Determining the elemental composition of raw materials, excipients and active pharmaceutical ingredients, as well as final formulations, is an important quality control requirement. Techniques such as Inductively Coupled Plasma Mass Spectrometry (ICP-MS) and Inductively Coupled Plasma Optical Emission Spectrometry (ICP-OES), used for trace metal analysis, require precise sample preparation methods to minimize the presence of total dissolved solids. Closed vessel microwave digestion systems are frequently used as they are easy to use, can rapidly process many samples at a time and well suited to the analysis of insoluble materials as they destroy the sample matrix. However, the highly regulated pharma sector requires precise documentation for the use of microwave digestion systems. Berghof has therefore developed an additional pharma package for the speedwave XPERT microwave digestion system, consisting of 21 CFR Part 11 conforming software and an IQ/OQ package to provide complete documentation of the digestion processes. This combination of the 21 CFR Part 11 compliant control software and the IQ/OQ package allows consistent traceability and documentation of the use of the speedwave XPERT and guarantees that it fulfils internationally valid pharma regulations, especially those of the FDA and GLP/GMP or GAMP.
speedwave XPERT Pharma Package
FDA CFR 21 Part 11 requirements include security and data audit tracking, appropriate operator access levels, details of operator logins and logouts, and when each test is created, changed, deleted or aborted. Audit trails must provide an accurate history of data. The optional speedwave XPERT Pharma Package complies with 21 CFR Part 11 by covering user management, password protection, audit trail and documentation as well as export and print functions.
speedwave IQ/OQ Package
IQ (Installation Qualification) and OQ (Operational Qualification) support ensures that instrument performance can be verified to manufacturers??? default thresholds and all servicing and validations are backed up by documentary evidence, highlighting the next time key parameters should be independently checked. IQ shows that the instrument complies with the manufacturer???s specification on installation, while OQ provides documented evidence for continued operability and data integrity. The speedwave XPERT IQ/OQ qualification package ensures that the speedwave XPERT meets legal requirements.
speedwave XPERT digestion system from Lambda
Lambda is a leading supplier of analytical instruments and preparation equipment for a wide range of applications, including the speedwave XPERT from Berghof. If you would like more information, simply contact a member of the team today.