UV-Visible Spectrophotometer is FDA compliant.
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Press Release Summary:
Featuring 1 nm bandwidth optical system, Libra S35PC includes 8-position sample changer and Press-to-Read deuterium lamp technology, which only runs source at maximum energy during actual measurement sequence. Providing 21 CFR part 11 compliance, Acquire software incorporates password protection and audit trail facility that is permanently active to record every transaction. CFR Administrator tool defines access privileges for individual operators or groups.Original Press Release:
New Biochrom UV-Visible Spectrophotometer is FDA Compliant
The new Libra S35PC UV-Visible Spectrophotometer system has a high-performance 1nm bandwidth optical system and can be combined with a new version of the Acquire applications software that has been updated for 21 CFR part 11 compliance. Optical specifications exceed Pharmacopoeia requirements over the operating range of 190 to 1100nm and built-in Instrument Performance Validation is provided for GLP purposes. Other hardware features include Biochrom's unique "Press to Read" deuterium lamp technology, an innovation that increases source lifetime by only running the source at maximum energy during an actual measurement sequence, and an 8-position sample changer supplied as standard. The 21 CFR part 11 version of Acquire software is fully FDA compliant in terms of electronic records and signatures, and incorporates full password protection and an Audit Trail facility that is permanently active to record every transaction. The CFR Administrator tool can be used to define access privileges for individual operators or operator groups. All the features of the original Acquire software are retained, including wavelength scanning, kinetics, quantification and multi-wavelength programmes. Results can be directly transferred into LIMS, printed or exported in spreadsheet format or as a *.pdf file.
Also new to the Libra range is the 1nm bandwidth Libra S35 with full local keyboard control, ideal for the analytical laboratory that does not need full 21 CFR part 11 compliance but still requires optical performance of a high standard. For more details visit www.biochrom.co.uk
For further information about this press release, please contact:
Jim Shannon
U.S. Sales and Marketing Manager
Biochrom Ltd.
Tel.: (978) 597-3372
