Sustainability Phase

Phase Three of Design & Implementation

Once the PAT Measurement Device is implemented, Expo's commitment to post-commission support is demonstrated in the following strategy. Expo maintains the device, both with applications and service support.

Applications Support

Applications support is offered to ensure success of the PAT implementation. Expo personnel are available to assist in any method development issues. We can offer assistance with:

• Software operation
• Instrument validation
• Quantitative method development
• Qualitative method development
• Real time process analysis

Scope and depth of the applications support can be mutually agreed prior to the visit. A certificate of competence is provided on completion of the required training. Expo personnel are automatically covered under a confidentiality agreement, but further assurances that data and its analysis are protected can be supplied.

Service Support and Calibration Integrity

The ePAT series of devices are designed to be modular such that components of the device can be easily swapped out by the Expo trained plant operator or by Expo support personnel. Through our robustness assessment documents we also understand the effect of component change of the device. Expo strongly recommends a Calibration Integrity Agreement is entered into to maintain the system at peak performance.

Calibration Integrity Agreement (CIA)

Expo offers the Calibration Integrity Agreement as a critical component of the Expo-customer partnership model. This agreement provides the highest level of assurance that Expo retains ownership and responsibility for the robustness, performance, and continued optimization of the instrument. Complete peace of mind regarding system performance is guaranteed. The calibration agreement includes the following terms and features:

• The agreement begins immediately following the expiration of the warranty or the expiration of the preceding CIA.
• All parts and labor are included. Expo reserves the option of utilizing rebuilt and re-qualified components for any repairs.
• One on-site visit for scheduled preventive maintenance and recalibration per year.
• Unlimited on-site visits for unscheduled service or repair. The customer is responsible for ensuring timely access to the equipment by Expo personnel. In extenuating circumstances, it may be necessary to return the instrument to the factory. If so, a formal RMA process will be followed.
• Expedited on-site response time.
• Yearly replacement of calibration standards.
• Upgrades to software (optional). Expo is aware of the requirements imposed by regulatory authorities and internal compliance departments. All software upgrades will be accompanied by sufficient documentation to allow an informed decision based upon a risk assessment. The customer is under no obligation to accept and implement software upgrades.
• Unlimited phone support (help desk and/or service personnel) during normal working hours.
• Renewal reminder notice 2 months before agreement expires.

Design and Implementation of Supporting Technology

A key component to the success and sustainability of a PAT implementation can be the Supporting Technology that surrounds the measurement device itself. Expo can design, integrate and implement devices such as the Auto-Calibration Unit. See Supporting Technology for more details.