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
Laboratory microbiology and bioburden testing
Culture-based testing, identification and bioburden quantification for devices, materials and environments.
Medical device decontamination
Decontamination of used or contaminated devices using EtO, steam, gamma, liquid chemistries or custom processes prior to analysis or manufacturing.
Contract packaging (sterile and non-sterile)
Turn-key packaging services for sterile barrier systems and non-sterile products, including specialized hydrogel packaging.
Sterilization validation and dose auditing
Validation of sterilization cycles using biological indicators and parametric monitoring, plus ongoing dose audits to maintain SAL and detect bioburden shifts.
Sterilization development and material compatibility (VHP and others)
Development of low-temperature sterilization cycles, efficacy testing and material compatibility assessments to support cycle implementation.
Environmental monitoring and air microbial testing
Air, surface and water monitoring programs to assess and control environmental contamination in manufacturing and cleanroom settings.
Laboratory microbiology and bioburden testing
Culture-based testing, identification and bioburden quantification for devices, materials and environments.
Medical device decontamination
Decontamination of used or contaminated devices using EtO, steam, gamma, liquid chemistries or custom processes prior to analysis or manufacturing.
Contract packaging (sterile and non-sterile)
Turn-key packaging services for sterile barrier systems and non-sterile products, including specialized hydrogel packaging.
Sterilization validation and dose auditing
Validation of sterilization cycles using biological indicators and parametric monitoring, plus ongoing dose audits to maintain SAL and detect bioburden shifts.
Sterilization development and material compatibility (VHP and others)
Development of low-temperature sterilization cycles, efficacy testing and material compatibility assessments to support cycle implementation.
Environmental monitoring and air microbial testing
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