Together with our global partners, we are proud to offer the complete design, engineering, start-up new pharmaceutical facilities, transferring the Know How, providing Validation Master Plans and Standard Operating Procedures, validating, aligning industrial processes to URS and regulatory requirements.
We propose reliable know-how & technologies about:
² LVP(Large Volume Parenterals) in PVC or PP bags
² LVP in Glass or Plastic Bottles
² SVP(Small Volume Parenterals) in Glass or Plastic vials and ampoules
² Pre-filled Syringes, nested vials and cartridgies
² Biotechnological Plants
² Multipurpose Pharmaceutical Plants
We perform a turnkey project through:
Ø Procurement of Licensors and Know How Transfers
Ø Conceptual Design and Design Qualification (DQ)
Ø Detailed Engineering
Ø Validation Master Plan & S.O.P
Ø Equipment Construction & Procurement
Ø Factory Acceptance Test(FAT)
Ø Shipment and Installation
Ø Site Acceptance Test(SAT)
Ø Standard & Validation Documentation (IQ/OQ/PQ Protocols)
Ø Training
Ø Commissioning, Calibration & Start up
Ø Regulatory Support
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