Container Closure Integrity Testing

LexaMed is pleased to announce the validation of additional Container Closure Integrity (CCI) testing capacity. The new, custom built unit has both vacuum and pressure operating capabilities and doubles the capacity of LexaMed’s current unit. The unit is utilized for testing the container closure integrity of hermetically sealed containers, i.e. vials, bottles, bags, etc., utilizing a microbial or dye ingress approach. Read more

Lori Swisher Joins LexaMed As National Sales Director

LexaMed is pleased to announce the addition of Lori Swisher to our sales team. Lori will serve as LexaMed’s National Sales Director. Lori has previously been affiliated with LexaMed having worked on various consulting projects. Lori has extensive experience in Quality Systems and Business Development, with an educational background in the medical and science fields.  Read more

Jerome Bell Joins LexaMed As VP of Engineering

LexaMed Ltd. is pleased to announce the addition of Jerome Bell to our executive management staff. Jerome will serve as LexaMed’s Vice President of Engineering. He has more than 30 years experience as a Senior Mechanical Engineering Manager and he is highly adept in terminal sterilization processes of medical devices and solutions. Read more

Carolyn Kinsley Provides EO Sterilization Training to FDA

LexaMed Senior Vice President Carolyn Kinsley recently provided training to FDA personnel on Ethylene Oxide sterilization in Puerto Rico. Carolyn has a great depth of knowledge for FDA / GMP regulations and AAMI / ISO guidelines governing the sterilization and release of medical products to market. Read more

Tom Bienias Joins LexaMed’s BOD

LexaMed Ltd. is pleased to announce the election of Tom Bienias to our Board of Directors. Tom has substantial experience and expertise in the medical device and pharmaceutical industries, including business development, strategic planning, marketing, engineering and project management. Read more

Laboratory Expansion

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. Read more

Addition to Growth-Chek Product Line

LexaMed is pleased to announce an addition to our BEC Growth-Chek™ Microbial Suspension product line: Pseudomonas aeruginosaP. aeruginosa is a Gram-negative rod that is specified as a required challenge organism for USP growth promotion evaluations. Read more

LexaMed Expands Testing Capabiltiies

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

Read more

Laboratory Upgrades

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.

LexaMed Develops Strategic Partnership

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.com/) to provide validated die cleaning, packaging and sterilization processes compliant with FDA and ISO standards and guidelines. Read more