This test is performed on containers which are squeezed to remove
the contents. A container when collapsed inwards during use should yield at least 90% of its
nominal contents at the required flow rate at ambient temperature.

iii) Transparency Test: The prepared 16 -fold dilution of a standard suspension should give
an absorbance value of 0.37-0.43 at 640nm. Five empty containers are filled to their nominal
capacity with suspension and viewed. The view through the containers should be the same as
compared with the container filled with water.

iv) Water Vapour Permeability Test: Five containers are filled with nominal volume of
water and heat sealed with aluminium foil -polyethylene laminate or other suitable seal. Each
container is accurately weighed and left undisturbed for 2 weeks at a relative humidity of 60
+/- 5% and a temperature between 20 -25°C.
After 2 weeks the containers are re -weighed, and the loss in weight in each container should
not be more than 0.2%.

v) Physicochemical Tests: These tests determine the physical and chemical properties of
plastics and their extracts. The following tests are performed after the extraction process:
a) Non-Volatile Residue: This test measures the solubilised organic/inorganic residue
(should not be more than 15mg) in extraction media.
b) Heavy Metals: This test measures the presence of metals such as lead, tin, and zinc.
c) Residue on Ignition: This test is performed when the non -volatile residue is more than
5mg.
d) Buffering Capacity: This test measures the acidity or alkalinity of the product.

vi) Compatibility Test: The packaging material and its components should be compatible
with the dosage form to prevent leaching. This is tested with mass spectrometry, liquid
chromatography, LC/MS, and GC/MS.

vii) Protection Test: Light-resistant containers are evaluated by the light transmission test
and the moisture-resistant containers are evaluated by the water vapour permeation test.

viii) Clarity of Aqueous Extract: Unlabelled, unmarked, and non-laminated portions from
suitable containers are randomly selected. These portions are cut into strips (having total
surface area of 20cm2), and washed with distilled water for about 30 seconds to remove
extraneous matter. In each case, the water is thoroughly drained off. The processed sample is
taken in a flask that was cleaned with chromic acid mixtures and washed with several
portions of distilled water. 250ml of distilled water is also added to the flask, which is then

Mr. VIVEKANAND PRAJAPATI, ASST. PROFESSOR, HCOP, LUCKNOW.

UNIT-5 INDUSTRIAL PHARMACY-I PART-3

covered and autoclaved for 30 minutes at 121°C temperature. Blank determination is

performed using 250ml distilled water. The contents are cooled after autoclaving and the
extract is
examined. It should be colourless and free from turbidity.

ix) Transparency Test

a) Standard Suspension Preparation: 1gm hydrazine sulphate is dissolved in 100ml water
and set aside for 6 hours. 25ml of this solution is added with 25ml of 10%w/v hexamine and
set aside for 24 hours.
b) Test Solution Preparation: Sample is prepared by 16 -fold dilution of the standard
suspension. Five empty containers are filled to their nominal capacity with suspension and
viewed. The view through the containers should be the same as compared with the container
filled with water. The absorbance value measured at 640nm should range within 0.37 and
0.43.

3) Other Tests: The other evaluation tests performed on packaging components are:
i) Tests for barium, heavy metals, tin, zinc, etc.
ii) Test on Extracts: The specified volume of extracting medium is taken in it. Plastic of
specified surface area is cut and extracted. The extract is checked for its appearance (should
be colourless), light absorption capacity, and presence of oxidisable substances.
iii) Bacteriological Tests: These tests determine the biological response of animals to
plastics and other polymeric materials by the instillation of specific extracts from the material
under test.
11.2.

Mr. VIVEKANAND PRAJAPATI, ASST. PROFESSOR, HCOP, LUCKNOW.