industry pr

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

Posts Tagged ‘Medical Device Manufacturing’


Monday, May 12th, 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.


Tuesday, January 14th, 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.

Download the brief from: http://microtestlabs.com/endotoxin-testing.

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.

# # #


Tuesday, June 4th, 2013

Medical Device Professionals to Learn “What They Need to Know” about Manufacturing Combinations Products & FDA Regulations at MD&M East Workshop

AGAWAM, MASS. — Medical device professionals will learn what they need to know about manufacturing combinations products and FDA Regulations at a workshop to be featured at MD&M East, the world’s largest medical OEM event, in Philadelphia on Tuesday, June 18, 2013.

Titled “Combination Products: What You Need to Know,” the workshop will outline a realistic approach for medical device professionals to use in navigating the regulatory standards required for the approval, marketing, and manufacture of combination products. Topics will include:

  • Defining a Combination Product
  • Current and pending FDA regulations re: their approval, marketing, and manufacture
  • Self-assessing the Primary Mode of Action (PMOA)
  • Integrating with the FDA through the Request for Designation (RFD) Guidance from the Office of Combination Products (OCP)
  • GMP issues involving the manufacture of a drug component with a medical device
  • Differences between medical device cGMPs and pharmaceutical cGMPs: Jargon, regulations, and general culture
  • Real-world case studies
  • Questions & answers

Microtest Laboratories Director of Project Management, Manufacturing, Alex Mello will lead the workshop. Microtest Laboratories is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Mello has more than 20 years of experience in Aseptic Fill/Finish, Microbiology, Method Transfer, Stability of Drug Product, Medical Devices/Combo Products, and Sterilization Sciences. He holds a graduate degree in Biological Sciences and is a Specialist Microbiologist (NRCM).

Combination Products: What You Need to Know” will be featured at MD&M East as part of the event’s “Innovation Briefs” series. The workshop will be held on Tuesday, June 18 at 1 p.m. in booth #957. Attendance is free for MD&M East guests and participants. For more information, contact Microtest Laboratories by phone at 1-800-631-1680 or by email at amello@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.


Thursday, January 6th, 2011

Century Park Capital Partners Announces the Recapitalization of Cirtec Medical Systems, LLC

January 6, 2011, LOS ANGELES – Century Park Capital Partners is pleased to announce that it led the recapitalization of Cirtec Medical Systems LLC (“Cirtec”) along with Charter Oak Equity and the company’s founders. Cirtec is a leading provider of client focused, comprehensive medical product design, engineering and manufacturing solutions. Cirtec provides its customers with highly technical solutions, utilizing its expertise in minimally invasive systems, active and passive implants, and medical electronics. Cirtec was formed in 2009 from the merger of Circle Medical Devices and Texcel Medical. The company operates out of locations in Los Gatos, California and East Longmeadow, Massachusetts.

“We chose to partner with Century Park because of their philosophy of collaborating with management and their track record of successfully helping businesses grow,” stated Barry Smith, CEO of Cirtec. “Century Park’s leadership and access to resources will allow us to maintain our industry leading position in the outsourced medical device design and manufacturing industry as we take our business to the next level.”

Larry Derose, one of the founders of the company said, “This partnership with Century Park is the next step in our company’s evolution. By coupling our success in the market with Century Park’s proven experience helping businesses of our size grow, we have become exceptionally well positioned to capture the tremendous opportunities that exist in our marketplace.”

Century Park Capital Partners has experienced success in the medical device arena through prior investments in the medical contract manufacturing sector.

Chip Roellig, a Managing Partner of Century Park, stated, “We are very enthusiastic about our new partnership with Cirtec. Cirtec’s reputation as the market leader and its customer relationships with major medical device OEMs in the neurostimulation and cardiovascular markets set the company apart from other medical device design and manufacturing firms. Cirtec is especially attractive because they offer their customers a range of highly technical capabilities that improve device design and reduce time to market for new devices, while offering a superior economic value proposition. Furthermore, Cirtec is well positioned to take advantage of the trend in increased outsourcing of medical device design and manufacturing. As neurostimulation and cardiovascular devices evolve and gain further acceptance, Cirtec is primed for growth.”

Terms of the transaction were not disclosed. The investment by Century Park was made from its latest fund, Century Park Capital Partners II, L.P.

About Cirtec Medical Systems

Cirtec Medical Systems, through its partnerships with its customers, has become a leading single-source provider of comprehensive medical product design and manufacturing solutions from concept through high-volume finished goods across all therapeutic categories. Its technically-driven, 130-person team has particular expertise in minimally invasive systems, active and passive implants, and medical electronics. Cirtec Medical Systems is ISO-13485 (2003) and FDA certified and maintains locations in Los Gatos, California and East Longmeadow, Massachusetts. For more information about Cirtec, please visit www.cirtecmed.com.

About Century Park Capital Partners

Century Park Capital Partners is a Los Angeles-based private equity firm that partners with owner/managers to build successful companies. The firm specializes in facilitating owner liquidity and business expansion by providing equity for recapitalizations, buyouts, growth financings, and acquisitions. More information on Century Park Capital Partners can be found at www.centuryparkcapital.com.

About Charter Oak Equity

Charter Oak Equity is a Westport, CT based private equity firm. Charter Oak Equity focuses on niche manufacturing, packaging, medical products & services, specialty chemicals, consumer products and financial services companies ranging in size from $5 million to $150 million in enterprise value.  More information on Charter Oak Equity can be found at www.charteroak-equity.com.

# # #

Public Relations contact, Boston:  Don Goncalves, dgoncalves@tizinc.com, 781-793-9380, for Tiziani Whitmyre Inc., http://www.tizinc.com/public-relations


Thursday, March 26th, 2009

Texcel Medical Appoints John Mulvihill as Vice President, Sales and Marketing

East Longmeadow, Mass. – March 26, 2009 – Texcel Medical, a full service medical device process design, development and contract manufacturing company, has announced the appointment of John Mulvihill as Vice President, Sales and Marketing.

Mulvihill, 49, of East Longmeadow, Mass., will direct the sales and marketing functions at Texcel Medical, which helps companies around the world by providing the manufacturing infrastructure and expertise they need to accelerate the commercialization of their surgical, interventional, multiparameter, and implantable medical device technologies. The firm is headquartered in East Longmeadow, Mass.

Texcel Medical President and CEO Barry Smith reinforced the significance of Mulvihill’s appointment. “John’s previous experience in the medical electronics industry and his achievements in leading and developing highly successful market driven teams is an ideal complement to Texcel Medical’s strategic growth initiatives as we move forward in creating long term partnerships with our clients,” Smith said.

Prior to joining Texcel Medical, Mulvihill served as Business Development and Vice President of Sales and Marketing for several medical device product and engineering companies. Most recently, Mulvihill was with Greatbatch, Inc., of Clarence, NY.

Texcel Medical’s 20+ years of experience provide companies increasingly sophisticated designs through reliable manufacturing, with particular expertise in Orthopedics, Cardiac Assist, Active Implantables, Combination Products, and General Instrumentation.

For more information, visit Texcel Medical’s website at www.texcelmedical.com or contact John Mulvihill at Texcel Medical, 55 Deer Park Drive, East Longmeadow, MA 01028, or by phone at (413) 525-5700 ext. 1010.

About Texcel Medical:
Texcel Medical (www.texcelmedical.com) creates long term partnerships with medical device companies in the areas of Class II medical electronics, Class III implantable electronics, IPG’s (Implantable Pulse Generators – Neuromodulation) and laser technology and manufacturing services. Texcel Medical has served the medical device community for over 20 years and is ISO-13485 (2003) certified.

# # #

Public Relations contact: Tiziani Whitmyre, Inc., www.tizinc.com/services/public-relations/


Monday, February 23rd, 2009

Texcel Medical Appoints Barry Smith as President, CEO

East Longmeadow, Mass. — February 23, 2009 – Texcel Medical, LLC, a full service medical device process development and contract manufacturing company, has announced the appointment of Barry Smith as President and CEO.

Smith will oversee all functions at Texcel Medical, which helps companies around the world by providing the manufacturing infrastructure and expertise they need to accelerate the commercialization of their surgical, interventional, and implantable medical device technologies. The firm is headquartered in East Longmeadow, Mass.

Texcel Medical Founder and Chairman Laurence Derose, emphasized the significance of Smith’s appointment. “Barry’s executive experience in the medical products market is an ideal compliment to Texcel’s strategic growth initiatives as we move to the next level as a long term partner,” Derose said.

Prior to joining Texcel, Smith served as Chief Operating Officer and Vice President of Operations and Product Development for several medical device product and engineering companies.

Derose continues in his role as Chairman and will expand his focus on identifying and securing strategic partnerships for the organization.

Texcel Medical’s medical device process development and manufacturing solutions and services includes design for manufacturability (DFM), design history file management, inventory management, quality and regulatory assistance, and process validation, along with general manufacturing, electronic testing, laser welding, and clean-room processing for a wide range of product applications. Texcel Medical has more than 20 years of experience assisting companies execute increasingly sophisticated designs through reliable manufacturing, with particular expertise in Orthopedics, Cardiac Assist, Active Implantables, Combination Products, and General Instrumentation.

For more information, visit Texcel Medical’s website at http://www.texcelmedical.com/ or contact Keith Checca at Texcel Medical, 55 Deer Park Drive, East Longmeadow, MA 01028, or by phone at (413) 525-5700.

About Texcel Medical:
Texcel Medical, LLC (http://www.texcelmedical.com/), a full service medical device process development and contract manufacturing company, creates long term partnerships with medical device companies in the areas of Class II medical electronics, Class III implantable electronics, IPG’s (Implantable Pulse Generators – Neuromodulation) and laser technology and manufacturing services. Texcel Medical has served the medical device community for over 20 years and is ISO-13485 (2003) certified.

# # #

Public Relations contact: Tiziani Whitmyre, Inc., www.tizinc.com/services/public-relations/


Tuesday, February 10th, 2009

Texcel Highlights Medical Device Development & Manufacturing Solutions


East Longmeadow, Mass. — February 10, 2009 — Texcel’s custom medical device development and manufacturing solutions helps companies around the world accelerate the commercialization of their surgical, interventional, and implantable medical device technologies. Texcel will highlight its full array of services and technologies at the MD&M West Expo, February 10-12, 2009, in exposition booth # 314.

Texcel provides the manufacturing infrastructure and expertise for a wide range of product applications – from endoscopic surgical instrumentation and spinal/orthopedic implants to total artificial hearts and neurostimulators.

Texcel’s specialized services and full medical device solutions include device design, development history file management, quality and regulatory assistance, process validation, along with general manufacturing, electronic testing, laser welding, and clean-room processing for a wide range of product applications.

Texcel, with more than 20 years of experience assisting companies execute increasingly sophisticated designs through reliable manufacturing, has particular expertise in five key areas:

  • Orthopedics, including products ranging from metal bone fastening devices to novel new materials;
  • Cardiac Assist, with expertise helping industry pioneers assemble and produce many types of cardiac assist devices;
  • Active Implantables, including a wide range of metal and non-metal biocompatible materials as well as dynamic mechanical and electrical features;
  • Combination Products, combining strong internal development and manufacturing capabilities with partners specializing in pharmaceuticals.
  • General Instrumentation, including a wide array of interventional products from durable medical equipment components to disposable catheter devices, and a full range of materials and assembly methods.

“By combining our comprehensive, highly integrated suite of capabilities and state of the art production facility into a single, seamless solution, we manage all the concerns of development and manufacturing process for our clients. We thus empower our clients to focus other priorities, such as developing new markets and therapies based on their proprietary technologies,” said Keith Checca, Director of Business Development, Texcel, (http://www.texcelmedical.com/).

The company is staffed with over fifty (50) talented, experienced, and passionate medical device industry employees within an ISO 13485 and ISO 9001 environment.

Based in East Longmeadow, Massachusetts, Texcel works with companies around the world.

For more information, visit Texcel at MD&M West 2009 in booth # 314; online visit http://www.texcelmedical.com/, or call 413-525-5700.

# # #

Download high resolution images from: http://www.flickr.com/photos/10956940@N08/sets/72157613280222222/

Public Relations contact: Tiziani Whitmyre, Inc., www.tizinc.com/services/public-relations/


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.

# # #

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.

# # #


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.

# # #


B2B News is proudly powered by WordPress.
WordPress