Middle Eastern Project Overview
Regency Health and partners will design and build turn key a continuous intravenous solutions production system to be located in the Middle East.
The project includes:
Þ Production equipment for a 16 million, ½-liter bag per year continuous, automated IV production line; WFI production through sterilized, ready-to-ship, finished product.
Þ The automated, continuous IV production line will be rated for 24 hours per day and 8,000 hours per year operation.
Þ The IV production system will be capable of producing an array of IV solutions in common use by the Middle East
Þ The intravenous solution production line will be built to conform to all applicable US FDA cGMP and US Pharmacopoeia requirements.
Local Solutions Production Benefits to Client:
Builds an advanced medical technology base
Generates skilled local employment
Ensures a secure source of high-quality solutions
Reduces dependence on imports
Can generate foreign exchange through exports
Provides a base upon which more advanced products can be added
and maybe most importantly, can be a highly profitable business
Proposed IV Solution Project:
Produce Large Volume Parenterals 250ml to 1000ml
Produce basic IV solutions
Advanced non-PVC flexible bags
Produce 8 million bags per year with 2-shift (4,000 hour) production, or 16 million bags per year with 4-shift (8,000 hour) production.
Use state-of-the-art, automated, continuous production technology from IV Solutions in the United States.
Regency Health and partners present IV-dialysis and other pharmaceutical solution production systems.
Our partner has invented continuous IV solution production technology in 1993.
Today we provide continuous technology, automated batch and manual batch technology.
Deliver systems with various container designs:
Þ Non-PVC flexible bags
Þ PVC flexible bags
Þ Blow-molded rigid/semi-rigid bottles
Þ Complete Turn-key Solution Systems from
Þ 8-64 million bags per year.
Water pre-treatment / Continuous WFI production
Continuous solution blending
Bag making and filling
Training and installation supervision
Validation and quality protocols / Regulatory expertise
Specialized engineering / Technical support
Start-up assistance / Facility specs
Who is IV Solutions?
Founded by professionals from Baxter and Xytel to apply continuous chemical production technology to medical solutions.
IV Solution’s technical team has applied decades of experience with computer-controlled, automated, continuous production in the chemicals, specialty chemicals and foods industries to the special needs and demands of sterile pharmaceutical production.
Technical team built the first continuous peritoneal dialysis production unit for Baxter.
IV Solutions Team Professionals have decades of Experience in:
Medical Solutions Production
Super Pure Water Production
Drawn from leading organizations:
Johnson & Johnson
Breadth of Experience
The members of the IV Solutions team have been responsible for the design and fabrication of over 600 pharmaceutical, solutions, chemical and specialty chemical production systems around the world
The team has experience in a broad array of advanced process technologies.
Pharmaceuticals / Fine chemicals
Peracetic Acid, Autoclave,
Electron beam, and
Vitamins and Ibuprofen
Lactic Compound Processes
Medical Tapes and Adhesives
Sorbitols and Edible Polyolefins
Supercritical Caffeine and Botanicals Extractions
High-pressure Enzyme Reactions
Superfine Psyllium for Solutions
The team holds over 20 process and medical device patents
Continuous chemical production
IV bag design
Managed Baxter IV and Dialysis Production Facilities
Introduced E-Beam sterilization into Baxter
For both IV devices and IV solutions
Managed Baxter’s Advanced Sterilization Technology Group
Managed FDA affairs for American Hospital Supply and Baxter
Worked for US FDA
Managed Baxter’s Advanced Technology Sourcing Group
Consultants to the FDA on advanced and future technology
IV Technical Team Member Clients Worldwide:
Air Products and Chemicals
Akzo Chemie America
Amoco Technology Company
Archer Daniels Midland
Corn Products Company
Dow Chemical Netherlands
Golden Technologies, Coors
Griffith Microscience Int'l
Panasonic US & Japan
Proctor & Gamble
Rohm & Haas
Saudi Royal Family
S. C. Johnson & Sons