Project Objective:

 

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

              Normal saline

              Dextrose

              Lactated Ringers

             Others

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

Sterilization

Clinical lab

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

Pharmaceuticals

Chemical Engineering

Chemistry

Sterilization

 

Drawn from leading organizations:

 

Baxter

Hollister

Johnson & Johnson

3M

US FDA

Xytel-Bechtel

Xytel Corporation

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.

Medical Solutions

Pharmaceuticals / Fine chemicals

Sterilization

               Peracetic Acid, Autoclave,

               Electron beam, and 

               Ethylene Oxide

Vitamins and Ibuprofen

Lactic Compound Processes

Medical Tapes and Adhesives

Sorbitols and Edible Polyolefins

Crystalline Fructose

Membrane Separations

Supercritical Caffeine and Botanicals Extractions

High-pressure Enzyme Reactions

Perfumes

Superfine Psyllium for Solutions

Fats Purification

Fungicides

Lyophilized Fats

 

The team holds over 20 process and medical device patents

     -continuous chemical production

     -IV bag design

     -automated pharmacy

 

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:

 

A.E. Staley

Air Products and Chemicals

Akzo Chemie America

Amoco Technology Company

Archer Daniels Midland

American Cyanamid

Baxter Healthcare

Bayer, Germany

Celanese

Corn Products Company

Dow Chemical

Dow Chemical Netherlands

DuPont

Essences SRL

Golden Technologies, Coors

 

Griffith Microscience Int'l

Henkel, Germany

Hercules

Hoechst Celanese

ICI Holland

Merck Pharmaceuticals

Nutrasweet Co.

Panasonic – US & Japan

Pfizer

Proctor & Gamble

Rohm & Haas

Saudi Royal Family

S. C. Johnson & Sons 

Toray

3M

 

 




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