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

New White Paper: Having a Solid Package Validation Program Can Prevent 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.
Press Contact: Don Goncalves, 781-793-9380, dgoncalves@tizinc.com
Microtest Laboratories, Inc.
104 Gold Street
Agawam, Massachusetts 01001-3807
Phone: (413) 786-1680
This release was published on openPR.
Permanent link to this press release:
Copy
Please set a link in the press area of your homepage to this press release on openPR. openPR disclaims liability for any content contained in this release.
You can edit or delete your press release New White Paper: Having a Solid Package Validation Program Can Prevent Failure of Combination Products here
News-ID: 152061 • Views: …
More Releases from Microtest Laboratories
New Scope of Reusable Medical Device Cleaning Validations is Examined in New Whi …
AGAWAM, MASS. – A new white paper detailing the new scope of reusable medical device cleaning validations is available free from Microtest Laboratories on the Web at http://www.microtestlabs.com/new-scope-cleaning-validation-paper.
“Cleaning validation for reusable medical devices is an important step in proving their safety. Available guidance documents now indicate that the traditional method of validating cleanliness, spore log reduction, will no longer be acceptable. Analytical assays capable of providing quantitative results will now…

“Environmental Monitoring and Certification in Controlled Environments” – …
– Environmental testing and monitoring programs are essential elements in pharmaceutical and medical device manufacturing. Companies must understand industrial sterilization and contamination control procedures to bring products to market on time and on budget.
In attempting to meet regulatory demands from sources such as the U.S. FDA and the European Pharmacopoeia, the greatest challenge for medical device and pharmaceutical manufacturers may be determining what exactly is required for compliance. How…

Microtest Laboratories Announces New Fast-Track Toxicity Testing for Medical Dev …
Microtest Laboratories has announced a new fast-track test to screen plastics and polymers in medical devices for toxicity using Zebrafish embryos (Danio rerio), a technique already widely utilized in drug development studies.
"Testing has revealed that Zebrafish embryos are highly susceptible to toxins. In fact, Zebrafish labs are ubiquitous in most universities and research hospitals," said Steven Richter, Ph.D., president and scientific director of Microtest Laboratories, and former U.S. Food…
New White Paper Helps Medical Device Manufacturers Validate Cleaning Processes
A free white paper that guides manufacturers of medical devices in the validation of their cleaning processes is available from Microtest Laboratories It is available to download from microtestlabs.com/cleaning-validation-paper.
As many medical devices are made of high-tech materials such as metallic alloys or synthetic plastics, manufacturers may require the use of various agents to aid in the manufacturing process, or produce contaminants that need to be removed. Thus, these products must…
More Releases for Program
Billionaire Brain Wave Program Reviews: Read Difference between The Genius Wave …
Introduction
Imagine having the ability to think like the world's top billionaires-making smart decisions, attracting wealth, and achieving unstoppable success. Sounds like a dream, right? But what if there was a way to tap into that billionaire mindset effortlessly?
That's where Billionaire Brain Wave comes in-a cutting-edge program designed to rewire your brain for wealth, success, and abundance. But is it really effective, or just another hype? 🤔
In this in-depth review, we'll…
QuickMountTV VETLAUNCH Program
The QuickmountTV VetLaunch program is an initiative designed to provide comprehensive support and assistance to military veterans who are interested in starting their own television mounting business through the QuickmountTV franchise opportunity.
The program is specifically tailored to address the unique challenges and needs that veterans may face when transitioning from military service to civilian life. QuickmountTV recognizes the valuable skills, discipline, and work ethic that veterans possess, and aims to…
GroupApp Annouces Beta Program
Walnut, CA: GroupApp today announced the launch of GroupApp's beta program. GroupApp is an all-in-one community platform for businesses and creators who are looking to build an online community for their customers or audience. They have been called the Slack for online community software.
Features and benefits of the GroupApp:
Create an online community on GroupApp in minutes, invite your audience, start discussions, ask questions, share content, and let customers connect with…
Lullaby Lavender Program
Bangkok – May 27th, 2016: Suffering from sleepless nights? Let Devarana Spa puts you into a slumber with a Lullaby Lavender Program - an emergency assistance for those who suffers from sleep deprivation to get the rest they need.
Poor sleep has a major impact on how a person functions during the day. Sleep-deprived people are chronically tired, moody and potentially depressed. To help the restless get sufficient rest, Devarana…
ADRC Announces 2013/2014 Program Sites For Alzheimer’s Art Expression Program
Bay Shore, NY – ADRC’s Executive Director and CEO, Mary Ann Malack-Ragona, announced today that twenty-seven sites across Nassau and Suffolk will participate in the Center’s 2013/2014 Art Expression Program developed for individuals with a diagnosis of Alzheimer’s Disease.
ADRC has been coordinating this very special program since 2003. The program includes training for professional coordinators, with ongoing support throughout the program year. The program culminates with ADRC’s Annual Tea and…
Patent Drafting Program
PATENT DRAFTING PROGRAM AT IIPTA
By Rachana
February 06, 2013
Delhi, Indian Institute of Patent and Trademark Attorney announces the introduction of Patent Drafting Program as one among the many Intellectual Property related programs offered by the company. This program is focussed mainly on providing an in-depth understanding and writing of patent language in an advanced level.
…