• Bram-Cor Pharmaceutical Technologies - Turnkey Plants for IV Bags
  • Bram-Cor Pharmaceutical Technologies - Turnkey Plants for LVP Bags
  • Bram-Cor Pharmaceutical Technologies - Turnkey Plants for IV Fluids and Parenteral Solutions
  • Bram-Cor Pharmaceutical Technologies - Turnkey Plants for IV Fluids and Parenteral Solutions
  • Turnkey Plant for IV Fluids and Parenteral Solutions
  • Bram-Cor Pharmaceutical Technologies - Turnkey Plants for IV Fluids and Parenteral Solutions
  • BRAM-COR IV FLuids- Large Volume Parenterals
  • Bram-Cor Pharmaceutical Technologies - Commissioning - SCADA control system
  • Bram-Cor Processing Systems - Formulation and preparation for pharmaceutical plants
  • Bram-Cor Pharmaceutical Equipment - Turnkey Plants for IV Fluids and Parenteral Solutions
  • Bram-Cor Pharmaceutical Technologies - Turnkey Project
  • Bram-Cor Turnkey Plant for Blood Bags
  • Bram-Cor Processing Systems - LVP Large Volume Parenteral production
  • BRAM-COR turnkey project for parenteral solutions
  • Bram-Cor Processing and Filling Systems - LVP Large Volume Parenteral production
  • Bram-Cor Technologies - Pharmaceutical Processing Systems - Training session
  • BRAM-COR IV FLuids Turnkey Project

Turnkey plants for Dialysis

WE ARE AN IMPORTANT PARTNER FOR A SO SPECIFIC SECTOR

Sodium Bicarbonate, Peritoneal Dialysis, Isotopes of Calcium, Glucose, Dialysis Fluid, Icodextrin, Hemodialysis, Lactic Acid, Peritonitis, Ultrafiltration, …. These are clear terms for pharmaceutical companies that need to manufacture or intend to innovate dialysis products.

We offer complete facilities to produce Products for Haemodialysis and Peritoneal Dialysis. Note that in several cases these manufacturing lines are installed in devoted areas of Intravenous Solutions Projects. See also the related page in this web site: Tunkey Plants for IV Fluids

Is really clear the benefit of BRAM-COR "turnkey strategy" about this critical area, that is the production of Dialysis concentrate solutions. We allow the new, small or mid-positioning pharmaceutical brands to obtain a concrete return in term of investments and products marketing, thanks to the great support we offer in WFI, IV Fluids, LVP, SVP production parameters, for the best useful choices. This promise is certainty corroborated by BRAM-COR knowledge in engineering, manufacturing and validation services.

BRAM-COR Parenteral Solutions - Dialysis Turnkey Plant

Our company is considered in effect as world leader for small-mid size IV projects, but kindly note we have a solid experience on more sophisticated project such as: Blood Bags, Plasma Fractionation, Vaccines (our machines currently operate with prestigious pharmaceutical brands engaged in research against covid-19), Oncologic Drugs, Orals Solid and Semisolid projects for Generics, Insulin (see also: pharmaceutical-turnkey.com).

To request information and quotes on BRAM-COR strategies regarding turnkey plants for IV Fluids and Parenteral solutions, please write to: international@bram-cor.com
 

Below: detail of the lay out of a factory for the production of Dyalisis concentrate solutions built by Bram-Cor

Dialysis Solutione Lay Out-Bram-Cor Italy.

 

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

 

DIALYSIS CONCENTRATE SOLUTIONS MANUFACTURING EQUIPMENT

Thanks to a fruitful experience in many branches of making pharmaceuticals, BRAM-COR has matured a coherent path, able to face meaningful business opportunities for customers who wish to diversify or set up production lines of Dialysis solutions, both for bags and for canister, within turnkey or segmented projects.

 

Our specific knowledge begins from raw water and from its transformation into a basic element for the pharmaceutical process, with a trouble-free production stages in storage and distribution, processing and filling. This holistic vision is a key strategy to obtain flexibility, efficiency and convenience in small or large volume parenterals, and in a wide range of products, including dialysis systems.

Bicarbonate is the principal buffer used in dialysate. Producing bicarbonate dialysate requires a specifically designed system that mixes a bicarbonate concentrate and an acid concentrate with PW (Purified Water). This is why it is so important to start from an excellent vision of pretreatment and water treatment, aspects for which Bram-Cor is certainly the world leader.

During the mixing procedure, the acid in the acid concentrate will react with an equimolar amount of bicarbonate to generate carbonic acid and carbon dioxide. The final concentration of bicarbonate in the dialysate is generally fixed in the range of 33–38 mmol/L. Peritoneal Dialysis solutions whose composition more closely mirrors physiologic conditions in terms of pH, osmolality, osmotic agent, manufacturing-induced breakdown products of osmotic agents, and buffer are generally considered “biocompatible” PD solutions.

In Bram-Cor turnkey is considered the production of more “biocompatible” PD solutions employing alternative osmotic agents (e.g., amino acids), buffers (e.g., lactate/bicarbonate or pure bicarbonate), and dual-chambered containers to reduce GDP content.

 

Among the many dialysis concentrae solutions and products:


DIALYSYS SOLUTIONS

Priming Solution
Haemodialisys Concentrate
Pre-mixed Heparin

DIALYSIS FORMS

    Canisters
    Bags
    Multichamber bags
    Cartridges

DIALYSIS PRODUCTS

    3.4 / 5 L  Diacetate bags
    5 /  8  / 10 L Diacetate and Bicarbonate canisters
    CAPD bags
    Bicarbonate cartridges
    Priming bags
    Multichamber bags

In our turnkey offers we usually exlude those items that can be procured locally at reasonable prices by the customer itself (like land, buildings, black utilities, ...). Of course we therefore provide, on demand : 

- Advanced Know How Transfer for additional IV solutions, TPN, etc. - Post-Start up assistance - Raw Materials and Consumables - Black Utilities