Navigation Links
White Paper Explains Package Validation Requirements For Medical Devices & Combinatory Products
Date:6/9/2009

AGAWAM, Mass., June 9 /PRNewswire/ -- Validation requirements and combination products pose a unique set of challenges to the medical device engineer. A new whitepaper from Microtest Laboratories discusses how an engineer can best to utilize packaging validation programs and discusses options when testing medical device packaging.

The white paper, "Package Validation Requirements For Medical Devices and Combinatory Products" provides an insight into the general requirements in microbiological and physical testing programs. It is available for download at: http://www.microtestlabs.com/package-validation-paper/

Specifically, the white paper discusses that medical device stability package validation programs should be designed to encompass the overt product storage and shipment conditions and that performing accelerated aging studies does little to address liability during shipment and storage.

The white paper discusses:

  • The necessity to develop a robust packaging validation regimen
  • That a packaging validation program should include transportation simulation testing with concomitant sterility testing.
  • A comprehensive regulatory approach to validation during early product development can save many weeks of redevelopment and testing activities.

The white paper is authored by Steven Richter, Ph.D., is President and Chief Scientific Officer of Microtest Laboratories, (www.microtestlabs.com), a contract manufacturer and provider of contract manufacturing testing.

To download the white paper, "Package Validation Requirements For Medical Devices and Combinatory Products" visit: http://www.microtestlabs.com/package-validation-paper/

Or, visit Microtest at the 2009 MD&M East, June 9th-11th, in Booth 1442 in the Jacob K. Javitz Convention Center New York, NY.

About Microtest

Microtest is a leader in aseptic processing contract manufacturing and contract manufacturing testing services for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, USA, the company's expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

Available Topic Expert(s): For information on the listed expert(s), click appropriate link.

Steve Richter, Ph.D.

https://profnet.prnewswire.com/Subscriber/ExpertProfile.aspx?ei=42622


'/>"/>
SOURCE Microtest
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Ability to cope with stress can increase good cholesterol in older white men, study finds
2. New Study Reports High Injury Rates for Hotel Workers, Even Higher Rates for Women and Nonwhites
3. Glass Lewis Recommends Arrow Shareholders Vote on the White Proxy Card for Merger With Teleflex and for Current Board of Directors at Arrow Annual Meeting
4. Arrow International Sends Letter Reminding Shareholders to Vote White Proxy Card in Support of Teleflex Merger and Election of Current Board of Directors
5. Prime Access Creates Groundbreaking Ads Targeting Urban Teens for the White Houses National Youth Anti-Drug Media Campaign
6. Older blacks and Latinos still lag whites in controlling diabetes
7. New RAPS White Paper Details Career Development of Healthcare Products Regulatory Professionals
8. Black gay men, lesbians, have fewer mental disorders than whites, says Mailman School of PH study
9. Marian Jones Should Return Olympic Medals, Says Ex-White House Drug Spokesman Bob Weiner
10. Whites take supplemental breast cancer therapy more often than blacks
11. Differences observed between black and white women in use of breast cancer therapy
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/29/2016)... ... , ... Coalition Duchenne, a Newport Beach, California based charity ... participated in the April 25 U.S. Food and Drug Administration advisory committee hearing ... at the Marriott Conference Center in Hyattsville, Maryland was attended by over than ...
(Date:4/29/2016)... ... April 29, 2016 , ... Yisrayl Hawkins, Pastor and ... highlighting inconsistencies of adding BC and AD, saying it is time to set the ... After Christ. Yisrayl says this simply cannot possibly be true and offers explanation. , ...
(Date:4/28/2016)... , ... April 29, 2016 , ... Sublime Beauty® is offering a special deal on ... for 50% off. The discount is applied to the product with lesser value. In ... those who purchase $250 or more in products. , "So many women (men, too) love ...
(Date:4/28/2016)... , ... April 28, 2016 , ... ... is proud to partner with AquaShieldUSA, the country's oldest waterproof cast protector ... and medical supply stores, the largest selection of daily, night, weatherproof and waterproof ...
(Date:4/28/2016)... ... 2016 , ... Cosmetic Town, an online plastic surgery community, announces the relaunch ... recently revamped and upgraded to allow even more interaction between doctors and patients as ... According to the senior editor of Cosmetic Town, “We are excited that our ...
Breaking Medicine News(10 mins):
(Date:4/27/2016)... , April 27, 2016 ... USD 2.14 billion by 2022, according to a ...      (Logo: http://photos.prnewswire.com/prnh/20150105/723757 ) , ... affecting the efficiency and accuracy delivered by the ... demand for novel urinalysis instruments and consumables. For ...
(Date:4/26/2016)... Mich. , April 26, 2016 Diplomat ... promotion of Jennifer Hagerman , Pharm D., to ... her growing role at Diplomat, Hagerman will continue to ... the company that delivers custom education and training to ... the specialty pharmacy industry. Diplomat University also houses the ...
(Date:4/26/2016)... 27, 2016 Research and Markets ... Diagnostics Market 2016-2020" report to their offering. ... global molecular diagnostics market is projected to grow at ... Molecular diagnostics is a technique that involves measurement ... level to detect changes in biochemical pathways. The aim ...
Breaking Medicine Technology: