Validation
Validation relates to demonstrating that measurement systems have been tested to show that what they report corresponds to what they are measuring. The term validation relates particularly to processes and equipment used in the pharmaceutical (life science) sector.
Validation of a measurement process can take a considerable amount of time and investment. This can delay, impede or rule out the use of particular measurement technologies, even if these could improve the performance of critical processes.
To address this issue, and improve its effectiveness in meeting customer needs, ITS has invested in validating its p2000 instrument system for a number of applications. This was carried out with the expert assistance ABB Life Sciences. This effectively tests the use of ITS technology against criteria set out in the GAMP5® industry guide.
In validating the p2000 instrument system, ITS has ensured that:
- User requirements are met by tracing the requirements through the design and verification phases.
- Formal testing practices are adopted.
- Software test scripts are embedded in the code to facilitate 100% regression testing.
- A risk based approach is applied to validation.
- 21 CFR Part 11 technical compliance is achieved.
- ITS’s quality management system (QMS) fully supports the validation.
ITS, in conjunction with ABB Life Sciences, has developed a clear validation methodology based on validation of the p2000 standard product (“product validation”), plus validation of the implementation of the p2000 system for a particular User application (“project validation”). This methodology enables Users to purchase a product that is already validated, and greatly reduces the required validation effort to the application of the p2000 system to the User’s process (as defined through their URS – user requirement specification).
This approach is illustrated through the Validation Life Cycle shown in the simplified diagram below (V-model). ITS is open to working with life science companies in the areas of PAT (process analytical technology), QbD (Quality by Design) and other methodologies in ensuring that our technology meets with your process requirements.
Shaded blue boxes denote validation activities for the Product Development life cycle already carried out by ITS. Lightly shaded grey boxes denote validation activities for the Project Delivery life cycle that will be carried out for a particular User installation.
At present, the generic applications for process tomography, which have been validated through to factory acceptance testing, are:
- interface detection with linear sensor; this is of particular benefit in liquid-liquid separation, where organic and aqueous phases are mixed and then separated. Frequently the end point of this process is hard to determine and the precise position of the interface difficult to identify. A linear process tomography probe can meet each of these challenges.
- homogeneity measurement with linear sensor; determining when two components are properly mixed, or identifying when a well prepared mixture is in danger of separating, is very difficult to achieve with conventional sensing technologies. Conventional sensors usually rely on single point measurements or sampling at the end of a batch, both of which run the risk of missing outliers. Process tomography sensors can scan a volume and determine the variance of concentrations of products within that volume, so providing a measure of homogeneity.
- two phase flow visualisation with circular sensor; the nature of flow of a multi-phase mixture can be extremely important to downstream processing and overall product quality. One of the key application areas of process tomography has been in flow visualisation.
Each of these applications has been with a p2000 instrument operating through in Ex modulue.
If you are interested in further details on ITS’s approach to validation or would like to use tomography in a validated environment please forward details so we can help to address your requirements.
References:
The Good Automated Manufacturing Practice (GAMP) guide: “A risk-based approach to compliant GxP computerized systems”, GAMP5® (ISPE/GAMP, 2008)
http://www.ispe.org/gamp/
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