It is IMPORTANT to note that this release update to the TOC Talk Event Procedures REQUIRES that the Syringe Pumper firmware be version 1.14 or higher to remain compatible at these speeds. If you are unsure of your Syringe Pumper firmware version, please contact Technical Support for details on identifying the Syringe Pumper version. (See the end of this document for contact information)

Analytical
In updating the analytical process, we have:
1.) Improved recycling of purified water during the blanking process of Range 2. Recycled purified water from the UV reactor is used to rinse with instead of new purified water. This yields a lower more consistent blanking process.
2.) Improved sample handling of TOC Range 2 Analysis. Recycled water from the UV reactor is used to rinse with instead of new purified water. This produces a low level TOC analysis with greater precision.

Syringe speeds have been optimized to produce less noise during liquid handling for methods:
Cleaning Procedures
Blank TC Range 2
TOC Range 2 Analysis

Injections into the reactors may be louder than other movements because lower speeds are used for greater accuracy in sample volume delivery. However, a majority of syringe movements should be less noisy.

The applications laboratory has determined that five new methods are needed for TOC analysis. Four of the methods are in our most popular range 0.1 - 20ppmC. The fifth is a new method for Solid TOC analysis.

1 & 2 - The first set of methods, “Pharma TOC Range 0.01 - 5ppmC” and “Pharma TC Blank Range 2”, was created for Pharmaceutical TOC analysis (both Cleaning Validation and Water For Injection Analysis). These methods are specially designed to yield lower blanks and improve speed, accuracy and precision for Pharmaceutical TOC analysis.

3 & 4 - The second set of methods, “Drinking Water H2O Range 0.1-20ppmC” and “Drinking Water H2O Blank Range 2”, is designed for TOC analysis of Drinking Water. These methods are designed to remove Inorganic Carbon more efficiently and improve efficiency of analysis across the analytical range.

5 - The last TOC method was created for Solid TOC Analysis for use with the 183 Solid Boat Sampler.

Programmatic
The installation has a minor update to allow the person running the install to backup the current install target folder if it already contains a previous version.

In Teledyne Tekmar's desire to continuously improve our 21 CFR Compliance tools within our software, we have made the following changes to help our users to more easily reach compliance.

Electronic Signatures - Accessible from Sample Results (formerly Multiple Analysis Results), this allows the user to add, view, and print signatures and reasons for those signatures to the results files that are viewed from this display window.

Add a Signature - From Sample results, open one or more results files and select “Add Signature to Files” from the Sample Results “Edit” menu. The software will then prompt for a user name and password for the person who wishes to sign the file(s). Note that the person signing the records must already exist within the normal list of users for TOC Talk. The user will then be given the chance to add the reason they are adding this signature to the file(s). This process can be repeated as often as is needed if the user wishes to add more than one signature to the file(s).

View Signatures - From Sample Results, open one or more results files and select “View Signatures” from the Sample Results “File” menu. The software will show you all the signatures associated with each distinct file that is currently being referenced in the Sample Results window.

Print Signatures - This feature is actually an incremental improvement to the current “Print Summary Report” and “Print Detailed Report” features of Sample Results. The printouts will now contain the signatures and reason for the signatures given within the printout.

New User Account Features - Accessible from User Manager, the new features of User Manager are:

User Account Deletion is now Disable User Account - We have decided to strengthen the user account maintenance by changing user deletion with disabling of the user account. This feature will help prevent reuse of existing user accounts by keeping previous users in the system while disabling their TOC Talk access which, as a side benefit, will disallow the reuse of existing account names. Therefore, in User Manager the “Delete User” button is now “Disable User” or “Enable User” depending on the current state of the selected user account.

Failed Login Attempts action - In this new version, this feature is controllable within the User Manager window so that the "Administrator" is able to specify how many consecutive failed login attempts will disable the user account for a specified number of minutes. Also, in this version the "Administrator" may specify that the account is disabled permanently until the "Administrator" enables that particular user again.

Password Recycle Days - This feature is now easily accessible from the User Manager window.

Autosampler Setup - When the user selects the TC Blank range 2, the user is now prompted to manually select either the Pharmaceutical or Drinking Water Method.

System History Elements - Additional events surrounding the archive process are now recorded into the System History.

Installation
Some minor changes were added to the installation. The Windows user running the installation must be in the Windows administrators group for that PC. However, the installation now allows the setting of the installation folder security permissions for either:
Everyone
Power Users
Administrators

It is important to note that unless you are using Teledyne Tekmar’s TDRunAs program or some other method to allow normal users access permissions to the installation folder files through TOC Talk, then you should select “Everyone” or TOC Talk will not function properly. Consult your local MIS/IT group for more details. This installation disallows the installation onto a 64-bit Windows platform as TOC Talk is not validated to run on such platforms at this time. The installation will try to prevent you from selecting a folder path that will immediately cripple TOC Talk. In general, with TOC Talk, it is better to choose short install path name lengths.