Navigation Links
Unilife Successfully Completes Industrialization of Unifill Syringe
Date:6/29/2011

itized prefilled syringes currently being marketed by incumbent device manufacturers. Our Unifill technology platform can deliver a unique competitive edge to pharmaceutical companies that are marketing their injectable drugs within increasingly crowded therapeutic markets."

Over the past eighteen months, Unilife has executed an extensive and rigorous verification and validation plan, a required step in the industrialization of medical devices, to ensure that the Unifill syringe is ready for commercialization. The verification and validation processes are designed to meet the requirements of Unilife's Quality Management System (QMS), which sets a high standard in the medical device industry.  The successful completion of these verification and validation steps by Unilife clears the path for the Unifill syringe to be shipped to pharmaceutical customers.  

Upon the receipt of the Unifill syringe, pharmaceutical companies will typically conduct drug compatibility and stability studies in which their injectable drugs or vaccines are tested in combination with the device. The resulting data is filed as the last step in completing the regulatory process for the drug-device combination product.  This step is typically followed by the pharmaceutical company building up inventory of the drug-device combination in anticipation of commercial launch.

One of the key components of Unilife's strategy is product quality.  Unilife has developed and implemented a best-practice QMS that adheres to the highest industry standards, including the FDA's Quality System Regulations and ISO 13485:2003. Unilife's QMS governs all product development and manufacturing activities to ensure the quality, reliability and functionality of its products.  The QMS is further enhanced by full integration with Unilife's SAP Enterprise Resource Planning [ERP] system, ensuring the highest level of quality and accuracy across its entire supply chain.

Ab
'/>"/>

SOURCE Unilife Corporation
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. Unilife Hosts White House Business Council Meeting
2. Unilife to Present at the 2011 Jefferies Global Healthcare Conference in New York City
3. Unilife to Present at the 2011 UBS Global Specialty Pharmaceuticals Conference in London
4. Unilife Announces Financial Results for the Third Quarter of Fiscal 2011
5. Unilife Corporation to Announce Financial Results for Fiscal 2011 Third Quarter on Monday, May 16, 2011
6. Unilife to Present at the 36th Annual Deutsche Bank Health Care Conference on Monday, May 2, 2011 in Boston
7. Unilife Announces Chairmans Letter to Shareholders
8. Unilife Realigns Operations to Drive Sales and Support Commercial Production of Unifill Syringes
9. Unilife Commences Initial Production of Unifill Prefilled Syringe
10. Unilife COO Makes Open Market Purchase of Approximately $250,000 in Companys Publicly Traded Shares
11. Unilife CEO Makes Open Market Purchase of A$500,000 in Companys Publicly Traded Shares
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/22/2014)... Dec. 22, 2014 TWi Biotechnology, Inc., ... Allowance for AC-201, TWi Biotechnology,s lead drug candidate, ... China for patent application numbered ... acceptable salts, active metabolite for treatment of type ... of treatment using AC-201 for type II diabetes, ...
(Date:12/19/2014)...  Advanced Medical Isotope Corporation ("AMIC") (OTCQB:  ADMD), ... the development of brachytherapy devices and medical isotopes ... a Life Sciences Discovery Fund (LSDF) Proof of ... is the commercialization partner.  The award was made ... titled "Optimized Injectable Radiogels for High-dose Therapy of ...
(Date:12/19/2014)... , Dec. 19, 2014  Monarch America Inc. ... Kinetics Corp.) is pleased to provide this review of ... growth in 2015. "Over this past year, ... and I am extremely proud to say that Monarch ... today than it has ever been," stated Eric ...
Breaking Medicine Technology:TWi Biotechnology Receives Notice of Patent Allowance for Its Lead Drug Candidate AC-201 for the Indication of Type II Diabetes in China 2TWi Biotechnology Receives Notice of Patent Allowance for Its Lead Drug Candidate AC-201 for the Indication of Type II Diabetes in China 3Advanced Medical Isotope Corporation Awarded LSDF Grant As Commercialization Partner 2Advanced Medical Isotope Corporation Awarded LSDF Grant As Commercialization Partner 3Monarch America Inc. CEO Reviews Recent Achievements and Provides Outlook for 2015 2Monarch America Inc. CEO Reviews Recent Achievements and Provides Outlook for 2015 3
(Date:12/22/2014)... Physicians in China are most eagerly ... of non-Hodgkin’s lymphoma (NHL), according to a new report ... consulting firm. MabThera is the only biologic available to ... form of NHL. , According to Kantar Health’s report, ... of NHL in China has been growing and is ...
(Date:12/22/2014)... 2014 Give a loved one the ... of health and vitality. , For a limited time, ... anti-aging formulas in special Holiday Wellness gift packages at ... , Each bottle contains cutting-edge, proven nutritional support for ... as well as we age. , Joint ...
(Date:12/22/2014)... Austin, Texas (PRWEB) December 22, 2014 ... hustle and bustle of Black Friday shopping and opted ... publishing and marketing education company, for their 5th annual ... Marketer charged just $7 to attend the 5 ... sales that they promptly donated to support two Central ...
(Date:12/22/2014)... 22, 2014 NAPW honors ... Woman of the Year. She is recognized with this ... most recognized networking organization of professional women in the ... Association of Professional Women is a vibrant networking community ... , Ms. Kreider is passionate and committed to best ...
(Date:12/21/2014)... In this report, the global powered ... product, and application. The market, by power source, ... By product, the market covers the handpieces; power ... market is further subdivided into drills, saws, reamers, ... shavers, wire/pin drivers, and others. Moreover, the power ...
Breaking Medicine News(10 mins):Health News:Physicians in China See Most Significant Demand for MabThera Biosimilar 2Health News:Physicians in China See Most Significant Demand for MabThera Biosimilar 3Health News:You Still Have Time to Give the Gift of Health and Vitality to a Mature Loved One 2Health News:Austin Company Digital Marketer Raises 100K to Fight Childhood Cancer 2Health News:Austin Company Digital Marketer Raises 100K to Fight Childhood Cancer 3Health News:National Association of Professional Women Announces Cheryl A. Kreider, President / CEO of Kreider Health Solutions, LLC, a 2014 Professional Woman of the Year 2Health News:Global Powered Surgical Instruments Market Hit to $2.1 billion by 2019 - New Research Report by MarketsandMarkets 2Health News:Global Powered Surgical Instruments Market Hit to $2.1 billion by 2019 - New Research Report by MarketsandMarkets 3Health News:Global Powered Surgical Instruments Market Hit to $2.1 billion by 2019 - New Research Report by MarketsandMarkets 4
... May 6 Volcano Corporation (Nasdaq: VOLC ... of products for the diagnosis and treatment of coronary ... be participating in the Bank of America and Merrill ... presentation by Scott Huennekens, president and chief executive officer, ...
... Incorporated has initiated a voluntary, nationwide recall of one lot ... healthcare professionals as an aid in the diagnosis of myocardial ... to reports of low recovery of quality control samples containing ... affected lot. Although there have been no reported issues ...
... HOUSTON - A newly discovered gene known as DEAR1 is ... local recurrence-free survival in early-onset breast cancer, a research team ... Anderson Cancer Center reports in the journal PLoS Medicine ... because so many young women have recurrences in the breast, ...
... The Mobile Massage Team ( www.mobilemassageteam.com ), a ... programs, promotional events, and special affairs, today announced that the ... Annual GlobalFit Worksite Wellness Summit ( http://www.globalfit.com/summit/ ... Down Town Club in Center City Philadelphia. Team members ...
... - Leadership in Fight Against Tobacco Recognized Nationally -WASHINGTON, May ... of Greenfield, Ind., has been named the National Youth Advocate ... her leadership in the fight against tobacco. Emily is being ... 6) with four regional winners and a group winner. (Logo: ...
... released today by Ernst Berndt and Mark Trusheim of ... that eliminating FDA,s preemption protection would decrease patients, access ... reduce medical device industry employment. The paper, ... Devices on Patients, Innovation and Jobs," comes as ...
Cached Medicine News:Health News:Volcano Corporation Presentation at Bank of America/Merrill Lynch Conference to be Webcast 2Health News:Biosite Incorporated Issues Voluntary, Nationwide Recall for Cardiac Marker Test 2Health News:Novel gene predicts local recurrence in early onset breast cancer 2Health News:Novel gene predicts local recurrence in early onset breast cancer 3Health News:Campaign for Tobacco-Free Kids Honors Emily Kile, Greenfield, IN, as National Youth Advocate of the Year 2Health News:Removing Medical Device Preemption Impacts Jobs, Health Care Costs, Patient Access 2
... The XL Advantage delivers higher magnification for ... crisp, true image, even at the highest ... edge clarity and precise color rendition is ... with an anti-reflective coating produce a superior ...
... delivers higher magnification for advanced surgical procedures. ... even at the highest magnification. 3.5x, 4.5x ... precise color rendition is ideal for surgical ... coating produce a superior image. The compact ...
... Advantage delivers higher magnification for advanced surgical ... image, even at the highest magnification. 3.5x, ... and precise color rendition is ideal for ... anti-reflective coating produce a superior image. The ...
... Prismatic loupes are higher ... guarenteeing edge to edge ... rendition., ,Keeler Prismatic loupes ... treated with anti reflective ...
Medicine Products: