TOC Vials from Qorpak offers 10 Parts Per Billion (PPB) Level 40 ml Vials for Pharmaceutical/Biotechnology applications.

Applications
• 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
• Vials are certifi ed 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 confi rm that the TOC vials comply with the quality specifi cation (TOC< 10 ppb). The vial, closure and dust cover undergo sequential independent cleaning steps that comply with stringent quality standards and specifi cations.

Quality Assurance
The Certifi cate of Analysis is included in every 80-pack case. 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 TOC vials.