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 sh
'/>"/>

SOURCE Microtest
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3

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:12/22/2014)... DUBLIN , Dec. 22, 2014 Research and ... addition of the "US Self-monitoring Blood Glucose Market" ... http://photos.prnewswire.com/prnh/20130307/600769 This market insight focuses ... in the United States . Reimbursement ... studied. Thorough product analyses for more than 73 SMBG ...
(Date:12/22/2014)... Dec. 22, 2014  ConvaTec, a privately-held medical products ... been appointed Interim Chief Executive Officer of the company, ... Ken Berger .  "The Board of Directors of ... ConvaTec over the past three years," said Magnus ... "We are confident that the company is well positioned ...
(Date:12/22/2014)... , Dec. 22, 2014 /PRNewswire/ -- RXi Pharmaceuticals Corporation ... focused on discovering, developing and commercializing innovative therapies ... today issued the following open letter to shareholders ... Dr. Med. Sc. Dear RXi Shareholders, ... number of inaccurate statements posted on certain social ...
Breaking Medicine Technology:US Self-monitoring Blood Glucose Market 2ConvaTec Names Paul Moraviec Interim CEO Effective December 22, 2014 2RXi Pharmaceuticals Issues Open Letter to Shareholders 2RXi Pharmaceuticals Issues Open Letter to Shareholders 3RXi Pharmaceuticals Issues Open Letter to Shareholders 4RXi Pharmaceuticals Issues Open Letter to Shareholders 5RXi Pharmaceuticals Issues Open Letter to Shareholders 6
... Inc. (NASDAQ: VVUS ) today announced that ... review the company,s new drug application (NDA) for its investigational ... The target date for the FDA to complete its review ... announced results from the pivotal phase 3 trials, patients treated ...
... 2011 Kimberly-Clark Health Care (KCHC) announced today ... on synthetic exam gloves due to unprecedented demand ... butadiene and acrylonitrile.   "Despite aggressive ... along with inflationary pressures have been beyond expectations," ...
Cached Medicine Technology:VIVUS Announces FDA Acceptance of Avanafil New Drug Application for Treatment of Erectile Dysfunction 2VIVUS Announces FDA Acceptance of Avanafil New Drug Application for Treatment of Erectile Dysfunction 3
(Date:12/25/2014)... CA (PRWEB) December 25, 2014 The short ... was created in honor of a true 9/11 hero, ... two film festivals including the 24 hours of Nuremberg International ... in Bangladesh. , Actress, screenwriter and director Luciana ... produce this film together with her husband, Gregory Graham ...
(Date:12/25/2014)... When head lice hits a home or school, parents ... rid of it while keeping it from taking over the ... the solution right in their neighborhood: Lice Troopers . ... full spectrum head lice screening and treatment services to families ... Biscayne, Brickell, Coconut Grove, Kendall, Pinecrest and South Miami. , ...
(Date:12/25/2014)... THURSDAY, Dec. 25, 2014 (HealthDay News) -- Overeating is common ... you eat in moderation, an expert says. "Don,t arrive ... up calories if you know you,ll be attending a party, ... Jill Ashbey-Pejoves, lead dietitian at Northern Westchester Hospital in Mount ... better to eat healthy during the day and even to ...
(Date:12/25/2014)... December 25, 2014 Thousands of transvaginal ... forward in a number of multidistrict litigations currently underway ... Bernstein Liebhard LLP reports. According to an Order issued ... convene a Joint Status Conference in all of the ... have been directed to submit a proposed agenda to ...
(Date:12/25/2014)... 2014 Each year trauma accounts for ... hospital admissions across the nation (according to the ... CDC’s National Hospital Ambulatory Medical Care Survey collected ... in 2010. They estimated that there were between 3.5 ... a primary diagnosis of broken bone or fracture. ...
Breaking Medicine News(10 mins):Health News:The True 9/11 Hero Story “Color of Honor” Premieres in Germany and Bangladesh: Luciana Lagana Plays the Mother of the Lead and Co-Produces with Blaise Dolcemaschio. 2Health News:The True 9/11 Hero Story “Color of Honor” Premieres in Germany and Bangladesh: Luciana Lagana Plays the Mother of the Lead and Co-Produces with Blaise Dolcemaschio. 3Health News:Coral Gables Florida Gets Ready to Be Lice-Free with Lice Troopers 2Health News:Federal Court Overseeing Thousands of Transvaginal Mesh Lawsuits Set to Convene Joint Status Conference for All Litigations, Bernstein Liebhard LLP Reports 2Health News:Federal Court Overseeing Thousands of Transvaginal Mesh Lawsuits Set to Convene Joint Status Conference for All Litigations, Bernstein Liebhard LLP Reports 3Health News:Federal Court Overseeing Thousands of Transvaginal Mesh Lawsuits Set to Convene Joint Status Conference for All Litigations, Bernstein Liebhard LLP Reports 4Health News:Every Year Four Million Emergency Department Visits Result from Accidents Involving Bone Trauma 2Health News:Every Year Four Million Emergency Department Visits Result from Accidents Involving Bone Trauma 3Health News:Every Year Four Million Emergency Department Visits Result from Accidents Involving Bone Trauma 4
... Reproductive pressures, dietary preferences all contribute, anthropologist suggests , , ... those extra cavities on their hormones, a new study ... prehistoric and current human populations found that women have ... and fertility issues linked to female-specific hormones. , ...
... blood pressure condition can pose serious threat to woman ... -- Pregnant with her second child, Joan didn,t make ... symptoms worsened. By the time she saw her doctor, ... level, triggering an emergency Caesarean section. , Joan ...
... CALGARY, Oct. 17 /PRNewswire-FirstCall/ - The Westaim ... between its wholly owned,subsidiary iFire Technology Ltd. ... will sell its equipment, patents and intellectual ... The sale is subject to,several conditions, including ...
... Oklahoma Academy of Ophthalmology hosts event October 24 ... OKLAHOMA CITY, Oct. 17 Oklahoma Academy ... benefiting the,Juvenile Diabetes Research Foundation (JDRF) Central Oklahoma ... Sullivan will headline the,event. Lorena and Gary Story ...
... Texas, Oct. 17 When most people go,out to mow ... some spring,cleaning, the last thing they think about is protecting ... October is Eye Injury Prevention Month, and Eye M.D.,s across ... extraordinary,damage often caused by the most ordinary of activities., ...
... Oct. 17 American Well today announced that ... product management;,and Michael Stollar, vice president of marketing ... (HMSA), will provide a live, public,demonstration of Online ... residents,in January 2009. This "Deep Dive Demonstration" will ...
Cached Medicine News:Health News:Hormones May Be to Blame for Women's Cavity Rates 2Health News:Research May Help Predict Preeclampsia 2Health News:Research May Help Predict Preeclampsia 3Health News:Research May Help Predict Preeclampsia 4Health News:Westaim announces sale of iFire Technology Ltd. assets 2Health News:Second Annual 'Eye Ball' Fights Juvenile Diabetes, Says Oklahoma Academy of Ophthalmology 2Health News:Second Annual 'Eye Ball' Fights Juvenile Diabetes, Says Oklahoma Academy of Ophthalmology 3Health News:The Most Ordinary Things Can Cause the Most Extraordinary Eye Injuries, Says Texas Ophthalmological Association 2Health News:American Well Systems CEO Roy Schoenberg to Present Live Public Demo of First Online Care Service at Health 2.0 Conference 2
The design of this table top is based on advanced functionality for specific urological requirements. This composite product sets a new standard for urological imaging....
Drew Scientific has been making leading edge and top quality CBC systems for over 15 years.,The Excell 16/18 offers a reliable alternative for a 3 part differential....
... First Step Select® Heavy Duty is a pressure ... air loss therapy specifically to the BariKare® Bed., ... 250 and 650 lbs., Large patients at risk ... using a static mattress that would benefit from ...
... Maxxis™ 300 is a healthcare bed system ... individuals in the home care setting, ... combined weight of 2) ,Healthcare frame ... frame size selected, ,CONTRAINDICATIONS: ,Total weight ...
Medicine Products: