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Press release news from the public relations clients of Tiziani Whitmyre, Inc.

Posts Tagged ‘sterility validation’


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.


Thursday, January 29th, 2009

Microtest Labs Offers Free Microbial Identification Testing, Free Shipping on Other Tests, to MD&M West Attendees

AGAWAM, MASS. – January 29, 2009 – To highlight its 20 years of experience as a leader in medical device testing services, Microtest Laboratories (www.microtestlabs.com) is offering free microbial identification testing, along with free shipping on other lab tests, to eligible attendees visiting the Microtest exhibit, #828, at MD&M West 2009 in February.

The free offers highlight Microtest’s wide range of laboratory testing and validation services – and problem solving approach – that combine to assist medical device manufacturers to gain a competitive marketplace advantage.

“We work with our clients throughout the testing and validation process to help reduce down-time, lower costs and risk, speed regulatory approvals and time to market, and minimize schedule disruptions,” said Dr. Steven Richter, Microtest President and Chief Scientific Officer.

The free microbial identification offer demonstrates the fast, precise and reliable bacteria, mycoplasma, and mold identification services that Microtest provides by utilizing its two in-house MicroSeq® Microbial Identification Systems.

With two MicroSeq systems, Microtest delivers precise and reliable test results in a 24-hour time period – rather than traditional testing that’s often less accurate and requires a week or more turn around. Microtest is one of only a few labs in its area with such technology.

Microtest is also offering one year of free standard ground shipping to spotlight the dozens of other medical device testing services it offers, including Gamma/ethylene oxide (EO) sterilization validation, and Reusables, Endotoxin, and Sterility testing and related services.

To receive any of the free offers, companies must register at the Microtest exhibit (booth #828) during the MD&M West 2009 Expo. Current Microtest clients are not eligible.

Microtest’s medical device testing facilities are ISO 9001 and ISO 17025:2005 certified, and U.S. FDA-regulated, meeting all GLP/GMP standards. For more information, visit Microtest at MD&M West 2009 in booth #828, on the Web at www.microtestlabs.com, or call 1-800-631-1680.

About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, 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., http://www.tizinc.com/pr-boston-public-relations/


Monday, June 4th, 2007

Med-Conduit Turns to Microtest for Medical Device Testing Services

AGAWAM, MASS., June 4, 2007 – Med-Conduit, an innovative developer and marketer of central venus catheters (CVCs) has teamed with Microtest Laboratories of Agawam, Mass., a leading provider of testing services to the medical device industry.

CVCs are found in use at intensive care and long term units in hospitals. When inserted into a patient, it enables that patient’s skin to grow into the device and form a biological seal that has a significant impact on preventing infection at the site of insertion, explained Dr. Gerald Bousquet, M.D., President, Med-Conduit.

Microtest is conducting bacteria testing on a new cap that Med-Conduit is implementing for its CVCs, said Dr. Bousquet.

Dr. Bousquet turned to Microtest for its current testing needs after working with the company and its founder, Steve Richter, Ph.D., on a previous project.

Dr. Richter had assisted Dr. Bousquet to navigate the stringent US Food and Drug Administration (FDA) application process and successfully obtain the critical FDA approvals he required to manufacture and sell a product at his previous company, Microwave Medical Systems. The product, the Microwave Sanitizer, is a microwave designed to sanitize the catheter connection area to decrease the risk of infection for patients in peritoneal dialysis.

“Dr. Richter’s prior experience working at the FDA, combined with his deep expertise and background in medical device development, and his personal passion to succeed, made all the difference in securing the approvals we required,” Dr. Bousquet said. “Dr. Richter even traveled with our company principles to meet with the FDA in Washington, DC.”

Microtest offers a host of single-source solutions that assist medical device manufacturers facing a rising volume and complexity of challenges in product development and validation, including:

  • Medical device sterilization validations
  • Package validations
  • Microbiology and clean room services, and
  • Analytical services.

A new free white paper written for medical device manufacturers discusses sterility testing as well as reviews different testing methodologies Titled “Sterility Testing: Essential Things You Must Know,” it’s authored by Dr. Richter, and is available for download at: http://www.microtestlabs.com/sterilitypaper.

About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, 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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Wednesday, May 30th, 2007

Microtest to Highlight Medical Device, Analytical Capabilities at MD&M East

AGAWAM, MASS. – May 30, 2007 – Microtest Laboratories will highlight its expanded medical device, contract manufacturing and analytical testing capabilities at the Medical Device & Manufacturing (MD&M) East Conference, June 11-14 at the Jacob Javits Convention Center in New York City.

With the completion of a $7.5 million capital improvement program, the addition of new resources and skilled professionals, and the purchase of a MicroSeq® Microbial Identification System, Microtest has bolstered its services and emerged as a leader in the medical device manufacturing market.

Microtest’s enhanced medical device sterility validation and release testing services (www.microtestlabs.com/medical-device-testing) includes:

  • Gamma/EO Sterilization Validation: Bioburden; Bioburden Recovery; Bacteriostasis/Fungistasis; Sterility; Dose Calculation; Spore Strip Population; Ethylene Oxide Residuals
  • Reusables: High/Low Level Disinfection; Cleaning Studies; Steam / EO / Chemical SterilizationEndotoxin: FDA / USP Gel Clot; Chromogenic; Turbidimetric
  • Sterility: USP; ANSI/AAMI/ISO; Product Immersion; Product Flush; Biological Indicator; Membrane Filtration; Steritest(TM) / Sterisolutest(TM)

Microtest’s upgraded analytical services (www.microtestlabs.com/analytical-chemistry-testing), performed as needed in accordance with USP/ISO/BP/AOAC/AAMI/JP requirements, include:

  • Services: ETO, ECH, EGLY Residuals Analysis; ETO, Pilot Vessel Studies; Formaldehyde Residuals Analysis
  • Water Testing: TOC (Total Organic Carbon); pH and Conductivity; Total Chlorine; Total Nitrates and Heavy Metals
  • Wet Chemistry: Heavy Metals; Non-volatile Residues; Residues on Ignition; Direct Titration; Nitrates

For more information on Microtest capabilities and services, visit Steve Richter, PH.D., Microtest President, in the Microtest booth, number 1544, at MD&M East, June 11-14 in the Jacob Javits Convention Center in New York City. Or, visit the Microtest website at www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

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.

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