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Process Analytical Technology

PROCESS ANALYTICAL TECHNOLOGY

Ensure Quality, Enhance Efficiency, and Accelerate Time-to-Market by Deploying Process Analytical Technology (PAT)

Life Sciences manufacturers are under intense pressure to deliver treatments quickly and cost-effectively around the globe. With the world’s new focus on rapid results, gone are the days when the product could sit in work-in-progress (WIP) for days, weeks, or even months, waiting on lab testing for quality validation. PAT drives stability and performance by bringing spectral waveform data from process analyzers directly into the controls environment. At Apperture Solutions, our consulting team can provide techniques for in-line, real-time, continuous, closed-loop process verification and control, which facilitates automated real-time quality release, while building a foundation for better regulatory management and optimization of facility performance and throughput.

Partnering With Apperture Solutions to
Install a PAT Solution Can Provide the Following Benefits:

Improved Product Quality

PAT helps ensure that each batch or lot of a drug or biologic meets the required specifications for purity, potency, and safety, without relying on post-production testing alone. Real-time monitoring allows for immediate corrective actions to maintain quality.

Faster Time-to-Market

By reducing the need for extensive batch testing, which can be time-consuming, PAT can shorten the time required to validate processes and products. This is crucial in highly regulated industries like Life Sciences, where meeting market demand quickly is often essential.

Cost Savings

With better process control, PAT reduces waste and rejects, lowers energy usage, and decreases the need for off-spec products to be discarded or reworked. Real-time adjustments also reduce the likelihood of equipment malfunctions, minimizing production downtime.

Regulatory Compliance

PAT aligns with regulatory guidelines, such as those from the FDA (Food and Drug Administration) and EMA (European Medicines Agency), particularly in supporting continuous manufacturing and process validation. Regulatory agencies recognize the value of PAT in ensuring consistent quality, which may lead to more efficient approvals.

Risk Management

PAT minimizes risks associated with production, such as contamination, incorrect formulations, or deviations from acceptable quality standards, by catching problems early in the process. This proactive approach helps mitigate the risk of non-compliance and ensures patient safety.

Continuous Manufacturing

PAT is particularly important in continuous manufacturing, where drugs are produced non-stop in a continuous flow rather than in batches. In these cases, PAT provides real-time feedback and ensures that the process remains within acceptable limits, making continuous manufacturing more reliable and efficient.

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