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Six Critical Areas to Ensure Regulatory Compliance in Aseptic Manufacturing are Outlined in New Management Brief
AGAWAM, MASS. — An unscheduled inspection of an aseptic
manufacturing process can hit a pharmaceutical company with the fury of a New
England nor’easter. But a new management brief explains how a best-practice
control and monitoring system can minimize the danger of FDA noncompliance. The
brief is available for download from http://www.microtestlabs.com/weathering-the-storm-brief.
In the aseptic manufacturing business, all processes must be best
practice to ensure the process will comply with the regulations. If any are
poorly designed, not utilized, or deviated from, then the entire aseptic
manufacturing system is considered out of compliance. This means that the
checks and balances of a quality system must ensure that the sterile
environments and surrounding support SOPs truly are working and show no signs
of trending towards failure.
• Training and professional development
• Environmental monitoring (EM) procedures
• Incorporation of single-use technology
(e.g. needle/tubing sets)
• Facility design and maintenance
• Process simulation
• Raw material control, preparation, and
sterilization
“The FDA has been very critical of aseptic fill/finish companies
whose manufacturing environments are out of trend or outside of
specifications,” noted management brief author Alexander (Alex) Mello, M.S., SM
(NRCM), the director of Project Management, Manufacturing at Microtest
Laboratories, Inc., in Agawam, MA.
“Rigorous production system control and
monitoring through data generation and analysis will pave the way for best-practice
pharmaceutical manufacturing,” he stated.
About Microtest Laboratories
Microtest Laboratories is a leader in testing services and
contract manufacturing for medical devices, pharmaceuticals, and biotechnology.
Founded in 1984, the company’s expertise and flexible processes enhance product
safety and security, speed time to market, and minimize supply chain
disruption. Microtest’s unique single-source capability to provide testing and
manufacturing solutions allows the company to support a full pharmaceutical or
medical device product release. Our facilities in Agawam, Massachusetts,
include state-of-the-art aseptic manufacturing areas; analytical chemistry, microbiological,
and virological laboratories; Class 100 clean rooms; onsite steam and ethylene
oxide sterilization, plus depyrogenation capabilities; purified water systems;
and voice/data systems. For more information, visit
http://www.microtestlabs.com or call 1-413-786-1680 or toll-free
1-800-631-1680.
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Labels: Aseptic, Aseptic Fill/Finish Contract Manufacturer, Fill/Finish, Pharmaceutical Manufacturers, pharmaceutical manufacturing, pharmaceutical testing
Free White Papers Detail Sterility Testing Essentials for Medical Device, Pharmaceutical Manufacturers
AGAWAM, MASS. – January 12, 2009 – Two new white papers detailing sterility testing essentials are now available for free download from Microtest ( http://www.microtestlabs.com/). The white papers, one which is customized for medical device manufacturers and one which is specialized for pharmaceutical manufacturers, presents the general concepts and problems associated with sterility testing and reviews different testing methodologies. For medical device manufacturers, sterility testing of medical devices is required during the sterilization process as well as for routine quality control. Understanding sterility testing is essential when designing the validation process. The need to provide adequate and reliable test data is an important quality control issue. False positive results and test failures can have significant impact on production schedules and device time-to market. Medical device manufacturers can download the white paper at: http://www.microtestlabs.com/sterilitypaper/sterility-paper.htm. The author of the white papers is Steven Richter, Ph.D., President and Scientific Founder of Microtest, a leading provider of medical device and pharmaceutical services for medical device designers and manufacturers. The firm recently expanded its facilities, resources, and technology, and with more than 15 years of experience, is a single-source manufacturing solution. For information on Microtest’s unique single-source solutions that minimize schedule disruptions and accelerate time to revenue visit Microtest on the Web: http://www.microtestlabs.com/ or toll-free: 1-800-631-1680. About Microtest Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, biotechnology industries. Based in Agawam, Massachusetts, USA, 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. # # # Labels: Compliance, FDA regulations, medical device, Microtest, pharmaceutical manufacturing, pharmaceutical testing, sterilization, white paper, whitepaper
“Biosafety Testing of Cell Lines Used in Vaccine and Virus Vector Production” is Focus of Presentation at WilBio Viral Vectors and Vaccines Conference
Merribeth Morin, PhD, of Microtest Laboratories will present “ Biosafety Testing of Cell Lines used in Vaccine and Virus Vector Production” at the WilBio Viral Vectors and Vaccines conference for Pandemic Viruses, Cancer Vaccines, and Gene Therapy, at 11:15 am-Noon, on Tuesday, Nov. 4, 2008 in Santa Barbara, Calif. Dr. Morin’s presentation will discuss the safety concerns for the use of cell lines, in reference to their use in vaccine and vector production. “The use of cell lines for the production of virus vectors and vaccines is widely applied. The ability to manipulate cells in culture and grow them to large scale is advantageous, and in the case of vaccines, presents a more attractive and consistent process than some more traditional methods for vaccine products. As for any type of biological product, using cell lines presents various safety considerations. There are a number of regulatory guidance documents that address the characterization of cells used for the production of biological products. The safety program for cell lines needs to be reasonable, but thorough, to address the safety concerns outlined in these documents,” said Dr. Morin. Dr. Morin is Director of Virology for Microtest Laboratories, ( http://www.microtestlabs.com/), a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. She received her PhD in Virology from Harvard University and has spent a number of years in both in vaccine research and in contract testing. Her research included developing DNA vaccines for the treatment of influenza virus infection and other infectious diseases, and the development of an attenuated vaccine for Herpes simplex virus infection. Based in Agawam, Mass., Microtest'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. The Viral Vectors and Vaccines Conference for Pandemic Viruses, Cancer Vaccines, and Gene Therapy runs Nov. 3-5, 2008. For more information, visit http://www.wilbio.com/.
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Labels: biosafety testing, medical device, Microtest, pharmaceutical manufacturing, pharmaceutical testing, vaccine and virus vector, Viral Vectors and Vaccines, virology
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