WHAT WE OFFER
Complete facilities to produce IV Fluids and Parenteral Solutions both in Small (SVP) and in Large (LVP) volumes in standard or even modular configuration with capacities from 500 upto 24.000 pcs/h.
BRAM-COR is considered as world leader for small-mid size IVF projects but kindly note we have a solid experience on more sophisticated project such as: Blood Bags, Plasma Fractionation, Vaccines, Oncologic Drugs, Orals Solid and Semisolid projects for Generics, Insulin. 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, TPN (Total Parenteral Nutrition), SPECIAL SOLUTIONS
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
Paracetamol
Plasma Expanders
Mannitol
Lidocainje hydrochloride 0.4% and glucose 5%
Sodium bicarbonate 1.26 – 4.2%
Phosphate IV solution
Metronidazole
Ciprofloxacin
Levofloxacin
Fluconazol
FROM DESIGN TO VALIDATION, WE ARE ALWAYS CLOSE TO THE CUSTOMER
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.
BRAM-COR TURNKEY FOR IV FLUIDS AND PARENTERAL SOLUTIONS / STANDARD STEPS
√ Basic Engineering √ Detailed Engineering √ Design Qualification √ Inlet Water Pretreatment Plant √ Pharmaceutical Water Systems (Softened, Purified and Distilled Water) √ Pharmaceutical Processing and Solution Preparation Systems √ Pharmaceutical Forming, Filling, Inspecting, Packaging lines √ Clean Rooms √ Epoxy coating of the floors √ HVAC and air treatment plant √ Autoclave √ Pure Steam Generator and PS circuit √ Laboratories of Analysis (Microbiological / Chemical) √ Site Master Plan √ Validation Master Plan √ Installation √ Training √ Start up √ Technical Files & Documentation √ IQ/OQ √ PQ Protocols √ Validation at Site √ Standard Operating Procedures √ Initial Know How Transfer √ GMP preAudit √ Spareparts for n years
