Navigation Links
New White Paper: Having a Solid Package Validation Program Can Prevent Failure of Combination Products

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:

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:

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

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 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. :

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:
(Date:11/24/2015)... 2015  DILON Diagnostics and GE Healthcare are pleased ... DILON to distribute GE,s Discovery NM750b Molecular Breast Imaging ... this distribution agreement will provide Dilon,s experienced distribution network ... and is considered an initial step in an ongoing ... clinicians and their patients. --> ...
(Date:11/24/2015)... November 24, 2015 Sectra (STO: ... has entered into a multi-year agreement to deploy ... investment will provide the Breast Center a future-proof platform ... (STO: SECT B) announces that Breast Center of ... deploy Breast Imaging PACS in its two freestanding imaging ...
(Date:11/24/2015)... FRAMINGHAM, Mass. , Nov. 24, 2015   ... leading innovator of less-invasive, miniaturized circulatory support technologies that ... announced that President and Chief Executive Officer Doug ... Jaffray 27 th Annual Healthcare Conference on December ... being held December 1-2 in New York ...
Breaking Medicine Technology:
(Date:11/25/2015)... WASHINGTON, D.C. (PRWEB) , ... November 25, 2015 , ... ... driving fatalities on our nation’s roadways has dropped below 10,000 for the first time ... to 10,076 in 2013. , According to data released by the National Highway Traffic ...
(Date:11/25/2015)... ... November 25, 2015 , ... An ... is resulting in a way for homeless people to have a more dignified ... a new initiative whereby they are repurposing plastic bags into sleeping mats for ...
(Date:11/25/2015)... ... November 25, 2015 , ... ... offering lower prices in an early celebration of the early holiday shopping season. ... of $29.95 each (normally $33.95 ea). Black Friday promotional pricing is in addition ...
(Date:11/24/2015)... ... November 24, 2015 , ... Young patients with a ... Dr. Angela Wolfman and Dr. Kedar S. Lele, who are pediatric dentists in ... and fillings, the WaterLase iPlus 2.0™ system causes minimal discomfort and bleeding to the ...
(Date:11/24/2015)... ... 24, 2015 , ... DMG Productions announced that they will feature Aphria, Inc., ... via Discovery Channel. Dates and show times TBA. , Aphria, Inc., is a publicly ... of producing and supplying medical marijuana pursuant to the Marijuana for Medical Purposes Regulations ...
Breaking Medicine News(10 mins):