Container for injectable dosage form is a device which holds the content of product in it , closure is a device which seals the container to exclude oxygen , caorbon dioxide and moisture and microorganisms, at the same time preventing the loss of volatile components from preparation of a ijectable dosage form.Communly used containers are ampoules for unit dosage form , Vials for multiple dosage and large volume parantrals .
What are the desirable features of containers and closures for Injectable dosage form.
1.Containers and closures should be inert , should be non reactive with content of injectable dosage form.
2.Containers and closures should not leach out its contents from surface in to injection solution.
3.Should not show any absorbtion or adsorbtion of ingredients of the preparation of a injection.
4.Containers and closures for injection should be sturdy enough to with stand the regours of processing handeling and shiping .
5. Containers and closures for injection should offer complete protection against physico chemical agents and microorganisms.
6.Containers and closures for injection should have transparancy to facilitate visual inspection.
7.Containers and closures for injection should have uniform dimentions to facilitate processing by automated unit.
Steps in processing for terminaly sterilised injections.
1.Washing of containers–>2.rinsing–> 3.Dry heat sterilisation of containers —>4.filling —–>5. Sealing—>6.Sterilisation
Steps in processing for asepticaly processed injectable dosage form.
1.Washing of containers–>2.rinsing–> 3.Dry heat sterilisation of containers —>4.Aseptically filling of sterile product and Sealing .
1.Washing of containers for injectable dosage form
Washing containers is done in a environment controlled aria where particle count is controlled and is with in 1000 class.Water used for washing is a purified water meeting the standards for MLT and other standards.water should be filtered before it is supplied for washing through prefilter and then through sintered glass filters of 0.45 µm , to get rid of microorganisms and particles.
Automatic washing machines used contains series of jets over which containers are placed in inverted position and purified water is forced in the form of jet stream through needles which cleans inner surface of containers ,automatic washing machines may be rotary or conveyer type.
mostly detergent is not required , and if it is required example in hospitals for Large volume parantrals manufacturing a neutral detergent is used example sodium pyrophosphate.
2.Rinsing of Containers is done with water for injection which obviously which is free from pyrogen and microorganisms.
3.Drying is done as per below mentioned conditions which ensures the sterility as well as freedom from pyrogens
A. 180 ºC FOR 3 to 4 Hours
B. 269 ºC FOR 45 mins
C. 600 ºC for 1 mins
Filling of injectable dosage form
Is carried out by automated filling machines while feeling of injection liquid ,needle should not touch the wall of containers ,
There is a specification for net fill volume of a given injection in respective pharmacopoeia’s , the net extractable volume should be achieve , to attain that we have to fill little excess the volume of solution which should not exceed the prescribed limit in pharmacopoeias.
3.Sealing of injection containers and closures
Neck of ampoule is sealed by fusion by heating in flame , tip of ampoule’s is placed in oxidising flame and rotated and a capillary is gradually formed while pulling out and this is subsequently fuses .
In case of vials and large volume parenteral bottles are sealed by placing a rubber stopper , further this is sealed by means of a aluminium cap.
4.Leak Test for injectable dosage from ampoules :
Finally sealed ampules are tested for leaks by this test , the ampoules are placed in die solution of methylene blue and vacuum is applied for 1 min, the vacuum is released slowly and ampoules are allowed to stand in solution at atmospheric pressure .
If there are cracks leaks due to initial displacement of of air ,the coloured solution will enter the ampoule imparting blue colour to entire preparation.
Leak test can be done by making use of similar principle in autoclave , while the preparation is being terminally sterilised by using autoclave.
Materials used for Injection dosage form containers
1.Glass 2. PVC tubes for large volume parantrals.
Glasses are made of sand (Si o2 ) which is fused with metallic oxides (Na2O K2O,B2O )
Types of glasses
1.Type 3 Type III soda lime glass:-
Silica (Si o2 ) fused with Na2O ,CaO) .
These types of glasses leaches out lots of alkali from its surface hence it causes PH Change in pharmaceutical preparation hence are not preferred.
2.Type 2 Type II Surface treated with SO2 , sulfured glass:-
Surface of soda lime glass is treated by exposing containers to moist SO2 and heat at 500 ºC , this treatment causes neutralisation of surface alkali on glass
This glass is used in single dosage dry powder for injection by reconstitution .
3.Type 1 Type I Glass, neutral glass, borosilicate glass.
Type 1 glass is frequently preferred for injectable dosage form as this type of glass is made by fusing silica with Al2O3 and B2O3. Al2O3 is a amphoteric oxide and B2O3 is acidic so there is no leaching of alkali. This class of containers for injectables can be repeatedly autocalved .
For Large Volume parantrals PVC and PVDC plastic polymer containers are used which do not require any closers , they can be made as self sealable.
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