SpectrumLabs.com is a leader in the manufacture and supply of single-use hollow fiber filtration modules and tangential flow filtration systems for the Diagnostic, Bioprocessing and Pharmaceutical Industries. In addition to the largest selection of single-use hollow fiber filters, Spectrum’s KrosFlo® process filtration products include filtration systems for tangential flow filtration and bioreactor perfusion.
SpectrumLabs’s KF Comm is a software program that allows users to collect real-time data from the KR2i or KMPi pumps and auxiliary components (optional scales, pumps, and valves) in a Microsoft® Excel® spreadsheet.
The software records 12 real-time operating parameters:
All process parameters are recorded at user-defined intervals eliminating the need for manual recording. In doing so, KF Comm enables quick analysis using Excel graphs and facilitates optimization, scale-up and process documentation. SpectrumLabs.com uses ExcelSafe™ to provide compliance with 21 CFR11 in the KF Comm software.
ExcelSafe is available for the following versions of KF Comm software;
For KF Comm to be 21 CFR Part 11 Compliant it needs to be used with a KF Comm Compliant Workbook and interface with the Ofni Systems’ ExcelSafe™ software package.
We also can provide a complete validation package for KF Comm. Each validation package includes a Functional Specification, Design Specification and Installation/Operational Test Protocol. The validation package also includes an example execution of the test protocol and a Validation Summary Report. There is also a separate validation package for ExcelSafe.
Contact Ofni Systems or Spectrum Labs for more information about ExcelSafe or the KF Comm software.