PAT Implementation Management

Features:

• Integrated approach to implementation
• cGMP and hazardous location compliance
• Practical custom solutions
• Works on new installations or retrofit
• Expo takes the strain and delivers

The PAT Challenge

In many cases the analytical systems need to be added on to existing plant and equipment. The instruments themselves may need to be operated in a GMP environment for which they were not originally designed. GMP and Hazardous Location requirements must be adhered to. Documentation must be of a high standard to meet validation requirements. Software must comply with 21CFR part 11 whilst still being user friendly.

These challenges may seem daunting and an obstacle to the end user in implementing and reaping the benefits from PAT. Valuable time of Scientists and plant personnel can be used chasing the engineering issues. Instrument suppliers may be distracted from their core competencies in instrument design.

The EXPO Answer

Expo Technologies applies custom engineering skills and small scale project management to co-ordinate the activities required for successful PAT implementation. Using its own in house manufacturing facilities Expo can engineer the custom solutions that will make a PAT application work in a real world plant environment.

In addition we will liaise with the equipment manufacturers to ensure that equipment design incorporates the necessary features for practical implementation of PAT. This can be by specification and collaboration on design of new build equipment, or modification of existing plant.

Expo also ensures that realistic project plans are made and adhered to. This sometimes even involves our engineers in the uncomfortable job of progress chasing the customer! However the result is a successful implementation.

Application Example

Expo worked with a major pharmaceutical manufacturer to develop practical implementations of NIR spectroscopy for blending applications. The base instrument was a Corona NIR diode array spectrometer manufactured by Carl Zeiss.

Expo repackaged this instrument, working closely with the manufacturer. We ensured that the packaging was GMP compliant and that it could be mounted onto the existing blenders. The Lab scale blender is one example. In this case Expo developed an integrated battery power system for the instrument, working with experts in the field of batteries to select the correct technology, and ensure its safe and reliable implementation.

The battery power, together with RF data transmission selected by Expo, ensured that the instrument could operate as the blender bin rotated, without having wires or slip rings attached. The host computer runs 21CFR part 11 compliant software from SpectrAlliance Inc.

Expo modified the bin of the blender to include a suitable window for the NIR analyser to see the product and also incorporated an optical tilt sensor to trigger acquisition when the product is at a known position, ensuring consistent measurement for trend analysis.

How we work

As shown in the example, by pulling together expertise from diverse suppliers as well as from our own engineers, we ensure an efficient and trouble free implementation for the customer, saving him hundreds of man hours co-ordination and designing the full solution.

Expo applies its skills and its relationships with experts in many fields to provide and implement PAT in the real world. The company's history, beginning with customised pneumatic controls, and then providing custom housings for hazardous locations has developed the skills which we now also apply to PAT. Other applications include particle sizing, Mid IR, Vis and UV spectroscopy, Gas Chromatographs, UV sterilisation.

We are often involved in new process development, confidentially working with world leaders in their fields.