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TURNKEY

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TURNKEY PLANTS FOR DIALYSIS PRODUCTS

IV FLUIDS MANUFACTURING EQUIPMENT

The production of IV solutions represents the principal provided by BRAM-COR’s “Turnkey projects”. This service ensures small or medium size pharmaceutical brands to reach concrete investment & product marketing returns through our support offered in plants specialised in water for injection (WFI), intravenous fluids (IVF), large volume parenterals (LVP), small volume parenterals (SVP) and production parameters. This service is corroborated by BRAM-COR’s extended knowledge in engineering, manufacturing and validation processes.

Our company is considered as the world leader for small to medium size IV projects. Nevertheless, note that our expertise also ranges to more sophisticated project such as: Blood Bags, Plasma Fractionation, Vaccines, Eye drops and Ointments, Oncologic Drugs, Orals Solid and Semisolid projects for Generics and Insulin. See also: pharmaceutical-turnkey.com, ivfluids-parenteralsolutions.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

A COHERENT PATH FOR YOUR BUSINESS OPPORTUNITIES

Thanks to fruitful experiences in many different branches of pharmaceutical industries, BRAM-COR has matured a solid expertise, enabling our customers to diversify or set up production lines of parenteral solutions, both for bags and for bottles, within turnkey or segmented projects.
We ensure flexibility, efficiency and convenience in small or large volume parenteral, and in a wide range of products:

- STANDARD IVF & ELECTROLITES - DIALYSIS SOLUTIONS - Total Parenteral Nutrition (TPN) - SPECIAL SOLUTIONS

Our turnkey offers do not usually include aspects of the project which can be procured directly by the customer, such as land, buildings, black utilities etc.

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

PONDERING THE MARKETS

BAGS are known to be more suitable for pharmaceutical outcomes than BOTTLES, due the following reasons:
•    Bags enable many more liquid capacity formats, from 50 up to 5000 ml;
•    Bags allow to have two independent ports;
•    Bags are easier & cheaper to transport;
•    Bags do not require air vented giving sets (which are compulsory for BOTTLES and involve a risk of contaminating the solution, as all vented giving sets are made in          China);
•    Bottles are mostly made in HDPE (polyethylene) which:

•    Does not stand 121°C during sterilization
•    Permits the solution to evaporate, therefore does not comply with the solution concentration

IV FLUIDS MANUFACTURING PROCESS

The standards of good manufacturing practice (cGMP) require special attention related to risk assessment and verification procedures: “… it is a requirement of good manufacturing to identify the activities of validation necessary to demonstrate the control of critical aspects of specific operations. Significant changes applied to installation, equipment and processes should be validated, as they could affect the quality of the product. A procedure for risk assessment should be utilised to determine the scope and extent of validation.”

The Validation Master Plan serves to ascertain that all the equipment and processes 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

WHAT KIND OF PHARMACEUTICAL PRODUCTS?

Parenteral drugs are formulated as solutions, suspensions, emulsions, liposomes, microspheres, nanosystems, and powders to be reconstituted as solutions. Parenteral dosage forms are different from any other type of pharmaceutical products for some characteristic values:

  • The final products must be sterile;

  • The product must be free from pyrogenic contamination;

  • All the injectable solutions must be free from visible matter;

  • All products must be chemically, physically and microbiologically stable throughout the whole shelf life.

Naturally, parenterals dosage forms must be compatible, whether applicable, with intravenous diluents, delivery systems, and co-administered drugs.

STANDARD IVF & ELECTROLITES

- NaCl 0,18 – 2.7%

- Glucose 2,5 - 50%

- Sodium Lactate (Hartmanns’s) Solution

- Ringer Lactate

- Water for injection

- Sterile Water for Irrigation

- Sodium Chloride 0.9% for irrigation

- Sodium Chloride 0.18 – 0.45% and Glucose 4 – 10 %

- Potassium Chloride  0.15 – 0.3% in Sodium Chloride 0.9%

- Potassium Chloride  0.15 – 0.3% in Glucose 5%

TPN (TOTAL PARENTERAL NUTRITION)

- Aminoacids

- Fat Emulsion

SPECIAL SOLUTIONS

- Paracetam.l

- Plasma Expanders

- Mannit.l

- Lidocainje hydrochloride 0.4% and glucose 5%

- Sodium bicarbonate 1.26 – 4.2% 

- Phosphate IV solution

- Metronidaz.le

- Levoflox.cin

- Fluconaz.l

ABOUT CSP PRODUCTS

Maintaining the correct level of fluid and electrolytes within the body (homeostasis) is crucial for life. When some conditions influence normal fluid intake and output, the body may be at risk of dehydration.

The fast method of rehydration is through the injection of parenteral solutions into the body supply. The large majority of Compounded Sterile Preparations (CSPs) set by IV technicians are LVPs. Because these products are administered directly into the human blood supply, the solutions must possess certain chemical properties that render them safe for the patients. For example, the human blood plasma has a pH of 7,4 (slightly alkaline) and this value must be maintained for optimum health. In this regard, some facilities inject a buffer solution into the CSP, such as sterile sodium bicarbonate, to neutralize the pH and inhibit misaligned values.


The isotonic property means that the CSPs have relatively the same number of dissolved particles and the same osmotic pressure as human blood plasma (conversely: Hypertonic solutions -typically TPN- contain a greater number of dissolved particles; Hypotonic solutions contain fewer dissolved particles). In light of potential hazards, CSP preparations must be in adherence to USP Chapter Guidelines (Pharmaceutical Compounding - Sterile Preparations) or other reference pharmacopoeias, such as Ph. Eur. or JP

IV SOLUTIONS: LARGE VOLUME PARENTERALS

Maintaining the correct level of fluid and electrolytes within the body (homeostasis) is crucial for life. When some conditions influence normal fluid intake and output, the body may be at risk of dehydration.

The fast method of rehydration is through the injection of parenteral solutions into the body supply. The large majority of Compounded Sterile Preparations (CSPs) set by IV technicians are LVPs. Because these products are administered directly into the human blood supply, the solutions must possess certain chemical properties that render them safe for the patients. For example, the human blood plasma has a pH of 7,4 (slightly alkaline) and this value must be maintained for optimum health. In this regard, some facilities inject a buffer solution into the CSP, such as sterile sodium bicarbonate, to neutralize the pH and inhibit misaligned values.


The isotonic property means that the CSPs have relatively the same number of dissolved particles and the same osmotic pressure as human blood plasma (conversely: Hypertonic solutions -typically TPN- contain a greater number of dissolved particles; Hypotonic solutions contain fewer dissolved particles). In light of potential hazards, CSP preparations must be in adherence to USP Chapter Guidelines (Pharmaceutical Compounding - Sterile Preparations) or other reference pharmacopoeias, such as Ph. Eur. or JP

IV SOLUTIONS: LARGE VOLUME PARENTERALS

According to reference pharmacopoeias, a Small Volume Parenteral (or SVI - Small Volume Injection) is an injection that is packaged in containers labelled as containing not more than 100 ml. Under the class of SVP/SVI there are, consequently, all the sterile products packaged in vials, ampoules, cartridge, syringes, bottles (or any other container that is 100 ml or less). Ophthalmic products packaged in squeezable containers, although topically applied to the eyes (and not administered by injection), also fall under Small Volume Injections (SVI) classification.

Small volume parenteral products can be formulated and packaged in several ways and include a wide range of products like biological products, allergenic extracts, liposome and lipid products, radiopharmaceutical products, genetically engineered or biotechnology products, … The injection is a preparation intended for parenteral administration and/or diluting/constituting a parenteral. Examples of preparations: drug injection, injectable emulsion, injectable suspension; drug for injection, drug for injectable suspension.

DIALYSYS SOLUTIONS

See related page in this web site: Turnkey Plants for IV Fluids