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Integrated Systems

Gravity transfer system

Rapid Mixer GranulatorThe most traditional yet the most robust system in Granulation suites which utilizes material handling system for product transfer. The system is particularly beneficial where the ingredients are dosed individually with good flow rate. The particles follows the integrated granulation track and hence results in minimal human intervention with qualitative improvement.

Multi-level transfer system

Downstream approach with smaller footprint every floor, this Suite best suited for much specialised operation where the ordered process is the requirement for larger capacity range. The equipments are integrated with each other through the levels with automated systems for automatic operation of the Suite. The particles follow the integrated granulation track with minimum travel distance to achieve and maintain the integrity of the process. Critical parameters like cleaning validation can be achieved easily.

Vacuum transfer system

Vacuum transfer suite is the Quick, direct & the most efficient system which utilizes vacuum system to transfer product. Equipments in the suite are Integrated with each other with special fitments to achieve and maintain the media(Vacuum) of material transfer which ensures shorter batch times & more productivity.

Documentation

Tapasya assures quality product with good documentation practices. In a cGMP environment documentation needs to meet certain requirements to ensure product quality and product safety. The cGMP regulations from FDA, PIC/S and EU all include mandatory sections on documentation.

Documentation provides both
  • Information on when, where, who, why, and how to complete tasks, and
  • Evidence proving that the tasks have been completed as they should be
Documents provide the information or evidence or may serve as an official record.
Drawings
  • Assembly and Erection Drawings
  • Equipment Support Drawings
  • Drawing of schematic and piping arrangements
  • Drawings for Air Handling Unit Instrument
  • Data sheets loop diagrams
  • General Assembly drawings
  • Electrical and Pneumatic drawings
  • Process & Instrumentation diagrams & necessary layouts
  • Final As-built Drawing
  • Contact surface area drawing
Certificates
  • Material of construction reports
  • Certificates for all direct / indirect product contact surfaces
  • Instrument calibration reports or certificates
  • Integrity test certificate
  • Guarantee / warranty certificates for the equipment and bought-out items
Operation manuals
  • Operation and maintenance manuals for the main equipment as well as all the bought out items
  • Operation and maintenance manuals for the major components Software ladder logic / operation and controls
  • Software manual
  • Instrument manual
  • Equipment manual and trouble shoot guide manuals
  • Interlock description flow charts for operation and maintenance
Protocols and qualification documents
  • Factory Acceptance Test protocols
  • Design Qualification
  • Installation Qualification
  • Operation Qualification
  • Installation instructions/ guidelines
  • Recommended SOP's for operation, cleaning and maintenance

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