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).
____________________________________*______________________________________