Analytical Method Development

Consultancy and Advice

InProcess-LSP offers consultancy services to explore and advise on realistic possibilities to address your analytical challenges either for PAT methods or offline approaches. We can support you by exploring technical possibilities and provide transparent information of estimated associated costs and possible risks to evaluate your business case.

Feasibility Studies

We perform feasibility studies at two stages: paper feasibility and experimental feasibility studies.

For a specific demand we can perform a paper feasibility study to examine possibilities and challenges. Experimental feasibilities can be performed using our lab facilities. We recognize the importance of setting clear objectives and requirements together with the customer to ensure the desired result. We make use of up-to-date literature and knowledge using our own experience as well as our extensive knowledge network.

Method Development & Validation PAT (in/online)

Applications are developed and validated in accordance with existing regulations and guidelines, based on clear process performance requirements. All development and validation activities are carried out according to a detailed working plan as discussed with the customer. For larger projects the development and validation phase can be subdivided in a number of phases with clear milestones. InProcess-LSP provides extensive experience of risk-based validation of PAT applications in order to ensure robust process performance.

Method Development & Validation at-line/lab Systems

Besides in/on-line PAT applications we develop and validate applications for at-line and lab-systems as well. Typical non-invasive spectroscopic and optical techniques like NIR, Raman, and OCT can be used effectively to analyse your samples within minutes without extensive sample preparation or analytical handling.

Implementation

We can support you to implement your application successfully within your organization. Implementation involves configuration of your system to ensure readiness for routine operation and training for involved users, staff, or your quality organization. InProcess-LSP can support you where needed by setting up procedures and necessary work instructions as well.

Examples