Navigation Links
New White Paper: Having a Solid Package Validation Program Can Prevent Failure of Combination Products
Date:11/16/2010

AGAWAM, Mass., Nov. 16, 2010 /PRNewswire/ -- A new white paper urges medical device and combination product manufacturers to employ a solid package validation program as a means of preventing the failure of combination products.

"FDA concerns regarding terminally sterilized medical products are based on years of data that implicate failures in primary packaging. Approximately 47% of failures occur due to inadequate package validation programs," said Steven Richter, Ph.D., founder, president and chief scientific officer of Microtest Laboratories in Agawam, Mass.

Richter is author of the new white paper that provides insight into the general requirements in a microbiological and physical testing program. In it, he discusses how combination products pose a unique set of challenges to package validation engineers.

Titled, "Get with the Program: Having a Solid Package Validation Program Can Prevent Failure of Combination Products," the paper is available for download from: http://www.microtestlabs.com/packaging-validation-paper.

In the white paper, Richter discusses the challenges of packaging validation and some of the options for testing. He provides a summary of the standardized test methods commonly used in the U.S. for satisfying ANSI/AAMI/ISO 11607 requirements, and outlines the steps in the packaging validation process. He also focuses on the points to consider during packaging validation studies for cell therapy products.

"All device and combination product manufacturers are required to have a robust package validation program, and medical device stability package validation programs should be designed to encompass the overt product storage and shipment conditions," Richter said. "The necessity to develop a robust packaging validation regimen cannot be overstated. A comprehensive regulatory approach to validation during early product development can save many weeks of redevelopment and testing activities.

"This white paper is presented to give medical device and combination product manufacturers a starting point for package validation programs," he said.

Download the new, free white paper, "Get with the Program: Having a Solid Package Validation Program Can Prevent Failure of Combination Products," from: http://www.microtestlabs.com/packaging-validation-paper.

Steven Richter, Ph.D., is founder, president, and chief scientific officer of Microtest Laboratories, Inc., in Agawam, Mass. Dr. Richter founded Microtest in 1984 after a distinguished career at the U.S. Food & Drug Administration. Under his leadership, Microtest has provided the medical device, pharmaceutical, and biotechnology industries with premier testing and manufacturing support.

Follow Microtest Labs on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.

About Microtest

Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, U.S.A., 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: For information on the listed expert, click appropriate link.

Steven Richter, Ph.D. : https://profnet.prnewswire.com/Subscriber/ExpertProfile.aspx?ei=42622


'/>"/>
SOURCE Microtest
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. ImmuneRegen BioSciences, Inc. Demonstrates Radilex(TM) Increases Disease-Fighting White Blood Cells
2. AHF Seeks White House Clarification After Press Room Flap Over CDCs HIV Numbers
3. White Nose Syndrome: Is Pennsylvania Next?
4. White Paper Explains Aspects of Testing From Purified Bulk Drug Substance to Sterile Liquid Final Drug Product
5. ALP Life Sciences, LLC Announces Nanoveson(TM) Patent Filing and Whitepaper Availability on Proposed Therapy for Non-Alcoholic Fatty Liver Disease (NAFLD) and Comorbid Diseases
6. Society of Gynecologic Oncologists Issues White Paper on HPV Vaccines Impact on Cervical Cancer Prevention
7. BIA Publishes White Paper: ISO 9000 Role in Document Review, Emphasizes Quality Equals Defensibility
8. Whitepaper From Mirial Explains how Visual Communication Technology can Improve Healthcare Services
9. New White Paper Examines Advanced Mycoplasma Tests - How Real-Time PCR Analysis Helps Save Time and Money for Biopharmaceutical Manufacturers
10. Dr. Robert B. Arnot Releases White Paper on the Silent Threat of H1N1 and Other Infectious Diseases
11. Abbott Chairman and CEO Miles D. White to Present at Sanford Bernstein Strategic Decisions Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/24/2017)... Research and Markets has announced the addition of the ... offering. ... Hemophilia Drugs Price Analysis and Strategies - 2016, provides drug pricing data ... following questions: What are the key drugs ... the Global Hemophilia market? What are the unit prices ...
(Date:2/24/2017)... -- Physician General Dr. Rachel Levine and ... Smith commended South Central EMS today for their ... a life-saving overdose reversal drug. The recognition event also ... overdose survivor who was saved due to the administration ... part of fighting the opioid epidemic is making sure ...
(Date:2/24/2017)... Feb. 24, 2017 Medical information groups ... increase their self-service capabilities to manage inquiries from ... New research from consulting leader Best ... developed self-service website portals where HCPs can sign ... one of many findings to emerge from the ...
Breaking Medicine Technology:
(Date:2/24/2017)... ... February 24, 2017 , ... Only two months after ... Travel Market (ILTM) show in Cannes (France), XO Private has initiated a second print-run ... 420-page book measures almost a metre across when open, weighs in at more than ...
(Date:2/24/2017)... , ... February 24, 2017 , ... ... of Liberty University, has officially announced the appointment of Peter A. Bell, DO, ... of Osteopathic Medicine (LUCOM), beginning April 10. Dr. Bell comes to Liberty ...
(Date:2/24/2017)... ... February 24, 2017 , ... With ... is so critically important that we all are aware of our options and ... is proud to announce the launch of its newest edition of "Vision and ...
(Date:2/24/2017)... , ... February 24, 2017 , ... With ProGlass Prism ... Pro X . Users have total control over position, rotation, distortion, edge softness, edge ... within Final Cut Pro X. , With ProGlass Prism users are given the tools ...
(Date:2/24/2017)... ... , ... The International Association of Eating Disorders Professionals (iaedp) announces the 2017 ... image mannequin art competition. Selected from 15 submissions from around the nation, the top ... 31st annual iaedp Symposium, March 22 – 26 in Las Vegas. , This year, ...
Breaking Medicine News(10 mins):