| Quality Focus |
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The entire area for filtration, sterile API dispensing, as well as sterile corridor has Grade B environment though the regulations accept the provision of a lower class like Grade C for BFS processes |
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The facility has the provision of sterile compounding of API in pre filtered bulks. This gives the flexibility to make sterile suspensions without the need for in house sterilization of the API. Pre sterilized API can be used straight away. |
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The facility is designed for aseptic processing inclusive of flexibility for compounding of sterile API in pre filtered sterile bulk, we have a much better classification and hence a higher sterility assurance. |
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The actual results for all clean utilities like the purified water, WFI as well as Pure Steam are much better than the minimum stands prescribed. |
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| State-of-the-Art Technology |
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The entire set of critical equipments like the BFS machines (Weiler Engineering Inc., USA), terminal sterilizers (Fadegari Autoklaven AG, Switzerland ), leak testing machine (Wilco AG, Switzerland), Capping machine (Kaps-All Packaging Systems, USA), multi column distillation combo unit ( Aqua-Nova, Sweden) , water purification system (Christ Pharma & life sciences AG, Switzerland) etc. are all imported and have an excellent qualification package for each. |
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Excellent analytical laboratories with all required instrumentation like HPLCs, GCs, TOC analyzers (both on line and off line) etc. |
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All the transfer lines like those from bulk manufacturing to filtrate hold tanks as well as from filtrate hold to filling lines are (Clean in place / Steam in place)CIP/SIP enabled providing a much higher sterility assurance. |
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| Production Flexibility |
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For incubation, the entire rooms (for bacterial and Mold incubation) have been designed to act as incubators so that the large load especially during aseptic media fill can be safely handled. |
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The diversity in terms of presentations like the Injectable Vials, Eye Drops, Re-loseable units, etc. is probably the largest diversity available in India. |
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Fully modular rooms for all classified areas including those for manufacturing as well as microbiology. |
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An excellent and visually appealing ambience throughout the facility. |
