40ml <10ppb Glass TOC Vials
Qorpak offer pre-cleaned 40 ml glass vials certified for Total Organic Carbon particles (TOC vials). We offer TOC vials certified to contain less than 10 Parts Per Billion (PPB) for use for pharmaceutical and biotechnology applications.
Applications of TOC Vials
• USP Method 643
• Testing of pharmaceutical grade waters
• Water for Injection (WFI)
• High Purity Water (HPW)
• Cleaning Validation Testing/Samples
• Testing Pre-and Post-cleaning efficiency
• Traceability as associated with “Good Manufacturing Practices” (GMP)
• TOC calibration, validation and system suitability
• Calibration Standards(s) storage
Benefits of Qorpak TOC Vials
• Vials are certified and traceable; documentation is provided for GMP
• High Level Quality Control and Process Control for lower TOC background
• Consistently lower levels of background TOC for statistical studies
• 80-pack slotted case can be used in clean room applications
• 40 ml vial can be used in most TOC autosamplers
• Individual “Bar Code” stickers can be provided separately for identification purposes
Quality Control Process
The manufacturer’s Lot number for each component of this product is tracked until all cleaning procedures are completed at which time a final lot number is assigned and documented. A randomly selected collection of vials from each completed lot are submitted to an independent validation laboratory for quality control purposes to confirm that the TOC vials comply with the quality specification (TOC< 10 ppb). The vial, closure and dust cover undergo sequential independent cleaning steps that comply with stringent quality standards and specifi cations.
The Certifi cate of Analysis is included in every 80-pack case of TOC vials. Upon request, Qorpak® will provide additional raw data and include the “Third Party” Validation Analytical report that supports and validates the certified lot of completed <10 ppb glass TOC vials.