2. DEFINITION
• A closure can be defined as any method for closing a
pack so that the product is properly contained &
protected.
• A closure is a device that seals a product within a pack
but which can be removed to allow the product to be
accessed.
4. • Adequate seal until contents are required for the use
• The degree of seal tightness, is dependent on the product
packed, closure, container, & seal desired, the resiliency of
liner, the flatness of the sealing surface & tightness or torque
with which the closure is applied.
• Many packages today are ergonomically designed systems
capable of easy opening & dispensing & also affording critical
access control.
• A tight seal with easy access
Positive seal
Access
5. • These controls are of two major types:
tamper-evident & child-resistant
• The closure mustn’t affect the contents of the
container, nor be affected by them.
• Closures may be fitted with liner so that the closures
material does not contact the content.
Control
Product-closure compatibility
6. • The closure is focal point of the container.
• Three communication forms include styling aesthetic,
typography, & graphic symbols.
• The closure also have to be resistant to cracking & creep
in order to withstand excess torque during screwing (as
with screw caps) or other internal forces..
Verbal & visual communication
Impact resistance
8. Continuous Thread
Closures
• These are the most common type used for drugs.
• Screw threads on the bottle & on the closure mesh to form a
mechanical bond that when tightened generates torque.
Torque is the measured force that produces compression
between the lip of the bottle or jar & the closure.
• Screw-threaded closures have a thread following a helical
(spiral) pattern on the inside, which must be matched up with
the thread on the neck of the container.
9. LUG CLOSURES
• A lug closure is pressed down on the finish if the jar or bottle
& by using a very short quarter or half turn the closure fully
engages the threads & achieves the torque necessary to seal
the container.
• The difference with this closure is that it only contacts the
thread in 2, 3, 4, or 6 point engagement locations around the
circumference of the jar or bottle.
10. METAL ROLL-ON CLOSURES
• A roll-on closure takes advantage of a hard glass bottle finish
(the threads at the top of the bottle) & the ductility of
aluminium to produce a threaded closure on a container that
does not require torque for application.
12. BOTTLE CROWN
CLOSURES
• They are used in pharmaceutical
packaging on bottles for laxatives &
other liquid products designed for
complete consumption after opening.
• The steel or tinplate material crimped or
folded into a number of indentations
around the circumference of the closure.
• The closure is always lined, & it is
applied over a ridge or formed area at
the top of a bottle.
13. SNAP FIT CLOSURES
• Snap is any clasp or fastener that closes with a click.
• When the closure is in place, some resilient part of the closure
system that is in contact with the container remains deformed,
& provides a seal as it attempts to return to its original
dimensions.
• For opening, the top is designed to pry off or break off, or
have a built in dispenser.
14. PRESS-ON VACUUM
CAPS
• Vacuum caps are a unique style of closure
used to protect oxygen-sensitive products.
• In pharmaceutical applications they are
found on metal containers for powdered
infant formula.
• A vacuum is applied to a container,
creating a partial vacuum in the container
headspace below the closure.
15. VIAL STOPPERS
• Vial stoppers are elastomeric friction seals for injectable drug
containers.
• The stopper acts as the seal in the mouth of the bottle & as a
permeable self-sealing membrane that allows the needle on a
syringe to be inserted for withdrawing the drug.
Various designs for stoppers are –
• Flanged plug elastomeric stoppers
• Flanged hollow plug with cutouts for lyophilized products
• Flanged elastomeric plug with plastic overseal
• Metal closure with an elastomeric disk
16. FLANGED PLUG
ELASTOMERIC STOPPERS
• Most common vial closure for injectable drugs.
• The flange design of the elastomer plug maintains a tight fit
between the plug & the vial neck & the flange & the end of the
vial.
• The aluminium overaseal on the end of the vial locks this
contact of the flanged plug in place.
• The aluminium band has a hole in the center, permitting
access to the elastomer seal by a needle.
17. FLANGED HOLLOW PLUG WITH
CUTOUTS FOR LYOPHILIZED
PRODUCTS
• The plug is partially inserted in the vial &
the cutouts along the plug sidewall permit
water vapor to exit the glass vial during the
lyophilization (freeze drying) process.
• After completion of lyophilization, the plug
is pushed the remainder of the way into the
vial, creating the same type seal found in
the first example with the flanged plug.
• An aluminum overcap is applied to the
completed vial in the same way to lock the
seal in place.
18. FLANGED ELASTOMERIC
PLUG WITH PLASTIC
OVERSEAL
• This type adds another feature to the closure process.
• A plastic overcap is fitted to the elasomer plug that has been
put in place as described in the last two examples. The plastic
overcap maintains the seal & the sterile conditions under the
overcap where it contacts the plug.
• When the needle is inserted for the first use of product, the
plastic overcap is removed & discarded.
19. METAL CLOSURE WITH AN
ELASTOMERIC DISK
• An aluminium cap, similar to that described in the first two
examples of plugged vials is applied.
• The difference is the elastomer is not a plug placed in the
neck of the bottle, but a thin gasket applied to the bottom of
the overcap.
• This membrane acts as a gasket for sealing & a plug for
inserting the needle.
• The top of the closure is open exposing the membrane.
20. SPECIALTY CLOSURE
• There is a wide variety of specialty closures designed to make
a product easier to use by the patient or consumer.
Flip-spout closures Push-pull closures
21. DISPENSING CLOSURES
• This closure has application & dispensing capabilities.
Closure with dropper Closure with pump
dispenser
22. CHILD-RESISTANCE CLOSURES
Child-Resistance Closures have become a common part of most
pharmaceutical packages. Most of the packaging manufactures
begin with the following assumptions -
• Children are very persistent & can use their teeth to open a
package.
• Children’s teeth & fingernails are sharp & small enough to fit into
any gap in the packaging.
• Children’s motor skills will not permit them to perform two or
more motions at the same time.
23. • Children can learn quickly from watching adults.
• Children in these age groups cannot read instructions &
cannot determine alignments of components.
The combination of downward
pressure & simultaneous turning of
the closure opens the bottle.
Press-turn closures
24. TAMPER-EVIDENT
PACKAGING CLOSURES
• These closure has an indicator or barrier to entry which, if
breached or missing, can reasonably be expected to provide
visible evidence to consumers that tampering has occurred.
Breakable caps Tear bands
26. METALS
• Aluminium, aluminium alloys, tinplate, tin free steel,
stainless steel
• Metal caps are used today for general, vacuum &
pressurized applications.
• Tinplate & tin-free steel are used in the production of
continuous thread, press-on closures, lugs, overcaps &
crown caps.
• Aluminium closures are primarily continuous thread caps
& roll-on designs.
27. GLASS
• They are used in the stopper of the chemical reagent
bottles in laboratories.
28. PLASTICS
• They are unbreakable & light in weight.
• A liner is used in these closures.
Thermoplastics (polypropylene & polyethylene)
• Light weight, versatility of design, good chemical resistance
to a wide range of chemicals & manufacturing processes.
Thermosets (phenolic & urea compounds)
• Wide range of chemical compatibility & temperature
tolerances.
29. RUBBER/ELASTOMERS
• Elastomers are primarily used as stoppers / closures on
parenteral containers.
Properties of elastomers :
• Coring resistance (the ability to resist fragmentation when
penetrated by a needle)
• Solvent resistance
• Resistance to radiation
• Resistance to interaction with the packaged components
• Impermeability to gas & moisture
• Flexibility
30. • Common rubbers used in pharmaceutical packaging are
–
• Butyl rubber
• Chlorobutyl rubber
• Natural rubber
• Silicone rubber
31. TESTS FOR THE
RUBBER CLOSURE
• Sterilization test
• Test for extractable matter
• Fragmentation test
• Self sealability test
• Test for free sulfur content
• Test for reducing substance
• Test for heavy metals
32. LINERS
• A liner may be defined as any material that is inserted in a cap
to affect a seal between the closure & container.
• A composite lining material consists of a backing & a facing.
• The backing is a material thick enough & compressible
enough to produce a gasket effect on the lip of the container,
creating a seal.
• The facing material provides functional performance such a
gas barrier, moisture barrier, & isolates the closure from the
contents of the container.
34. LINERLESS CLOSURES
• Linerless closures eliminate the need for a liner.
• The seal of a linerless closure is achieved by molded
embossments forming diaphragms, plugs etc.
35. REFERENCE
• Closures & Dispensing Devices for Glass & Plastic Containers, The
Packaging User’s Handbook, Edited by F. A. Paine, Pg. No. 348 –
381, 1991.
• Edward J. Bauer, Chapter 6 Pharmaceutical Packaging Materials,
Pharmaceutical Packaging Handbook, Pg. No. 268-271, 2009.
• U. K. Jain, D. C. Goupale, S. Nayak, Chapter 2 Packaging Materials,
Pharmaceutical Packaging Technology, Pg. No. 36 – 40, 2008.
• Atul Kaushik, Bhaskar Chaurasia & Virendra Dhakar, Chapter 10
Closure & Liners, Textbook of Pharmaceutical Packaging Technology,
Pg. No. 241 – 279, 2011.
• Edward J. Bauer, Chapter 10 Container Closure System: Completing
All Type of Filled Pharmaceutical Containers, Pharmaceutical
Packaging Handbook, Pg. No. 387 - 430, 2009.
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