Jeff Martin Joins LexaMed’s Consulting Team


June 19, 2017

LexaMed is pleased to announce the addition of Jeff Martin to our consulting team. Jeff currently stands as the co-chair for the AAMI Industrial EO Standards working group.   With over twenty years of experience, Jeff has  national and international industry recognition for his subject matter expertise in terminal sterilization, Quality Systems and operations.

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With Overwhelming Success, LexaMed is Continuing the Growth-Chek™ Promotion for New Clients

LexaMed is pleased by the overwhelming success through the first quarter of the Growth-Chek™ promotion and is continuing it through June 30,2017.  New Customers will continue to receive 50% off their first  Growth-Chek™ Order .  Excludes special order/custom made suspensions. When ordering, please mention internet ad for new clients.  Discount does not apply to shipping/handling charges. Offer Expires 6-30-2017.

LexaMed has over 30 years of proven performance history in the manufacturing of microbial suspensions.  These microbial suspensions are specially prepared for simplifying the performance of USP Growth Promotion, Monograph <71>, Bacteriostasis/Fungistasis testing, and other Quality Control Measures for Growth Media.  They are shipped ready-to-use; they require no additional preparation or dilution prior to use. LexaMed can also produce special, made-to-order microbial suspensions. All organisms listed can be manufactured in various concentrations.

NRCM Certifies Xiao-qun Zeng

FOR IMMEDIATE RELEASE
Xiao Zeng_edit

Xiao-qun Zeng Certified NRCM Registrant
WASHINGTON, DC—July 26, 2016—Xiao-qun Zeng, Project Team Lead, LexaMed, Ltd, Toledo, OH, is
now a Registrant of the National Registry of Certified Microbiologists (NRCM). On June 27, 2016, she
became certified as a Specialist Microbiologist in Pharmaceutical and Medical Device Microbiology. Ms.
Zeng received her M.S. degree from University of Toledo, College of Pharmacy and Pharmaceutical
Sciences, OH. To earn the NRCM credential, Ms. Zeng first met rigorous educational and experiential
eligibility requirements and then passed a comprehensive written examination. She has demonstrated
the knowledge and skills necessary to supervise the effective operation of a pharmaceutical and medical
device microbiology testing laboratory.

The NRCM is a voluntary certifying body which was founded in 1958 and has certified microbiologists in
all 50 states, the District of Columbia, and Puerto Rico and on six continents. The goals of the NRCM are
to minimize risk to the public by identifying qualified microbiologists; encourage mastery of
microbiological knowledge and skills that contribute to improving the human condition; and
foster professional pride and a sense of accomplishment in qualified microbiologists. Employers use
NRCM certification to distinguish their company and attest to their employees’ competency.

The American College of Microbiology, a component of ASM’s Professional Practice Committee, is
responsible for certification of microbiologists and immunologists, accreditation of postdoctoral training
programs, and other programs consistent with its mission of providing leadership in promoting the high
quality and ethical practice of the microbiology and immunology professions for the benefits of human,
animal, and environmental well-being.

LexaMed Presenting at BioOhio FDA Regulatory 101 Series: Medical Device Testing, Emerging Trends and Regulatory Expectations

August 18, 2016/in Events /by computol

Come and join us at the BioOhio Meeting on Wednesday, September 28, 2016. LexaMed President, Bob Reich will be speaking Join us to learn more about FDA requirements for reprocessing reusable medical devices (cleaning/disinfection/sterilization), AET, Environmental Isolates and Quality Management.

For more information, click here

 

Where:
Ascend Innovations

241 Taylor Street
Dayton, OH 45402 United States + Google Map

Website:
http://ascend-innovations.com/

Registration:
Click here to register

bio ohio

FDA Continuing to Issue 483’s to Compounding Pharmacies

FDA continues to issue 483s to compounding pharmacies for a lack evidence and cGMP
framework in preventing/mitigating beta-lactam cross-contamination

Warning Letters and significant FDA 483 observations continue to plague the compounding pharmacy industry with over 40% of compounders inspected receiving Warning Letters and nearly 100% receiving critical observations. One of the more common observations cited by the FDA directly relates to the implementation of manufacturing controls to prevent cross-contamination of finished pharmaceuticals and active pharmaceutical ingredients (APIs) with non-penicillin beta-lactam drugs.

In the April 2013 guidance document released by the FDA entitled Non-Penicillin Beta Lactam Drugs: A Current Good Manufacturing Practice cGMP Framework for Preventing Cross-Contamination, the agency goes as far as to say that manufacturers generally should utilize separate facilities for the manufacture of these compounds. Beta-lactam antibiotics include the following four classes:

• cephalosporins (e.g., cephalexin, cefaclor)
• penems (e.g., imipenem, meropenem)
• carbacephems (e.g., loracarbef)
• monobactams (e.g., aztreonam)

As a result, the FDA expects and recommends that manufacturers of these antibiotics establish appropriate separation and control systems designed to prevent two types of contamination:
(1) The contamination of a non-penicillin beta-lactam by any other non-penicillin beta-lactam
(2) The contamination of any other type of product by a non-penicillin beta-lactam.

As a manufacturer, it is critical that you evaluate your manufacturing operations for the possibility of cross-contamination and that you implement appropriate controls to reduce or mitigate the potential for cross-contamination. The FDA will expect direct manufacturing control related to the isolation and separation of intermediate and derivative materials, facilities, equipment, and personnel.
LexaMed has considerable experience and expertise in the testing for and development of control strategies for beta-lactam contamination. We have developed and validated an analytical method for detecting trace amounts of beta-lactam and can coordinate swab testing of manufacturing and storage areas to demonstrate control. We can also advise on facility design and procedural controls to assure compliance with FDA expectations for beta-lactam cross-contamination control and isolation.

http://www.fda.gov/downloads/Drugs/…/Guidances/UCM246958.pdf

For more information on developing appropriate manufacturing controls and further clarity on FDA expectations for non-penicillin beta-lactam drugs, please contact LexaMed.

705 Front Street
Toledo, OH 43605
Office: 419-693-5307
Email: jkoenker@lexamed.net

Total Organic Carbon (TOC)

February 19, 2016- LexaMed now offers Total Organic Carbon (TOC) analysis compliant with United States Pharmacopeia (USP) Chapter <643>. TOC provides a quantitative measurement of carbon dissolved in water or other solvents.  Pharmaceutical and medical device manufacturers using purified water need to ensure the water entering their facility and produced in their facility contains safe levels of organic compounds.  Purified Water must meet the requirements of the USP for TOC content along with Conductivity and Bioburden Count.

Filter Integrity Test

February 18, 2016- LexaMed has expanded its Filter Integrity Test offerings by now offering Bacterial Retention Testing as recommended in the Food and Drug Administration (FDA) Guidance on Sterile Drug Products Produced by Aseptic Processing.   When filtration is used as a method for sterilizing drug product solutions, the filter must be validated to demonstrate that it can reproducibly remove viable organisms from the process and produce a sterile product.  Testing is conducted using scaled down processing parameters with direct inoculation of a challenge organism into the drug product to provide an assessment of the effect of the drug product on the filter matrix.  In the case of products with inherent bactericidal activity appropriate alternative methodology is employed.

LexaMed at Florida Medical Manufacturing Consortium

Come and join us at the Monthly FMMC (Florida Medical Manufacturing Consortium) Meeting on Tuesday, November 17, 2015.  Our President, Bob Reich will be speaking on:

MEDICAL DEVICE TESTING – EMERGING TRENDS AND REGULATORY EXPECTATIONS 

What are the challenges we all face with Medical Device Testing?  What new tests are coming down the pipeline?  Get up to speed on all of the regulatory changes in Medical Device Testing at the FMMC’s November Executive Briefing!

FMMC

Where:
Hilton Carillon Park
950 Lake Carillon Drive
Van Gogh Room
St. Petersburg, Florida 33716
United States

 

Registration:
Online registration is available until: 11/17/2015
Follow the link: Register »

LexaMed Exhibits at the Med Tech World MD&M 2015

MedTechWorldMDM

LexaMed will be attending and exhibiting at the Med Tech World MD&M Florida show being held on November 18 – 19, 2015 in Orlando at the Orange County Convention Center.

If interested in attending the show and are not registered as of yet, please follow:
http://mdmflorida.mddionline.com/

Come visit LexaMed’s booth (#326), say hello and speak with one of our experts within the Medical Device industry.  We all look forward to meeting with our current clients, as well as potential customers.  If you would like to set up a meeting during the show, please contact Lori Swisher at 419-350-9727 or lswisher@lexamed.net for arrangements.

LexaMed Attends Connecting the Dots for Innovation on June 10, 2015

Several representatives from LexaMed will be attending “Connecting the Dots for Innovation” on June 10, 2015 at the Grand Plaza Hotel in downtown Toledo. This event, hosted by ProMedica Innovations, is the second annual ProMedica Innovations conference focusing on incubating and cultivating medical technology. Read more