• Bram-Cor turnkey equipment and plants for biopharmaceutical industry
  • Bram-Cor Pharmaceutical systems - Training- Human resources management
  • Bram-Cor Pharmaceutical technologies - turnkey services
  • Bram-Cor Pharmaceutical turnkey plants - site installation
  • Bram-Cor Pharmaceutical plants - site installation
  • Bram-Cor Pharmaceutical turnkey plants - site installation
  • Bram-Cor Pharmaceutical turnkey - projects and services
  • Bram-Cor Pharmaceutical Equipment - Site Installation
  • Bram-Cor Technologies - Turnkey Projects and Plants
  • Bram-Cor Technologies - Turnkey Pharmaceutical Projects and Plants
  • Bram-Cor Technologies - Turnkey Projects and Plants

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.

 

Activity

Procedure

Title

Design

PO 73_01

Design Management

Purchase

PO 74_01

Purchase Management

PO 74_02

Supplier’s Assessment

Production and Installation

PO 75_01

Job Management

PO 75_02

Customer’s Properties

PO 75_03

Assistance

PO 75_04

Identification and Traceability

PO 75_05

Process Control

PO 75_06

Delivery and Commissioning

PO 75_08

Machines Construction

PO 75_09

Sanitary Piping

PO 75_10

Technical Documentation

Inspection & Monitoring

PO 76_01

Measuring Instruments Management

PO 83_01

CAPA Management

 

 

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.

Below: a  typical process flow-chart for infusional bags production

Diagram Flux - BRAM-COR IV Solutions Plant

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  FormingFillingInspectingPackaging 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


 

Turnkey plants for Dialysis

Sodium Bicarbonate, Peritoneal Dialysis, Isotopes of Calcium, Glucose, Dialysis Fluid, Icodextr., Hemodialysis, Lactic Acid, Peritonitis, Ultrafiltration, ….
Read all

Turnkey Plants for IV Fluids

We allow the new, small or mid-positioning brands to obtain ...
Read all