TOTAL ORGANIC CARBON (TOC) VIALS
Applications:![Vials](/wp-content/uploads/2015/05/1editor735hpim0328.jpg)
- 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 Standard(s) storage
Benefits:
- C & G’s 80-pack slotted case can be used in clean room applications
- 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
- 40 ml vial can be used in most TOC autosamplers
- Shelf -Life Study
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 <10ppb).
The vial, closure, and dust cover undergo sequential independent cleaning steps that comply with C & G Container’s Performance-Based Specifications (PBS). Each phase of the cleaning process is monitored to ensure the process adheres to C & G’s standard operating procedure, meeting quality assurance specifications.
Quality Assurance:
The Certificate of Analysis is included in every 80-pack case. Upon request, C & G Containers will provide additional raw data and include the “Third Party” Validation Analytical report that supports and validates the certified lot of completed
ORDER INFORMATION
SIZE | CAP | SEPTA | DUST COVER | QTY/CS | <10PPB | <20PPB |
40ml Clear |
Polypropylene 24-410 |
Teflon/Silicon .060″ |
Polypropylene | 80 | LFV040700005 | LFV040700500 |