Microbiology & Testing
Laboratory Department
Ashlee Lehrman
Specializing in bioburden, sterility testing, B/F validation, endotoxin assays, and environmental monitoring programs.
Phone: (817) 279-1945 Ext. 5
Direct Technical Access
Departmental Contact Directory
Connect directly with our division managers for expert consultation on microbiological analysis, decontamination, and contract packaging.
Medical Device Cleaning
Decontamination Division
Jordan Hadaway
Managing complaint device decontamination, reusable medical device reprocessing, and fast 72-hour turnaround workflows.
Phone: (817) 279-1945 Ext. 6
Production & Packaging
Manufacturing Division
Thomas Lee
Overseeing hydrogel contract formulation, cleanroom packaging, sealing validation, and shelf-life stability studies.
Phone: (682) 500-2967
Dual-Site Infrastructure
Our USA Facility Locations
Operating 19,000 square feet across two specialized facilities in Granbury, Texas to serve global medical device manufacturers.
Laboratory & Administrative Facility
1410 Southtown Drive, Granbury, TX 76048
Housing our accredited microbiological testing suites, regulatory consulting team, administrative offices, and customer QA audit rooms.
Core Capabilities:
- Bioburden & Sterility Validation Labs
- Bacteriostasis & Fungistasis Assays
- Chromogenic Endotoxin Testing
- ISO 13485 & MDSAP Document Control
Decontamination & Manufacturing Facility
2449 Bob White Drive, Granbury, TX 76049
Dedicated cleanroom environments for device decontamination processing, automated cleaning, hydrogel manufacturing, and contract packaging.
Core Capabilities:
- 72-Hour Objective Decontamination TAT
- Hydrogel Formulation & Packaging Lines
- Sterile Package Sealing Validation
- ISO Class 7 & Class 8 Cleanroom Capacity
Overseas Buyer FAQ
International Sample Submission & Compliance
How do international clients ship testing samples?
We provide comprehensive chain-of-custody protocols and customs documentation guidance for medical device samples shipped from international locations to our Granbury, Texas facilities.
What international standards do your validations adhere to?
Our protocols strictly comply with ISO 11135 (Ethylene Oxide), ISO 11137 (Radiation/E-Beam), ISO 17665 (Steam), ISO 15883 (Washer-Disinfectors), AAMI ST79, and FDA 21 CFR Part 820 quality systems.
Can overseas companies perform remote quality audits?
Yes. We support virtual quality audits, digital documentation review, and full facility transparency for global quality managers and regulatory compliance auditors.
What are your standard business operational hours?
Our laboratories operate Monday through Friday, 8:00 AM to 5:00 PM Central Standard Time (CST), with emergency technical support available for time-critical decontamination and testing projects.
Ready to Validate Your Medical Device?
Speak directly with our scientific staff for custom protocol design, testing quotes, and regulatory compliance consulting.
Get a Quote