Optimal synTQ Consulting
Pharma 4.0 starts with PAT leader synTQ
Optimal’s synTQ software helps clients achieve the huge cost saving benefits of PAT enabled manufacture. Continuous manufacturing enabled by PAT is cutting production cycle times and enabling real time release of product. synTQ meets all compliance requirements and guides you through equipment adaptor selection and even offers custom adaptors if the equipment you need is not a standard offering in the PAT space. Software integrations include:
- Spectral instruments
- MVA packages
- Control systems
- Laboratory systems
Why Choose synTQ?
synTQ is and can be easily upgraded and expanded as needed.
Versions exist for all levels of organizations:
- Single unit operations
- Small scale configurable
- Large multi-instrument
- Enterprise Management
synTQ allows you to choose whatever instrument and MVA package you need – their portfolio of ‘adaptors’ supports common PAT equipment and the team will get in contact with vendors to create an integration as needed.
Expert Technical Support is provided 24/7/365.
Customers all have access to Optimal’s online knowledgebase anytime for troubleshooting or accelerating learning.
Who Can Take Advantage?
synTQ is suitable for a variety of different industries though Lean Biologix provides tailored synTQ expertise in life sciences since 2015. Lean Biologix helps businesses to better understand PAT benefits and apply and maintain compliant software to increase operational effectiveness. We are experienced in enterprise-wide installation across multiple manufacturing sites utilizing both on-premise and cloud infrastructure.
synTQ Core Features
Instrumentation Management and Control – Implement complex instrumentation such as NIR, Raman, UV Vis, Particle Size, Mass Spec, UPLC, HPLC, etc. synTQ controls instruments, executes data transformation and combination if needed, and passes the data into a predictive model(s) for CQA prediction. CQAs that have been generated by the real time prediction engine to be fed into either a control module within synTQ and output to your existing control system using common protocols such as OPC. synTQ stores all data automatically and makes data immediately available at all levels of the organization in real time.
Data Integrity, Storage, & Reporting – All synTQ data communications are encrypted and ensure robust data exchanges. Cyber Secure gateways have been developed and synTQ is compliant with all the industry guidance standards, requirements, and regulations such as 21 CFR Part 11. The use of industry standard databases enables synTQ users to access and build out reporting in their Business Intelligence tool of choice.
Analysis, Real Time Prediction, & Continuous Improvement – Using synTQ and real-time predictive models can provide several benefits, including:
- Improved Process Control: PAT can help monitor and control critical process parameters in real-time, which can lead to improved process performance, reduced variability and increased efficiency.
- Enhanced Quality Control: PAT provides real-time monitoring and control of quality-critical parameters, enabling rapid identification and correction of issues to minimize product waste and improve product quality.
- Increased Productivity: Real-time predictive models can help to optimize processes and predict potential issues, enabling proactive corrective actions that can increase productivity and reduce downtime.
- Better Understanding of Processes: PAT provides a wealth of data that can be analyzed to gain a deeper understanding of processes and to identify areas for improvement.
- Compliance with Regulations: PAT can help to ensure compliance with regulations by monitoring and reporting on critical parameters and providing real-time alerts when limits are exceeded.
- Improved Safety: Real-time monitoring and control of critical parameters can help to identify and mitigate potential safety risks in a timely manner.
Integrations and Beyond
In-Line & On-Line control – Transition from time consuming off-line QC testing and enable real time monitoring of a reaction’s progress. Client are able to control processes in real time to optimize for product quality and bring wastage to a minimum.
Incoming Materials – synTQ can be used to pass data to LES for real-time release of raw materials
Continuous pharmaceutical production – condition of raw materials can be tested using an automated probe. The synTQ system stores that data and makes use of it to adjust control parameters when that batch of material is introduced into the manufacturing process