Design overview

Design overview

Scientific analytical instruments are the base tool for all other industries. However, development of advanced instruments often does not require idustrial level quality so the projects for such advanced instruments often ignore the quality process at first, and follow up later using Operational Qualification (OQ) and Performance Validation (PV). We will discuss this in detail later in the chapter.

I have been working on instrument design and development for over 30 years. Most of the instruments I have designed are well known common technologies such as HPLC and Mass Spectrometers. These instruments are used as tools in other areas of science such as cell biology, the petroleum industry, or other industrial activities such as QC sample analysis. These types of analytical instruments have different requirements from the market.

Design Qualification (DQ) is a process followed to develop a design from appropriate requirements. The first step of DQ is to make a list of critical items for development. Then, each critical item is verified that it meets the design. I would recommend consider following items as a part of DQ:

1. Verify that the business plan matches up with the quality plan. For example, if the business plan requires 100 units shipped per year, then Mean Time Between Failure (MTBF), production lead time, service and support lead time, etc. should match up with the expected operation hours at the customers site.
2. Verify the sample load and process throughput. For example, if the customer expects to use the instrument to analyze 1000 samples per day, seven days per week , then the auto-sampler should be big enough to accommodate the sample load and the data system should provide enough data storage and process speed to generate the necessary reports. In addition to this, all consumable parts life should match up with instrument running cycles.
3. Verify the precision of the data. A mass spectrometer that has a mass accuracy specification of 1ppm requires more than seven digits of accuracy. All software and hardware affecting instrument performance should be validated for accuracy and calculation precision according to the mass accuracy specification. A Standard Operating Procedure (SOP) should be provided for validation.

We will guide you though the DQ of LC/MS instrument development in this chapter.