Project Overview   Especially considering the current changes in the health care market place and emphasis on cost savings in the United States and throughout the world, the introduction of IVPC Facility will certainly revolutionize manufacturing and distribution of IV solutions for the estimated $4 billion to $5 billion only in U.S. alone. With current world demand being supplied almost exclusively by three major producers, the IVPC Facility™ will for the first time provide extremely efficient, low cost/high quality IV solution manufacturing on a local basis. With end users and reseller/distributors alike establishing local IVPC Facility™ manufacturing plants, the opportunity for cost savings (both in direct product costs and reduced freight charges estimated at 4% to 5% of total costs) and additional income from new profit centers will have major impact on individual institutions and purchasing organizations as well as the health care industry as a whole. IV Production Center (IVPC Facility) The IVPC Facility™ is a complete manufacturing facility for the production of solutions for parenteral (intravenous or intramuscular administration) medical requirements. The facility produces IV solutions from local water sources using blow/fill/seal (BFS) aseptic packaging which eliminates the ordering, shipping, storing, handling, cleaning and sterilization of pre-made containers. With its design incorporating a unique, free-standing class 1000 clean room and single-operation blow-fill-seal machine, the facility exceeds U.S. and international quality standards by factors of up to 3,000 percent, while producing product at unit costs of 45% to 65% less than current market pricing. For the first time, extremely efficient, low cost, high quality IV solutions manufactured on a local basis will be available to almost any country and locality. Turn-key Program EWMA provides an integrated, turn-key program for the IVPC Facility™, including site engineering, building structure, build-out, systems equipment, computer hardware, systems software, complete erection and installation, and operational training. In addition, EWMA personnel provide marketing assistance, training programs for local doctors and medical staff, and on-going quality assurance and technical and maintenance assistance as part of the comprehensive program. (Building structure may be deleted where not desired as part of the program.) Facility Constructed from a modular design, the facility is completely prefabricated for shipment to and erection at the selected site. Prior to construction and shipping, engineers from EWMA will visit the site to determine infrastructure capability, local resource availability and site-specific requirements. Modifications dictated by local conditions are thus made at the earliest possible stage to avoid duplication of effort, unnecessary engineering and the associated increases in cost. All segments of the manufacturing process are addressed in facility operations, including labeling, mixing, packaging, quarantined warehousing, inventory control, shipping and receiving. The patented, state-of-the-art production equipment integrates new automation, digital control and monitoring to guarantee the most effective and valid method of filling and packaging sterile pharmaceutical, biological and medical device products that is in total compliance with FDA, GMP and ISO9004 requirements. Standard IVPC facilities are available in two production sizes: a 6 million unit/year facility and an 12 million unit/year facility. The 12 million unit/year facility has the added advantage of incorporating two completely independent systems providing total production redundancy virtually eliminating downtime due to testing, maintenance/repairs, or product line changes. Product Diversity Using state-of-the-art technology, the IVPC facility can produce virtually any IV solution product in virtually any size aseptically-filled and terminally-sterilized medical grade plastic container. Standard molds based on local criteria and use are supplied with the initial facility equipment. Custom and specialty admixtures can be produced on a real time basis and delivered to facilities ready to hang, saving on site pharmacist/RN solution prep time under less sterile conditions than the IVPC facility clean room. Product expansion and diversification is simple and convenient. Each facility is, in essence a licensed pharmacy fully capable of dispensing a broad range of patient-specific drug combinations and dosages with the added safety and quality assurance associated with adherence to GMPs. Special pharmaceutical formulations of all dosage forms as well as admixes and delivery of TPN (Total Parenteral Nutrition) solutions and select IVPB (Intravenous Piggy-Back) antibiotics and chemotherapy follow from the initial IV solution product line. The IVPC facility is designed to implement large-scale preparation of prescriptions as well as to batch compound IND (Investigational New Drug) formulations on a non-patient-specific basis using exempt technician labor as opposed to more costly registered pharmacists. The operation combines the effencies of small-scale facilities batch admixing, and computer enhanced filling technologies to offer admixtures at pricing that allows substantial labor cost savings and local inventory reduction. Cost and Profitability The complete cost for a turn key IVPC Facility™ project starts at $8.75 million for minimum of 6 million units per year production output, and $14.5 million for minimum of 12 million units per year production capability. Site improvement expenses and costs of the recepticle building are not included. Costs and associated initial operating capital requirements allow for an extremely short return on investment (ROI) of only 2 to 3 years, depending on location and market variables. ROI is projected using very conservative figures and a realistic operational model of only two 8-hour shifts per day. With profitability typically being established at only 50% production capacity, IVPC purchasers have great latitude in improving both profitability and ROI by adjusting product mix and operational modes. Considering that the facility is capable of producing one U.S. domestic unit of an IV solution for $0.38-$0.412 (weighted average production cost for 8 most common solutions), production costs are 45% to 65% lower than current market pricing for simple IV solution primary lines. Secondary product line with significantly higher profit margins (compounded, specialty and custom IV solutions with market prices of up to $10 to $20 per unit) can be produced at any time to greatly enhance profitability while long distance shipping costs are eliminated within the target market area. Product Lines The IVPC Facility™ has the capability to produce all possible combinations of solution formulations, concentrations and volumes. Typical container volumes include 150ml, 250ml, and 500ml. 250ml and 500ml blow-fill-seal molds are included in the purchase price of the facility. Primary Product Line The primary product line of the facility is the simple IV solution which contains pure water for injection and low concentrations of carbohydrates and salts. While there are over 80 different solutions, typical formulations and concentrations include: • dextrose (2.5%, 5%, 10%, 20%) . fructose (5%, 10%) • sodium chloride (0.22%, 0.33%, 0.45%. 0.9%) • dextrose (2.5%, 5%, 10%) and sodium chloride (0.22%, 0.33%. 0.45%, 0.9%) Ringer solutions of sodium, calcium, and potassium chlorides (156mEq/L) • Lactated Ringer solutions adding sodium lactate (28mEq/L) • dextrose in lactated Ringer solutions multiple electrolytes (all combinations and concentrations) sodium lactate solution (167mEq/L) dextrose and fructose (various concentrations) Additional Product Lines The simple IV solutions discussed above, in addition to being administered alone, are also used as the base solvents for the administration of various medications in low concentrations. These medications include antibiotic drugs for use against infection and amino acids to provide total parenteral nutrition for patients who are unable to eat or digest food. Additional products include specialty solutions commonly required in specialty/tertiary care facilities or in advanced stages of disease, including cardioplegic solutions for heart surgery, medical-grade water solutions for burn victim treatment, and peritoneal dialysates for the care of advanced kidney disease. Other uses include treating infantile diarrhea, malaria and Deang fever. Very low-cost and highly profitable solutions are: Opthalmics Respritory Therapy Irrigation Lactated ringers Albuterol Prostaglandines Approved chemical entities Dilutants Emulsions Suspensions Antibiotics WFI Biologics 0.x% saline New chemical entities These higher profit margin products take advantage of the regional production capability of and are unique to the IVPC Facility™ . The profit potential outperforms that of the primary product line and, while these markets require cultivation and development within local areas, the early engagement of these markets provides the means to expand production facilities and profit margins at little risk.   back | top | next