Our Services

LexaMed Provides Medical Device and Pharmaceutical Manufacturers Contract Laboratory Testing Services Complimented With Industry Leading Technical Consulting Services

Medical Device

Lot release testing including, sterility, endotoxin, and bioburden product testing

Pharmaceutical

Pharmaceutical testing services

Consulting

Technical consulting to complement your medical device or pharmaceutical product.

Routine Bacterial Endotoxin Testing

Routine bacterial endotoxin testing with results in 7 days of receipt.

Routine Sterility Testing

Natural product sterility testing with results in 15 days of receipt. Biological indicator sterility testing with results in 8 days of receipt.

Routine Bioburden Testing

Routine bioburden determinations with results within 10 days of receipt of samples

Microbial Stability Study (MSS)

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

D-value Verification

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.

Reusable Medical Device Validations

Manufacturers of medical devices must provide complete written instructions for the handling, cleaning, packaging and sterilization of the products to support the label claim.

Featured Projects

Reusable Medical Devices

Cleaning and sterilization validation programs to meet FDA requirements.

Cleanroom Validation

A cleanroom is qualified that the conditions are suitable for manufacturing.

Sterilization Validations

Methods include EO, Steam, VHP, Radiation, UV, Ozone, Pulsed-Light, Dry Heat, and Liquids.

Container Closure Integrity

Container Closure Integrity (CCI) of non-porous packages and breathable packages.

Core Benefits of Partnering With LexaMed

Quality Service

Priority for all employees is to exceed customers expectations and drive change in the industry

Timely and Accurate Results

Reports are published 99.99% error free

Certifications Held

ISO 13485 Certified, ISO 17025 Accredited, DEA Registered, FDA registered, and State of Ohio Drug License

Our Latest Information

April 7, 2025 No Comments

Sterilization Process Validation

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 […]

March 20, 2025 No Comments

Cleaning Validation for Reusable Medical Devices

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 […]

February 18, 2025 No Comments

LexaMed Turnaround Times

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 […]

The LexaMed associates I've been in contact with for our company testing and projects have been responsive and professional. We tend to end up with short deadlines internally which also impact our contract testing deadlines, LexaMed has done a great job of helping us meet our goals and communicating.

Karen H.

Everyone I have worked with at LexaMed has gone above and beyond to meet our (often urgent) requests. We would not be able to meet our customers' requirements without the responsiveness and hard work that LexaMed offers.

Eric G.

The level of support that we get when needed is top notch. No other company in this industry can match the support, cost, and speed at which things get done.

David C.