It's really clear the benefit of BRAM-COR "turnkey strategy" about this critical area, that is the production of IV 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, Eye drops and Ointments, Oncologic Drugs, Orals Solid and Semisolid projects for Generics, 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: firstname.lastname@example.org
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 parenteral solutions, both for bags and for bottles, within turnkey or segmented projects. Our specific knowledge begins from 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:
- STANDARD IVF & ELECTROLITES - DIALYSIS SOLUTIONS - TPN (Total Parenteral Nutrition) - SPECIAL SOLUTIONS
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
As a matter of fact BAGS are worldwide recognized as better quality than traditional BOTTLES. These are some key factors:
Since bottles are mostly made in HDPE (polyethylene) which:
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.
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
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, with no exception.
The product, anyway, must be free from pyrogenic contamination.
All the injectable solutions must be free from visible particulate 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 drugs co-administered.
- 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%
- Priming Solution
- Haemodialisys Concentrate
- Pre-mixed Heparin
- Fat Emulsion
- Plasma Expanders
- Lidocainje hydrochloride 0.4% and glucose 5%
- Sodium bicarbonate 1.26 – 4.2%
- Phosphate IV solution
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 for 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, large volume parenterals. 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 -tipically 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, as EP or JP.
Large-volume parenteral (LVP) -or, simply, LVPs- are sterile preparations of 250 ml or greater that are administered parenterally. The most common LVPs are IV solutions compounded from a standard/base solution, such as 0.9% sodium chloride (known as NS, too), dextrose 5% in water (D5W), dextrose 5% in normal saline (D5NS), and Lactate Ringer (LR) solution.
These IV solutions can be administered as either a continuous infusion or a drip; a continuous infusion—also called a maintenance infusion, replacement infusion, or hydration infusion—typically consists of a base solution with additives; unlike continuous infusions, drip solutions are used to continuously deliver an IV medication to treat a specific medical condition. Note that the most common volumes for LVPs are 250 ml, 500 ml, and 1000 ml, but BRAM-COR design can generate turnkey projects for any size, up to 5000 ml for bags or canister.
According to reference pharmacopoeias, 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.