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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
Pharmaceutical Consultants are Focus of May 16th Conference in Boston
AGAWAM,
MASS. — May 2, 2012 — Pharmaceutical
consultants are invited to learn how to reap the benefits of single-source
production and testing at a Pharmaceutical Consultants Conference sponsored
by Microtest Laboratories on Wednesday, May 16, 2012, at the MIT Endicott House
in Dedham, Massachusetts.
The conference will explore the wide range of new revenue and
partnership opportunities that are available for pharmaceutical consultants leveraging
Microtest Laboratories’ flexible, aseptic
fill finish and combination product capabilities — as well as
its complete portfolio of support testing services. Conference topics will
include:
- A virtual
tour
- Aseptic,
combination product, clean fills
- Supporting
testing services
- Environmental
services
- Partnership
opportunities
The seminar is sponsored by Microtest
Laboratories, a Massachusetts-based, FDA-audited company with a history of
exceptional regulatory compliance.
The Pharmaceutical Consultants Conference is scheduled for 10 a.m. to 2 p.m. on Wednesday, May 16,
2012, at the MIT Endicott House, 80 Haven Street, Dedham, Massachusetts —
located just minutes from Boston.
There’s no cost for qualified
pharmaceutical consultants. Lunch and a networking reception are included.
About Microtest Laboratories
Microtest Laboratories is a leader in
testing services and contract manufacturing for the medical device,
pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts,
USA, the company provides expertise and flexible processes that 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. Follow Microtest Laboratories on
Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs. Labels: Aseptic, aseptic fill finish, Boston, clean fills, combination product, environmental services, pharmaceutical consultants, testing services
Microtest Labs Doubles Microbial Identification, Analytical Services
The MicroSeq is a state-of-the-art DNA sequence-based system that enables Microtest technicians to more quickly and accurately identify bacteria isolates that are not viable or easily identified. “With the purchase of our second MicroSeq system, we are not only complimenting our existing unit but doubling our analytical capacity and ability to service our clients,” stated Dr. Steven Richter, Microtest President and Chief Scientific Officer. “As one of the only testing labs in the area with this technology, we are providing our customers with a significant competitive advantage.” Using the MicroSeq system, Microtest technicians can provide precise and reliable bacteria, mycoplasma, and mold identification in a 24-hour time period. Traditional bacteria and mold identification lab tests are often less accurate, and require up to a one-week turn around time. “In the highly competitive biotechnology industry, accuracy and speed cannot be compromised,” stated Dr. Richter. “Our ability to provide rapid identification helps our customers minimize down-time, which directly affects their bottom-line. When manufacturing is halted or a cleanroom is shut-down and awaiting test results, there is no product going out the door and that translates to an interruption in sales.” The MicroSeq system is integrated for use across the spectrum of services that Microtest provides. Customers that will benefit most are those that utilize their analytical testing services in: · Contract Manufacturing
· Pharmaceutical Testing & Validation
· Medical Device Testing & Validation
· Environmental Control and Testing
· Water Validation
· Mold Identification
· Biologics/Virology The MicroSeq systems are 99% reliable with repeatable results, and is especially beneficial for companies with pharmaceutical and medical device manufacturing applications. Made by the Applera Corporation, the MicroSeq Microbial Identification System is the most accurate and rapid bacterial identification system available today. About Microtest Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical and 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: Aseptic, Contract Manufacturer, drug, Fill/Finish, laboratory, manufacturing, Microseq, Microtest, pharmaceutical, Sterility Testing, virology
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