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.
Sterilization Process Validation Published: April 7, 2025 Author: Jim G. Whitcomb Topics: Sterility Assurance Level, Ethylene Oxide (EO), Gamma, E-Beam, Steam, Bioburden Determinations, Protocol Report Generation Related Services: Quarterly Dose Audits, Cycle Development, Bacterial Endotoxin, Population of Biological Indicators, D-Value Determination Sterilization concepts can be a confusing and formidable challenge for companies looking to establish […]
Cleaning Validation for Reusable Medical Devices Published: March 20, 2025 Author: Anne M. Schuler Topics: reusable medical devices, cleaning validations, reprocessing of reusable medical devices, end-of-life conditioning, AAMI ST98, ISO 17664, medical device IFU, protein analysis, hemoglobin analysis Related Services: End-of-life conditioning, 21 CFR 801, instruction for use development Reusable medical devices are devices that […]
LexaMed . Lot Release Testing Turnaround Times Published: February 18, 2025 Author: Hayden Rowan Topics: Medical Device Testing, Pharmaceutical Testing, Lot Release Testing, Turnaround Times Related Services: Sterility Assurance, USP <71> Bioburden Determinations, ISO 11737-1, Microbial Limits, USP <61>, USP <62>, Bacterial Endotoxin Testing, Limulus Amebocyte Lysate, LAL, USP <85>, AAMI ST72 At LexaMed, we […]