CLOSURES
PREPARED BY MRS.M.JANANI DEPARTMENT OF COMMERCE (INTERNATIONAL BUSINESS) GOVERNMENT ARTS COLLEGE, COIMBATORE – 18. REFERENCE: https://www.slideshare.net/anvitaj1/closures-46931311
INTRODUCTION Packaging closures are an important piece of the total packaging solution. All bottles, jars and even some flexible packages require a closure to seal the contents of what is inside. Closures perform a variety of functions based on the size and contents of the container they are sealing. A closure is typically used to seal a container after the initial opening in order to preserve the product for use at a later time. Closures also assist in the dispensing of the product.
COMMON TYPES OF CLOSURES AND USES
CT - Continuous Thread Closures • These are the most basic and commonly used packaging closure.
• They pair with a container that has a continuous spiral protruding on the outside of the finish or neck, as the closure itself has a thread on the inside of it.
• These are typically used across a number of industries including food, household items, pet products, and health & beauty.
COMMON TYPES OF CLOSURES AND USES
CR or CRCs - Child Resistant Closures
• These are typically used for products that are required by the
Consumer Product Safety Commission to be packaged in child-
resistant packaging.
• That means the packaging must be significantly difficult for children
under five years old to open within a reasonable amount of time,
while not being overly difficult for a typical adult to use properly.
• These are typically used for pharmaceuticals and chemical products
COMMON TYPES OF CLOSURES AND USES
TE - Tamper Evident Closures
• These are used when the closure has to provide assurance that the original product is intact.
• These are very common in the food, beverage, and health and beauty industries.
COMMON TYPES OF CLOSURES AND USES
Dispensing Closures • These are used to control the amount of product that gets dispensed
when used.
• They are commonly used for food, household and health and beauty
products.
• There are dispensing closures better suited for dry products like spices
and fertilizers and those best suited for liquids of varying viscosities.
• Sprayers and pumps are also types of dispensing closures, though they
can sometimes be in their own closures category as well.
COMMON TYPES OF CLOSURES AND USES
Bar Top / T-Top Closures
• These types of closures are commonly used for spirits and specialty foods.
• The top part of their closure can be made of plastic, wood, metal, or glass while the bottom part is typically natural or synthetic cork.
FUNCTIONS OF CLOSURE
Positive seal
• 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.
Access
• Many packages today are ergonomically designed systems capable of easy opening & dispensing & also affording critical access control.
• A tight seal with easy access. FUNCTIONS OF CLOSURE
Control
• These controls are of two major types: tamper- evident & child-resistant
Product-closure compatibility
• 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. FUNCTIONS OF CLOSURE
Verbal & visual communication
• The closure is focal point of the container.
• Three communication forms include styling aesthetic, typography, & graphic symbols.
Impact resistance
• 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. THREADED CLOSURES
Continuous Thread Closures Lug Caps Metal Roll-on Closures THREADED CLOSURES
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.
THREADED CLOSURES
LUG CLOSURES
• The lug cap is 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
• Unlike the threaded closure, it requires only a quarter turn
• The cap is widely used in the food industry
THREADED CLOSURES
ROLL-ON CLOSURES
• The aluminum roll-on cap can be sealed securely, opened easily, and resealed effectively
• It finds wide application in the packaging of food, beverages, chemicals, and pharmaceuticals
• The roll-on closure requires a material that is easy to form, such as aluminum or other light-gauge metal
FRICTION-FIT CLOSURES Some containers have a loose lid for a closure. A friction fit requires some force to close and open, providing additional security. Paint cans often have a friction fit plug. Friction-fit closures rely on a number of different methods to create friction or some type of interference fit between the closure & the bottle.
Bottle Crown Closures
Snap-fit Closures
Press-on Closures
Vial Stoppers FRICTION-FIT CLOSURES
Bottle Crown Closures
• This style of cap is commonly used as a crimped closure for beverage bottles and has remained essentially unchanged for more than 50 years.
• 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.
FRICTION-FIT CLOSURES
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.
FRICTION-FIT CLOSURES
Press-on Closures
• 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.
FRICTION-FIT CLOSURES
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
FRICTION-FIT CLOSURES
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.
FRICTION-FIT CLOSURES
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. FRICTION-FIT CLOSURES
Flanged elastomeric plug with plastic overseal
• This type adds another feature to the closure process.
• A plastic overcap is fitted to the elastomer 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. FRICTION-FIT CLOSURES
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. 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
DISPENSING CLOSURES A wide variety of convenience dispensing features can be built in to closures. Spray bottles and cans with aerosol spray have special closure requirements. This closure has application & dispensing capabilities.
Closure with dropper Closure with pump dispenser
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.
• Children can learn quickly from watching adults.
• Children in these age groups cannot read instructions & cannot determine alignments of components. PRESS-TURN CLOSURES
The combination of downward pressure & simultaneous turning of the closure opens the bottle. 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. TORQUE TESTING
Controlling cap tightness on a packaging line with a torque tester can prevent: Evaporation Leakage of the product Breakage of a plastic molded closure COMPOSITION OF CLOSURE
Closures are made of Rubber Plastics Glass Metal Cork RUBBER CLOSURES
Rubber is used in the pharmaceutical industry to make
closures, cap liners and bulbs for dropper assemblies.
The rubber stopper is used primarily for multiple dose
vials and disposable syringes.
Preparations for powders and for freeze-dried powders QUALITY CONTROL OF CONTAINER CLOSURES
A number of quality control checks are required for the manufacture and release of container-closures. These include: a) After the material has been mixed b) Post-compression and molding c) Washing process d) Post-washing and post-siliconization e) Packaging After packaging f) Sterilization QUALITY CONTROL OF CONTAINER CLOSURES a) After the material has been mixed • Specific gravity • Color • Dispersion in relation to particle size • Hardness b) Post-compression and molding • Here the material is checked for rubber thickness c) Washing process During the loading of stoppers into a washer, the quality of the water should be checked for bioburden and endotoxin (using compendial methods). QUALITY CONTROL OF CONTAINER CLOSURES d)Post-washing and post-siliconization After the stoppers have been washed, a number of quality control checks should be performed. These include:
Mechanical and Material Tests
• Compression set
• Hardness
• Fragmentation
• Penetrability (what happens when a needle passes through the stopper?
• Assessment of dimensions and flexibility QUALITY CONTROL OF CONTAINER CLOSURES
Physical Tests
• Resistance to sterilization
• Particle testing
Chemical Testing
Tests for extractables and leachables: Extractables are chemical substances that are obtained by exposing the packaging to a variety of solvents under exaggerated incubation conditions of time and temperature. Leachables differ from extractables in that they are chemical substances that migrate under normal conditions of use from the stopper into a drug product QUALITY CONTROL OF CONTAINER CLOSURES Silicone oil determination: The effect of subvisible silicone particles should be assessed, for these can cause aggregation with proteins, and the new complex can potentially trigger an immunochemical reaction within the body of the patient receiving the drug.
Biological Tests
Cytological testing
Bioburden assessment
Some manufacturers undertake an examination for mesophilic counts whilst others focus on examining for thermophilic bacteria.
Bacterial endotoxin testing
The testing of container-closures for endotoxin, using the Limulus amebocyte lysate (LAL) method QUALITY CONTROL OF CONTAINER CLOSURES e) Packaging After packaging A selection of bags should be examined for tears as a part of quality control assessment f) Sterilization Container-closures are typically sterilized by one of two methods: steam sterilization (using autoclaves) and gamma irradiation
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