Reaction Monitoring

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Cleaning Validation (Rinsate)

The ePAT771 is a UV-Vis spectrophotometer system designed for Reaction Monitoring and Rinsate Monitoring for Cleaning Optimization and Validation. The integrated system consists of a single or dual channel process spectrometer, process deuterium lamp, process tungsten-halogen lamp and xenon flash lamp.

The system includes a 15” touch screen display designed for use in Zone 1 environments.

The ePAT 771 can utilize a wide range of sample interface options from ATR probes to transflectance and transmission cells via a fiber optic coupling measurement accessory. Various ATR, transmission and flow cell configurations are available.

With the dual channel system the spectrometer modules may be operated independently or used in a dual channel mode (reference and sample). The system is capable of working in typical plant environment, 5°C to 40°C and 25‰ to 85‰ humidity range.

Reaction Monitoring/Crystallization Monitoring
Real time fast reaction monitoring can be performed using the ePAT771. Dip or transmission probes can be used with the system

 

Cleaning Verification Process
Spectroscopic Clean-In-Place techniques reduce the time required to meet FDA and GMP guidelines. Off line techniques, such as HPLC, are replaced by real-time analysis of the cleaning solution. Rinsing cycles can be ended as soon as zero-change state is reached.

Method development is developed for a cleaning campaign and from that the ePAT771 is set up for optimal configuration of the API. In routine monitoring mode, the system displays the results from the cleaning process and they are in turn communicated to the DCS.

Expo Technologies are able to assist with the Application Feasibility Study

Flow Cell

A key component of the ePAT 771 is the flow cell sample interface. Expo Technologies is able to provide a number of configurations of flow cell in order to meet the need of specific applications. The components which come into contact with the rinsate are made of stainlesss steel or Hastelloy and polished to an Ra of 0.6 ?m or better. All flow cells are optimized for use in the UV wavelength range.

Following is a specification for a typical flow cell design.

• Variable Path Length 1-25 mm
• Overall length 200mm
• Pressure Rated to 6 bar at 100°C