Sodium Bicarbonate, Peritoneal Dialysis, Isotopes of Calcium, Glucose, Dialysis Fluid, 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.
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: firstname.lastname@example.org
Below: detail of the lay out of a factory for the production of Dyalisis concentrate solutions built by Bram-Cor
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. Startup 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
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.
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, ...). Following an explicit request from our customer we are able to provide:
- Advanced Know How Transfer for additional IV solutions, TPN, etc. - Post-Start up assistance - Raw Materials and Consumables - Black Utilities