News
February 2, 2012 TOLEDO, OH. LexaMed's own President and industry expert, Robert R. Reich will be presenting at the MD&M West Conference on Thursday, 2/16/2012 at Session 404: The A,B,C's of Product Sterilization Selection. (Session Chair: Karl Hemmerich, President, Ageless Processing Technologies) The MD&M West Conference is February 13-16, 2012 (Exposition is February 14-16, 2012) at the Anaheim Convention Center, Anaheim, CA. You can register at www.MDMWestConference.com or contact Joseph Gharghoury directly at 310-996-9417 or via email at joseph.gharghoury@ubm.com who can assist you individually or provide you direction on group discounts. Register today! MD&M West Conference 2012 offers the premier conference programs for research and development, design, engineering, quality, manufacturing, and regulatory affairs professionals within the medical device industry. Find new ideas and insights from 120 industry experts at the MD&M West Conference. See the session agenda with 20 full-day conference programs or download the full Conference Brochure.
January 3, 2012 TOLEDO, OH. LexaMed is pleased to announce that it now maintains a FDA Drug Registration in addition to the existing Device Registration. LexaMed is committed to providing you with quality services by continuously expanding its capabilities to meet customer needs.
December 5, 2011 TOLEDO, OH. LexaMed is pleased to announce the expansion of its FDA-registered, ISO 13485 certified laboratory operation to include the testing of fabrics used to manufacture gowns and drapes for the healthcare market. LexaMed can perform all the testing required by ANSI/AAMI PB70:2003/(R) 2009, Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities. These tests include the blood penetration, ASTM 1670. Additionally, LexaMed has recently qualified the ASTM 1671 viral penetration test in this same area. For information on these tests, and our other laboratory and consulting services, please contact info@lexamed.net.
October
4, 2011 TOLEDO, OH. LexaMed will present
"How to establish an integrated, compliant Environmental Monitoring Program",
Thursday,
November
10, 2011, from 9am-4pm EST, at the
Hilton Garden Inn, located at 6165 Levis Commons Boulevard, Perrysburg,
OH 43551. The cost is only $195 which includes lunch. Contact
Becky Gilsdorf via email at
bgilsdorf@lexamed.net or via phone at 1-888-232-5227 x169 for additional
information or to
register today!
This seminar (download flyer) is presented by LexaMed Subject Matter Experts with first-hand knowledge, experience and expertise in assessing, designing, executing and managing environmental monitoring programs. This is your opportunity to address current monitoring problems and challenges with LexaMed experts! Bring questions for active discussion and resolution!
March 4, 2011 TOLEDO, OH. Please join LexaMed at the MD&M Florida Exposition and Conference, March 16-17 at the Orange County Convention Center in Orlando, FLlorida. Visit LexaMed in Booth 654!
Simply
click on the logo to the left to visit the show Web site, where you will
find detailed information and easy
online registration
for complimentary expo hall admission by using Promo Code:
XG.
If you do not wish to register online, click on the coupon below to print it and bring it with you to the show. We look forward to seeing you in Orlando March 16-17, 2011 - LexaMed will be in Booth 654!
February 15, 2011 TOLEDO, OH. LexaMed is pleased to announce an addition to our BEC Growth-Chek™ Microbial Suspension product line: Pseudomonas aeruginosa. P. aeruginosa is a Gram-negative rod that is specified as a required challenge organism for USP growth promotion evaluations. The first lot for commercial distribution is now available. Growth-Chek™ microbial suspensions are specially prepared for simplifying the performance of USP Growth Promotion, Monograph <71>, and Bacteriostasis/Fungistasis testing USP <71>, and are also useful for other quality control microbial challenges. Growth-Chek™ suspensions have been providing quality microbial challenge suspensions to the medical products industry for over 20 years. LexaMed manufactures these suspensions in our FDA registered, ISO 13485 certified laboratories and ships them ready-to-use; they require no additional preparation or dilution prior to use. Each lot is derived from recognized culture collections identified in USP and ISO/TS 15883-5, and is certified for purity and population (<100 organisms per dose).
January 25, 2011 TOLEDO, OH. LexaMed has expanded our testing capabilities to include the following assays:
• Antimicrobial Preservative Effectiveness (USP <51>)
• USP <61> Microbiological Examination of Non-sterile products: Microbial Enumeration Tests
• USP <62> Microbiological Examination of Non-sterile products: Tests for Specific Microorganisms
The Antimicrobial Preservative Effectiveness test is designed to verify the efficacy of a preservative system to reduce bacterial populations and prevent growth of fungi in multiple dose injectables, multiple dose topical and oral materials and other solutions which contain antimicrobial preservatives. This test should be performed on all aqueous-based products such as ophthalmic, optic, nasal, oral and irrigation solutions. This test is conducted in compliance with USP <51>.
In May of 2009, harmonization of USP with the European Pharmacopeia (EP) resulted in two new chapters for the evaluation of non-sterile products, USP <61> and USP <62>. USP <61> describes a total aerobic standard plate count whereas USP <62> is the method for screening of Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Salmonella species, fungal organisms, and a quantitative MPN for Bile Tolerant Gram Negative bacteria. Conducting both these methods will accomplish similar testing as previously performed by the USP Microbial Limits test. This testing is recommended for all pharmaceutical raw materials, certain non-sterile medical devices and dietary supplements.
September 8, 2010 TOLEDO, OH. LexaMed will present "Meet the Experts", an interactive learning session with industry subject matter experts on Tuesday, October 26, 2010 from 9am - 4pm at The Marquette, 710 Marquette Avenue, Minneapolis, MN. Learn from present and past ISO/AAMI Sterilization Working Group Co-Chairs: Carolyn Kinsley, Philip Schneider, Robert Reich and James Kulla. The seminar will address compliance issues facing industry in four technology update sessions: (1) Ethylene Oxide Sterilization, (2) Biological Indicators, (3) Radiation Sterilization, and (4) Aseptic Processing / Manufacturing. This is a unique opportunity to learn from and discuss your specific questions with industry recognized subject matter experts! The cost is $250 and lunch will be provided.
To register, contact Becky Gilsdorf at (419) 693-5307 / (888) 232-5227 or via email at bgilsdorf@lexamed.net . Download Flyer Download Agenda
July 30, 2010 TOLEDO, OH. Please join LexaMed at the MD&M Minneapolis show, October 13-14, 2010 at the Minneapolis Convention Center in Minneapolis, MN. Visit LexaMed in Booth 757! Simply click on the logo to the left to visit the show Web site, where you will find detailed information and easy online registration for complimentary expo hall admission by using Promo Code: XG.
If you do not wish to register online, click on the coupon below to print it and and bring it with you to the show.
We look forward to seeing you in Minneapolis October 13-14, 2010 - LexaMed will be in Booth 757!
July 26, 2010 TOLEDO, OH. LexaMed is proud to announce the launch of its newly enhanced and updated website, www.lexamed.net. The redesigned website has new navigational tools that facilitate easier access to the website's expanded content and graphics that highlight LexaMed's continuously expanding services, products and capabilities. Now you can also find, browse, and/or become a fan of LexaMed on Facebook!
July 21, 2010 TOLEDO, OH. LexaMed is pleased to announce the completion of upgrades to its corporate laboratories in Toledo, Ohio. The improvements include new dedicated air handling systems and construction of additional laboratories - all designed to support the expanding product offerings and laboratory capabilities in order to better service clients' needs.
June 30, 2010 TOLEDO, OH. LexaMed, a FDA-registered, ISO 13485 certified consulting and contract laboratory organization, has developed a strategic working relationship with Steel Rule Diemasters (SRD) (Web Site: www.steel-rule-die-fda.com) to provide validated die cleaning, packaging and sterilization processes compliant with FDA and ISO standards and guidelines. LexaMed can also conduct all product specific release testing to meet specific client requirements, i.e. sterility testing, bacterial endotoxin (LAL) testing, particulate testing, cytotoxicity, etc. SRD can coordinate the delivery of clean, packaged and sterilized dies that meet client specific specifications as well as FDA requirements and expectations.
May 17, 2010 TOLEDO, OH. LexaMed presents "Meet the Experts" on Monday, May 17, 2010 from 9am - 4pm at the Hilton Garden Inn at Levis Commons in Perrysburg, OH. Learn from present and past ISO/AAMI Sterilization Working Group Co-Chairs: Carolyn Kinsley, Philip Schneider, Robert Reich and James Kulla. The seminar will consist of four technology update sessions: (1) Ethylene Oxide Sterilization, (2) Biological Indicators, (3) Radiation Sterilization, and (4) Aseptic Processing / Manufacturing. This is a unique opportunity to learn from and discuss your specific questions with industry recognized subject matter experts! To register, contact Becky Gilsdorf at (419) 693-5307 / (888) 232-5227 or via email at info@lexamed.net .
May
16, 2010 COLUMBUS, OH.
BioOhio is
happy to have LexaMed as an exhibitor for the March 16, 2010 Suppliers &
Service Providers Expo in Columbus, OH.
http://www.bioohio.com/news/Events-Calendar/Suppliers-Service-Providers-Expo.aspx
January 4, 2010 TOLEDO, OH. LexaMed is pleased to announce an addition to our BEC Growth-ChekTM Microbial Suspension product line: Staphylococcus aureus. S. aureus is a Gram-positive coccus that has recently been specified as a required challenge organism for USP growth promotion evaluations. The first lot for commercial distribution is expected to be released on January 4, 2010. Growth-Chek microbial suspensions are specially prepared for simplifying the performance of USP Growth Promotion, Monograph <71> and Bacteriostasis /Fungistasis testing and are also useful for other quality control microbial challenges. Growth-Chek suspensions have been providing quality microbial challenge suspensions to the medical products industry for over 20 years. LexaMed manufactures these suspensions in our ISO 13485 certified laboratories and ships them ready-to-use; they require no additional preparation or dilution prior to use. Each lot is derived from recognized culture collections identified in USP, and is certified for purity and population (<100 organisms per dose). Further expansion of our Growth-Chek product line, including additional organisms and higher challenge concentrations, are currently under development. LexaMed is a company dedicated to providing the medical device, pharmaceutical and biotechnology industries with quality, compliant, state-of-the-art services in the areas of consulting, auditing, training and contract laboratory services.
December 15, 2009 TOLEDO, OH. LexaMed Ltd., a provider of contract laboratory and consulting services to the medical device, pharmaceutical industries and related industries, announced today that it had received ISO 13485:2003 certification from SAI Global, an internationally known Notified Body registration firm. ISO 13485 is an internationally recognized standard that demonstrates that the company has the appropriate Quality Management Systems in place to consistently provide services to the medical device and related industries that meet customer and regulatory requirements. This certification is the result of the integrated efforts and dedication of all LexaMed employees to develop and support a dynamic Quality Management Systems that continuously strives for improvement. This is consistent with LexaMed's mission statement and corporate strategy of meeting or exceeding client expectations with cost-effective quality services. LexaMed also has an ISO: 9001 certification.
November 1, 2006 TOLEDO, OH. LexaMed Ltd. has completed an asset purchase of Biological & Environmental Control (BEC) Laboratories. Robert Reich, LexaMed president, stated that LexaMed will continue to offer the laboratory and sterilization services provided by BEC for the past 26 years. In addition, LexaMed plans to expand efforts into customized microbiological and chemical testing. The lab will also offer dedicated space and support services for conducting customized, confidential evaluations, and R&D studies.
LexaMed provides international consulting and training services to medical device, pharmaceutical, and biologics manufacturers. The company's core group of senior consultants offers more than 300 years of combined industry experience. According to the company, many of these consultants are industry subject-matter experts and opinion leaders. Consulting services cover a wide variety of areas including microbiology, quality systems, sterilization (steam, ethylene oxide, dry heat, radiation, and VHP), process and equipment validations, aseptic processing, isolator technology, engineering, API audits, regulatory and compliance, and analytical method development and validation. LexaMed consultants serve as participating members in a, number of industry and regulatory associations including, AAMI, ISPE, PDA, and ISO. They also provide training for the FDA.
LexaMed will be headquartered at the former BEC Laboratory facility at 705 Front Street in Toledo. Reich anticipates that LexaMed will expand the laboratory and consulting staff significantly over the next two years.
