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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.
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.
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.
Labels: Accuratus Lab Services, Ampersand Capital Partner, ATS Labs, Microtest Laboratories, Microtest Labs
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.
- 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.
# # #
Labels: assay acceptance, definition, endotoxin testing, endotoxin-free, endotoxins, medical device manufacturers, Medical Devices
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.
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.
Labels: disinfectant qualifications, environmental cleaning, manufacturing environment, medical device manufacturing, Medical Devices, pharmaceutical manufacturing, pharmaceuticals
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.
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.
Labels: cGMP, compounding manufacturer, compounding pharmacies, compounding pharmacy, Drug Quality and Security Act, HR3204, USP <797>
Parenteral Drug Association to Discuss Rapid Micro Systems and Tour Microtest Laboratories on May 6th in Agawam, Mass
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.
Labels: biological testing, New England Parenteral Drug Association, New England PDA, Parenteral Drug Association, PDA, rapid micro systems
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.
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.
Labels: Contamination control, environmental excursions, environmental monitoring, life science, manufacturing, microbiology, quality assurance, quality control
Fundamentals of Endotoxin Testing for Medical Device Manufacturers are Detailed in New Technical Brief
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.
- 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.
# # #
Labels: endotoxin testing, FDA, medical device, medical device manufacturing, medical device testing
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