Processing
QC Class Production lots of vials and their components (closures, septa, etc.) are cleaned to meet the U.S. EPA’s “Specification and Guidance for Contaminant-Free Sample Containers”, OSWER Directive 9240.0-05A, December 1992. Each production lot is assigned a unique lot number.

PC Class
Production lots of vials and their components (closures, septa, etc.) are cleaned to meet the U.S. EPA’s “Specification and Guidance for Contaminant-Free Sample Containers”, OSWER Directive 9240.0-05A, December 1992.

Analysis
QC Class
Representative Finished Good vials of each production lot are sent to independent, certified environmental laboratories for analysis using U.S. EPA Drinking Water Method 524.2 plus Fuel Oxygenates.

PC Class Random Finished Good vials are sent to independent, certified environmental laboratories for analysis using U.S. EPA Drinking Water Method 524.2 plus Fuel Oxygenates.

Certification
QC Class Each case of vials comes with a QC Certificate of Analysis (includes the ESS Product Number and ESS Lot Number) and ESS Lot Number Bottle Labels.

PC Class
Each case of vials comes with a date stamped PC Certificate of Compliance and ESS Bottle Labels.

Lot Control

QC Class

Lot Number
Each case of vials has an 8 character (seven digits, one alpha) lot number that can be found on the Product Description label. This number represents the production lot and associated analysis.

Component Number Label
Each case of vials has a 12 digit number and bar code label that can be found in the lower left hand corner of the top flap of the vial carton. The first six digits identify the septa manufacturer’s septa lot number. Each septa lot is analyzed by Heated Headspace GC/MS Method TO-15 (ppt). The other numbers identify the vial manufacturer and ESS’ processing information.

Date Stamp Number
Each case of vials has a 6 digit date stamp number on the top flap of the carton. This number represents the date that the case of vials was prepared for shipment from an ESS facility. This number assists laboratories in monitoring shelf life.

PC Class
Component Number Label
Each case of vials has a 12 digit number and bar code label that can be found in the lower left hand corner of the top flap of the vial carton. The first six digits identify the septa manufacturer’s septa lot number. Each septa lot is analyzed by Heated Headspace GC/MS Method TO-15 (ppt). The other numbers identify the vial manufacturer and ESS’ processing information.

Date Stamp Number
Each case of vials has a 6 digit date stamp number on the top flap of the carton. This number represents the date that the case of vials was prepared for shipment from an ESS facility. This number assists laboratories in monitoring shelf life.

ESS - Sterile Bacti Bottles