C&G Containers offers comprehensive solutions for sterilization and depyrogenation processes, targeting the pharmaceutical, biotech, and medical industries. Below are the detailed specifications and benefits of each process:
Sterilization
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 Sterility (C of A): Verifies product sterility
- Certificate of Process: Outlines the sterilization method used
Depyrogenation
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)
Key Features & Benefits
- Validated Processes: Ensure compliance with strict industry standards.
- Dual Purpose: Both sterilization and depyrogenation methods tailored to pharmaceutical needs.
- Customizable Packaging: Options to meet cleanroom and sterility requirements.
- Certifications Provided: Full traceability and assurance for all processes.
Recent Comments