Microwave Reaction System provides complete Compliance of Pharmaceutical Regulations

The pharmaceutical industry is the most regulated of all sectors. The supply chain of pharmaceutical companies comprises of several steps and processes.

This supply chain can be divided into two specific areas: R&D and quality control.  R&D requires high precision instrumentation that suits specific needs, whereas quality control, including entrance and in-process/after-process control, requires, robust, easy-to-use instruments. Since the whole supply chain, except research, is strictly regulated, instrumentation with quality documentation is an absolute must.

Anton Paar has been working in the field of microwave technology for over 3 decades.  Using quality materials and innovative solutions, Anton Paar defines the standard for high level instrumentation.  The Multiwave PRO Microwave Reaction System offers the full range of microwave-assisted techniques: acid digestion, solvent extraction and synthesis.  The instrument is robust and easy to use featuring intuitive software.  Depending on its rotor configuration, The Multiwave PRO can serve the most demanding requirements whilst offering all proven methods for pharmaceutical samples.

Compliance with pharmaceutical regulations is ensured by the Multiwave PRO’s intuitive software which complies with 21 CFR Part 11 and features access control, electronic signature and a complete audit trail.  The Multiwave PRO’s Qualification and Validation Documentation, meets pharmaceutical regulations including GMP, 21 CFR Part 11, GAMP-5 and USP chapter <1058>, following the 4Q-Model - Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ), and additionally contains, a traceability list, risk analysis, a user standard operating procedure (SOP) as well as a protocol for 21 CFR Part 11.

The Multiwave PRO Microwave Reaction System delivers synthesis and sample preparation solutions for all aspects within the pharmaceutical industry.

Synthesis, enabling convenient and efficient parallel method development and optimisation with software-documented on-the-fly of relevant reaction parameters (temperature, time, power). Several rotor types allow high-throughput preparation of valuable compounds from milligram to multigram quantities.

Sample preparation, providing comprehensive qualification documentation based on the latest regulations required in the pharmaceutical industry, saving time and money in the qualification process.  An integrated library with tested methods for a variety of pharmaceutical samples simplifies the daily workflow.