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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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.

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 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.

David Brodersen Joins LexaMed’s Executive Management Team

LexaMed is pleased to announce the addition of David J. Brodersen to our executive management team. David will serve as LexaMed’s Director of Technical Services and Strategic Initiatives where he will focus on the management of several of LexaMed’s services in the areas of sterilization, validation and microbiological-compliance. Read more

FDA Releases Final Guidance for Reprocessing Medical Devices on Mar. 17, 2015

The FDA has finalized the long awaited guidance document, “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling” on March 17, 2015 following the draft of the document which was issued on May 2, 2011. While the majority of changes made include minor rewording, additional reference to resources, and expansion upon topics to provide clarity, there is a notable emphasis placed on device design and reprocessing of complex devices. Read more

LexaMed Expands Chemistry Capabilities

LexaMed has recently upgraded its in-house chemistry capabilities to better serve our clients’ needs. The upgrades include expanded GC capabilities, HPLC developmental work and stability testing capabilities, UV analysis for selected compounds and protein, and carbohydrate and hemoglobin analysis in support of cleaning studies. We have experienced chemists available Read more

LexaMed Laboratory Water System

LexaMed has a comprehensive water treatment system to control the quality of water utilized in its laboratory operation located at 705 Front Street, Toledo, Ohio.

The System was designed and installed by Evoqua Water Technologies LLC (formally Siemens). The system consists of the following basic elements: Read more