Post00253 UNIJECT UPDATE 23 May 2000 CONTENTS 1. UNIJECT UPDATE 1. UNIJECT UPDATE Debbie Kristensen, PATH, has kindly posted an update on the UNIJECT a proprietary, auto-disable, prefilled device. It combines drug or biological, syringe, and needle packaged in a sealed foil pouch. UNIJECT technology was developed by PATH, extensively field tested, and was subsequently licensed to Becton Dickinson, a syringe manufacturer. Vaccines and pharmaceuticals will begin to appear in Uniject presentations this year. Extracts of this 8 page document are posted below. The complete update file: UnijectStatus2-2000.pdf is available for download from the web at: ftp://ftp.acithn.uq.edu.au/Technet/1-ClickHereForTECHNETfiles/Injection/ click on the file: UnijectStatus2-2000.pdf or send an email to: [[email protected]][email protected][/email] with the message: get technet UnijectStatus2-2000.pdf From: "Kristensen, Debra" To: sign moderator Subject: Uniject Update Date: Fri, 7 Apr 2000 I enclose a status report on the Uniject prefilled injection device. Please use as appropriate. Regards, Debbie Kristensen Technical Officer Program for Appropriate Technology in Health (PATH) 4 Nickerson Street, Seattle, WA 98109-1699 USA Telephone: (206) 285-3500; Fax (206) 285-6619 E-Mail: [[email protected]][email protected][/email]; PATH Web Site: http://www.path.org ___________________________________________________________________________ EXTRACTS OF: Status Report on the Uniject Prefilled Injection Device PATH (Program for Appropriate Technology in Health) 4 Nickerson Street, Seattle, WA 98109-1699 U.S.A. March 29, 2000 --- Table of Contents Status Report on the Uniject Prefilled Injection Device Uniject History Description of Uniject Rationale for Uniject Production Status Clinical and Field Experience with Uniject Ongoing Oxytocin-in-Uniject Studies Uniject Introduction Activities Vaccines Injectable contraceptives Uniject Introduction Issues Cost-effectiveness Cold Chain Storage Capacity Training Disposal The Future of Uniject --- UNIJECT HISTORY A decade ago, prefilled syringes were too costly for use in public-sector health programs, and no prefilled syringe on the market offered an auto- disable feature. With support primarily from the United States Agency for International Development (USAID) under the Technologies for Health (HealthTech) project, and input and technical assistance from the World Health Organization (WHO) and a multitude of other collaborators, PATH developed a proprietary, auto-disable, prefilled device known as Uniject. Today, the Uniject device is licensed to Becton Dickinson and Company (BD) for commercial production and distribution. This report provides an update to public-sector agencies on the status of Uniject. DESCRIPTION OF UNIJECT Uniject is a prefilled, single-dose injection device specifically designed to prevent attempts at reuse. It combines drug or biological, syringe, and needle packaged in a sealed foil pouch. Uniject devices are available in 0.25-, 0.5-, 1.0-, and 2.0-ml dose sizes and can be ordered with any standard needle size. RATIONALE FOR UNIJECT The Uniject device was designed with the following features in mind: * Single dose-to minimize wastage and facilitate outreach to individual patients. * Prefilled-to ensure that the correct dose is given, and to simplify procurement and distribution logistics. * Non-reusable-to minimize patient-to-patient transmission of blood- borne pathogens. *Easy-to-use-to allow self-injection and use by health workers who do not normally give injections, and to facilitate use in emergency situations. *Compact size-for easy transport and disposal. PRODUCTION STATUS BD produces Uniject devices in Singapore with a fully automated, high- volume production line and markets them globally to pharmaceutical companies through their regional sales offices. The process required for a pharmaceutical company to offer a drug or biological in Uniject devices is more complex than one might expect, and usually includes the following steps: 1. Identification and characterization of the potential market for the product; 2. Pilot fills of the drug or biological into Uniject devices using equipment loaned by BD; 3. Compatibility and stability testing of the Uniject/drug combination; 4. Clinical or user-acceptability studies (if required by the company or national regulatory authorities); 5. Identification and/or design of appropriate processing equipment to fill, seal, inspect, label, and package Uniject devices; 6. Purchase, installation, and validation of processing equipment; and 7. Completion of regulatory approval processes for the Uniject/drug combination. From start to finish, the process listed above can be expected to take a minimum of two to three years. Fortunately, at least 37 pharmaceutical companies are well into the process. The targeted drugs include vaccines, injectable contraceptives, uterotonics, and analgesics. Seventeen companies have already conducted pilot fills, and two have purchased processing equipment. The first commercial products in Uniject will become available in 2000. They include hepatitis B vaccine and tetanus toxoid from P.T. BioFarma (Indonesia), and Cyclofem injectable contraceptive from Aplicaciones Farmace?s (Mexico). ____________________________________*______________________________________
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