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.

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Microwave digestion in the filed of pharma analysis

Berghof Products for Pharma Analyses

Микроволновое разложение проб

speedwave XPERT Инновационные технологии для надежного разложения проб

Максимальная многовариантность при разложении проб при температурах до 260° C и давлении до 100 bar.

 К продукту
Микроволновое разложение проб

speedwave ENTRY Базовый вариант для рутинной пробоподготовки

Для рутинных процессов с температурами до 220° C и давлением до 75 bar.

 К продукту
Автоклавы высокого давления

DAB-2/3/3XXL Автоклавы высокого давления для разложения проб

Для проведения опытов при температуре до 250° C и 200 бар и объемах до 420 мл.

 К продукту

21 CFR Part 11 Conform Software

Berghof 21 CFR Part 11 compliant 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
  • documentation
  • 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.

IQ/OQ Package

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:

  • IQ-documentation
  • OQ-documentation
  • print templates
  • qualification badges

In addition, there is a repeat-OQ for the annual recertification available.

speedwave microwave IQ/OQ package