C.G. Laboratories
C.G. Laboratories, Inc. is a multi-service company specializing in validation, development, and testing services for the medical device, pharmaceutical, and biotech industries. With over 40 years of experience, the company offers a wide range of services including laboratory testing, sterilization validation, decontamination, contract packaging, and validation consultations. They are ISO 13485:2016 and MDSAP certified, and have a team of experts dedicated to ensuring product safety, quality, and regulatory compliance. Their mission is to provide high-quality results, timely turnaround, and responsive customer service, with a focus on helping clients succeed through service and guidance.
Industries
Nr. of Employees
small (1-50)
C.G. Laboratories
Services
Culture-based testing, identification and bioburden quantification for devices, materials and environments.
Decontamination of used or contaminated devices using EtO, steam, gamma, liquid chemistries or custom processes prior to analysis or manufacturing.
Turn-key packaging services for sterile barrier systems and non-sterile products, including specialized hydrogel packaging.
Validation of sterilization cycles using biological indicators and parametric monitoring, plus ongoing dose audits to maintain SAL and detect bioburden shifts.
Development of low-temperature sterilization cycles, efficacy testing and material compatibility assessments to support cycle implementation.
Air, surface and water monitoring programs to assess and control environmental contamination in manufacturing and cleanroom settings.
Culture-based testing, identification and bioburden quantification for devices, materials and environments.
Decontamination of used or contaminated devices using EtO, steam, gamma, liquid chemistries or custom processes prior to analysis or manufacturing.
Turn-key packaging services for sterile barrier systems and non-sterile products, including specialized hydrogel packaging.
Validation of sterilization cycles using biological indicators and parametric monitoring, plus ongoing dose audits to maintain SAL and detect bioburden shifts.
Development of low-temperature sterilization cycles, efficacy testing and material compatibility assessments to support cycle implementation.
Air, surface and water monitoring programs to assess and control environmental contamination in manufacturing and cleanroom settings.
Expertise Areas
- Medical device sterilization and validation
- Contract packaging and sterile barrier systems
- Microbiological testing and bioburden control
- Packaging integrity, seal strength and shelf-life testing
Key Technologies
- Ethylene oxide sterilization
- Vaporized hydrogen peroxide sterilization
- Gamma irradiation sterilization
- Electron-beam (e-beam) sterilization
News & Updates
Certification that demonstrates compliance with international standards for medical device quality management systems, facilitating regulatory approval and market access.
Information regarding the transition to new manufacturing methods for DuPont Tyvek material used in medical packaging, including testing and validation efforts to demonstrate functional equivalence.
Details on VHP sterilization technology, its advantages, and CG Labs’ services in validation and testing for this method.
Information on endotoxin testing and validation to ensure product safety, especially for injectable drugs and implants.
Overview of environmental testing services for air, water, and soil to identify hazards and ensure safety.
Certification that demonstrates compliance with international standards for medical device quality management systems, facilitating regulatory approval and market access.
Certification that demonstrates compliance with international standards for medical device quality management systems, facilitating regulatory approval and market access.
Information regarding the transition to new manufacturing methods for DuPont Tyvek material used in medical packaging, including testing and validation efforts to demonstrate functional equivalence.
Details on VHP sterilization technology, its advantages, and CG Labs’ services in validation and testing for this method.
Information on endotoxin testing and validation to ensure product safety, especially for injectable drugs and implants.
Overview of environmental testing services for air, water, and soil to identify hazards and ensure safety.
Certification that demonstrates compliance with international standards for medical device quality management systems, facilitating regulatory approval and market access.