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Wednesday, December 5th, 2012

“Processing Compounded Sterile Products,” Information Session Set for Dec. 12 in Springfield, Mass.

AGAWAM, MASS. — Dec. 5, 2012 — A free information session focusing on the challenges of meeting U.S. regulations mandating tighter control of sterile preparations in compounding pharmacies, has been scheduled for Dec. 12, 2012, in Springfield, Mass.

The session, “Processing Compounded Sterile Products,” will be presented by Microtest Laboratories, a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries.

Designed for managers of controlled environments in the pharmaceutical industry, experts in the session will offer technical presentations, practical advice, and solutions on issues relating to General Chapter <USP 797>, including:

  • Environment contamination control and testing
  • FDA aseptic guidance
  • USP <797> and <1116>
  • Technician training and qualification requirements
  • Product testing that includes: sterility/endotoxin, potency/ID, beyond use dating
  • Assessing current practices and next steps

“Processing Compounded Sterile Products” is scheduled for Wednesday, December 12, 2012, at the Hilton Garden Inn, 800 Hall of Fame Avenue, Springfield, Mass., from 9:30 to 11:30 a.m. Registration is at 9 a.m. The session is free — complimentary entry, parking, and refreshments will be provided — but space is limited and advance reservations are required. For more information or to reserve admission, visit the Microtest Laboratories website at http://www.microtestlabs.com/pdfs/seminar-registration-form_1212.pdf, call 1-800-631-1680 extension 192, or email jadamski@microtestlabs.com.

Microtest Laboratories is a Massachusetts-based, FDA-audited company with a history of exceptional regulatory compliance. Microtest’s environmental sciences group helps its clients maintain control of their controlled environments and is a proven resource for contamination testing needs arising from the manufacturing of medical devices or pharmaceuticals, as well as sterile compounding in hospital pharmacies.

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.

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Posted in Biosciences, Health/Medical, Life Sciences |


Monday, November 26th, 2012

Immunetics, Inc. Names John Yonkin as CEO

Boston, Mass. — November 26, 2012 — Immunetics, Inc., an innovative developer of state-of-the-art assay technology for infectious disease diagnosis and blood screening, today announced that the company’s Board of Directors has appointed John Yonkin as Chief Executive Officer.

Mr. Yonkin will assume the post of CEO effective December 1, 2012. He will also serve as a member of the Board of Directors.

Mr. Yonkin brings more than 25 years of business experience in the clinical diagnostics field to Immunetics. Previously, he served as Vice President for Strategic Projects at Alere, Inc., and as President of Alere’s predecessor, Inverness Medical Innovations. While at Alere, he was the lead executive responsible for the integration of Biosite, Inc., following its acquisition by Alere in 2007. At Inverness, Mr. Yonkin was President of Nutritionals and Pharmaceuticals from 2005-2007, and Vice President of U.S. Sales and Marketing from 2001-2005. His previous experience includes positions managing sales and marketing and product development at Baxter, Genzyme, and Inverness.

“I am very excited to be joining the very talented scientific team at Immunetics as the company prepares to bring to market the innovative BacTx® rapid test for bacterial contamination of platelets,” Mr. Yonkin said.

The BacTx test addresses a critical, global infectious risk in transfusion, caused by the  estimated 1 in 2,000 platelet units that are contaminated with bacteria. Medical studies are increasingly showing that such contamination is a significant cause of illness and death among transfusion recipients. Worldwide, more than 10 million platelet units are collected per year.

Immunetics received U.S. Food and Drug Administration (FDA) clearance for its BacTx test in June 2012. The company has issued patents on the BacTx technology, which was initially developed with support from the National Institutes of Health.

Mr. Yonkin succeeds Dr. Andrew Levin, the company’s founder. Dr. Levin will remain President at Immunetics and will continue to lead the Research and Development group.

About Immunetics

Immunetics, Inc. offers state-of-the-art assay technology for infectious disease diagnosis and blood screening, and for more than ten years has been a leading innovator of tests for bacterial, viral, and parasitic diseases. The produces and markets a range of infectious disease assay kits and instruments. The company has issued patents on its BacTx® test for bacterial contamination of platelets. It has developed and markets other FDA-cleared products, including a test for Lyme disease, and is actively working on new tests for Babesiosis and Chagas disease — both of which are emerging risks to the blood supply. Immunetics is headquartered in Boston. The company’s mission is to deliver better, cost-efficient care through more accurate diagnosis. For more information, visit the Immunetics website at http://www.immunetics.com.

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Posted in Biosciences, Life Sciences |


Monday, September 10th, 2012

Immunetics Receives $3.7 Million NIH Contract for Babesia Blood Screening Test

— Will Carry Out Clinical Trials with Blood Systems Research Institute,
Creative Testing Solutions —

BOSTON — September 10, 2012 — Immunetics, Inc., has received a $3.7 million, two year SBIR contract from the National Heart, Lung and Blood Institute, an agency of the National Institutes of Health (NIH), to support clinical trials of a new blood screening test for Babesia infection.

“Babesia is among the top infectious threats to blood safety and, at present, there is no licensed test available. The NIH contract will allow us to address this gap in blood safety with the first cost-effective test designed for high-throughput screening of the blood supply.  We are honored to have been entrusted by NIH to carry out this public health mission,” said Andrew E. Levin, Ph.D., Immunetics Chief Executive Officer and Scientific Director.

Babesia is a parasite which is transmitted by the same ticks that transmit Lyme disease. While it is often asymptomatic in healthy people, Babesia infection can lead to severe or fatal illness, especially in immunocompromised patients. The parasites can remain viable in blood donations and infect transfusion recipients. In recent years, nine fatal cases of transfusion-transmitted babesiosis have been reported. Surveillance carried out by the Centers for Disease Control and Prevention (CDC) revealed over 1,000 cases of infection nationwide in 2011 — a number that appears to be growing. The US Food & Drug Administration (FDA) sponsored a workshop in 2008 focused on Babesiosis as an emerging threat to the blood supply, and the Blood Products Advisory Committee convened a meeting in 2010 to advise the FDA on approaches to blood screening for Babesia.

The contract award will enable Immunetics to bring its Babesia test, developed under initial NIH support, through clinical trials and regulatory licensure. The trials will be carried out in collaboration with Blood Systems Research Institute of San Francisco, Calif., and Creative Testing Solutions of Tempe, Ariz. Creative Testing Solutions currently tests about 25% of the US blood supply, including regions endemic for the parasitic agent. The Babesia test will initially be made available through Creative Testing Solutions’ laboratories.

“We look forward to partnering with Immunetics and BSRI in the development and FDA approval process of a Babesia assay for use in blood screening,” said Creative Testing Solutions President Sally Caglioti. “It is always our intent to offer innovative services that provide our customers with the best donor testing possible. Active collaboration in the development of diagnostic tests that fit the immediate needs of the blood banking community is the next logical step to support CTS’ mission.”

“When the screening test identifies antibody-reactive donors, we will enroll and conduct rigorous testing of donation-derived and follow-up samples from those donors so that we can more fully understand the natural history of Babesia infection in asymptomatic donors,” said Michael P. Busch, M.D., Ph.D., Blood Systems Research Institute Director and Senior Vice President for Research and Scientific Affairs at Blood Systems. “The information that we derive will help guide the development of policies on how the test can be used most effectively. It will also determine whether and how donors who have had a positive result on the screening test could safely donate in the future.”

For more information, visit the company’s website at http://www.immunetics.com or call 1-617-896-9100 or toll-free 1-800-227-4765.

Immunetics is a leading developer and provider of innovative tests for a variety of bacterial, viral, and parasitic diseases. Recently, the company received FDA clearance for its BacTx® test for bacterial contamination in platelets. The company has developed and markets other FDA-cleared products, including a test for Lyme disease, and is actively working on new tests for HIV and Chagas disease — both of which are known or emerging risks to the blood supply.

About Immunetics

Immunetics Inc. (http://www.immunetics.com) offers state-of-the-art assay technology for infectious disease diagnosis and blood screening, and for more than ten years has been a leading innovator of tests for bacterial, viral, and parasitic diseases. The company produces and markets a range of infectious disease assay kits and instruments. Its mission is to deliver better, cost-efficient care through more accurate diagnosis. Immunetics is headquartered in Boston. Follow Immunetics on Twitter at http://twitter.com/immunetics.

About Creative Testing Solutions

Creative Testing Solutions (www.myCTS.org), a joint venture of Blood Systems and Florida-based OneBlood, is the largest independent blood donor testing laboratory in the United States, specializing in high-volume blood donor testing and infectious disease reference work. This non-profit organization, headquartered in Tempe, Arizona, tests nearly 4.5 million samples annually at three national laboratories in Dallas, Phoenix and Tampa that, combined, provide testing for more than 25 percent of the U.S. blood supply.

About Blood Systems

Blood Systems (www.bloodsystems.org) is one of the nation’s oldest and largest non-profit community blood service providers and operates community blood centers serving more than 500 hospitals in 18 states, biological products distribution services, a quality consulting group and a world-renowned transfusion medicine research institute.

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Posted in Biosciences, Health/Medical, Life Sciences |


Tuesday, August 14th, 2012

Use Notebook Studies to Ensure Successful Reusable Device Cleaning Validations, Recommends Microtest Laboratories

AGAWAM, MASS. —August 14, 2012 — A new management brief from Microtest Laboratories recommends that medical device manufacturers use notebook studies to help ensure successful reusable device cleaning validations. The lab bases the advice on its performance of validations for various types of medical instruments over the years.

The brief discusses the document, “FDA Draft Guidance for Industry and Staff, Processing /Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling,” which was released in May 2011.

“Even though it’s labeled as a draft, experience has shown that most reusable device cleaning validations are being evaluated based on this document,” said Patrick Kenny, manager of analytical services at Microtest Laboratories — and author of the new brief titled, “Notebook Studies to Ensure Successful Reusable Device Cleaning Validations.”

Kenny’s brief focuses on areas of the FDA guidance document that are causing difficulties in cleaning validations, and demonstrates how pre-validation laboratory work can help save time and money. It also identifies areas that can cause issues during validations if they are not thoroughly addressed prior to initiating the protocol. These include:

  • The use of worst-case conditions
  • The switch from microbial-based assays to chemical-based assays
  • The determination of an acceptable residual level
  • The validation of a reusable device’s cleaning instructions

“The good news is that almost all of these issues can be eliminated with some up-front work,” Kenny said. “And this preparatory work can best be performed by notebook studies prior to initiating GLP studies. The information obtained in these relatively quick studies often saves significant time later in the filing process.”

“In short, we recommend the use of notebook studies prior to beginning the validation to eliminate as many unknowns as possible,” he said.

To obtain a copy of the new management brief, “Notebook Studies to Ensure Successful Reusable Device Cleaning Validations,” visit http://www.microtestlabs.com/notebook-studies-brief or call 1-413-786-1680, or toll-free 1-800-631-1680.

About Microtest Laboratories

Microtest Laboratories is a full-service medical device testing laboratory and provider of related services for the medical device, pharmaceutical, and biotechnology industries. Medical device testing is performed in-house by seasoned regulatory microbiologists and chemists under strict GMP/GLP regulations. Microtest is both ISO 9000 and 17025 certified. Testing services include bioburden, sterility, endotoxin, accelerated aging, and toxicity (ISO 10993). In addition, Microtest recently introduced a fast-track test to screen plastics and polymers in medical devices for toxicity using Zebrafish embryos.

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 on Twitter at http://twitter.com/MicrotestLabs.

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Press Contact: Don Goncalves, Tiziani Whitmyre, 781-793-9380, dgoncalves@tizinc.com

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Posted in Health/Medical, Life Sciences |


Tuesday, July 31st, 2012

Six Critical Areas to Ensure Regulatory Compliance in Aseptic Manufacturing are Outlined in New Management Brief

AGAWAM, MASS. — July 31, 2012 — 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.

The new management brief, “Weathering the Storm of Regulatory Compliance in Aseptic Manufacturing,” outlines six critical areas that should be addressed to avoid the possibility of product contamination:

  • 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.

The new management brief discusses how. Download a copy of “Weathering the Storm of Regulatory Compliance in Aseptic Manufacturing,” from http://www.microtestlabs.com/weathering-the-storm-brief.

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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Posted in Biosciences, Life Sciences, Manufacturing |


Tuesday, July 24th, 2012

New White Paper, “Five Biggest Myths about Medical Products Outsourcing,” Finds OEM’s Concerns are Often Unfounded

BILLERICA, MA — July 24 2012 — A new white paper, “The Five Biggest Myths about Medical Products Outsourcing,” examines the reasons why five typical areas of concern about outsourcing medical products manufacturing are often unfounded. In addition, the paper outlines the advantages that outsourcing can provide original equipment manufacturers (OEMs) in terms of delivering quality products on time and on budget. The paper is available now for download at http://resources.labmedical.com/medical-products-outsourcing from LAB Medical Manufacturing.

Outsourcing medical product manufacturing is a thriving industry. In the U.S. alone, more than 3,000 firms offer their services as a contract manufacturer (CM) for medical devices, instruments, and implants. Most leading original equipment manufacturers (OEMs) of medical products employ at least some CMs; many have made them permanent parts of their manufacturing resource strategy.

However, some OEM planners resist using CMs, or have difficulty selecting the right one.

The white paper, titled “The Five Biggest Myths about Medical Products Outsourcing,” discusses the five top myths about outsourcing medical product manufacturing that lure OEMs into falling prey to misunderstandings or concerns. These include cost, quality, or product complexity, or about maintaining control of intellectual property, or feel insecure about utilizing any but the very largest CMs.

The five myths are:

  • Myth #1: The lowest purchase price equals the lowest cost.
  • Myth #2: Every source offers the same quality.
  • Myth #3: You can only outsource the simple stuff.
  • Myth #4: Outsourcing equals losing control.
  • Myth #5: Size matters most.

OEMs may entertain several fears that make them reluctant to use new contract manufacturers, or indeed to employ CMs at all, according to the white paper. However, the right CM, with the relevant resources and with experience in a given product type, can often be a good fit to an OEMs’ requirements.

A nimble, right-sized CM can offer a fruitful collaboration that produces improved medical instruments and implants — on time and on budget — to achieve enhanced patient outcomes, the white paper reports.

Download the new white paper, “The Five Biggest Myths about Medical Products Outsourcing,” from http://resources.labmedical.com/medical-products-outsourcing.

About LAB Medical Manufacturing

LAB Medical Manufacturing, Inc., is a world-class contract manufacturer of high-precision medical devices and implants for leading original equipment manufacturers (OEMs). Its high-quality, cost-effective solutions help achieve better patient outcomes while reducing health care expenses. Founded in 1984, the company combines a passion for problem-solving with comprehensive in-house resources; exceptional engineering; unmatched application expertise; and flexible, integrated manufacturing. It is ISO 13485:2003 certified and FDA registered as a contract manufacturer. LAB Medical maintains facilities in Billerica, Massachusetts, USA, and Nowa Deba, Poland. Visit the company website at http://www.labmedical.com.

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Posted in Health/Medical, Life Sciences |


Wednesday, June 13th, 2012

Immunetics Receives FDA Clearance for BacTx Rapid Test for Bacterial Contamination of Platelets

BOSTON, MA – June 12, 2012 – Immunetics, Inc., has received U.S. Food and Drug Administration (FDA) clearance for its BacTx® rapid test for bacterial contamination in platelet units, Andrew E. Levin, Ph.D., Immunetics Chief Executive Officer and Scientific Director, announced today.

Immunetics’ BacTx rapid test addresses the greatest infectious risk in transfusion today. An estimated 1 in 2,000 platelet units is contaminated with bacteria — and medical studies are increasingly showing that such contamination is a significant cause of illness and death among transfusion recipients.

The FDA clearance allows use of the BacTx test on leukocyte-reduced whole blood-derived platelet units, a type of platelet preparation which exhibits relatively high rates of bacterial contamination due to the pooling of units from multiple donors. In the studies reported to the FDA, the BacTx test detected all of the bacterial strains tested, with sensitivity and specificity meeting or exceeding clinical requirements.

“Existing approaches to the detection of bacterial contamination have fallen short, leaving patients at risk. They rely mainly on the culturing of the platelet units, a decades-old method that takes up to several days to yield a result,” Dr. Levin noted.

“By contrast, the BacTx test can be run in about 45 minutes, making it suitable to test platelet units shortly before they are transfused into a patient,” he said.

With the FDA clearance, the BacTx test is now available for immediate evaluation and sale. Additional trials are underway to expand the range of applications for the test.

“Receiving FDA clearance for the BacTx test is a critical milestone for Immunetics,” Levin said, “culminating years of work in which we’ve taken a novel technology from concept through clinical trials and regulatory approval — and are now ready to address an urgent need in the blood bank and transfusion services market.”

Worldwide, more than 10 million platelet units are collected per year.

The results of clinical trials of the BacTx test were presented by Drs. Andrew Heaton (NSLIJ Health System, New York) and Michael Jacobs (University Hospital – Case Medical Center, Cleveland), the clinical investigators leading the trials, at the American Association of Blood Banks (AABB) meeting in October 2011.

Immunetics has issued patents on the BacTx technology, which was initially developed with support from the National Institutes of Health. The company has developed and markets other FDA-cleared products, including a test for Lyme disease, and is actively working on new tests for Babesiosis and Chagas disease — both of which are emerging risks to the blood supply.

For more information about the BacTx® rapid test for bacterial contamination in platelet units, visit the Immunetics website at http://immunetics.com/bactx.html or contact the company at 1-617-896-9100 or toll-free at 1-800-227-4765.

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About Immunetics
Immunetics Inc. (http://www.immunetics.com) offers state-of-the-art assay technology for infectious disease diagnosis and blood screening, and for more than ten years has been a leading innovator of tests for bacterial, viral, and parasitic diseases. The company produces and markets a range of infectious disease assay kits and instruments. Its mission is to deliver better, cost-efficient care through more accurate diagnosis. Immunetics is headquartered in Boston. Follow Immunetics on Twitter at http://twitter.com/immunetics.

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Posted in Biosciences, Health/Medical, Life Sciences |


Wednesday, May 2nd, 2012

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.

For more information, visit the conference webpage at http://www.microtestlabs.com/conference, or contact Julie Adamski, toll-free, at 1-800-631-1680, ext. 192, or jadamski@microtestlabs.com.

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.

 

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Posted in Biosciences, Life Sciences |


Monday, April 30th, 2012

Industry Perspective on Reusable Medical Device Cleaning and Validation Requirements Outlined in New Management Brief

AGAWAM, MASS. — April 30, 2012 — A new management brief discusses the potential impact on reusable medical device cleaning validations and testing requirements resulting from the US Food & Drug Administration’s (FDA) draft guidance document, “Draft Guidance for Industry and FDA Staff – Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.” The new brief is available from Microtest Laboratories at http://www.microtestlabs.com/reusable-med-device-brief.

“Although the FDA guidance document is not legally enforceable, it describes the agency’s ‘current thinking and should be viewed as recommendations,’” said Steven Richter, Ph.D., president and scientific director of Microtest Laboratories — a former FDA official — and author of the brief.

In his brief titled “Reusable Medical Device Cleaning Validation and Testing Requirements (An Industry Perspective),” Richter discusses a variety of issues raised by the document which the FDA released last May for industry comment. The issues include:

  • “Spore tag reduction” and Hucker’s soil challenges
  • Cleaning methods using protein, carbohydrates, red blood cells and lipids
  • Separation of cleaning, disinfectant and sterilization validation activities
  • ASTM Simulated Use Test
  • Three log reduction for cleaning validations
  • Empirical data in 510(k) submissions
  • Reducing manufacturing materials to “safe levels”

While Richter emphasized that “the FDA document was issued for comment and is not for implementation, the medical device industry understands that changes from current best practices will be required immediately.”

His brief seeks to “raise the industry discussion of issues that must be anticipated, discussed, and thoroughly evaluated for the time when implementation is required,” he said.

Dr. Richter founded Microtest Laboratories in 1984 after a distinguished career at the FDA. Under his leadership, Microtest Laboratories provides the medical device, pharmaceutical, and biotechnology industries with premier testing and manufacturing support.

Download a copy of the management brief, “Reusable Medical Device Cleaning Validation and Testing Requirements (An Industry Perspective),” from http://www.microtestlabs.com/reusable-med-device-brief.

Microtest Laboratories, based in Agawam, Massachusetts, is a full-service medical device testing laboratory and a leader in medical device testing and related services for the medical device, pharmaceutical, and biotechnology industries. Testing is performed in-house by seasoned regulatory microbiologists and chemists under strict GMP/GLP regulations. Microtest is both ISO 9000 and 17025 certified. Testing services include bioburden, sterility, endotoxin, accelerated aging, and toxicity (ISO 10993). In addition, Microtest recently introduced a fast-track test to screen plastics and polymers in medical devices for toxicity using Zebrafish embryos.

For more information, visit Microtest’s web site at http://www.microtestlabs.com or call 1-413-786-1680, or toll-free 1-800-631-1680.

 

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Posted in Biosciences, Life Sciences |


Friday, April 13th, 2012

New Analytical Methods on Testing Protein, Hemoglobin & Carbohydrates is Focus of Tech Presentation at BIOMEDevice Boston, April 25

AGAWAM, MASS. – April 13, 2012 – BIOMEDevice Boston attendees will learn about new analytical methods on testing protein, hemoglobin, and carbohydrate in an Innovation Briefs Theater presentation on Wednesday, April 25, by Patrick Kenny, Director of Analytical Services at Microtest Laboratories Inc.

The focus of Kenny’s technology presentation — titled “Flushing It Out” and of interest to anyone who is bringing a device to market — will include:

  • Regulations and Guidance, Background, Cleaning Validation Purpo
  • Why Chemical Tests?
  • Why Protein, Hemoglobin, and Carbohydrates
  • Method Detection Limit vs. Device Detection Limit
  • Validation Testing
  • Test Soil
  • Spiking Location
  • Extraction
  • Residual Protein, Hemoglobin, and Carbohydrate Assays

Flushing It Out will be presented at 12 p.m., Wednesday, April 25, in the Innovation Briefs Theater, Booth 1051, at BIOMEDevice Boston. Admission is free with BIOMEDevice Boston admission credentials. No reservations are needed.

Kenny has over 14 years of laboratory experience, including five supervising the Analytical Chemistry department at Microtest Laboratories, a leader in medical device testing and related services for the medical device, pharmaceutical, and biotechnology industries. Kenny holds BS and MS degrees in chemistry and is the author of numerous articles, including the white paper, “Five Steps to Validating the Cleaning Process of Medical Devices,” available for download athttp://www.microtestlabs.com/cleaning-validation-paper.

Kenny’s lab routinely performs cleaning validations on reusable and one-time use medical devices. In addition to medical device testing, the lab performs analysis of pharmaceutical drug products and combination products in support of all phases of development.

For more information, visit Microtest Laboratories at BIOMEDevice Boston in booth 1023, April 25-26, 2012. Or, visit Microtest’s web site athttp://www.microtestlabs.com or call 1-413-786-1680, or toll-free 1-800-631-1680.

About Microtest Laboratories
Microtest Laboratories is a leader in medical device testing and related 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 Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.

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Posted in Life Sciences |

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