Successfully reported this slideshow.
We use your LinkedIn profile and activity data to personalize ads and to show you more relevant ads. You can change your ad preferences anytime.
SUBMITTED BY:
RAJAT KALRA
16121004
DIKSHA KATARIA
16124001
M.PHARMACY 1ST YEAR
SUBMITTED TO :
MRS.ARCHANA KAPOOR
 Introduction
 Containers
 Types Of Containers
 Their Good Qualities
 Material Used For Manufacture Of Containers And...
Containers can be defined as an object that can be used to hold
or transport something.
OR
Pharmaceutical container is a...
 Packaging can be used as the economical means of
providing presentation, protection, identification ,
information, conve...
CLASSIFICATION OF THE PACKAGING
PACKAGING
Blister Pack, Strip Pack, Glass
Bottles, Plastic Bottles
Vials, Ampoules, cartri...
The materials selected must have
following characteristics:
 They must protect the preparation from environmental conditi...
Containers – refers to storage media
in which product is placed & enclosed
& it is in direct contact with the drug.
( gla...
 Cartons : outer covering which gives
sec. protection against mechanical
and environmental hazards also
display written i...
A device in which drug is enclosed & in direct
contact with the drug
Containers :-
The container must be neutral towards the material
which is stored in it.
The container must not interact physically or
...
 It should be made of materials which
can withstand wear and tear during
normal handling.
 It should be able to withstan...
Types of containers:
Containers are divided into following types on the basis of their utility :
Well – closed containers...
Multi dose containers: These
containers allow the withdrawal of dose
at various intervals without changing the
strength, ...
Air-tight containers: These are also
called hermetic containers. These
containers have air-tight sealing or
closing. Thes...
 Child-proof containers:-A container that is fitted with
a closure that prevents opening by children.
 Child-Resistant P...
Material Used For Manufacture Of Containers
 There are mainly four types of material used in
manufacture of containers:-
...
 Glass has been widely
used as a drug
packaging material
 For a large number of
pharmaceuticals,
including medicinal
pro...
Colored Glass Containers
 Is obtained by the addition of small
amounts of
metal oxides, chosen according to the
desired s...
Types Of Glass
 Type I-borosilicate glass(neutral
glass)
 It is highly inert type of
pharmaceutical glass.
 It has high...
 Note:-
 Except for type I glass containers, glass containers for
pharmaceutical preparations are not to be re-used.
Con...
 Type II-treated soda lime glass
 Type II containers are made of commercial soda lime glass
that has been Dealkalised or...
 Type-III regular soda lime glass
 Containers are untreated are made of commercial soda
lime glass.
 It contains high c...
 Type 4 NP-general purpose soda lime glass
 Containers are made of soda lime glass supplied for
non parenteral products,...
Overview of Glasses Used In
Pharmaceutical Practice
Glass type General
description
Test method Uses
TYPE 1 Highly resistan...
Types of Glass Containers
Bottles
 Used in the dispensary for packaging of medicine which
are available in sizes from 50 ...
 Ribbed (fluted) oval bottles:- are used to package various
product that should not be taken orally.
 Widely used for pa...
 The parenteral products are packed and administered
in large volumes i.e. 100 ml to 1000 ml per day.
 For LVP, type 2 g...
Dropper Bottles
 Eye drop and dropper bottles for ear and nasal use are
hexagonal- shaped amber color glass containers
 ...
Jars
 Powders and semisolid preparations are generally
packed in wide mouthed cylindrical jars made of clear
or amber gla...
Ampoule
 An ampoule (also ampule, or ampulla) is a small
sealed vial which is used to contain and preserve a
sample, usua...
Types Of Ampoules
 One Point Cut Ampoules
 Before opening One-Point
Cut (OPC) Ampoule
Use an antiseptic to clean
the amp...
Directions for Use of One-Point Cut (OPC)
Ampoule
Hold the bottom part of the ampoule with the
colored dot facing you.
Put...
Apply pressure to the top part and snap the ampoule away from
you.
Features: Long lasting structure
Perfect finishing
Resi...
Flat Based And Constricted Neck Ampoule
Features:
 Optimum hygiene level
 Longer service life
34
Flame Cut Ampoules
 Optimum hygiene
level
 Ease in sterilization
 Can be easily broken
to take out the
product
35
Vials
 A glass or plastic
container closed with a
rubber stopper and sealed
with an aluminum crimp.
Vials are available f...
Advantages And Disadvantages of Glass Vial
 Advantages
 Glass vial has increased dose flexibility
 Has decrease cost pe...
Advantages of Glass Containers
1. It allows easy inspection of the containers
contents.
2. It also have the great advantag...
Disadvantages of Glass Containers
1. They are brittle and break easily
2. They may crack when subject to
sudden changes in...
Plastic Containers
Plastics are synthetic polymers of high molecular
weight
 Plastics as packaging have proved useful fo...
DRUG-PLASTIC CONSIDERATIONS
A packaging system must protect the drug without altering
the composition of the product until...
Permeation:
It is the transmission of gases, vapors or liquids through
plastic packaging material.
Permeation of water vap...
Leaching:
Some plastic containers have one or more ingredients
added to stabilize it, these may leach into the drug
produc...
Sorption:
This process involves the removable of constituents
from the drug product by the packaging material.
The therape...
Chemical reactivity:
Certain ingredients in plastic formulations may react
chemically with one or more components of the d...
Types of Plastics
 There are Two main types of plastics :–
 Thermoplastics
 These are softened by heat and can be
mould...
 Thermo sets Plastics
 These are formed by heat process but are then set
(like concrete) and cannot change shape by
rehe...
Other Classifications
 PLASTIC ARE OF TWO FORMS
48
AMORPHOUS PLASTIC CRYSTALLINE PLASTIC
 They give good transparency.
...
Plastic Containers For Pharmaceutical
Products Are Primarily Made From The
Following Polymers
 Polyethylene
 Polypropyle...
Polyethylene
 Its is flexible, very light but tough plastic
 It is impermeable to water vapour and does not
deteriorate ...
 It is divided into
 HDPE (HIGH DENSITY POLYETHYLENE )
 LDPE ( LOW DENSITY POLYETHYLENE )
 HDPE: -Rigid, withstand tem...
Uses Of Polyethylene And
Polypropylene
 Polypropylene and polyethylene are most widely used
in parenteral plastic contain...
Polyvinyl Chloride (PVC)
 It is less flexible , heavier and more permeable to
water vapors as compared with normal polyth...
Polystyrene
 It is a hard, rigid , light material
 It can be easily molded into any shape
 So it is used for preparing ...
Polymethyl Methacrylate (PMMA)
 It is hard , strong but light, transparent plastic
 It softens at about1000c
 It is use...
Polycarbonate
 It is transparent, has high impact strength and very
good heat resistance.
 It is used in the preparation...
Types of Plastic Containers
 Plastic Ampoules
Advantages
 Breaking is easy, no shreds, no sharp edges, no
danger for sca...
 It is easy and energy efficient on automatic process
machines, with high precision of dosing.
 The raw material is envi...
Plastic Vials
 Plastic vials, often used to store medication as
liquids, powders or capsules.
 They can also be used as ...
Plastic Tubes
 During the last decade, plastic blood collection tubes
have been progressively replacing glass tubes.
 Pl...
Plastic Syringe
 A syringe is a simple pump consisting of a
plunger that fits tightly in a tube.
 The plunger can be pul...
PVC Collapsible Bags
 It is the part of large volume parenteral
products (100ml to 1000 ml per day) containers.
 These a...
 Advantages
 Durable and light weight
 No air interchange. The bag collapses as it empties.
 Disadvantages
 They adso...
Semi Rigid Polythene Containers
 These containers are used for different volume of
parenteral products:-
 100ml for elec...
Sterilization of Plastic Containers
Method of sterilization Sterilization condition
Moist heat 121 degree Celsius for 15 m...
 Leakage test
 Water Permeability Test
 Collapsibility test
 Clarity test
 Biological toxicity test
66
ADVANTAGES OF PLASTICS DISADVANTAGES OF PLASTICS
 They are light in weight
and can be handled
easily
They are transporte...
 Metals are used for construction of containers.
ADVANTAGES
 They are impermeable to light, moisture and gases
 They ar...
 These metal containers are prepared by using different
metals
 Aluminium
 Aluminium foil
 Tin
 Lead
 Stainless stee...
70
METAL COLLAPSIBLE TUBES
TIN ALUMINIUM LEAD
Most expensive
Most chemically
inert of all metal
collapsible tubes
Light...
 Aluminium:- is able to resist the corrosion.
Aluminum tubes offer significant savings in product
shipping costs because ...
 Tin:- Most expensive and can be highly polished
 It is used as a protective coat for other metals in
order to prevent c...
 Lead :-Lead has the lowest cost of all tube metals and
is widely used for non food products such as adhesives
,inks ,pai...
 Stainless Steel- Chromium (12 to 14 %) and
Nickel up to 0.7%) are widely used for
manufacturing of equipment's
74
Advantages
 It is an attractive container that permits
controlled amount to be dispensed easily with
adequate protection ...
 These are light in weight and unbreakable
Disadvantages
 Corrosion
 Breakage
 Poisoning
76
RUBBER
 Rubber is used in manufacture of closures, caps,
vials wrappers and plungers
 Closure is a device tightly pack t...
 RUBBER VIALS
78
 PLUNGER
Ophthalmic preparations are
specialized dosage forms
designed to be instilled onto
the external surface of the
eye, admini...
 Ophthalmic products have several types i.e.
 Eye Drops
 Eye Lotions
 Eye Ointments
 Eye Creams
 Eye Gels
 Contact ...
Eye drops(Single-
dose containers):
Plastic
bottles(LDPE) are
widely used.
Eye drops(Multiple-dose
containers): Traditionally, glass
bottles with rubber teat dropper
were widely used. Now-a-days,
p...
Eye ointments:
Flexible plastic or
collapsible metal
tubes are used.
Currently almost all commercially available ophthalmic
products are packaged in plastic containers
 Advantages
 Ease Of...
 Parenteral dosage forms differ from all other dosage
forms because they are injected directly into body
tissue through t...
 NOTE:
 These requirements place A heavy responsibility on the
pharmaceutical industry to practice current good manufact...
 Small Volume Parenteral Product Containers (volume up to
100 ml)
 Single dose containers:-ampoule
 Multi dose containe...
 Ampoules
A parenteral product container made
entirely of glass and intended for single
use.
The ampoules can be broken a...
 A glass or plastic container
closed with a rubber stopper
and sealed with an
aluminum crimp. Vials are
available for sin...
HDPE Plastic Vials
Type 1 Glass Vial for multi
dosing purpose
Syringes are devices for injecting,
withdrawing or instilling fluids. Syringes
consists of a glass or plastic barrel with ...
Disposable plastic
syringe
Disposable glass
syringe
 For glass
 Powder glass test
 Water attack test
 Light transmission test
 For plastic
 Leakage test
 Permeation te...
EVALUATION OF PACKAGING
MATERIALS
TESTS FOR GLASS CONTAINERS:
1) Powdered glass test
2) Water attack test
Preparation of s...
place 1 portion in a mortar
Crush further by striking 3 or 4 blows with hammer
Nest the sieves (# 20,40 at least)
Empty th...
Spread the specimen on a glazed paper
and remove iron particles with the help of magnet
Wash with 6 portions of 30ml aceto...
1) POWDERED GLASS TEST: (according to USP volume
27)
Transfer 10gms of prepared specimen in a 250ml conical flask digested...
Wash the residue powdered glass(4 times with 15ml purity water)
Add the decanted washings to main portion.
add five drops ...
WATER ATTACK TEST:(USP)
rinse 3 or more containers with high purity water
fill each container to 90%of its over flow capac...
TESTS FOR PLASTIC CONTAINERS
1.Leakage test for plastic containers(non
injectables and injectables 1996 IP):
fill 10 plas...
2.WATER PERMEABILITY TEST FOR PLASTIC
CONTAINERS(INJECTABLE PREPARATIONS IP
1996):
fill 5 containers with nominal volume
o...
 test is applicable to containers of oral liquids, unlabelled,
unmarked portion from suitable containers are randomly
sel...
4. Biological toxicity test-
 Invitro test – extract placed in contact with
mammalian cells to check to toxicity.
 Inviv...
Protection
 a container intented to provide protection
from light , or offered as alight resistant must
meet the requirem...
 Compatibility
 Container component will not interact with
the dosage form & may not show leaching.
 Other changes such...
 Introduction
 Purpose of closures
 Classification of closures
 Material employed for formation of
closures
 Quality ...
 Retains the contents
 Provides a barrier to dirt, oxygen, moisture,
etc
 Keeps the product secure from undesired and
p...
Clas
sific
atio
n of
clos
ures
Cap type
Plain
Threaded
Continuous
LuggedPlug type
Crown cap
Roll on
Pilfer proof
Special
t...
In this form, closure is an external cap over
the neck.
These are used to secure the closure to the
container in order to ...
i. Plain or snap fit-
 In this the cap is pressed to seal
 It closes with a click
 Can be applied very quickly
ii. Threaded or Screw cap-
 It is a mechanical device which is
screwed on and off a container
 Either continuous threads...
Screw cap consists of 3 components
1. Cap
2. Wad
3. Liner
Cap:- may be of metal, usually tin plate or
aluminium or may als...
Wad:- It should be effective to provide
satisfactory seal and inert to avoid
contamination of the product.
 Silicon rubbe...
a. Continuous-
When cap is applied, its threads are
engaged with the corresponding threads
molded on the neck of the bottl...
b. Lugged- similar to the threaded screw cap
and operates on the same principle.
It is simply an interrupted thread on the...
 It is a push fit into the neck of
the container.
 Eg. Cork or glass stopper, but
both of these have been
replaced by pl...
These are shallow metal caps
that are crimped into locking
position around the head of the
bottle. Generally made up of ti...
 Requires a material that is
easy to form.
 The roll on caps can be
sealed securely, opened easily
and reclosed effectiv...
 It is similar to roll on closure but has
a greater skirt length
 This additional length extends below the
threaded port...
 These are additional closures for simple
dose measurement
i. Tamper evident-
 Having an indicator or barrier
to entry which, if missing, can
reasonably be expected to provide
visi...
 These are designed to prevent accidents
and malicious tampering to create safe
packaging
 Each retail package is requir...
 Breakable cap ring
systems
 Sealed tubes
 Heat sealed bands
or wrappers
 Inner mouth seals
 Tape seals
 Aerosol con...
 Breakable caps:-
 Cap or part of it must be broken in order to
open the container and remove the
product
 it must not ...
 Sealed metal tubes, plastic heat sealed
tubes:-
 must have both ends sealed
 mouth has to be punctured to gain access
...
 Heat sealed bands or wrappers:-
 must be placed over the union of primary
closure (cap, lid, etc.) and container
 must...
 Inner seals:-
 Whether made of paper, plastic film, foil or
combinations, they must have a distinctive
design
 Must be...
 Tape seals:-
 involves the application of a glued or
pressure sensitive tape or label around or
over the closure of the...
 Aerosols:-
 Considered to be inherently tamper
resistant
 direct printing on the container is
preferable to a paper la...
 Cans and composite containers:-
 Top and bottom of a composite must be
joined to the walls so that they can’t be
pulled...
ii. Child resistant-
These are difficult for young children
(under 5 years of age) to open but not
difficult for adults to...
1. Press and turn
2. Lift and turn
3. Squeeze and turn
4. Line up arrows and flip
5. Pop lock closure
1. Press and turn:-
the cap is removed by applying a
downward pressure while the
closure is rotated.
Click-lock closure is...
2. Lift and turn:-
it involves applying an upward force while rotating
the closure.
3. Squeeze and turn:-
force is applied...
4. Line up arrows and flip:-
once the alignment is
established the miss-fit between
cap and container is removed
and the c...
 Metals ( aluminium, aluminium alloys,
tinplate, stainless steel)
 Rubber ( natural & synthetic)
 Plastic ( thermosetti...
 Metal caps are usually coated on the
inside with an enamel for resistance
against corrosion
 Almost all metal crowns an...
The two basic types of plastics generally
used for closures are :-
1. Thermosetting Resins-
is used for making screw caps ...
Advantages of plastic-
1. Flexible and not easily broken
2. Low density and thus light in weight
3. Easily molded in vario...
 Rubber consists of
several ingredients,
one of them is
elastomer
 These closures do
not pose a problem
and can be used ...
1. Butyl rubber (copolymer of isobutylene
and isoprene or butadiene)
2. Nitrile rubber (butadiene-acrylonitrile co-
polyme...
1. Butyl rubber- cheap, chemical resistant,
low water vapor/air permeability. It is not
good for oils.
2. Nitrile rubber- ...
1. Common flanged closure
2. Slotted or freeze dried product
closure
3. Cartilage and Disposable syringe
closure
 Most commonly used in closing of vials
and bottles.
 These closures has a slot or pathway for
the ice sublimation
 Used to seal the freeze dried products or
lyophilized pro...
 Cartilage is made of glass, one end of
which is sealed with the rubber piston and
the other end with aluminium over seal...
1. It should not become sticky upon storage
2. It should not become hard on exposure to
atmosphere
3. It should not become...
1. Test for alkalinity (for glass)
2. Test for rubber closures
a. compatibility with contents
b. permeability to water
c. ...
 Coarsely crush the glass and then crush
finely
 Sieve the crushed glass
 Take 2 conical flasks, one should be
treated ...
Cont.
 Autoclave both for prescribed period of
time
 Add NaOH solution to both of container
 Filter the solution and wa...
a. Compatibility with other
components-
All the sterile products are packed
aseptically in sterile containers and
several ...
At given time intervals up to a year, except for
the 500C test, which are continued for 3
months only, the samples are exa...
b. Permeability to water-
Put calcium chloride in vial and close it with
rubber closure and seal it with aluminium seal.
W...
c. Self sealability test-
Take a vial and filled it with methylene blue
solution
Inset needle into rubber closure 20-25 ti...
d. Fragmentation test for rubber closures (IP
1996)
Take 12 clean vials
Place a volume of water corresponding to nominal
v...
Repeat the above operation 4 times for
each closure
Count the number of fragments visible to
the naked eye
Total number of...
e. Penetrability test (by piercing
machine)-
 inverted vial is fitted on clamp and the
clamp is allow to move downward at...
f. Quality test-
Rubber closures must not be tacky after
washing in a detergent, rinsing several
times, autoclaving for ha...
4. Child test- (Acc. to 1995 US Protocol)
 200 children of 42-51 months divided
approximately equally b/w the sexes and 1...
 If they are unsuccessful they receive a
non-verbal demonstration and a further 5
minutes to try again
 Adults are asked...
1. Pharmaceutical product development by N.K. Jain
2. Cooper and Gunn’s “Dispensing for pharmaceutical
students”,CBS Publi...
Containers & closures
Containers & closures
Containers & closures
Upcoming SlideShare
Loading in …5
×

Containers & closures

47,419 views

Published on

pharmacuticals Containers & closures

Published in: Science
  • If we are speaking about saving time and money this site ⇒ www.HelpWriting.net ⇐ is going to be the best option!! I personally used lots of times and remain highly satisfied.
       Reply 
    Are you sure you want to  Yes  No
    Your message goes here
  • I shared this simple 7 second ritual with one of my clients a couple of month ago. She had been struggling with her weight pretty much all her life. And seemed to be stuck in a perpetual limbo of weight loss, weight gain, weight loss, weight gain... But when she started doing THIS 7 second daily ritual things rapidly changed... She had fast fat loss from her hips, thighs face and arms.While enjoying an increase in energy and zest for life. She also had a youthful glow to her skin that she hadn't seen in years. >> Try This Simple 7 Second Daily Ritual For Yourself Here ➜➜➜ http://tinyurl.com/y46t9ja3
       Reply 
    Are you sure you want to  Yes  No
    Your message goes here
  • 7 Second Daily Ritual Melts Stubborn Fat While You Sleep ➣➣➣ https://bit.ly/2PJu978
       Reply 
    Are you sure you want to  Yes  No
    Your message goes here
  • Vitiligo Miracle Video - Heal Vitiligo In 7 Days ❤❤❤ https://bit.ly/3kTNHDZ
       Reply 
    Are you sure you want to  Yes  No
    Your message goes here
  • 7 second ritual melts 62 pounds of fat ✄✄✄ http://tinyurl.com/y46t9ja3
       Reply 
    Are you sure you want to  Yes  No
    Your message goes here

Containers & closures

  1. 1. SUBMITTED BY: RAJAT KALRA 16121004 DIKSHA KATARIA 16124001 M.PHARMACY 1ST YEAR SUBMITTED TO : MRS.ARCHANA KAPOOR
  2. 2.  Introduction  Containers  Types Of Containers  Their Good Qualities  Material Used For Manufacture Of Containers And Their Composition  Container Used For Opthalmic And Parentral Preparation  Material Used For Containers And Their Composition  Evaluation Of The Material Used For Making Of Containers.
  3. 3. Containers can be defined as an object that can be used to hold or transport something. OR Pharmaceutical container is a device that hold the pharmaceutical product and it may or may not be in direct contact with it. 3 3 Introduction
  4. 4.  Packaging can be used as the economical means of providing presentation, protection, identification , information, convenience ,compliance (conformity), integrity and stability of the product. 4 Why We Do Packing Of Drugs In Containers? IDENTIFICATION PRESENTATION INFORMATION
  5. 5. CLASSIFICATION OF THE PACKAGING PACKAGING Blister Pack, Strip Pack, Glass Bottles, Plastic Bottles Vials, Ampoules, cartridges, glass Bottles, Plastic Bottles Foil, paper Or Plastic Pouch, Glass Or Plastic Bottles Collapsible Tubes Film Wrappers For Tablets Or Capsules Like Unit Dosage Forms For Liquid Preparations For Powder Or Granules For Semisolid Preparations For Suppositories Containers For Aerosols Paper and boards cartons TERTIARY PACKAGING MATERIAL Corrugated box Brown cardboard box Wood pallets Shrink wrap Secondary packaging material
  6. 6. The materials selected must have following characteristics:  They must protect the preparation from environmental conditions.  They must not be reactive with the product.  They must not impart to the product tastes or odors & color change.  Must be non toxic.  They must be “FDA” approved.  They must meet applicable tamper – resistance requirements.  They must be adaptable to commonly employed high-speed packaging equipment
  7. 7. Containers – refers to storage media in which product is placed & enclosed & it is in direct contact with the drug. ( glass, plastic) Closures – is a device tightly pack the container to exclude O2, co2, moisture & micro o/s & prevent loss of water & volatile substance from the product during transport & handling. It is a part of container system but doesn’t come in contact with drug. (Aluminum, rubber)
  8. 8.  Cartons : outer covering which gives sec. protection against mechanical and environmental hazards also display written information . (Cardboard) o Box :a device which is generally used for packaging of products. It gives prime protection against external hazards provided containment & absorbs shocks . (Cardboard & wood.)
  9. 9. A device in which drug is enclosed & in direct contact with the drug Containers :-
  10. 10. 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. QUALITIES OF GOOD CONTAINER:
  11. 11.  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.  Surface of the container must be clear for easy labelling .  Size of the container must be selected acc. To the size of preparation  They should not allow any loss of product during leakage , spoilage or permeation.
  12. 12. 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 and vials
  13. 13. 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 injectable. 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.
  14. 14. 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 injectable, 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.
  15. 15.  Child-proof containers:-A container that is fitted with a closure that prevents opening by children.  Child-Resistant Package Testing  Critique of directions for package/product-use  Package preference  Product preference  Swallow ability testing 15
  16. 16. Material Used For Manufacture Of Containers  There are mainly four types of material used in manufacture of containers:-  GLASS  PLASTIC  METAL  RUBBER 16
  17. 17.  Glass has been widely used as a drug packaging material  For a large number of pharmaceuticals, including medicinal products for oral and local administration, glass containers are usually the first choice. (e.g. bottles for tablets, lotions or inhalers). 17
  18. 18. Colored Glass Containers  Is obtained by the addition of small amounts of metal oxides, chosen according to the desired spectral absorbance  Principally glass is silicon dioxide tetrahedron whose physiochemical properties are altered by adding oxides of sodium ,iron, magnesium etc. 18
  19. 19. Types Of Glass  Type I-borosilicate glass(neutral glass)  It is highly inert type of pharmaceutical glass.  It has high melting point so can with stand high temperatures range  It can resist strong acids, alkalies and all types of solvents  Reduced leaching action. USES Laboratory glass apparatus. For injection and water for injection Widely used as glass ampoule and vials. 19
  20. 20.  Note:-  Except for type I glass containers, glass containers for pharmaceutical preparations are not to be re-used. Containers for human blood and blood components must not be re-used. 20
  21. 21.  Type II-treated soda lime glass  Type II containers are made of commercial soda lime glass that has been Dealkalised or treated to remove surface alkali.  The de-alkalizing process is know as sulphur treatment.  Sulphur treatment neutralizes the alkaline oxides on the surface, rendering the glass more chemically resistant. 21 Contd… USES Used for alkali sensitive products. Infusion fluids, blood and plasma. Large volume container. Used to produce container for eye preparations
  22. 22.  Type-III regular soda lime glass  Containers are untreated are made of commercial soda lime glass.  It contains high concentration of alkaline oxides and imparts alkalinity to aqueous substances  Flakes separate easily 22 Contd… Uses For all solid dosage forms. For oily injections For non aqueous parenteral products.
  23. 23.  Type 4 NP-general purpose soda lime glass  Containers are made of soda lime glass supplied for non parenteral products, intended for oral or topical use. 23 USES:  For oral use.  For solid, liquid preparations Contd…
  24. 24. Overview of Glasses Used In Pharmaceutical Practice Glass type General description Test method Uses TYPE 1 Highly resistant borosilicate glass Powdered Glass test For buffered and unbuffered aqueous solutions, powders TYPE 2 Treated (sulphur dioxide fumes) soda lime glass Water attack test For buffered aqueous solution with pH below 7 and for dry powders TYPE 3 Soda lime glass Powdered Glass test For dry powders and oleaginous solutions, not for aqueous preparations TYPE 4 General purpose soda lime glass Powdered Glass test Not for parenterals and for suspension and emulsion 24
  25. 25. Types of Glass Containers Bottles  Used in the dispensary for packaging of medicine which are available in sizes from 50 ml to 500 ml.  Types:  Amber metric medical bottles:- Widely used for packaging of oral medicines. 25
  26. 26.  Ribbed (fluted) oval bottles:- are used to package various product that should not be taken orally.  Widely used for packing of liniments ,lotion, inhalation and antiseptic solution. 26 Contd…
  27. 27.  The parenteral products are packed and administered in large volumes i.e. 100 ml to 1000 ml per day.  For LVP, type 2 glass is used but type 1 can also be used for the products having high pH. 27 Large Volume Parenteral Glass Bottles
  28. 28. Dropper Bottles  Eye drop and dropper bottles for ear and nasal use are hexagonal- shaped amber color glass containers  They are fitted with cap, rubber teat and dropper as the closure.  The bottles are used at a capacity of 10ml to 20ml 28
  29. 29. Jars  Powders and semisolid preparations are generally packed in wide mouthed cylindrical jars made of clear or amber glass.  Jars varies from 15ml to 500 ml.  Jars are used for packing prepared ointments and pastes. 29
  30. 30. Ampoule  An ampoule (also ampule, or ampulla) is a small sealed vial which is used to contain and preserve a sample, usually a solid or liquid. Ampoules are commonly made of glass, although plastic ampoules do exist  These are used for packing of parenteral solution intended for single use. Glass ampoules are more expensive than bottles and other simple containers 30
  31. 31. Types Of Ampoules  One Point Cut Ampoules  Before opening One-Point Cut (OPC) Ampoule Use an antiseptic to clean the ampoule. Gently tap the top part of the ampoule to get all the liquid into the bottom part 31
  32. 32. Directions for Use of One-Point Cut (OPC) Ampoule Hold the bottom part of the ampoule with the colored dot facing you. Put the other hand on the top of the ampoule as shown. 32
  33. 33. Apply pressure to the top part and snap the ampoule away from you. Features: Long lasting structure Perfect finishing Resistance to chemicals. 33 Contd…
  34. 34. Flat Based And Constricted Neck Ampoule Features:  Optimum hygiene level  Longer service life 34
  35. 35. Flame Cut Ampoules  Optimum hygiene level  Ease in sterilization  Can be easily broken to take out the product 35
  36. 36. Vials  A glass or plastic container closed with a rubber stopper and sealed with an aluminum crimp. Vials are available for single dosing or for multiple dosing  Injection vials can be obtained in either neutral or soda glass and occasionally in treated soda glass 36
  37. 37. Advantages And Disadvantages of Glass Vial  Advantages  Glass vial has increased dose flexibility  Has decrease cost per unit dose  Cost of handling, transportation and storage is less  Disadvantages  Closures fragment may be released into the product when needle is inserted through the closure  Risk of interaction between product and closure  Repeated withdrawn of injection solution increase the risk of microbial contamination 37
  38. 38. Advantages of Glass Containers 1. It allows easy inspection of the containers contents. 2. It also have the great advantage of preserving a certain temperature for a longer period of time. They do not dilate when it is too warm or shrink when exposed to lower temperature 3. They are available in various shapes and sizes 4. They are economical and readily available 5. They can protect the photosensitive medicaments from light during their storage 6. They do not deteriorate with age 38
  39. 39. Disadvantages of Glass Containers 1. They are brittle and break easily 2. They may crack when subject to sudden changes in temperatures 3. They are heavier in comparison to plastic containers 4. They can cause light transmission 39
  40. 40. Plastic Containers Plastics are synthetic polymers of high molecular weight  Plastics as packaging have proved useful for a number of reason i.e.  Ease with which it can be formed  Durability and Flexibility  The freedom to design.  Plastic containers are extremely resistant to breakage and offer safety consumers 40
  41. 41. DRUG-PLASTIC CONSIDERATIONS A packaging system must protect the drug without altering the composition of the product until the last dose is removed. Drug-plastic considerations have been divided into five categories: 1. Permeation 2. Leaching 3. Sorption 4. Chemical reaction 5. Alteration
  42. 42. Permeation: It is the transmission of gases, vapors or liquids through plastic packaging material. Permeation of water vapor and oxygen through plastic wall into the drug is a major problem is 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.
  43. 43. 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.
  44. 44. Sorption: This process involves the removable 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 and temperature etc…
  45. 45. 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. Modification: The physical and chemical alteration of the packaging material by the drug product is called modification. Some solvent systems found to be considerable changes in the mechanical properties of the plastics. For example oils have a softening effect on polyethylene, hydrocarbons attack polyethylene and PVC.
  46. 46. Types of Plastics  There are Two main types of plastics :–  Thermoplastics  These are softened by heat and can be moulded. Thermoplastic polymers have been established as packing material for sterile preparations such as large volume parenteral, ophthalmic solutions, and also small volume parenteral.  Good examples are acrylic, polypropylene, polystyrene polythene and PVC. 46
  47. 47.  Thermo sets Plastics  These are formed by heat process but are then set (like concrete) and cannot change shape by reheating  Harden reversibly by cross linking  Good examples are Melamine (kitchen worktops), Bakelite (black saucepan handles), Polyester and Epoxy resins. 47
  48. 48. Other Classifications  PLASTIC ARE OF TWO FORMS 48 AMORPHOUS PLASTIC CRYSTALLINE PLASTIC  They give good transparency.  They are hard but posses little brittleness.  They are more permeable to gases and vapour.  They are of less inert. They are opaque They are more flexible They are less permeable to gases and vapour. For photo sensitive drugs this type of plastics are selected. More inert
  49. 49. Plastic Containers For Pharmaceutical Products Are Primarily Made From The Following Polymers  Polyethylene  Polypropylene  Poly Vinyl Chloride  Polystyrene  Polymethyl Methacrylate  Amino Formaldehyde  Poly Carbonates 49
  50. 50. Polyethylene  Its is flexible, very light but tough plastic  It is impermeable to water vapour and does not deteriorate with age unless it is exposed to sunlight for long time  It has permeability to certain oils and preservatives.  Its melting point being in the range of 1100 to 1500c  It has high melting point and can sterilized by autoclaving. 50
  51. 51.  It is divided into  HDPE (HIGH DENSITY POLYETHYLENE )  LDPE ( LOW DENSITY POLYETHYLENE )  HDPE: -Rigid, withstand temperature up to 120 degree Celsius  LDPE :-Flexible, withstand temperature up to 80 degree Celsius 51 Contd…
  52. 52. Uses Of Polyethylene And Polypropylene  Polypropylene and polyethylene are most widely used in parenteral plastic containers  Low density polyethylene and polystyrene are generally not autoclavable  Polyethylene containers mostly used for ophthalmic preparation. 52
  53. 53. Polyvinyl Chloride (PVC)  It is less flexible , heavier and more permeable to water vapors as compared with normal polythene  It has high clarity and not effected by sunlight  It is used for preparing eye ointment tubes  Flexible PVC is main component for intravenous bags. 53
  54. 54. Polystyrene  It is a hard, rigid , light material  It can be easily molded into any shape  So it is used for preparing bottles, tubes ,jars for ointments and cream ,boxes and syringes. 54
  55. 55. Polymethyl Methacrylate (PMMA)  It is hard , strong but light, transparent plastic  It softens at about1000c  It is used for preparing bottles and tubes. 55
  56. 56. Polycarbonate  It is transparent, has high impact strength and very good heat resistance.  It is used in the preparation of surgical equipment.  It has been used in blood oxygenators, blood reservoirs, and blood filters used in the bypass circuit for more than 20 years. 56
  57. 57. Types of Plastic Containers  Plastic Ampoules Advantages  Breaking is easy, no shreds, no sharp edges, no danger for scars or cuts of the skin.  Plastic ampoule is not fragile, no need for special handling with care during shipment, storage or the final application.  Filling up doesn’t need the expensive and hazardous technology of flame welding. 57
  58. 58.  It is easy and energy efficient on automatic process machines, with high precision of dosing.  The raw material is environment friendly and fully recyclable polypropylene. Size range is:- 1.5 ml, 3 ml, 5 ml, 7 ml, 11 ml.  DISADVANTAGE OF PLASTIC AMPOULE  Not as transparent as glass.  Leaching may occur  Difficult in sterilization  Can not tolerate high temperature range. 58
  59. 59. Plastic Vials  Plastic vials, often used to store medication as liquids, powders or capsules.  They can also be used as sample vessels, for instance, in auto sampler devices in analytical chromatography.  Modern vials are often made of plastics such as polypropylene. 59
  60. 60. Plastic Tubes  During the last decade, plastic blood collection tubes have been progressively replacing glass tubes.  Plastic tubes are not only less expensive but also safer than glass tubes, because they are less likely to break.  They have been shown to influence the measured concentrations or stabilities of several drugs. 60
  61. 61. Plastic Syringe  A syringe is a simple pump consisting of a plunger that fits tightly in a tube.  The plunger can be pulled and pushed along inside a cylindrical tube (called a barrel), allowing the syringe to take in and expel a liquid or gas through an orifice at the open end of the tube.  The open end of the syringe may be fitted with a hypodermic needle, to help direct the flow into and out of the barrel.  Syringes are often used to administer injections, insert intravenous drugs into the bloodstream. 61
  62. 62. PVC Collapsible Bags  It is the part of large volume parenteral products (100ml to 1000 ml per day) containers.  These are used to pack most infusion fluids.  They are design with a port for the attachment of administration set and additive port for the addition of small volume parenteral fluid. 62
  63. 63.  Advantages  Durable and light weight  No air interchange. The bag collapses as it empties.  Disadvantages  They adsorb some drugs  They permits a high moisture penetration  NOTE:- Ethylene vinyl acetate film(EVA) are also used in the formation of flexible collapsible bags 63
  64. 64. Semi Rigid Polythene Containers  These containers are used for different volume of parenteral products:-  100ml for electrolyte solution  3 litre for total parenteral nutrition solution  Up to 5ml for dialysis solution. 64
  65. 65. Sterilization of Plastic Containers Method of sterilization Sterilization condition Moist heat 121 degree Celsius for 15 min. Dry heat 160-180 degree Celsius for 1 to 3 hrs Gaseous sterilization Ethylene oxide with negative pressure or inert gas Chemical disinfectant Formalin 65
  66. 66.  Leakage test  Water Permeability Test  Collapsibility test  Clarity test  Biological toxicity test 66
  67. 67. ADVANTAGES OF PLASTICS DISADVANTAGES OF PLASTICS  They are light in weight and can be handled easily They are transported easily. They are unbreakable. They available in various shapes and sizes. They are resistant to inorganic chemicals. They are permeable to water vapour and atmospheric gases. They are poor conductor to heat. They may absorb chemical substances, such as preservative for solutions. They are relatively expensive. 67
  68. 68.  Metals are used for construction of containers. ADVANTAGES  They are impermeable to light, moisture and gases  They are made into rigid unbreakable containers by impact extrusion  They are light in weight DISADVANTAGES  They are expensive  They react with certain chemicals 68
  69. 69.  These metal containers are prepared by using different metals  Aluminium  Aluminium foil  Tin  Lead  Stainless steel 69
  70. 70. 70 METAL COLLAPSIBLE TUBES TIN ALUMINIUM LEAD Most expensive Most chemically inert of all metal collapsible tubes Light in weight Provides attractiveness of tin at low cost Cheaper than other materials Should never used alone for anything taken internally because of chances of lead poisoning
  71. 71.  Aluminium:- is able to resist the corrosion. Aluminum tubes offer significant savings in product shipping costs because of their light weight.  They are attractive in nature.  Aluminium foil:- is also called al-foil. It is also called tin foil but it is not made from tin. 71 Contd…
  72. 72.  Tin:- Most expensive and can be highly polished  It is used as a protective coat for other metals in order to prevent corrosion or chemical reaction.  Tin containers are preferred for food, pharmaceuticals and any product for which purity is considered 72
  73. 73.  Lead :-Lead has the lowest cost of all tube metals and is widely used for non food products such as adhesives ,inks ,paints and lubricants  Lead should never be used alone for anything taken internally because of the risk lead poison 73
  74. 74.  Stainless Steel- Chromium (12 to 14 %) and Nickel up to 0.7%) are widely used for manufacturing of equipment's 74
  75. 75. Advantages  It is an attractive container that permits controlled amount to be dispensed easily with adequate protection of product usually made up of aluminium, lead and tin metals  If product is incompatible with base metal than interior surface is coated with wax or lacquer. 75
  76. 76.  These are light in weight and unbreakable Disadvantages  Corrosion  Breakage  Poisoning 76
  77. 77. RUBBER  Rubber is used in manufacture of closures, caps, vials wrappers and plungers  Closure is a device tightly pack the container to exclude oxygen, carbon dioxide, moisture & microorganisms & prevent loss of water & volatile substance from the product during transport & handling. It is a part of container system but doesn’t come in contact with drug. (Aluminium, rubber) 77 CAPS CLOSURES
  78. 78.  RUBBER VIALS 78  PLUNGER
  79. 79. Ophthalmic preparations are specialized dosage forms designed to be instilled onto the external surface of the eye, administered inside or adjacent to the eye or used in conjunction with an ophthalmic device.
  80. 80.  Ophthalmic products have several types i.e.  Eye Drops  Eye Lotions  Eye Ointments  Eye Creams  Eye Gels  Contact Lens Solutions  Parenteral Products  Ophthalmic Inserts And  Powders. 81
  81. 81. Eye drops(Single- dose containers): Plastic bottles(LDPE) are widely used.
  82. 82. Eye drops(Multiple-dose containers): Traditionally, glass bottles with rubber teat dropper were widely used. Now-a-days, plastic bottles(LDPE) are widely used.
  83. 83. Eye ointments: Flexible plastic or collapsible metal tubes are used.
  84. 84. Currently almost all commercially available ophthalmic products are packaged in plastic containers  Advantages  Ease Of Use  Less Spillage  Less Breakage  The plastic bottles for packaging of ophthalmic products are generally made of:-  Low Density Polyethylene(LDP)  Polypropylene(PP)  High Density Polyethylene(HDPE) 85
  85. 85.  Parenteral dosage forms differ from all other dosage forms because they are injected directly into body tissue through the primary protective system of the human body, the skin and the mucous membranes.  They must be exceptionally pure and free from physical, chemical and biological contaminants. 86
  86. 86.  NOTE:  These requirements place A heavy responsibility on the pharmaceutical industry to practice current good manufacturing practices(cgmps) in the manufacture and packaging of parenteral dosage forms.  Colorless or colored glass is used for the other pharmaceutical preparations. It is recommended that all glass containers for liquid preparations and for powders for parenteral use permit the visual inspection of the content. ,  Containers for aqueous parenteral preparations are tested for arsenic release and coloured glass containers are tested for spectral transmission. 87
  87. 87.  Small Volume Parenteral Product Containers (volume up to 100 ml)  Single dose containers:-ampoule  Multi dose containers: vials  Prefilled Syringe  Large Volume Parenteral Product Containers  Glass Bottles  PVC Collapsible Bags  Semi rigid Polythene Containers 88
  88. 88.  Ampoules A parenteral product container made entirely of glass and intended for single use. The ampoules can be broken at the neck restriction either by scoring or by having a ceramic point (ring or spot) baked on during the manufacture thus causing a weak point. However breaking on the ceramic point can cause colored particles to fall into the product. this led to an alternative where the the ampoule is scored and then has a colored ring above or below the score to indicate the break point( one point cut/open point cut method).
  89. 89.  A glass or plastic container closed with a rubber stopper and sealed with an aluminum crimp. Vials are available for single dosing or for multiple dosing. Injection vials can be obtained in either neutral or soda glass and occasionally in treated soda glass. Vials
  90. 90. HDPE Plastic Vials Type 1 Glass Vial for multi dosing purpose
  91. 91. Syringes are devices for injecting, withdrawing or instilling fluids. Syringes consists of a glass or plastic barrel with a tight fitting plunger at one end, a small opening at the other end accomodates the head of a needle. Needle Gauge is the outside diameter of the needle shaft; the larger the number, the smaller the diameter. Gauges in common use range from 13 (largest diameter) to 27. Subcutaneous injections usually require a 24-gauge or 25-gauge needle. Intramuscular injections require a needle with a gauge between 19 and 22. Needles between 18 gauge and 20 gauge are commonly used for compounding parenteral.
  92. 92. Disposable plastic syringe Disposable glass syringe
  93. 93.  For glass  Powder glass test  Water attack test  Light transmission test  For plastic  Leakage test  Permeation test  Collapsibility test  Test for clarity of aq. Extract etc.  Biological testing
  94. 94. EVALUATION OF PACKAGING MATERIALS TESTS FOR GLASS CONTAINERS: 1) Powdered glass test 2) Water attack test Preparation of specimen for powdered glass test: Rinse 6 or more containers and dry them Crushed in to fragments Divide 100gms of coarsely crushed glass in to three equal parts
  95. 95. place 1 portion in a mortar Crush further by striking 3 or 4 blows with hammer Nest the sieves (# 20,40 at least) Empty the mortar in to sieve 20 Shake the sieves and remove the glass particles from # 20 and 40 Crush them again and sieve them Transfer the retained portion on # 50
  96. 96. Spread the specimen on a glazed paper and remove iron particles with the help of magnet Wash with 6 portions of 30ml acetone Dry the contents for 20mins at 140oc Transfer to weighing bottle and cool in a desiccator Final specimen should be used in powdered glass test
  97. 97. 1) POWDERED GLASS TEST: (according to USP volume 27) Transfer 10gms of prepared specimen in a 250ml conical flask digested previously with high purity water in a bath at 90o c Add to conical flask containing 50ml high purity water Cap all the flasks and auto clave Adjust temperature to 150oc Cold the temperature to 121oc for 30mins Cool the flasks under running water
  98. 98. Wash the residue powdered glass(4 times with 15ml purity water) Add the decanted washings to main portion. add five drops of methyl red solution. Titrate immediately with 0.02N sulphuric acid. Record the volume of 0.02N sulphuric acid. Volume does not exceed i.e. indicated in the USP as per the type of glass concerned
  99. 99. WATER ATTACK TEST:(USP) rinse 3 or more containers with high purity water fill each container to 90%of its over flow capacity cap all the flasks and autoclave for 60mints empty the contents and cool the contents in 250ml conical flasks to a volume of 100ml add 5 drops of methyl red solution titrate with 0.02N sulphuric acid while warm record the volume of 0.02Nsulphuric acid consumed volume should not exceed as indicated in USP as for type of glass
  100. 100. TESTS FOR PLASTIC CONTAINERS 1.Leakage test for plastic containers(non injectables and injectables 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
  101. 101. 2.WATER PERMEABILITY TEST FOR PLASTIC CONTAINERS(INJECTABLE PREPARATIONS IP 1996): fill 5 containers with nominal volume of water and sealed weigh each container allow to stand for 14 days at relative humidity of 60 % at 20-250ºC
  102. 102.  test is applicable to containers of oral liquids, unlabelled, unmarked portion from suitable containers are randomly selected.  these portion are cut into strips and washed twice with distilled water for 30 sec. & then water is drained. Strips are transferred to a clean flask (previously washed with chromic acid & water). Added 250 ml of distilled water. the flask is covered & autoclaved for 30 min. at 120c.  Inference- extracts content are cooled & examined. It should be colorless & free from turbidity.
  103. 103. 4. Biological toxicity test-  Invitro test – extract placed in contact with mammalian cells to check to toxicity.  Invivo test –  systemic inj. Test – mice  intracutaneous inj. – rabbit  implantation test & eye irritation test - rabbit
  104. 104. Protection  a container intented to provide protection from light , or offered as alight resistant must meet the requirement of the USP light transmission test.  The ability of a container to protect against moisture can be identified by performing the USP water vapour permeation test.
  105. 105.  Compatibility  Container component will not interact with the dosage form & may not show leaching.  Other changes such as pH shift , precipitation , discoloration should be evaluated.  Safety  Packaging components should be constructed of material that will not leach harmful or undesirable amounts of substances.
  106. 106.  Introduction  Purpose of closures  Classification of closures  Material employed for formation of closures  Quality control of closures i. Test for alkalinity ii. Turbidity test iii. For rubber closure iv. Child test
  107. 107.  Retains the contents  Provides a barrier to dirt, oxygen, moisture, etc  Keeps the product secure from undesired and premature opening  Provides a means of reclosing or reusing the container  Assists in dispensing and using of product  Minimizes the effect of change of surroundings such as changes of relative humidity, temp. or pressure  Provides a totally hermetic seal. This is a closure that permits no exchange b/w the contents and outside of the pack
  108. 108. Clas sific atio n of clos ures Cap type Plain Threaded Continuous LuggedPlug type Crown cap Roll on Pilfer proof Special type Tamper evident Child resistant Over cap
  109. 109. In this form, closure is an external cap over the neck. These are used to secure the closure to the container in order to maintain the integrity of the seal under normal conditions of handling and storage.
  110. 110. i. Plain or snap fit-  In this the cap is pressed to seal  It closes with a click  Can be applied very quickly
  111. 111. ii. Threaded or Screw cap-  It is a mechanical device which is screwed on and off a container  Either continuous threads or lugs are used  It must be engineered to be cost- effective  Provide an effective seal  Compatible with the contents  Complies with product, package, environmental laws and regulations.
  112. 112. Screw cap consists of 3 components 1. Cap 2. Wad 3. Liner Cap:- may be of metal, usually tin plate or aluminium or may also be a plastic material which may be of thermosetting type (for more rigidity)  Plastic caps are more beneficial as compared to metal caps, as they are capable of resisting corrosion & do not contaminate the product.
  113. 113. Wad:- It should be effective to provide satisfactory seal and inert to avoid contamination of the product.  Silicon rubber can be used but in practice wads are commonly of cork composition. Liner:- must be inert. Material that are used include metal foils, plastic films, rubber or paper impregnated with a suitable resin, wax or plastic.
  114. 114. a. Continuous- When cap is applied, its threads are engaged with the corresponding threads molded on the neck of the bottle. For opening, closure is rotated.
  115. 115. b. Lugged- similar to the threaded screw cap and operates on the same principle. It is simply an interrupted thread on the glass finish, instead of a continuous thread.It requires only 1/4th rotating.
  116. 116.  It is a push fit into the neck of the container.  Eg. Cork or glass stopper, but both of these have been replaced by plastic stoppers. Glass stopper Cork stopper Plastic stopper
  117. 117. These are shallow metal caps that are crimped into locking position around the head of the bottle. Generally made up of tin.
  118. 118.  Requires a material that is easy to form.  The roll on caps can be sealed securely, opened easily and reclosed effectively.
  119. 119.  It is similar to roll on closure but has a greater skirt length  This additional length extends below the threaded portion and fastens to the basic cap by the series of narrow bridges  When the closure is removed the extra portion remains in the space on neck of the container  The user can reseal the closure but the detached bond indicates that the package has been opened
  120. 120.  These are additional closures for simple dose measurement
  121. 121. i. Tamper evident-  Having an indicator or barrier to entry which, if missing, can reasonably be expected to provide visible evidence to consumers that tampering has occurred.  A tamper evident package may involve systems intended to provide a visible indication of package integrity.
  122. 122.  These are designed to prevent accidents and malicious tampering to create safe packaging  Each retail package is required to contain a statement that is prominently placed so that consumers are altered to the specific tamper-resistant feature of the package  Labeling statement is required to be so placed that it will be unaffected if the tamper-resistant feature of package is missing.
  123. 123.  Breakable cap ring systems  Sealed tubes  Heat sealed bands or wrappers  Inner mouth seals  Tape seals  Aerosol containers  Metal and composite cans
  124. 124.  Breakable caps:-  Cap or part of it must be broken in order to open the container and remove the product  it must not be possible to replace it in its original state.
  125. 125.  Sealed metal tubes, plastic heat sealed tubes:-  must have both ends sealed  mouth has to be punctured to gain access to the product  crimped ends are only acceptable if they can’t be unfolded and refolded without visible damage.
  126. 126.  Heat sealed bands or wrappers:-  must be placed over the union of primary closure (cap, lid, etc.) and container  must have a distinctive design  must get shrunk by heat  must be cut or torn to gave access  must not be worked off without leaving visible evidence  a perforated tear strip enhances tamper evidence.
  127. 127.  Inner seals:-  Whether made of paper, plastic film, foil or combinations, they must have a distinctive design  Must be torn or broken to gain access  Heat induction seals are considered superior to adhesive seals.
  128. 128.  Tape seals:-  involves the application of a glued or pressure sensitive tape or label around or over the closure of the package, which must be destroyed to gain access to the packaged product  if used on cartoons they must be applied over all flaps.
  129. 129.  Aerosols:-  Considered to be inherently tamper resistant  direct printing on the container is preferable to a paper label
  130. 130.  Cans and composite containers:-  Top and bottom of a composite must be joined to the walls so that they can’t be pulled apart and replaced.
  131. 131. ii. Child resistant- These are difficult for young children (under 5 years of age) to open but not difficult for adults to use properly.  These have been produced in response to demand for greater protection of children against accidental poisoning  Used for drugs, house cleansing agents, pesticides etc.
  132. 132. 1. Press and turn 2. Lift and turn 3. Squeeze and turn 4. Line up arrows and flip 5. Pop lock closure
  133. 133. 1. Press and turn:- the cap is removed by applying a downward pressure while the closure is rotated. Click-lock closure is one of the most successful of this type. It also incorporates a form of alarm for an adult in that if the cap is turned without pressing then a clicking sound is heard.
  134. 134. 2. Lift and turn:- it involves applying an upward force while rotating the closure. 3. Squeeze and turn:- force is applied to the sides of the closure while the screw cap is rotated.
  135. 135. 4. Line up arrows and flip:- once the alignment is established the miss-fit between cap and container is removed and the cap will lift. 5. Pop-lock closure:- can only be operated after a tab on its top has been released and then opening is achieved by pulling on it.
  136. 136.  Metals ( aluminium, aluminium alloys, tinplate, stainless steel)  Rubber ( natural & synthetic)  Plastic ( thermosetting & thermoplastic)  Glass ( used for formation of stoppers)
  137. 137.  Metal caps are usually coated on the inside with an enamel for resistance against corrosion  Almost all metal crowns and closures are made from electrolytic tinplate, a tin coated steel on which the tin is applied by electrolytic deposition. Tin is most chemically inert.
  138. 138. The two basic types of plastics generally used for closures are :- 1. Thermosetting Resins- is used for making screw caps for glass and metal containers. The thermosetting plastic first softens under heat and then cures and hardens to a final state. 2. Thermoplastic Resins- Polystyrene, polyethylene and polypropylenes are the materials used in 90% or more of all thermoplastic closures.
  139. 139. Advantages of plastic- 1. Flexible and not easily broken 2. Low density and thus light in weight 3. Easily molded in various shapes 4. Cheap Limitations- 1. Not chemically inert 2. Undergo stress cracking and distortion from contact with some chemicals 3. Not heat sensitive 4. May possess an electrostatic charge and will attract particles.
  140. 140.  Rubber consists of several ingredients, one of them is elastomer  These closures do not pose a problem and can be used in contact with large number of drug preparations.
  141. 141. 1. Butyl rubber (copolymer of isobutylene and isoprene or butadiene) 2. Nitrile rubber (butadiene-acrylonitrile co- polymers) 3. Neoprene rubber 4. Silicon rubber
  142. 142. 1. Butyl rubber- cheap, chemical resistant, low water vapor/air permeability. It is not good for oils. 2. Nitrile rubber- resistant to oil, heat treatment, vapor absorption but leaching and bactericide absorption is high. 3. Neoprene rubber- resistant to heat and oil with low water absorption permeability as compared to natural rubbers. 4. Silicon rubber- most heat resistant (about 250oC) with very low water absorption and permeability, but costly.
  143. 143. 1. Common flanged closure 2. Slotted or freeze dried product closure 3. Cartilage and Disposable syringe closure
  144. 144.  Most commonly used in closing of vials and bottles.
  145. 145.  These closures has a slot or pathway for the ice sublimation  Used to seal the freeze dried products or lyophilized products.
  146. 146.  Cartilage is made of glass, one end of which is sealed with the rubber piston and the other end with aluminium over seal and rubber septum.
  147. 147. 1. It should not become sticky upon storage 2. It should not become hard on exposure to atmosphere 3. It should not become dark on exposure to air and light 4. Ease in penetrability and elasticity (in case of vials) 5. Ease in sterilization- rubber closure must withstand heat at least about 1200C 6. It must not become sticky during autoclaving 7. It should not allow water vapor and air to pass through it 8. It should be free from leaching and sorption.
  148. 148. 1. Test for alkalinity (for glass) 2. Test for rubber closures a. compatibility with contents b. permeability to water c. self sealability d. fragmentation e. penetrability f. quality g. finish test 3. Child test
  149. 149.  Coarsely crush the glass and then crush finely  Sieve the crushed glass  Take 2 conical flasks, one should be treated as “blank” while other as “sample container”  Put the powder in the conical flask and consider as sample container  Add some distilled water in both of the flasks  Close both the flask with closure
  150. 150. Cont.  Autoclave both for prescribed period of time  Add NaOH solution to both of container  Filter the solution and wash with water  Titrate the filtrate with standard normal acid  Calculate the normality of alkali and then the concentration is calculated  The conc. of alkali should not exceed the prescribed limit.
  151. 151. a. Compatibility with other components- All the sterile products are packed aseptically in sterile containers and several are stored under different conditions.
  152. 152. At given time intervals up to a year, except for the 500C test, which are continued for 3 months only, the samples are examined for- a. Foreign insoluble matter, using standard conditions of illumination. b. Loss of potency and preservatives, and increase in toxicity. c. Signs of deterioration of the closure, such as sponginess and discoloration. The latter should be checked after drying overnight because absorption of water and certain solutes often produces a bleached appearance.
  153. 153. b. Permeability to water- Put calcium chloride in vial and close it with rubber closure and seal it with aluminium seal. Weigh the vial Place it for a limited time period Weigh again If weight noted down later is more than previous then test fails as weight is increased due to the absorption of water vapors.
  154. 154. c. Self sealability test- Take a vial and filled it with methylene blue solution Inset needle into rubber closure 20-25 times within a circle of 5 mm diameter Vial is inverted in water in a container to which a prescribed vacuum is applied for half an hour There must be no signs of leakage in the water or on the closure
  155. 155. d. Fragmentation test for rubber closures (IP 1996) Take 12 clean vials Place a volume of water corresponding to nominal volume minus 4ml in each Close vial with closure and secure caps for 16 hours Pierce the closures with hypodermic needle and inject 1ml water and remove 1ml air
  156. 156. Repeat the above operation 4 times for each closure Count the number of fragments visible to the naked eye Total number of fragments should not be more than 10 except butyl rubber where the fragment should not exceed 15
  157. 157. e. Penetrability test (by piercing machine)-  inverted vial is fitted on clamp and the clamp is allow to move downward at a specified speed  stand having needle is fitted with piston type cylinder  as clamp moves downward with vial, needle will go inside the vial and the piston moves downward  force applied on the vial should not exceed a stated value.
  158. 158. f. Quality test- Rubber closures must not be tacky after washing in a detergent, rinsing several times, autoclaving for half an hour at 1210C in distilled water and drying for a day at 650C in vacuum. g. Finish test- They must be substantially free from adventitious dust, fibers, loose particles of rubber, smears of grease and pigment, and quite free from internal foreign matter.
  159. 159. 4. Child test- (Acc. to 1995 US Protocol)  200 children of 42-51 months divided approximately equally b/w the sexes and 100 normal adults b/w 18 and 65 years of age (70 female and 30 male) are selected  test involving children must be carried out in familiar environment such as school but the adults can be polled in any convenient centre  children operate in pairs under a qualified supervisor  each child is given a package containing a placebo drug and allowed 5 minutes to try and open it
  160. 160.  If they are unsuccessful they receive a non-verbal demonstration and a further 5 minutes to try again  Adults are asked to open the package individually within 5 minutes using only the directions that appear on the package itself and then to reclose it properly if it is re-closable type  After the full 10 minutes 80% of the children shall not succeed in opening the package and after 5 minutes 90% of the adults must be successful.
  161. 161. 1. Pharmaceutical product development by N.K. Jain 2. Cooper and Gunn’s “Dispensing for pharmaceutical students”,CBS Publishers,page no.-278-345 3. Modern pharmaceutics by G.S. Banker and C.T. Rhodes 4. Leon Lachman ,“The theory and practice of industrial pharmacy”,Lea &Febiger,U.S,2nd edition,page no.-241-306 5. Remington, “The Science and Practice of Pharmacy”, published by Lippincott Williams & Wilkins,page no. 356-386

×