Containers and closures for injectable dosage form Processing of containers and closures for injection

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 , carbon dioxide and moisture and microorganisms, at the same time preventing the loss of volatile components from preparation of a injectable dosage form. Commonly used containers are ampoules for unit dosage form , Vials for multiple dosage and Bottles/Bags for large volume parenterals .

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 the content of injectable dosage form. 2.Containers and closures should not leach out its contents from surface into the product. 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 rigours of processing handling and shipping . 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 terminally sterilised injections. 1.Washing of containers 2.Rinsing 3.Dry heat sterilisation of containers 4. Filling 5. Sealing 6.Sterilisation Steps in processing for aseptically 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 an environment controlled area where particle count is controlled and is within 1000 class.Water used for washing is a purified water meeting the Pharmacopoeial standards.Water should be filtered before it is supplied for washing through prefilter and then through sintered glass filters of 0.45 m , 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 paranterals manufacturing, a nonionic detergent is used e.g. Teepol.

2.Rinsing of Containers is done with water for injection which obviously is free from pyrogens and microorganisms. 3.Drying is done as per below mentioned conditions which ensures the sterility as well as freedom from pyrogens A. 180 C FOR 3 to 4 Hours B. 269 C FOR 45 mins C. 600 C 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 achieved - to attain that we have to fill little excess than what is required as per the overages specified.

3.Sealing of injection containers and closures Neck of ampoule is sealed by fusion by heating in a flame , tip of the ampoule is placed in oxidizing flame and rotated and a capillary is gradually formed while pulling out which subsequently fuses and then is rounded. In case of vials and large volume parenteral bottles, they are closed by placing a rubber stopper , and then sealed by means of a aluminium cap.

4.Leak Test for injectable dosage from ampoules : Finally sealed ampules are tested for leaks, 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 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 an autoclave.

CHARACTERISTICGLASSPLASTICTRANSPARENCYHIGHLY AUTOMATED LEVEL CONTROL AND PROBLEM - FREE PARTICLE EXAMINATION MODERATE AUTOMATED TEST DIFFICULT UV-LIGHT PROTECTION GUARANTEED GUARANTEED STERILISABILITY THROUGH -200 C TO +500 C LYOPHILISATION, HOT-AIR STERILIZATION, GAMMA RAY IRRADIATION-20 C TO ? LYOPHILISATION POSSIBLE/CERTAIN CONDITIONS HOT AIR STERILIZATION NOT POSSIBLE GAMMA-RAY IRRADIATION POSSIBLE UNDER CERTAIN CONDITIONS.AGEINGCANNOT BE PROVEDDEPENDING ON STORAGE CONDITIONS(ENVIRONMENT, STERILISATION)COMPACTNESS (PERMEATION) ABSOLUTELY GAS-TIGHT PERMEABLE FOR GASESINTERACTION PACKING/CONTENTS (MIGRATION) KNOWN IF PRESENT, EASY TO REGULATEPRESENT DIFFICULT EXAMINATIONINTERACTION CONTENTS/PACKING (SORPTION) NEGLIGIBLEPRESENT (CHANGE IN THE CONCENTRATION OF THE AGENT) DISPOSAL RECYCLING POSSIBLE DOWN CYCLING POSSIBLE OUTER PACKING/TRANSPORT MEASURE AGAINST BREAKAGEPROTECTION AGAINST BREAKAGE NECESSARYPROTECTION AGAINST SCRATCHES AND EMBRITTLEMENT NECESSARYLETTERING/PRINTING/LABELLINGSCREEN PRINTING+LABELLING PROBLEM-FREELABELLING+RELIEF-PRINTING PROBLEM FREE.MECHANICAL STABILITY (SHORT-TERM COMPRESSIVE STRENGTH) GOODPARTIAL CRITICAL EXPERIENCE WITH THE MATERIAL VERY HIGHLOW

CONCLUSION: AS COMPARED TO PLASTICS GLASS HAS DISTINCT ADVANTAGES IN 1) TRANSPARENCY 2) AGEING 3) LEACHABILITY 4) PERMEABILITY 5) STERILISABILITY BY AUTOCLAVING AND DRY HEAT STERILIZATION.