Name: 40 ml Amber Borosilicate Glass Vials, 24-410 PP Hole Cap &amp; PTFE/Silicone Septa, Dust Cover, Cleaned &amp; Certified, for TOC &lt;10ppb, case/80
SKU: QP-GLC-06161
Availability: InStock

Description

27.75 x 95mm 10 dram (40ml) Amber Borosilicate Vial with 24-400 Bonded White PP Hole Cap & PTFE/Silicone Septa Attached with Dust Covers, Cleaned & Certified for TOC <10ppb>40ml <10ppb>

offers pre-cleaned 40 ml glass vials certified for Total Organic Carbon (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 storage

Benefits of 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 specifications.

Quality Assurance
The Certificate of Analysis is included in every 80-pack case of TOC vials. Upon request, will provide additional raw data and include the “Third Party” Validation Analytical report that supports and validates the certified lot of completed <10>

Please note:Precleaned items are not returnable. Lead time and minimum order quantities may apply.

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