C&G Containers offers fully validated sterilization and depyrogenation solutions designed for critical pharmaceutical, biotech, and medical environments. Whether you need USP-compliant glassware for injectable drug applications, clinical trials, or stability testing, our processes ensure your components are sterile, pyrogen-free, and ready for cleanroom integration.
Sterilization: Validated and Compliant
Compliance:
- Complies with USP Method <71>
- Effectively destroys all forms of microbiological life, including spore stages
Common Applications:
- Injectable or parenteral drugs
- Clinical trials
- Stability studies
Process Details:
- Sterilization of glassware via dry heat
- Sterile foil-wrapped products available in single, double, or multiple layers
- Validated at 250°C for a minimum of three hours
- Packaging options:
- Bricked product
- Cleanroom-bagged items
Typical Certifications:
- Certificate of Process: Outlines the sterilization method used
- Certificate of Sterility (C of A): Verifies product sterility
Depyrogenation: Endotoxin Removal You Can Trust
Compliance:
- Complies with USP <85>
- Specifically reduces and removes endotoxin content
- Prevents pyrogenic or fever reactions from injections
Common Applications:
- Injectable or parenteral drugs
- Final packaging prior to drug delivery
- Clinical trials
- Stability studies
Process Details:
- Glassware depyrogenated using a validated dry-heat method
- Same process as sterilization (250°C for a minimum of three hours)
Typical Certifications:
- Certificate of Analysis (<0.25 EU/mL): Confirms endotoxin level compliance
- Certificate of Process: Outlines the depyrogenation method used
- Test Methods:
- LAL Gel-Clot Technique
- Kinetic Turbidimetric Method (KTM)
Why Choose C&G Containers for Sterilization, Depytogenation Glassware?
Fully Validated Processes. All methods are rigorously tested and validated according to industry best practices.
Comprehensive Documentation. Receive Certificates of Process, Sterility, and Endotoxin Analysis with each order.
Custom Packaging Options. From sterile foil wrap to cleanroom-ready formats, we provide packaging solutions that match your workflow.
Expertise You Can Rely On. Our team understands the regulatory landscape and partners with you to meet your project goals.
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Need sterile or depyrogenated glassware for your next clinical trial, drug study, or packaging run?
Contact us today to learn more or request a quote.