PAT Implementation Services

Implementing PAT is a challenge if you have to balance it with day-to-day activities.

We employ specialized technical skills to allow you to reap all the benefits.


Talk to our experts

PAT Implementation Services

Implementing PAT is a challenge if you have to balance it with day-to-day activities.

We employ specialized technical skills to allow you to reap all the benefits.


Talk to our experts

Generate Real-Time Measurements of Product Attributes

Minimize Human intervention in measurements

Enable Real-time Release

Seamless implementation in parallel with your day-to-day operations

A Pillar of the Pharmaceutical Processes

PAT has been around for almost two decades now, since the launch of the FDA's Process Analytical Technology Guidance for Industry in 2004.

Its relevancy to pharmaceutical manufacturing has been throughly demonstrated through numerous scientific and technical publications on industry cases.

PAT is a fundamental piece of the process control strategy, by providing real-time measurements of relevant material and quality attributes and allowing process adjustments on a timely manner to consistently achieve predefined quality targets.

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Why should you implement PAT

PAT works hand-in-hand with the Quality by Design (QbD) paradigm and plays a prominent role in the transition to Continuous Manufacturing and as an enabler of real time release.

Additionally, by reducing human intervention in the measurements and decision-making workflow, PAT provides enhanced data integrity.

Regulatory Agencies have consistently supported PAT through the publication of relevant guidelines and by working with industry on the PAT framework.

We employ specialized technical skills that support organisations balancing the implementation of improvements with the day-to-day business activities.

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How can 4TE support your PAT efforts

Wether you already have PAT systems in place, or you want to introduce PAT for the first time, our team of MS&T experts, Data Scientists and Quality Risk Management specialists can support on your PAT implementation, by:

  • Analysing your Analytical Target Profile (ATP)
  • Providing support building your application URS
  • Facilitating your risk assessment to guide method development and validation
  • Defining a sampling plan and strategy for model development and validation
  • Supporting the lifecycle management activities of your PAT method (e.g. model calibration transfer, model maintenance, etc.)
  • Implementing Real Time Release approach with PAT tools

The stages of product lifecycle that we impact

4TuneEngineering 4TuneEngineering lifecycle

The solutions we work with

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What can you expect when you work with us

  • We will have a Pre-project meeting so that we can understand your expectations in the short and medium-term.
  • When everything is lined-up, and if you are happy, we will enter into contract.
  • Our teams will meet to formalize the project kick-off, covering the project scope, schedule, milestones, deliverables, and anything else that is necessary.
  • We will install the necessary software with any customizations that we may have agreed before.
  • We will define Software training dates for your team in order to make sure you can make the most out of Risk Management Digitalization.
  • We will provide you support and follow-up during our partnership.
software-print

Let's implement Process Analytical Technology in your process