Pharmaceutical packaging naresh

1
Presented By
NARESH GORANTLA, M.Pharm.., (Ph.D)
Asso. Professor,
Balaji college of Pharmacy,
Anantapuramu
PACKAGING OF
PHARMACEUTICAL
PRODUCTS

Definition
2
Pharmaceutical packaging is the science, art and
technology of enclosing or protecting products for
distribution, storage, sale, and use. Packaging also refers
to the process of design, evaluation, and production of
packages.

Ideal packaging requirements
1. They must protect the preparation from environmental
conditions.
2. They must not be reactive with the product.
3. They must not impart to the product tastes or odors.
4. They must be nontoxic.
5. They must be FDA approved.
6. They must meet applicable tamper-resistance
requirements.
7. They must not be the cause of product degradation.
8. They must be adaptable to commonly employed high
3
speed packaging equipment.

Functions of packaging
4
1. Product Identification: Packaging greatly helps in
identification of products.
2. Product Protection: Packaging protects the contents
of a product from spoilage, breakage, leakage, etc.
3. Facilitating the use of product: Packaging provides
convenience to open, handle and use for the consumers.
4. Product Promotion: Packaging is also used for
promotional and attracting the attention of the people
while purchasing.
5. Marketing: The packaging and labels can be used by
marketers to encourage potential buyers to purchase the
product.

6. Convenience: Packages can have features that add
convenience in distribution, handling, stacking, display,
sale, opening, re-closing, use, dispensing, reuse,
recycling, and ease of disposal.
7. Barrier protection: A barrier from oxygen, water vapor,
dust, etc., is often required. Permeation is a critical factor
in design. Some packages contain desiccants or oxygen
absorbency to help extend shelf life. Keeping the
contents clean, fresh, sterile and safe for the intended
shelf life is a primary function.
8. Security: Packaging can play an important role in
reducing the security risks of shipment. Packages can be
made with improved tamper resistance to detect
tampering and also can have tamper-evident features to
help indicate tampering. Packages can be engineered to
help reduce the risks of package pilferage.
5

Selection of the Packaging Materials
6
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.
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 in turn the product is
affected.
7. On the cost of the product. Expensive products
usually justify expensive packaging
7

Types of packaging
8
Primary packaging is the material that first envelops the
product and holds it. This usually is the smallest unit of
distribution or use and is the package which is in direct
contact with the contents. Examples: Ampoules,Vials
,Containers , Dosing dropper , Closures (plastic, metal)
,Syringe, Strip package, Blister packaging.

Secondary packaging is defined as the packaging
that lies outside the primary packaging. It is
perhaps used to group primary packages
together. Example: Paper and
March 17 9
boards, Cartons ,Corrugated fibers ,Box manufacture)

Tertiary packaging is used for bulk handling , warehouse
storage and transport shipping. The most common form
is a palletized unit load that packs tightly into containers.
10

Apart from primary and secondary packaging, two
types of special packaging are currently in use, as
follows:
11
Unit-dose packaging: This packaging guarantees safer
medication by reducing medication errors; it is also more
practical for the patient. It may be very useful in
improving compliance with treatment and may also be
useful for less stable products.
Device packaging: Packaging with the aid of an
administration device is user-friendly and also improves
compliance. This type of packaging permits easier
administration by means of devices such as pre-ﬁlled
syringes, droppers, transdermal delivery systems, pumps
and aerosol sprays. Such devices ensure that the medicinal
product is administered correctly and in the right amount.

Types of packaging materials
12
I) Glass
II) Metals
III) Rubbers
IV) Plastics
V) Fibrous material
VI) Films, Foils and laminates

Glass
13
 Glass has been widely used as a packaging material in pharmacy.
 Glass is composed of sand, soda ash, lime stone & cullet.
 Si, Al, Na, K, Ca, Mg, Zn & Ba are generally used into
preparation of glass.
• Amber: light yellowish to deep reddish brown, carbon and
sulphur or iron and manganese dioxide
• Yellow: Compounds of cadmium and sulphur .
• Blue: Various shades of blue, cobalt oxide or occasionally
copper (cupric) oxide
• Green: iron oxide, manganese dioxide and chromium
dioxide

Advantages of glass:
• They are hygienic and suitable for sterilization.
• They are relatively non reactive ( depending on the
grade chosen).
• It can accept a variety of closures.
• They can be used on high speed packaging lines.
• They are transparent.
• They have good protection power.
• They can be easily labeled.
• They are available in various shapes and sizes.
• They can withstand the variation in temperature and
pressure during sterilization.
• They are economical and easily available.

Disadvantages
15
• It is relatively heavy.
• Glass is fragile so easily broken.
• Release alkali to aqueous preparation.
• Photosensitive drug can not be protected in the
transparent glass container. Amber color glass container
is required in this case.
• As glass is a chemical substance, some time it reacts with
the product contained inside it.

Types of glass
16
• Type I ( Neutral or Borosilicate Glass)
• Type II ( Treated Soda lime glass)
• Type III ( Soda lime glass)
• Type NP ( General purpose soda lime glass)
• Coloured glass

Type I (Borosilicate Glass)
17
Borosilicate Glass is produced by replacing the sodium
oxide by boric oxide(B2O2) and soda lime by
alumina (Al2O3) in the basic components of glass.
Least reactive & Resistant to chemical substance.
withstand high
High melting point and can
temperature.
Higher ingredients and processing cost therefore used
for more sensitive pharmaceutical products such as
parenteral or blood products.
Mostly ampoules and vials are made up of Type I
glass.

Type II ( Treated Soda lime glass)
18
Type II glass is made from commercial soda-lime glass
that has been de-alkalized or treated to remove surface
alkali. The de-alkalizing process is known as “Sulfur
treatment”.
• Sulfur treatment neutralizes the alkaline oxides on the
surface, rendering the glass more chemically resistant.
• Higher chemical resistance but not as much as type I.
• Cheaper than Type I.
• Acceptable for aqueous pharmaceutical with a pH <7 and
for dropper bottles.

Type III ( Soda lime glass)
19
It is ordinarily glass prepared from silicon dioxide, soda
ash and lime stone and is generally referred to as soda-
lime glass. Glass containers are untreated and made of
commercial soda-lime glass of average or better than
average chemical resistance.
 It is cheapest in quality.
 This types of glass is not suitable for alkali sensitive
products.
 has average or slight better than average resistance and is
suitable for non- aqueous parenterals and solid dosage
forms..
 Type III glass containers are normally dry sterilized
before being filled.

Type NP ( General purpose soda lime glass)
20
It is general purpose soda-lime glass used for oral
and topical preparation.
 It has lowest hydraulic resistance and is suitable for
solid products, some liquids and semi solids and not for
parenteral.

Coloured glass
21
• Coloured glass is obtained by adding small amounts of
metals during fusion of glass.
• Coloured glass is used for light sensitive products which
does not allow the UV rays to pass through it.
• Coloured glass should not be used for parenteral
preparation because it becomes difficult to check clarity
in such preparations.

Package type
Type of formulation
can be packed
Minimum quality of
glass that can be used
Ampoule
Aqueous Injectables of
Any pH
Type I
pH Less Than 7
Type II
Non-Aqueous Injectables Type III
Vial
Any pH
Type I
pH Less Than 7
Type II
Non-Aqueous Injectables Type III
Dry Powders For
Parenteral Use (Need To
Be Reconstituted Before
Use) March 17
Type IV
26

Package type
Type of formulation can
be packed
Minimum quality of glass
that can be used
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
23

Plastic Materials
24
standards institutes plastics
According to British
represents;
“ A wide range of solid composite materials which are
largely organic, usually based upon synthetic resins or
upon modified polymers of natural origin and possessing
appreciable mechanical strength. At a suitable stage in
their manufacturing, most plastics can be cast, molded or
polymerized directly into shape”.

Types of plastic materials
25
Plastic Materials
Thermoplastic type Thermosetting type
Thermoplastic type:
On heating, they are soften to viscous fluid which hardens
again on cooling. Resistant to breakage and cheap to
produce and providing the necessary protection of the
product in an attractive containers.
• E.g. polyethylene, PVC, polystyrene, polypropylene,
polyamide, polycarbonate.

Thermosetting type:
• When heated, they may become flexible but they do not
become liquid.
• During heating such materials form permanent crosslinks
between the linear chains, resulting in solidification and
loss of plastic flow.
• E.g. Phenol formaldehyde, urea formaldehyde, melamine
formaldehyde.
26

Advantages of plastic materials
27
 Low in cost.
 Light in weight.
 Flexible facilitating product dispensing.
 Odorless and inert to most chemicals.
 Unbreakable & Leak proof.
 Able to retain their shape throughout their use.
 Ease of handling & transportation
 They are poor conductor of heat.
 They are resistant to inorganic chemicals.
 They have good protection power.

DISADVANTAGES
 They are not as chemically inert as Type -I glass.
 They are not as impermeable to gas and vapour as glass.
 They may possess an electrostatic charge which will attract
particles.
 All are permeable to some degree to moisture, oxygen, carbon
dioxide etc and most exhibit electrostatic attraction, allow
penetration of light rays unless pigmented, black etc.

35
Polyethylene
 This is used as high and low density polyethylene
 Low density polyethylene (LDPE) is preferred plastic for squeeze
bottles.
 High density poly ethylene (HDPE) is less permeable to gases and
more resistant to
oils, chemicals and solvents.
It is widely used in bottles for solid dosage forms.
Polypropylene
 It is colorless, odorless thermoplastic material with excellent tensile
properties even at high temperature.
 Good resistance to heat sterilization.
 Excellent resistance to strong acids and alkalis.
 Low permeability to water vapour
 Suitable for use in closures , tablet containersandIVbottles.

Polyvinyl chloride (PVC):
30
 Versatility , ease of blending, strength / toughness, resistance to
grease/oil, resistance to chemicals, clarity.
 Used as rigid packaging material and main component of IV bags.
Poly vinyledene chloride (PVDC):
• Excellent barrier properties against: moisture, water vapour, UV light,
detergent base materials, emulsifying agents and wetting agents.
• Medical grade and non-toxic.
• High levels of transparency.
Polystyrene
 Versatility, insulation, clarity, easily foamed (“Styrofoam”).
 It is also used as jars for ointments & creams with low water content.

Plastic bottles made from
31
PP, HDPE and PS
Plastic pouches of HDPE Bottle- PET and
spray- PP

Product-Plastic interactions
32
Product-plastic interactions have been divided into five
separate categories:
 Permeation
 Leaching
 Sorption
 Chemical reaction
 Alteration in the physical properties of plastics or
products.

1. Permeation:
 It is the transmission of gases, vapours or liquids through plastic
packaging material.
 Permeation of water vapour and oxygen through plastic wall into
the drug is a major problem if the dosage form is sensitive to
hydrolysis and oxidation.
 The volatile ingredients might change when stored in plastic
containers and the taste of the medicinal products may change for
the same reason of permeation.
2. Leaching:
 Some plastic containers have one or more ingredients added to
stabilize it, these may leach into the drug product.
 Problems may arise with plastics when coloring agents are added
in small quantities to the formula.
 Particular dyes may migrate into the parental solution and cause a
toxic effect.

3. Sorption:
 This process involves the uptake of constituents from
the drug product by the 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 etc…
4. Chemical reactivity:
 Certain ingredients in plastic formulations 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 drug product.

5. Modification:
 The physical and chemical alteration of the packaging
material by the drug product is called modification.
 Some solvent systems found to show considerable
changes in the mechanical properties of the plastics.
 For example oils have a softening effect on polyethylene,
and hydrocarbons attack polyethylene and PVC.

Metals
36
Metals
Tin Linings
Lead
Aluminum

 Metal containers are used solely for medicinal products
for non-parenteral administration.
 Metal is strong, opaque, impermeable to moisture, gases,
odors, light, bacteria, and shatterproof, it is the ideal
packaging material for pressurized containers.
 It is resistant to high and low temperatures
 They include tubes, packs made from foil or blisters,
cans, and aerosol and gas cylinders.
 Aluminium and stainless steel are the metals of choice for
both primary and secondary packaging for medicinal
products.
 Form an excellent tamper evident containers.
37

 ALUMINIUM
1. It is relatively light yet strong
2. Barrier to light and chemicals
3. Impermeable and easy to work into a variety of formats,
depending on its thickness.
Thickest aluminium is used for rigid containers such as
aerosol cans and tubes for effervescent tablets.
Intermediate thickness are when mechanical integrity is
still important but the pack should be capable of being
reformed under a reasonable force. e.g. Collapsible tubes
for semi solid preparations or roll on screw caps.
Thinnest aluminium is used in flexible foil that are usually
a component of laminated packaging material.
38

Disadvantages and their overcome solution
39
• Major disadvantage is its reactivity in raw state, although
it rapidly forms a protective film of aluminium oxide it is
still liable to corrosion ( when exposed to some liquids
and semi solid formulations, particularly at extreme pH
or if the product contains electrolytes.
Overcome: To overcome this problem, Aluminium is lined
with epoxide, vinyl or phenolic resins.
• They are work hardening like collapsible tubes are made
by impact extrusion which tends to make aluminium less
flexible.
Overcome: To overcome, flexibility has to restored by an
annealing stage.

Tin
 Tin containers are preferred for food, pharmaceuticals and
any product for which purity is considered.
 Tin is the most chemically inert of all collapsible metal
tubes .
Lead:
Lead has the lowest cost of all tube metals and is widely
used for non food products such as adhesives, inks. paints and
40
for anything taken
lubricants.
Lead should never be used alone
internally because of the risk lead poison .
With internal linings, lead tubes are used for products such
as chloride tooth paste.

Linings
41
If the product is not compatible with bare metal, the
interior can be flushed with wax-type formulation or
with resin solutions, although the resins or lacquers are
usually sprayed on. A tube with an epoxy lining costs
about 25% more than the same tube uncoated. Wax
linings are most often used with water-based products in
tin tubes, and phenolic, epoxides, and vinyls are used
with aluminium tubes, giving better protection than wax,
but at a higher cost.

Rubbers (Elastomers):
47
• Excellent material for forming seals, used to form closures
such as bungs for vials or in similar applications such as
gaskets in aerosol cans.
 Categories of Rubbers:
1) Natural rubbers: Suitable for multiple use closures for
injectable products as rubber reseals after multiple insertion
of needle.
• Disadvantages are;
i. It doesn't well tolerate multiple autoclaving becoming
brittle and leads to relative degree of extractable
material in presence of additives.
ii. Risk of product absorbing on or in to a rubber.
iii.It has certain degree of moist
M
u
arc
rh
e
17& gas permeation.

Synthetic rubber:
• Have fewer additives and thus fewer extractable and tends
to experience less sorption of product ingredients.
• Are less suitable for repeated insertions of needle because
they tend to fragment or core pushing small particles of
the rubber in to the product. e.g. Silicone, butyl,
bromobutyl, chlorobutyl etc.
• Silicone is least reactive but it does experience
permeability to moisture and gas.
Softer rubbers experience less coring and reseal better,
harder rubbers are easier to process on high speed
packaging lines.
March 17 48

Fibrous materials
 The fibrous materials are the important part of pharmaceutical packaging.
 Fibrous materials include: Papers, Labels, Cartons, Bags, Outers etc.
 The Applications as well as Advantages of Cartonsinclude:
 Increases display area
 Provides better stacking for display of stock items
 Assembles leaflets
 Provides physical protection especially to items like metal collapsible tubes.
 Fiberboard outers either as solid or corrugated board also find substantial
application for bulk shipments.
 Regenerated cellulose film, trade names Cellophane & Rayophane, is used for
either individual cartons or to assemble a no. of cartons.
March 17 49

Films, foils & laminates
45
 Characteristics:
◦ Applicable to tablets, capsules, pills, etc.
◦ It's a good substitute for PVC sheet.
◦ No cracking, delamination or pinholes
◦ It has the quite good blocking properties effectively protecting
drugs from water vapor, oxygen and ultraviolet.
◦ It can extend the storage period of drugs.
◦ It is particularly suitable for packing moisture-sensitive drugs or
those sold in the hot and humid areas.
◦ Taking out a part of the drugs from the drug boards without any
impact on other well-packaged drugs.
◦ It is used by cold-moulding packaging machines.
◦ It is shaped easily by changing the mold.
◦ Nice appearance can upgrade drug's image

CONTAINERS
 A container for a pharmacopoeial article is intended to contain a drug
substance or drug product with which it is, or may be in direct contact.
The closure is a part of the container.
 QUALITIES OF GOOD CONTAINER:
 The container must be neutral towards the material which is stored in it.
 The container must not interact physically or chemically with the
substance which it holds.
 It should help in maintaining the stability of product against the
environmental factors which causes its deterioration.
 It should be made of materials which can withstand wear and tear
during normal handling.
 It should be made of materials which can withstand wear and tear
during normal handling.
 It should be able to withstand changes in pressure and temperature.
 The materials used for making of the container must be non-toxic.

 TYPES OF CONTAINERS:
 Containers are divided into following types on the basis
of their utility:
 Well – closed containers: A well-closed container
protects the contents from loss during transportation,
handling, storage or sale.
 Single dose containers : These containers are used to
supply only one of medicament and hold generally
parenteral products.
 E.g. ampoules

 Multi dose containers: These containers 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 injectables. E.g. vials
 Light-resistant containers: These containers protect
the medicament from harmful effects
 of light. These containers are used to store those
medicaments which are photo-sensitive.

 Air-tight containers: These are also called hermetic
containers. These containers have air-tight sealing or
closing. These containers protect the products from
dust, moisture and air. Where as air-tight sealed
containers are used for injectables, air-tight
closed containers are meant for the storage
of other products.
 Aerosol containers: These containers are used to hold
aerosol products. These containers have adequate
mechanical strength in order to
bear the pressure of aerosol packing.

Packaging material for :
 Solid dosage forms
 Liquid dosage forms
 Sterile products
 Ophthalmic dosage forms
 Aerosols

SOLID DOSAGE FORMS
(TABLETS, CAPSULES & POWDERS)
Glass Bottles
• Type III (Sodalime) glass and NP (Non-
parentral)glass is used.
• Transparent and Amber coloured glass
bottles.
• It is strong and rigid
• Impermeable to water vapors
Plastic Bottle :
• Bottles made from polyethylene (HDPE),
Polypropylene , Polystyrene .
• It is light weighted and non breakable.

UNIT DOSE PACKING
Blister packaging:
The primary component of a blister pack is a cavity or
pocket made from a formable web, usually a
thermoformed plastic and a backing membrane or a
"lidding" seal of aluminum foil.
Most basically Polyvinyl chloride (PVC) used for forming cavity or
pocket.
Others materials used - polychloro-trifloro-ethylene
- cyclic olefin copolymers for moisture prevention

Strip Packaging:
1. Strip packs present an alternative
form of pack for a unit dosage.
2. This pack consists of one or two plies,
made from regenerated cellulose, paper,
plastic, foil or combination of these.
3. The use of high barrier material like aluminum foil or
coated film with excellent seal formation for moisture-
sensitive products.
4. cellophane film -when transparency required.

POUCHES
 Plastic Pouches :
1. Made from strong LDPE film
2. With a re-sealable strip at the top,
easy to open and close.
3. It have Waterproof, air proof and
non-poisonous property .
 Especially suitable for hospital and
clinic.
 Aluminum pouches :
1. It have tear strip facility.
2. It offers excellent barrier properties
to the moisture, gas and light.

Solids-Rectal (Suppository) :
1) Aluminum Foil:
• Offers the highest possible protection against moisture,
oxygen, and light.
• Aluminum suppository package takes the shape of individual
doses .
• Aluminum foil quality offers protection even under the most difficult
climatic conditions.
• It serves Child resistant due to Non-transparent material.
• Excellent appearance.
• Have an easy opening feature with a peelable system, and Tearing.

2. Laminates:
• It is made of Polyolefine, Aluminum, PE.
• It gives protection from moisture, gas, vopours, light.
• The product is smooth, easy to tear, shape well, particularly
suitable for temperature & humidity- sensitive suppository.
• It directly contacts suppository medicines, no abnormal
toxicity, no physical and chemical matrix effects occurred.

LIQUID DOSAGE FORMS
1. Glass Or Plastic Bottle:
A. Bottle With Spray Pump:
1) Capacity: 50ml
2) Material: Bottle-polyethylene terephthalate;
Sprayer-polypropylene
3) Spray output: 0.05ml-0.20ml
4)Bottle is tough , excellent strength and have gas &
aroma barrier.
5)Used for body spray, oral spray, anti-bacterial
spray.

B. Bottle With DropperAssembly :
• Dropper assemblies can be supplied with
coloured caps.
• Type II glass is used.
• Dropper glass is of Sodalime glass(type III)
and Neutral glass(type I).
• Bottle capacity is from 2 to 100ml
• pipettes are up to 120 mm in length

STERILE DOSAGE FORMS
1. Ampoules
2. Vials
3. Disposable syringes
4. Prefilled syringes
5. Sterile plastic devices
1. Ampoules:
• Type I (borosilicate glass is used).
• Packaging is 100% tamper proof.
• One point or colour break ring offers easy breaking.
• Up to 3 colour can be placed for identification purpose.
• PVC mono films used for 20 packaging.

2. Vials:
• Vials are mainly used for multiple dose parenteral preparation and are
provided with the closure followed by aluminum seal to ensure the
perfect air tightpacking.
• Closure:
• Made from Butyl rubber, Nitrile rubbers ,Neoprene, Silicon Rubbers.
• It has compression recovery, coring resistance, solvent resistance, heat
resistant , radiation resistance with very low water absorption and
permeability properties.

4. Pre-Filled Syringe:
• It is used for small volume parenteral preparation.
• Reduction of medication errors likedrug overfill.
• It gives increased assurance of sterility.
3. Disposable Syringe:
 Material used are polycarbonate, polyethylene
and polypropylene.
 Material used for piston are natural rubbers, butyl rubbers for sliding well.
 Silicone and floroelastomer is more long lived than butyl rubbers.
 They have property of abrasion resistance, radiation resistance, excellent
self- life properties.

5. Sterile plastic devices
 Irrigation solution container :
 It is made of LDPE , Polyolefin , polypropylenes
 Avoid hanging breakable glass
 It is light in weight, transparent, impermeable
to water
 Material havehigh boiling point so that it is
sterilizable.

• It is made of acrylonitrile butadienestyrene
• Spike is made of nylon
• Tube is made of polyvinyl chloride
• Needle adapter is made of polymethacrylate
I.V. Infusion set :
Catheter:
• Catheter is inserted into a body cavity, duct,
vessels.
• It is made of Silicone because it is inert and
unreactive to body fluids and a range of
medical fluids with which it might come into
contact.

OPTHALMIC DOSAGE FORMS
1. Plastic bottles
2. Collapsible Tube
3. blow-Fill-Seal Plastic Bottle
1. Plastic bottles:
• Material used for plastic bottle is low density
polyethylene, HDPE.
• Consumers often get too little with each squeeze
• LDPE used in ophthalmics usually contains
minimal additives.
• for caps are harder plastic materials such as LDPE,
HighdensityP.E., or Polypropelene is used.

2. Collapsible Tube:
• It is made of metals like aluminum , tin and lead and plastics like
low density polyethylene.
• Material for cap is of high density polyethylene, polypropylene
and pvc.
• Adv. Of metal collapsible tube:
- risk of contamination of portion remaining in the tube is minimum
because inner material is not suck back.

3. Blow-Fill-Seal Plastic Bottle:
• The basic concept of blow fill seal (BFS) is that a container is formed,
filled, and sealed in a continuous process without human intervention,
in a sterile enclosed area inside amachine.
• Plastic containers are made up of polyethylene and polypropylene.
• Polypropylene is more commonly used for containers because it has
greater thermo stability which is further sterilized by autoclaving.

AEROSOL DOSAGE FORMS
Container:
Towithstand pressure 140-180 psig.
1) Tin plated container- it is sheet of steel
plates electroplated on both side with tin.
2) Aluminum container- it has seamless nature and greater
resistance to corrosion (corroded by pure water and pure
ethanol).
3) Stainless steel container –
used inhalation aerosol
- No coating required
-extremely strong
4) Glass container – type I glass is used

 Valve:
1. Mounting cup / ferrule –tin plate steel, Aluminum, Brass
- it is used to attach the valve proper to container
2. Valve body/Housing –
it is opening at the point of attachment of the dip tube.
-- Nylon or delrin
3. Dip tube –allows the liquid to enter thevalve
- Polyethylene and polypropylene.
4. Gasket: it is seal between the valve cup and aerosol can .
-Buna N and Neoprene rubber
5.Stem: -Nylon and Delrin or metal like Brass, stainless steel.
6. Spring -Hold gasket in place, made up of metal
7. Actuator – is used to delivered the product, made up of Plastic.

Pharmaceutical packaging naresh

More Related Content

What's hot

Similar to Pharmaceutical packaging naresh

More from Naresh Gorantla

Recently uploaded

In this document

Pharmaceutical packaging naresh