Unit Operation: Cleaning Validation (Rinsate)

The ePAT 671 Rinsate Monitor for Cleaning Validation is a real time, diode array based UV/NIR spectrometer, designed to measure cleaning and final rinse solutions during the cleaning of API and Drug Product vessels.

The integrated system consists of a 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 us in Zone 1 environments. The ePAT 671 uses a fiber optic measurement accessory with flow cell sample interface in order to monitor active ingredient. Various flow cell configurations are available.

The two 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%-85% humidity range.

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 ePAT671 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 as part of their Project Management Approach to Design and Implementation.

Outline Specification of ePAT671 Cleaning Validation (Rinsate)

Spectral Range	190 - 1010 nm
Resolution	<3 nm
Wavelength Accuracy	<1.0 nm
Wavelength Reproducibility	±0.1 nm
Photometric Accuracy	10mAU
Photometric Reproducibility	± 0.1mAU
Light Source	Process Deuterium Lamp Process Tungsten-Halogen Lamp Xenon Flash Lamp
Data Acquisition Time	12 ms
Power	110/240 V AC
Sampling Interface	Flow Cell. Available in a range of configurations
Sampling Area	5mm and 75mm
Enclosure	Mobile. cGMP, ATEX and NEMA 4X
Weight (Analyzer)	180 kgs
Size (Enclosure)	1400h x 915w x 610d (mm)
Communication	Ethernet connection to embedded PC
Computer	Embedded, ruggedized

Flow Cell

A key component of the ePAT671 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