Introduction: All laboratory testing is conducted in accordance with:
- Code of Federal Regulations
- U.S. Pharmacopeia Guidelines
- ISO/IEC 17025; 2005
Summary of Services: Radiation Cobalt-60 Ionizing Sterilization ANSI/AAMI/ISO 11137-CURRENT Ethylene Oxide Sterilization ANSI/AAMI/ISO 11135-CURRENT
- Aerobic Bioburden
- Anaerobic Bioburden
- Spore Forming Bioburden
- Biological Indicator Challenge
- Dose Audit Studies
- Bacteriostasis/Fungistasis
- Product Sterility Testing
Support Services:
- Water/Wastewater Analysis
- Contact Lens-Safe Medical Device Act (SMDA) Studies
- Package Integrity Studies
- EO Residual Analysis
- Cytotoxicity
- Endotoxin Testing
- Clean Room Certification
- Environmental Monitoring
- Bacterial Identification
Professional Affiliations:
- Association for the Advancement of Medical Instrumentation (AAMI)
- American Society for Quality (ASQ)
- American Society for Testing and Materials (ASTM)
- American National Standards Institute (ANSI)
- Association of Official Analytical Chemists (AOAC)
- Dallas District FDA Industry Medical Device Coalition (Previous Member)
Import/Export Assitance from Mexico - Import and Export devices as well as biologicals from your facility (maquiladora) to our lab (Dynatec Labs).
On-Site Capability - Dynatec can be at your facility within the contiguous United States as well as in Mexico, within 24 hours.
Internet Electronic Transmissions - In accordance with FDA CFR 21 Part 11.
- Dynatec can send, to you the customer, reports in a PDF format.
- Dynatec's Turn-Around Time is one of the most accurate and shortest in the industry.
In-House Workshops Available - Dynatec offers to its clients a host of in-house workshops that can vary from Cleanroom Certifications to Sterilization of Medical Devices.
Customized Medias - Dynatec offers custom medias that are made and delivered directly to you.
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