LexaMed’s ISO 13485: 2016 Certificate has been updated on our Company Document page.
Based on the current extraordinary events related to COVID-19, SIA Global has granted LexaMed with an extension of our current ISO 13485. The expiration date is now March 31, 2022. Please click here to download our extension letter for your records.
As 2021 comes to completion, we would like to thank all of our clients for the continued trust with all their needs. We look forward to continuing meeting all of you needs in 2022 and beyond.
LexaMed will be following the following schedule for the upcoming holidays.
Christmas:
LexaMed will be closed Thursday, December 23, 2021 at noon and closed all day Friday, December 24, 2021.
New Years:
LexaMed will be closed Friday, December 31, 2021. We will return to normal operating hours (8:30am EST – 5:00 pm EST) on Monday, January 3, 2022.
LexaMed is hiring for at least one full time microbiologist for out Toledo, OH laboratory. Qualified aplicants can email their resume or CV to [email protected]
Position Summary
Responsible for coordination and execution of client sponsored studies related to the pharmaceutical and medical device industry in compliance with FDA 21 CFR Part 820 cGMPs.Includes design of experiments, authoring protocols, executing projects, including coordination of project work schedule with Laboratory. Interfaces with clients outlining cost proposals, project status and issues final report.
Duties and Responsibilities
Primary duties and responsibilities include performance of the following:
Organizational Responsibilities
Education/ Experience Requirements
LexaMed is excited to announce that we will be rolling out a new client portal April 12, 2021 that will be the home to all of your final reports. This will enable you to:
Prior to the portal launch, you will receive an invitation from our team to create your password. All current final report recipients based on email addresses will have an account automatically created.
LexaMed offers testing for AAMI Level 1 Minimum Fluid Barrier Protection Isolation Gowns and other barrier materials as defined in ANSI/AAMI PB70:2012. Testing is conducted in accordance with AATCC Test Method 42-2007 Impact Penetration Test. The test measures the resistance of fabrics to the penetration of water by impact, and therefore can be used to predict the probable resistance of fabrics to fluid penetration.
The health and well-being of our Employees and Clients is our number one priority. Quality, and confidence in our services is critical now more than ever considering the growing concerns about COVID-19 impacting the global environment. We are continually monitoring the situation and are following the Centers for Disease Control and Prevention (CDC) guidelines. We will continue to work with our customers to ensure we can provide you with the services needed while taking the appropriate measures to protect our staff and your test samples. The following actions list some of the measures we are currently taking.
• Employees that have the ability to work at home will do so.
• Critical test activities have been defined and a plan developed which will allow microbiologists to work a rotating schedule in order to minimize contact between associates yet ensure critical tests are carried out as scheduled.
• We have increased our already rigorous cleaning and disinfection activities to include on-going activities throughout each work day in all laboratories and sample receipt/handling areas.
• Any employee that discovers they may have been in contact with a confirmed case of COVID-19 are required to report this to management and self-quarantine for 14 days.
• All international and non-essential domestic travel has been cancelled.
• On-site visits including audits will be postponed. You will be contacted to reschedule your visit.
At this time, we do not anticipate any major impact to testing, if we anticipate there may be a delay you will be contacted immediately. These measures are not static and considering the uncertainty and unknowns with the situation, we want to stress that there is potential for change and we ask for your understanding in that event. LexaMed is committed to protecting our employees and community while doing our best to service our customers, please contact us if you have any questions or concerns.
Sincerely,
Rocile Parton
President and CEO
July 18, 2019 – LexaMed is proud to announce that it has passed the assessment required to receive accreditation to ISO 17025:2017 General requirements for the competence of testing and calibration laboratories.
LexaMed’s accreditation demonstrates technical competence in activities related to the following assays:
USP/ISO Sterility Test, USP/EP Antimicrobial Test, USP/ISO Endotoxin Test, Bioburden Determination, USP/ISO Cytotoxicity Tests, USP Particulate Analysis, USP Chapter <61> and <62> Microbial Enumeration, ISO Population Verification, USP Container Closure Integrity Test, ISO Ethylene Oxide Residual Analysis and Cleaning and Disinfection Validations for Re-usable Medical Devices
The addition of this accreditation to our existing certifications and registrations re-enforces our commitment to conduct and deliver high quality technically accurate work capable of withstanding regulatory scrutiny.
FOR IMMEDIATE RELEASE
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.