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Posts Tagged ‘Sterility Testing’


Friday, April 19th, 2013

Microbiology Quality Control Seminar to Assist Medical Device Manufacturers Validate Sterilization, Cleaning Processes

A seminar on microbiology quality control — designed to help medical device manufacturers validate sterilization and cleaning processes, and maintain controlled environments — will be held on Thursday, May 16, in Boston.

“For today’s medical device manufacturers, the challenge is to validate their sterilization and cleaning processes to ensure patient safety and product integrity. This seminar will focus on a host of issues pertaining to the sterilization of medical devices including sterilization validation, bioburden, sterility, and endotoxin testing, as well as submitting samples to a contract testing laboratory,” said Steven Richter, Ph.D., president and scientific director of Microtest Laboratories, which is hosting the event.

Topics at the “Microbiology Quality Control Seminar will include:

  • MICRO 101
  • Sterilization Validation
  • Bioburden Testing
  • Sterility Testing
  • Endotoxin Testing
  • Testing Sample Submissions

The event will be held at the MIT Endicott House in Boston, Mass., on Thursday, May 16, 2013, from 9 a.m. to 3:30 p.m. Registration is 9 a.m. to 9:45 a.m. A networking reception and lunch are included.

To register, download the form from http://www.microtestlabs.com/pdfs/seminar-registration-form_1305.pdf. Or, contact Julie Adamski at Microtest Laboratories by phone at 1-800-631-1680, ext. 192, or by email at jadamski@microtestlabs.com. The registration fee is $149.

The event is one in a series of technical seminars and workshops for medical device and pharmaceutical manufacturers presented by Microtest Laboratories, a Mass.-based, FDA-audited company with a history of exceptional regulatory compliance.

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.


Monday, April 2nd, 2012

“Proposed Changes to 21CFR 610: The New Scope of Biologics Sterility Testing” is Subject of New Management Brief

AGAWAM, MASS. – April 4, 2012 – The new scope of biologics sterility testing, resulting from the U.S. Food and Drug Administration’s (FDA) proposed changes to 21 CFR 610, is discussed in a new management brief from Microtest Laboratories. Download the brief from http://www.microtestlabs.com/21-cfr-610-paper.

The FDA’s proposed amendments to 21 CFR Parts 600, 610, and 680, published in the Federal Register on June 21, 2011, for review and comment, are focused on expanding the scope of the current sections to allow for greater flexibility in testing methodology.

“Through these changes, the FDA is embracing the emergence of new non-culture based technologies. If approved, they will provide the opportunity to utilize these methods as alternatives to culture-based sterility tests,” explains James E.T. Gebo, B.S., M.P.A., RM (NRCM), Technical Representative, Laboratory Services, Microtest Laboratories, in the brief, “Proposed Changes to 21CFR 610: The New Scope of Biologics Sterility Testing.”

“The most significant proposed revision is the elimination of the specified sterility test methods,” writes Gebo. “But while the proposed changes seem extreme at first glance, in the grand scheme they are beneficial for all interested parties.”

The brief discusses the potential benefits, including the opportunity for manufacturers and quality control laboratories to streamline their testing and adopt new emerging sterility test technologies — such as rapid testing methods employing PCR — that will further support the drive to achieve quicker product release.

Download the new free management brief, “Proposed Changes to 21CFR 610: The New Scope of Biologics Sterility Testing,” at http://www.microtestlabs.com/21-cfr-610-paper.

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. Follow Microtest Labs on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.


Tuesday, June 3rd, 2008

Microtest Labs Doubles Microbial Identification, Analytical Services

AGAWAM, MASS. – June 3, 2008 – Microtest Laboratories (http://www.microtestlabs.com/) has doubled their microbial identification and analytical services with the purchase of an additional MicroSeq® Microbial Identification System.

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.

For more information about Microtest’s analytical testing and related services, visit contact the Microtest on the Web at: www.microtestlabs.com/medical-device-testing or by phone 1-800-631-1680.

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 www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

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Public Relations contact: Tiziani Whitmyre Inc.


Monday, December 11th, 2006

Microtest Enhances Analytical Lab Services with Addition of Advanced Microbial Identification System

AGAWAM, MASS. – December 11, 2006 – Microtest has dramatically enhanced their analytical lab services with the installation of a new, advanced technology, MicroSeqR Microbial Identification System. 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.

Using the MicroSeq system, Microtest technicians can provide precise and reliable bacteria, mycoplasma, and mold identification in a 24-hour time period. As one of the only testing labs in the area with this technology, Microtest is providing their customers with a significant competitive advantage. 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. Steven Richter, Microtest President. “Our new MicroSeq system enables our specialists to provide customers with consistent and rapid results that, unlike previous equipment, ensures that the issues and concerns that prompted our clients to undertake their testing are properly analyzed and resolved, thus putting their production back on track.”

“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,” said Dr. Richter.

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 new MicroSeq system is 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.For more information about Microtest’s analytical testing and related services, contact Dennis Champagne, Director of Lab Services, at 1-800-631-1680 or email dchampagne@microtestlabs.com, or visit Microtest on the Net at: www.microtestlabs.com.

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.

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Tuesday, November 14th, 2006

Microtest Offers New, Free White Paper: ‘Selecting An Aseptic Fill/Finish Contract Manufacturer: Avoiding the Most Common Mistake’

AGAWAM, Mass., Nov. 14 — Microtest has announced the availability of a new, free white paper titled: “Selecting An Aseptic Fill/Finish Contract Manufacturer: Avoiding the Most Common Mistake.”

Selecting and establishing an effective working relationship with an Aseptic Fill/Finish contract manufacturer can be a challenging task. The ramifications of making a poor decision can result in schedule delays, regulatory approval issues, and lost revenue.

In this new white paper, in addition to providing guidance on the selection process, John Dobiecki, Vice President/General Manager, Microtest, reviews the common mistakes made by potential clients.

These common oversights and their remedies are sourced from his collective experience base that covers contract aseptic fill/finish and bulk drug manufacturing.

Microtest offers fill/finish contract manufacturing services, integrated with stability and testing services, that lower costs, improve quality, and compress time-to-revenue for pharmaceutical manufacturers.

With 15 years of experience in medical device testing, Microtest is a single-source manufacturing solution.

Microtest is based in Agawam, Massachusetts, USA. 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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