At C.G. Laboratories, Inc., our 19,000-square-foot facility across two sites in Granbury, Texas, houses state-of-the-art analytical equipment, precision environmental aging chambers, steam autoclaves, and ISO Class cleanroom systems. Engineered to support medical device manufacturers globally, our laboratory infrastructure adheres strictly to FDA 21 CFR Part 820, ISO 13485:2016, MDSAP, and ICH regulatory standards.
Accelerated aging and real-time stability testing are critical for establishing packaging integrity, material durability, and shelf-life expiration dates under ISO 11607 and ASTM F1980 protocols. Our Hotpack stability chambers maintain precise temperature and relative humidity (RH) control mapped to ICH guidelines.
| Chamber Profile | Temperature (°C) | Relative Humidity (RH) | Primary Application |
|---|---|---|---|
| Real-Time Ambient (RT) | 25°C ± 2°C | Ambient / No RH Control | Real-time package & product shelf-life validation |
| Accelerated Thermal (Acc) | 55°C ± 2°C | Ambient / No RH Control | Rapid thermal stress & accelerated aging studies |
| Accelerated Climatic (Acc RH) | 43°C ± 2°C | 70% - 80% RH ± 5% | High-humidity accelerated barrier integrity testing |
| Controlled Room Temp (CRT) | 25°C ± 2°C | 55% - 65% RH ± 5% | ICH Standard intermediate humidity stability studies |
Our microbiology laboratory is outfitted with calibrated, industrial-grade autoclaves and multi-temperature incubators to ensure reliable sterilization validation, sterility testing, bioburden determination, and bacteriostasis/fungistasis (B/F) testing.
Fully validated Steris Steam Autoclaves and Getinge Steam Autoclaves configured for custom cycle development, steam sterilization validation (ISO 17665), and terminal sterilization of heat-stable devices.
Dedicated incubation units accommodating standard microbial growth requirements:
Frigidaire Low-Temp Freezers (-15°C to -30°C) ensuring secure, temperature-monitored sample retention, biological indicator storage, and reagent preservation under full chain-of-custody protocols.
For sensitive microbial testing, hydrogel manufacturing, and mechanical packaging validation, C.G. Laboratories maintains controlled environmental spaces and analytical instruments calibrated to NIST-traceable standards.
Every piece of equipment in our Granbury laboratory undergoes rigorous Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Combined with routinely scheduled calibration against NIST standards, our operational management guarantees accurate, repeatable data to support regulatory submissions (510(k), PMA, CE mark, and MDSAP).
With over 40 years of company history and 90+ years of combined scientific team experience, C.G. Laboratories provides technical consultation, custom validation protocol design, and rapid testing execution tailored to international medical device requirements.
