slide-4-min.jpg

Turnkey

Home / Turnkey

TURNKEY PROJECTS

A TURNING POINT FOR BIOPHARMACEUTICAL INDUSTRY

We provide complete design, engineering, construction, start-up of new pharmaceutical facilities, even assisting the Clients through scouting activities of potential Know How Licensor, transferring the Know How, providing Validation Master Plans and Standard Operating Procedures, validating, aligning industrial processes to URS and regulatory requirements.

For more details about turnkey plants for IV Fluids and Parenteral Solutions, you can see, too: ivfluids-parenteralsolutions.com

For more details about BRAM-COR Turnkey project, please visit us at pharmaceutical-turnkey.com

To request information regarding turnkey projects, please write to: international@bram-cor.com

BRAM-COR QUALITY SYSTEMS

BRAM-COR activities are regulated by BRAM-COR Corporate Quality System and described in the Quality Manual, detailed by the relevant Standard Operating procedures. The following list defines main BRAM-COR certified Quality System Procedures and main Operating Instructions regulating Design, Construction, Testing and Project Managing activities, also for Turnkey Projects.

TURNKEY PLANTS MANUFACTURING PROCESS

The standards of good manufacturing practice (cGMP) require special attention to risk assessment and verification procedures: “… it is requirement of good manufacturing identify the activities of validation necessary to demonstrate control critical aspects of particular operations. The significant changes made to installations, equipment and processes, which may affect product quality, should be validated. A procedure for risk assessment should be used to determine the scope and extent of validation.” The Validation Master Plan serves to make sure that all equipment, procedures, that may affect the quality or integrity or effectiveness of the product, are validated; it contains the general principles which comply during the validation task, and plans activities to be carried out for this purpose.

BRAM-COR STANDARD STEPS 

1. Basic Engineering  2. Detailed Engineering  3. Design Qualification  4.Inlet Water Pretreatment Plant  5. Pharmaceutical Water Systems (Softened, Purified and Distilled Water) 6. Pharmaceutical Processing and Solution Preparation Systems  7. Pharmaceutical  Forming, Filling, Inspecting, Packaging lines   8. Clean Rooms  9. Epoxy coating of the floors  10. HVAC and air treatment plant  11. Autoclave  12. Pure Steam Generator and PS circuit  13. Laboratories of Analysis (Microbiological / Chemical)  14. Site Master Plan  15. Validation Master Plan  16. Installation  17. Training  18. Start up  19. Technical Files & Documentation  20. IQ/OQ  21. PQ Protocols  22. Validation at Site  23. Standard Operating Procedures  24. Initial Know How Transfer  25. GMP pre Audit  26. Spare parts for n years

BRAM-COR PROPOSES RELIABLE KNOW HOW & TECHNOLOGIES ABOUT:

  • LVP (Large Volume Parenterals) in PVC or PP bags 

  • LVP in Glass or Plastic Bottles 

  • SVP (Small Volume Parenterals) in Glass or Plastic Vials and Ampoules 

  • Pre-filled Syringes 

  • IV products (bags, glass and plastic bottles)

  • Blood bags (LVP bags in PVC)

  • Dialysis concentrate solutions and powders (Canisters, Bags, Cartridges)

  • Plasma Fractionation

  • Biotechnological Plants

  • Multipurpose Pharmaceutical Plants

BRAM-COR PERFORMS A TURNKEY PROJECT THROUGH:

  • Procurement of Licensors and Know  How Transfers

  • Conceptual Design and Design Qualification (DQ)

  • Detailed Engineering

  • Validation Master Plan & S.O.P.

  • Equipment Construction & Procurement

  • Factory Acceptance Test (FAT)

  • Shipment and Installation

  • Site Acceptance Test (SAT)

  • Standard & Validation Documentation (IQ/OQ/PQ Protocols)

  • Training

  • Commissioning, Calibration & Start up

  • Regulatory Suppor

theme-21.jpg

Turnkey plants for Dialysis

Sodium Bicarbonate, Peritoneal Dialysis, Isotopes of Calcium, Glucose, Dialysis Fluid, Hemodialysis, Lactic Acid, Peritonitis, Ultrafiltration,

theme-21.jpg

Turnkey plants for Dialysis

Sodium Bicarbonate, Peritoneal Dialysis, Isotopes of Calcium, Glucose, Dialysis Fluid, Hemodialysis, Lactic Acid, Peritonitis, Ultrafiltration,