Monday, July 14, 2014

ATS Labs, Inc. Announces the Acquisition of MicroTest Labs, Inc.

Eagan, Minn., July 14, 2014 -- Today, ATS Labs, Inc. (ATS), majority owned by Ampersand Capital Partners, announced that it acquired the assets of MicroTest Labs, Inc. (MTL) of Agawam, MA.  The acquisition of MTL is the first step in the strategy of ATS to expand its microbiology and chemistry laboratory services platform to support the medical device and biopharmaceutical industries.  The combined companies will soon be known as Accuratus Lab Services, a name that personifies the quality and accuracy of testing results and scientific solutions that support the antimicrobial, consumer product, medical device, and biopharmaceutical industries.
“The acquisition of MicroTest by ATS has been a long time in the making and I could not be more pleased about the future of the two companies and how they will combine to create the market leader in providing microbiology and analytical chemistry testing services,” said Dr. Steve Richter, CEO of MTL.  Dr. Tom Burnell, Executive Chairman of ATS added, “Like ATS, MicroTest has a strong reputation in the industries it serves, which is supported by long-standing client relationships. Leveraging the strengths of the two companies will only further enhance our ability to continuously exceed our client’s expectations.”  It is expected that administrative functions will be consolidated, but the company will continue to operate at its locations in Eagan, MN and Agawam, MA.
About ATS Labs:
ATS Labs is the leading global provider of antimicrobial and biocide testing services; committed to improving public health and generating value for customers.  ATS Labs has been an expert partner to the developers, manufacturers, and users of antimicrobial products for over 20 years; providing a comprehensive range of microbiology, virology, and product chemistry services.
For more information on ATS Labs go to www.ATS-Labs.com.
About MicroTest Labs:
MicroTest Labs is a leader in testing services for the medical device, pharmaceutical and biotechnology industries.  Founded in 1984, the company’s expertise and flexible processes enhance product safety and security, speed time to market, and minimize supply chain disruption.
For more information on Microtest Labs go to www.MicroTestLabs.com.
About Ampersand Capital Partners:
Ampersand is a middle market private equity firm with a focus on growth equity investments in the Healthcare sector.  Over the past two decades, Ampersand has managed $1 billion in private equity partnerships.  Ampersand leverages its unique blend of private equity and operating experience to build value and drive superior long-term performance alongside its portfolio company management teams.  Ampersand’s portfolio has included more than 20 years of successful investments in the laboratory products and services industry.
Additional information about Ampersand is available at www.AmpersandCapital.com.

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Monday, May 19, 2014

Fundamentals of Endotoxin Testing for Medical Device Manufacturers are Detailed in New Technical Brief

AGAWAM, MASS. — The fundamentals of endotoxin testing for medical device manufacturers — from definition to assay acceptance criteria —are detailed in new technical brief available from Microtest Laboratories.
Bacterial endotoxins cause fever, septic shock, and other disease symptoms — and thus attract considerable regulatory scrutiny from such organizations as the U.S. Food & Drug Administration (FDA) and the United States Pharmacopeial Convention. Regulations require that devices that contact circulating blood or cerebrospinal fluid, or are used with intraocular products or in vitro fertilization procedures, are required to be endotoxin-free.

The Fundamentals of Endotoxin Testing,” available for download at http://microtestlabs.com/endotoxin-testing, is a step-by-step information resource for medical device manufacturers discussing and detailing the:
  • Definition of endotoxins;
  • Various tests used for their detection;
  • Use of depyrogenation and other ways to remove endotoxins;
  • Types of devices that should be tested;
  • Preparation and testing of samples;
  • Options for sampling containers;
  • Acceptance criteria for each of the assays; and
  • Sources of official information, reference, and guidance.

The Fundamentals of Endotoxin Testing” is authored by Steven Richter, Ph.D., said Steven Richter, Ph.D., president and scientific director of Microtest Laboratories — and a former FDA official.


The paper is one in a series about testing, manufacturing, and regulatory issues of concern for medical device manufacturers from Microtest Laboratories, a leader in testing services and contract manufacturing for medical devices, pharmaceuticals, and biotechnology.

About Microtest Laboratories
Microtest Laboratories is a leader in testing services and contract manufacturing for medical devices, pharmaceuticals, and biotechnology. It was 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 firm to support a full pharmaceutical or medical device product release. The company’s facilities in Agawam, Massachusetts, USA 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. Follow Microtest Laboratories on Twitter @MicrotestLabs on Facebook at http://goo.gl/TndoBg.
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Press contact: Don Goncalves, 1-781-793-9380, dgoncalves@tizinc.com

Download image for publication: http://flic.kr/s/aHsjNR56it

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Monday, May 12, 2014

Disinfectant Qualifications in Pharmaceutical Manufacturing Environments is Focus of White Paper

AGAWAM, MASS. – May 12, 2014 – A white paper outlining the six steps that pharmaceutical and medical device manufacturers must employ to qualify disinfectants used in their environmental cleaning processes is available from Microtest Laboratories. It is available for download from http://microtestlabs.com/6stepspaper-disinfectant-qualification.

“Sterile pharmaceutical and medical device manufacturing environments require an effective cleaning and disinfection program to maintain aseptic conditions and prevent the microbial contamination of the product. The qualification of the chemical disinfectants used in these environments is extremely important, yet it is often overlooked,” stated Deborah Ensign, supervisor, R&D of Microtest Laboratories, in the new white paper, “Six Steps to Qualifying Disinfectants.”

In fact, “disinfectant qualifications require more planning, time, and resources than many companies realize,” she said.

“Any time a new disinfectant is introduced into the cleaning process within the facility, a qualification should be performed. From start to finish, a disinfectant qualification can require from 2 to 12 months.

“The timeline for a disinfectant qualification will depend on a number of variables, including the number of disinfectants and challenge organisms being tested as well as the number of surfaces (for the coupon method) being evaluated,” Ensign noted.

“The bottom line is that no matter whether the disinfectant qualification is performed internally — or by an outside testing laboratory — these six steps must be addressed,” she warned.

Download a free copy of the white paper, “Six Steps to Qualifying Disinfectants” for pharmaceutical manufacturing companies from http://microtestlabs.com/6stepspaper-disinfectant-qualification.

Deborah Ensign is supervisor, R&D Lab, at Microtest Laboratories Inc. She has over 20 years of experience in regulatory microbiology and contract laboratory operations. Ms. Ensign supervises Microtest’s Specialized Microbiology department. She holds a bachelor of arts degree in microbiology and is a nationally registered microbiologist. Ms. Ensign oversees all reusable testing (cleaning, disinfecting, and sterilization) and serves as a resource for USP testing, specifically <51>, <61>, and <62>.

About Microtest Laboratories
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.

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Sunday, April 27, 2014

The Impact of the Drug Quality and Security Act on Compounding Pharmacies Is the Subject of May 13th Seminar in Boston

AGAWAM, MASS. — April 29, 2014 — A seminar focusing on the impact of HR3204 — the Drug Quality and Security Act — on compound pharmacies and manufacturers is the subject of a seminar set for May 13, 2014 in Dedham, Mass., near Boston.

Meeting the new guidelines will require substantial changes for many compounders. The seminar is designed to explain the stepping stones needed to comply with the new legislation as well as review USP <797> in its current state.

The seminar will provide pharmacies and compounders that do business as compounding manufacturers and outsourcing facilities with the knowledge they need to know about how the new regulatory expectations will affect their businesses.

Seminar topics will include:
·         Becoming a compounding manufacturer
·         Manufacturing under cGMP requirements
·         Meeting current USP <797> requirements

The seminar will be presented by Microtest Laboratories, a leader in testing services for the medical device, pharmaceutical, and biotechnology industries, on Tuesday, May 13, 2014, from 9 a.m. to 3 p.m. at the Endicott House in Dedham, Mass., just outside Boston. Registration is at 8:30 a.m. A continental breakfast, break refreshments, and a luncheon are included.

To register, visit http://www.microtestlabs.com/seminar or contact Julie Adamski 1-800-631-1680, ext. 192, or jadamski@microtestlabs.com. Advance registration is $149.

About Microtest Laboratories
Microtest Laboratories is a leader in testing services 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 Facebook at http://facebook.com/MicrotestLaboratories, on LinkedIn at http://goo.gl/H8ZLnM or on Twitter @MicrotestLabs.

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Saturday, April 26, 2014

Parenteral Drug Association to Discuss Rapid Micro Systems and Tour Microtest Laboratories on May 6th in Agawam, Mass

AGAWAM, MASS. — April 28, 2014 — The New England Chapter of the Parenteral Drug Association (PDA) will feature “Rapid Micro Systems: A New Tool in Navigating the Stormy Seas of Biological Testing” at a May 6 meeting in Agawam, Mass. The meeting also will include a tour of Microtest Laboratories, a leading provider of life science testing services for pharmaceutical and medical device companies.

Keynote speakers at the meeting will include the following:

Dr. Bradford O. Fanger, Ph.D., field applications scientist at Azbil BioVigilant, will discuss “Reducing Manufacturing Risk with Rapid Microbiological Methods.” In his presentation, Dr. Fanger will provide an overview of rapid microbiological systems, the different types available, and their advantages.

James Gebo, senior research and development scientist, Microtest Laboratories, will review “Evaluation and Implementation of Rapid Microbiological Methods.” His presentation will explore the applications for rapid microbiological systems, review the business case for purchasing the technology, and explain ROI reporting.

The dinner meeting will be held at Kaptain Jimmy’s Restaurant and Distillery, 916 Suffield Street, Agawam. The Microtest tour will leave the restaurant at 4 p.m. Both PDA members and non-members are invited to attend.


About the Parenteral Drug Association
The Parenteral Drug Association (PDA) is the leading global provider of science, technology, and regulatory information and education for the pharmaceutical and biopharmaceutical community. Founded in 1946 as a nonprofit organization, PDA is committed to developing scientifically sound, practical technical information and resources to advance science and regulation through the expertise of its more than 9,500 members worldwide. The New England Chapter was formed in 1988, and represents PDA members from the six New England states: Massachusetts, New Hampshire, Rhode Island, Vermont, Maine, and Connecticut.

About Microtest Laboratories
Microtest Laboratories is a leader in testing services 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 Facebook at http://facebook.com/MicrotestLaboratories, on LinkedIn at http://goo.gl/H8ZLnM or on Twitter @MicrotestLabs.

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Tuesday, March 11, 2014

Webinar Exploring “What’s the Risk? Fearing the Failure in Environmental Monitoring Systems” is Offered for Life Science Companies

AGAWAM, MASS. — March 11, 2014 — A webinar to help life science companies explore the importance of a well-implemented and understood environmental monitoring program, and its ability to generate valuable data, will be offered on Wednesday, March 26, from 1:30 p.m. to 3:30 p.m. EST. The online event will identify the common mistakes and misconceptions regularly encountered when managers “fear the failure” of environmental excursions.

Environmental monitoring systems demonstrate that a company’s various contamination control strategies are operating properly. Such systems can illustrate whether operations are in a state of control. Variations in the data can indicate a drift which could potentially impact product and patient safety.

But the data generated by environmental monitoring system may become skewed when a culture is created which fears environmental failures or excursions. The webinar, What’s the Risk? Fearing the Failure in Environmental Monitoring Systems,” will detail how key life science company management can work to avoid such cultures.

Webinar topics — tailored for quality assurance and control, manufacturing, microbiology, and facilities management in pharmaceutical, biotech, and medical device organizations — will include:
  • The big picture: what systems need to be monitored and why the data is valuable
  • Risk-based environmental monitoring program implementation
  • Culture and “buy-in:” how to create a culture of employee acceptance for contamination control programs
  • Responding to data: how to identify trends in the data and respond with appropriate actions
The webinar will be offered Wednesday, March 26, 1:30 p.m. to 3:30 p.m. EST. Featured speakers include Valerie Montgomery, environmental services manager, and Alison Zulick, environmental services leader, both of Microtest Laboratories, a leading provider of testing services and contract manufacturing for the life science industries.


About Microtest Laboratories
Microtest Laboratories is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and compounding pharmacy industries. Based in Agawam, Massachusetts, USA, Microtest leverages its 30 years industry experience to help its clients meet their regulatory requirements.  For more information, visit http://www.microtestlabs.com or toll-free 1-800-631-1680.

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Tuesday, January 14, 2014

Fundamentals of Endotoxin Testing for Medical Device Manufacturers are Detailed in New Technical Brief

AGAWAM, MASS. — January 14, 2014  The fundamentals of endotoxin testing for medical device manufacturers — from definition to assay acceptance criteria —are detailed in new technical brief available from Microtest Laboratories.

Bacterial endotoxins cause fever, septic shock, and other disease symptoms — and thus attract considerable regulatory scrutiny from such organizations as the U.S. Food & Drug Administration (FDA) and the United States Pharmacopeial Convention. Regulations require that devices that contact circulating blood or cerebrospinal fluid, or are used with intraocular products or in vitro fertilization procedures, are required to be endotoxin-free.

The Fundamentals of Endotoxin Testing,” available for download at http://microtestlabs.com/endotoxin-testing, is a step-by-step information resource for medical device manufacturers discussing and detailing the:
  • Definition of endotoxins;
  • Various tests used for their detection;
  • Use of depyrogenation and other ways to remove endotoxins;
  • Types of devices that should be tested;
  • Preparation and testing of samples;
  • Options for sampling containers;
  • Acceptance criteria for each of the assays; and
  • Sources of official information, reference, and guidance.

The Fundamentals of Endotoxin Testing” is authored by Steven Richter, Ph.D., said Steven Richter, Ph.D., president and scientific director of Microtest Laboratories — and a former FDA official.


The paper is one in a series about testing, manufacturing, and regulatory issues of concern for medical device manufacturers from Microtest Laboratories, a leader in testing services and contract manufacturing for medical devices, pharmaceuticals, and biotechnology.

About Microtest Laboratories
Microtest Laboratories is a leader in testing services and contract manufacturing for medical devices, pharmaceuticals, and biotechnology. It was 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 firm to support a full pharmaceutical or medical device product release. The company’s facilities in Agawam, Massachusetts, USA 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. Follow Microtest Laboratories on Twitter @MicrotestLabs on Facebook at http://goo.gl/TndoBg.

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