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:11/30/2015)... India , November 30, 2015 ... 2014, and is expected to grow at a CAGR of 7.6% ... was valued at USD 135.6 million in 2014, and is ... 2020. --> According to the new Market Research Report ... invasive, non-invasive), By End User (Hospitals, ambulatory care, others) - Analysis ...
(Date:11/30/2015)... PUNE, India , November 30, 2015 ... new market research report "Dental Lasers Market by Product (Soft ... Treatment, Periodontitis), End User (Hospitals, Clinics), and Geography - Global ... USD 224.7 Million by 2020, at a CAGR of 5.2% ... , Browse 140 market data Tables and 62 Figures spread ...
(Date:11/30/2015)... MOUNTLAKE TERRACE, Wash. and ST. ... Cross and Express Scripts (NASDAQ: ESRX ) today ... benefit agreement. The partnership, which began in 1999, will ... --> --> After evaluating pharmacy ... process, Premera concluded that Express Scripts continues to offer ...
Breaking Medicine Technology:
(Date:11/30/2015)... ... 30, 2015 , ... ChiliPad , Chili Technology’s temperature-controlled ... through quality sleep. Tim DiFrancesco, training coach for the LA Lakers, recommends ChiliPad ... precisely regulates the surface temperature of each side of the bed so that ...
(Date:11/30/2015)... ... November 30, 2015 , ... ... patient centered orthopedic care. Led by John Vitolo, M.D., the center offers ... condition, the team at Advocare Orthopedic & Sports Medicine is ready to help ...
(Date:11/30/2015)... ... November 30, 2015 , ... Dr. Seth D. Margulies ... locations, patients can visit Dr. Margulies to experience the best available orthodontic experience in ... title of "NJ Top Dentist"! , Orthodontics is the branch of dentistry that specializes ...
(Date:11/30/2015)... ... November 30, 2015 , ... Newly reviewed and approved “NJ Top Dentist”, ... Tufts School of Dental Medicine in 1935. His father graduated from NYU School ... in dentistry as well as their commitment and passion to the Practice of Dentistry. ...
(Date:11/30/2015)... ... November 30, 2015 , ... The recently ... Poison Data System (NPDS) reveals that in 2014, someone called a poison center ... two million of which were human exposure cases. , The American Association of ...
Breaking Medicine News(10 mins):