Small volume injections are manufactured in single dose of 1ml., 2ml., 3ml., 5ml. or 10ml. filled in transparent or amber color virgin glass ampoules form and in multi dose of 2ml., 10ml., 20ml. or 30ml. filled in transparent or amber color virgin glass vials form. All liquid injections which have aqueous base are filled in U.S.P. type 1 glass ampoules or vials.
Pyrogen free water distillation
Pyrogens are metabolites which can be killed by different processes due to high temperature in multi column distillation plant. Pyrogen moves in a straight line and gets stuck to the top wall where steam gives first contact and continuous heating for 45 minutes kills the pyrogen. Multicolumn gives all these advantages to the distilled water available for injections.
Bacterial endotoxin is a similar type of requirement and a substituted test for pyrogen. The distillation water from multicolumn meets this requirement.
Small volume Injection preparation & filteration
The material is mixed before sealing in sealed containers as shown in the picture and filteration is done with pressure of nitrogen through membrane filter. The filtrate is collected in a closed vessel which is carried out for filling. The in process testing including PH checking, identification of the bulk drug and other parameters as per standard operating procedure is also performed.
Vials filling and sealing
The multi dose containers are filled and sealed in automatic filling and sealing machine.
Ampoules filling and sealing
The single dose container of injectable are filled and sealed in automatic filling and sealing machine.
LIST OF MACHINERY
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