LexaMed Covid-19 Response

March 17, 2020

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.

Download a copy here: LexaMed Covid-19 Reponse

Sincerely,

Rocile Parton
President and CEO

17025 Accrediation

LexaMed Gains ISO 17025:2017 Accreditation

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.

Laboratory Testing

LexaMed ISO 13485 certified laboratories provide quality services in routine microbiology and chemistry testing, specific project testing, client R&D, sterilization, and packaging. Dedicated laboratory space and personnel are available for the execution of custom R&D protocols.

Microbial Suspensions

LexaMed manufactures “Growth-Chek” Microbial Suspensions that are derived from cultures traceable to a recognized culture collection identified in USP. They are specially prepared for simplifying the performance of Quality Control measures for growth media.

Consulting Services

LexaMed offers consulting services in all aspects of the pharmaceutical, medical device and biotechnology industries. We integrate our subject matter experts into problem-solving teams to provide the most cost-effective and practical solutions to our clients’ specific needs.

LexaMed offers consulting services to the pharmaceutical, medical device and biotechnology industries, provides microbiology and chemistry testing in our corporate laboratories, and manufactures microbial suspensions. LexaMed compliments its consulting and validation services, laboratory operations and microbial suspension product line with additional integrated services in quality management systems, regulatory assistance, auditing, testing programs for sterilization of packaging systems, cleaning and sterilization validation of reusable devices, client research & development, environmental monitoring, container closure integrity testing, and training and seminars. Please contact us to discuss your specific requirements and determine how our staff can best support you and your operation.