Microwave Digestion in the Field of Pharma Analysis
With reference to internationally valid pharma regulations
Analyses in the pharma sector often have to be in accordance with internationally valid regulations. The most important regulations are those of the FDA and GLP/GMP or GAMP. In order to fulfil these regaulations, Berghof has developped a pharma package for its microwave dogestion system speedwave XPERT.
The package consists of two components:
Furthermore, Berghof provides several application notes, that are relevant for pharma analyses, for all of its digestion systems.
Berghof Products for Pharma Analyses
For experiments at up to 250° C and 200 bar and volumes up to 420 ml.
21 CFR Part 11 Conform Software
The Speedwave XPERT can be orderd or upgraded with an additional 21 CFR Part 11 conform software package.
The compliance to 21 CFR Part 11 is ensured by the following components:
- user management
- password protection
- audit trail
- export and print functions
The combination of all of these components guarantees a complete traceability of all actions carried out with the Berghof speedwave XPERT.
Berghof offers an extensive IQ/OQ-package in order to fulfil the strict regulations of the pharma industry. The qualification package enables you to prove that the speedwave XPERT meets legal requirements during its use.
The IQ/OQ-package consists of the following compinents:
- print templates
- qualification badges
In addition, there is a repeat-OQ for the annual recertification available.