LABELLING AND PACKAGING OF DOSAGE FORMS

TYPES OF CLOSURES USED FOR PACKAGING OF DOSAGE

FORMS

TYPES OF CLOSURES USED IN PACKAGING OF PHARMACEUTICALS

closures are devices and techniques used to close or seal a bottle, jug, jar, tube, can, etc. Closures can be a cap, cover, lid, plug, etc.

closures tightly packs the container to exclude oxygen,carbondioxide,moisture , microorganisms ,prevents the loss of water and other volatile substances from the product

Purpose of closures : Many containers and packages require a means of closing.

It can be a separate device or seal or sometimes a integral latch or lock. Depending on the contents and container, closures have several functions:

Keep the container closed and the contents contained for the specified shelf life until time of opening

Provide a barrier to dirt, oxygen, moisture, etc. Control of permeation is critical to many types of products: foods, chemicals, etc.

Keep the product secure from undesired premature opening Provide a means of reclosing or reusing the container Assist in dispensing and use of product Allow reasonable ease to open the container by the

intended user. Difficult to open containers may cause wrap rage. The force or torque required to open a closure is an important consideration for packaging engineers

Many types of packaging with their closures are regulated for strength, safety, security, communication, recycling, and environmental requirements.

Types of closures (a)RUBBER CLOSURES (b)CAPS & OVERSEALS screw cap crown cap Snap on Friction fit (c)SPECIAL TYPES Tamper-evident Dispensing Child-resistant

RUBBER CLOSURES

Rubber consists of several ingredients,one of them is elastomer.rubber compounds used in pharmaceutical packaging contain only limited number of ingredients,which are difficult to extract.these closures do not pose a problem and can used in contact with large number of drug preparations.

Rubber closures for containers for aqueous parenteral preparations have been classified into 2 types,according toB.P.Type I are to be preferred:Type II closures are those,which have mechanical properties suitable for special use,cannot meet the requirements as severs as those for the 1st category because of the chemical composition.

Fragmentation test and self sealability of closures of parenteral preparation is given by…..

FRAGMENTATION TEST (IP 1996) FOR RUBBER CLOSURES

Place a volume of water corresponding to nominal volume minus 4ml in each of 12 clean vials

Close vial with closure and secure caps for 16hours

Pierce the closures with 21 SWG hypodermic needle and inject 1ml water and remove 1ml air

Repeat the above operation 4times 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

Vials

SELF SEALABILITY (IP 1996) TEST FOR RUBBER CLOSURES APPLICABLE TO MULTIDOSE CONTAINERS ONLY

Fill 10 vials with water to nominal volume and close the vials with closure,secure the cap

Pierce the cap 10times at different sites with 21SWG hypodermic needle

Immerse the vials in 0.1%w/v solution of methylene blue under reduced external pressure for 10min

Restore the normal pressure and keep the container immersed for 30minutes

Wash the vials.None of the vials should contain trace of

coloured solution

CAPS AND OVERSEALS : These are used to secure the rubber closure to the container

in order to maintain the integrity of the seal under normal conditions of handling and storage.It includes:

Screw capA screw cap or closure is a common type of closure for 

bottles, jars, and tubes

 Common screw closures: Plastic bottle with plastic screw cap,

Dispensing closure for salad dressing (with inner seal), Break-away closure for syrup, Dispensing pump closure, Dispensing closure (with inner seal), Spray pump, Metal closure on glass jar, Child resistant closure, Cap on toothpaste, Measuring cap

A "sports cap", which appears on many water bottles, seen in closed configuration at left an in open configuration at right, availing the water to pass around the central blue piece.

Usage A screw closure is a mechanical device which is screwed on

and off of a "finish" on a container. Either continuous threads or lugs are used. It must be engineered to be cost-effective, to provide an effective seal (and barrier), to be compatible with the contents, to be easily opened by the consumer, often to be reclosable, and to comply with product, package, and environmental laws and regulations. Some closures need to be tamper resistant and have 

child-resistant packaging features.

Crown cap

Crown capsMain article: Bottle cap

Beverage bottles are frequently closed with crown beverage caps. These are shallow metal caps that are crimped into locking position around the head of the bottle.

Bottle capFor the Nestlé candy, see Bottle Caps (candy).

A generic 21-teeth crown cork bottle cap

Bottle caps are a type of closure used to seal the openings of bottles of many types. They can be small circular pieces of metal, usually steel with plastic backings, and for plastic bottles a plastic cap is used instead. A bottle cap is typically colorfully decorated with the logo of the brand of beverage. Caps can also be plastic, sometimes with a pour spout. Flip-Top caps like Flapper closures provide controlled dispensing of dry products

Other types

pull-off bottle cap  

plastic bottle screw cap  used to seal a plastic bottle  

Bottle closure

Snap on

Friction fit

Some closures snap on . For opening , the top is designed to pry off, or break off, or have a built in dispenser

Some containers have a loose lid for a closure. Laboratory glassware often has ground glass joints that allow the pieces to be fitted together easily.

An Interference fit or friction fit requires some force to close and open, providing additional security. Paint cans often have a friction fit plug.

Special types of clousresTamper evident

Layers of tamper resistance: carton with adhesive, shrink band, cap, innersealMain article: Tamper resistantMain article: Tamper-evident

Resistance to tampering is required for some types of products. Container closures can be one of several layers of packaging to deter tampering and to provide evidence of attempts at tampering.Various types of tamper evident packagings are listed.They are-

Film wrappers breakable cap ring systems

Blister packs sealed tubes Bubble packs plastic blind end

sealed tubes Heat shrunk bands or wrappers sealed cartons Paper foil for plastic packs aerosol containers,and Bottle with inner mouth seals metal and composite

cans Tape sealsDispensing A wide variety of convenience dispensing features can be built in to

closures. Spray bottles and cans with aerosol spray have special closure requirements. Pour spouts, measuring attachments, sifting devices, etc. are common.

Child-resistantMain article: Child-resistant packagingChild-resistant packaging or C-R packaging has special closures designed to reduce the risk of children ingesting dangerous items. This is often accomplished by the use of a special safety cap. It is required by regulation for prescription drugs, over-the-counter medications, pesticides, and household chemicals.

Examples . spray bottle

coffee tin – square can with friction fit closure

rubber stoppers on flasks

spray duster with long tube for dispensing

 

Closure and roll-on device for deoderant

Inverted catsup bottle with innerseal and dispensing

closure

Bottle of Geritol with a child resistant cap

References REFERENCE : http://www.google.co.in/search?tbm=isch&h

l=en&source=hp&biw=1440&bih=809&q=dispensing+cap&gbv=2&oq=dispensing+&aq=7&aqi=g10&aql=undefined&gs_sm=e&gs_upl=4580l14749l0l18l18l7l1l1l0l416l2612l2-3.4.1l8

http://www.google.co.in/search?hl=en&biw=1440&bih=809&gbv=2&tbm=isch&sa=1&q=RUBBER+CLOSURES&oq=RUBBER+CLOSURES&aq=f&aqi=g1&aql=undefined&gs_sm=s&gs_upl=898013l906085l0l28l17l0l5l5l0l460l2693l2-1.2.4l7

http://www.google.co.in/search?hl=en&biw=1440&bih=809&gbv=2&tbm=isch&sa=1&q=VIALS&oq=VIALS&aq=f&aqi=g10&aql=undefined&gs_sm=s&gs_upl=14585l17901l0l19l9l0l0l0l0l607l1864l3-1.2.1l5

http://www.google.co.in/search?hl=en&biw=1440&bih=809&gbv=2&tbm=isch&sa=1&q=dispensing+cap&oq=dispensing&aq=8&aqi=g10&aql=undefined&gs_sm=e&gs_upl=19301l24985l0l14l12l0l1l1l0l1050l3752l2-1.3.2.1.0.1l9

http://www.google.co.in/search?hl=en&biw=1440&bih=809&gbv=2&tbm=isch&sa=1&q=tamper+evident+cap&oq=tamper+evident+&aq=5&aqi=g8&aql=undefined&gs_sm=c&gs_upl=5511l6246l0l5l5l0l0l0l0l957l957l6-1l1

http://www.google.co.in/search?hl=en&biw=1440&bih=809&gbv=2&tbm=isch&sa=1&q=child+resistant+closures&oq=child+resistant&aq=1&aqi=g3&aql=undefined&gs_sm=c&gs_upl=8967l15095l0l32l18l0l3l3l0l425l2304l0.1.2.2.2l9

http://www.google.co.in/search?hl=en&biw=1440&bih=809&gbv=2&tbm=isch&sa=1&q=friction+fit+closures&oq=friction+fit+closures&aq=f&aqi=&aql=undefined&gs_sm=s&gs_upl=7708l10147l0l9l9l0l7l0l1l531l865l3-1.0.1l2

http://www.google.co.in/search?hl=en&biw=1440&bih=809&gbv=2&tbm=isch&sa=1&q=snap+on+closures&oq=snap+on+closures&aq=f&aqi=&aql=undefined&gs_sm=s&gs_upl=29570l50689l0l36l21l0l7l7l0l460l2750l2-1.2.4l9

http://en.wikipedia.org/wiki/Closure_(container)

U.K. JAIN,D.C .GOUPALE,S.NAYAK-PHARMACEUTICAL PACKAGING TECHNOLOGY