LexaMed Provides Medical Device and Pharmaceutical Manufacturers Contract Laboratory Testing Services Complimented With Industry Leading Technical Consulting Services
Lot release testing including, sterility, endotoxin, and bioburden product testing
Pharmaceutical testing services
Technical consulting to complement your medical device or pharmaceutical product.
Routine bacterial endotoxin testing with results in 7 days of receipt.
Natural product sterility testing with results in 15 days of receipt. Biological indicator sterility testing with results in 8 days of receipt.
Routine bioburden determinations with results within 10 days of receipt of samples
Microbiological stability of drug products under specified storage conditions following reconstitution and/or dilution with specified diluents to demonstrate the product does not support microbial growth throughout storage in its end-use condition
Biological Indicator Evaluator Resistometer (BIER) units and sterilizers can be utilized to determine/verify the resistance of a biological indicator. This information can be utilized to confirm a biological indicator manufacturer’s label claim or certify a biological indicator’s performance.
Manufacturers of medical devices must provide complete written instructions for the handling, cleaning, packaging and sterilization of the products to support the label claim.
LexaMed’s ISO 17025 Accreditation Certificate has been updated on our Company Document page. You may also download a copy of it here.
LexaMed’s DEA Controlled Substance Registration Certificate has been updated on our Company Document page. You may also download a copy of it here.
ISO 13485 Certificate LexaMed’s ISO 13485: 2016 Certificate has been updated on our Company Document page.