Unit Operation: Supporting Technology

Key to any successful PAT implementation are the supporting technologies. Well designed supporting devices can make the PAT implementation much more robust. Here are just some of the examples of Expo Technologies' supporting technology.

Window Design

Expo Technologies' flush mounted window design is constructed of certified inert materials, sapphire, stainless steel 316L and Kalrez®. All window design and implementation work is performed at one of our manufacturing facilities in the US or Europe. The device is robustness tested and all documentation, including certifcates of material conformity and technical drawings is shipped with the client's modified lid. We have experience of a wide range of sizes and designs of blender lids.

Trigger Switch

Expo Technologies' trigger switch is designed to work with all ePAT blend monitoring devices and with NovaPAC© software. Manufactured from certified materials and designed to operate in classified environments, the ePAT trigger switch has undergone several hundred hours of robustness testing at various rotation speeds. The device may be modified to operate with a client's existing blend monitoring system.

Auto-Cal Unit (NIR)

Designed for Near IR based PAT devices, the Auto-Cal Unit is designed for those plant implementations where regular Performance Qualification (PQ) is difficult due to the location of the installation because either it is contained in a sealed manufacturing suite where a drug product being made is highly potent, or that simply the PAT is difficult to access on a routine basis.

The Auto-Cal Unit contains certified and traceable reflectance standards. The unit will automatically couple, run PQ and then decouple from the measurement device. It is contained in SS316L and is designed to work in classified environments.

Automatic Validation Workstation (AVW) for NIR PAT

The Automatic Validation Workstation is primarily designed for ePAT601, ePAT602, and ePAT642 , but can also be used with other non-Expo Technologies NIR based Process Analytical Technology.

The Automatic Validation Workstation (AVW) is a plant rugged workstation for the automatic validation of plant installed NIR spectrometers and is one of the ePAT series of plant robust solutions designed to enhance Process Analytical Technology. IP65 compliant workstation includes traceable photometric and wavelength standards, protected from harsh plant environment. Affords easy and reproducable connection of NIR spectrometer to workstation. Touch button control to start validation routine.

Designed for compatibility with most reflectance measurement based NIR spectrometers, features include:

• Traceable photometric and wavelength standards
• cGMP compliant hardware
• Easy and reliable connection of NIR to workstation
• Push button operation, independent from NIR spectrometer software
• IP65 compliant, ATEX Category 2, Zone 22
• Transportable on plant

Ruggedised Probe Technology

ePAT611 Probe

The ePAT611 Diffuse Reflectance measurement probe is designed to withstand the rigours of the granulation process and can work in temperatures up to 250°C and pressures of up to 10 bar. The probe head can be heated to ±1°C between 30°C and 70°C which has been shown to significantly decrease window fouling problems. Full control of the probe together with the measured temperature readout is integrated into the latest version of NovaPAC© instrument control software. The ePAT 611 Probe umbilical is supplied in a standard 3m length. Custom lengths are available for a fully engineered PAT solution For all ePAT611 probe applications, Expo recommends the use of ePrecision.

ePrecision

ePrecision is a high performance referencing solution. Designed to achieve the most accurate and reproducible reference possible with the ePAT Diffuse Reflectance Probe, the reflectance standard is incorporated into a holder manufactured to very high tolerances in order to ensure easy and accurate alignment under process conditions.

Other Supporting Technologies

For information on other supporting technologies designed for PAT implementations contact us.