There are many factors to consider when investing in new tablet testing equipment. This document outlines eight key criteria to help guide the selection of an oral solid dosage (OSD) CQA analyser.
Introduction
A robust and reliable testing platform should be fully scalable to commercial environments, enabling smoother technology transfer, enhanced In-Process Control (IPC), and more consistent Continued Process Verification (CPV). Moreover, real-time analytical capability can accelerate Real-Time Decision-making (RTD) and support Real-Time Release (RTR) of finished product.
1. CQAs
Today's Critical Quality Attributes (CQAs) — and tomorrow's requirements
The development of OSD products is driven by a constant tension between speed, reliability, and regulatory compliance.
Detectability studies must confirm whether the active pharmaceutical ingredient (API) can be reliably identified within a complex formulation. Yet these studies, when performed with traditional methods, are often slow and resource-intensive.
Category | CQA | Purpose |
Physical | Appearance, Weight, Hardness, Friability | Uniformity, handling, and physical integrity |
Performance | Disintegration, Dissolution, Content Uniformity | Drug release and bioavailability |
Chemical | Assay, Impurities, Moisture | Potency, safety, and stability |
Microbiogical | Bioburden, Pathogens | Product safety |
Formulation-specific | Coating, Polymorph, Particle Size | Controlled release and stability |
It is expected that the sample quantity, frequency, and CQA’s expectations will increase in future regulatory guidance. It is highly likely that the authorities’ requirements will become more stringent in terms of testing, such as determining the CU by correlating the individual mass with the individual % of APIs in tablets or capsules.
2. Integration
Integration with existing equipment and digital infrastructure
A next-generation analyser should align with your current manufacturing and R&D environment. This includes compatibility with existing tablet presses, capsule fillers, conveyors, and sampling systems, as well as smooth connection to MES, LIMS, SCADA, and historian platforms. Seamless digital integration reduces validation burden, simplifies data governance, and ensures that high-frequency PAT data can be efficiently digested by multivariate control systems.
3. Scalability
This allows perfect scalability between R&D - Pilot - Tech Transfer - Commercial Manufacturing. The system being independent from the line, it can be easily transferred from one department to another, or even from one site to another.
4. Versatility & Flexibility
Their modular architecture, compact footprint, and compatibility with multiple tablet presses and capsule fillers make them easy to relocate, requalify, and integrate into diverse production setups. This flexibility ensures companies can standardize analytical methods worldwide, streamline technology transfer, and maintain consistent CQA monitoring regardless of location—supporting a truly scalable global manufacturing strategy.
Here are some examples of flexibilities:
- Selection of the needed CQAs needed for a particular product
- Various way of testing: powder cup, single object First-in/First-out, multiple tablets or capsules
- Testing strategy: frequency of sampling, quantity per sample set, as well as a First In/Fist Out mode (FIFO) is also available to keep track on each object tested.
- Mobile QA Strategy scalable to the world: new generation of PAT analyser are mobile and process line supplier agnostic. They can be use in various configuration. They are easy transferable from site to site following the product (i.e. product transfer to CDMO). In other words, they can follow the product anywhere in the world and on any kind of processing line.
- Various control strategy: Off-Line, At-Line, On-Line, and In-Line
5. PAT Robustness
Ease of use with no specialist required
While PAT technologies for tablet and capsule characterization are inherently sophisticated, they should feel simple and intuitive to the people who use them every day. Many vendors claim to offer user-friendly software, but true ease of use is demonstrated by how robustly the system performs under real operational conditions -and how little specialized expertise is required to keep it running.
At Pharma Technology, this philosophy has guided product development from the beginning. “Let’s create a machine that a trained operator can use - from R&D to commercial manufacturing - without needing a PAT expert for routine operation,” says Martial DOLLINGER, CEO of Pharma Technology.
Achieving this level of accessibility requires more than a clean interface. It involves supporting the entire workflow: from setting up DoE studies, configuring the equipment, and tagging samples, to data acquisition, ordination, storage, and chemometric model application—all the way through to day-to-day routine operation.
The CQAs analyser software must be built for flexibility, allowing users to access straightforward visual outputs such as pass/fail indicators, statistics, or histograms, while still offering deeper access to raw data, spectral analysis, and advanced diagnostics when needed. Every step has been deliberately engineered around user requirements, ensuring that complex PAT capability is delivered through a stable, industrial, robust, and operator-friendly solution.
6. Data Integrity & Automation
For every monitored CQA, the system should provide immediate visualization, including individual measurements, statistical summaries, and histogram displays. Secure, real-time data exchange with central databases is enabled through OPC UA communication, while local logbooks and reports can be instantly generated and digitally signed to meet data-integrity expectations.
Beyond analytics, the platform must communicate directly with upstream or downstream equipment to support a fully automated control loop—allowing critical process parameters (CPP) to be adjusted in real time based on live CQA feedback, strengthening process robustness and paving the way toward Real-Time Release (RTR).
The analyser should feature a dust-tight design, with the testing area maintained under light negative pressure to ensure maximum operator safety. For handling highly potent or toxic compounds, Pharma Technology provides analysers configured to meet a range of Operator Exposure Band (OEB) security levels, guaranteeing compliance with strict safety standards while maintaining reliable testing performance.
7. Return On Investment
Next-generation PAT analysers accelerate development work across production equipment, offering multiple tangible benefits: reduced material consumption during R&D, streamlined support for Design of Experiments (DoE) and Quality by Design (QbD) with instant CQA’s access, smoother scale-up to commercial manufacturing, enhanced In-Process Control (IPC), and faster batch release. Together, these efficiencies translate directly into operational cost savings and a faster, more reliable path from R&D to market-ready products.
8. Strong service network
Over the years, Pharma Technology has expanded its global presence, providing customers with access to worldwide service teams and strategically located spare parts. Tablet & capsules testing specialists are positioned around the globe to maintain equipment, train users, and help clients fully leverage their investment.
What ultimately counts is not just service availability, but the depth of scientific expertise behind the technology. Can their team communicate effectively with your scientists? Are they simply delivering a machine, or are they also enabling your team to master it?
At Pharma Technology, our foundation in pharmaceutical process equipment, combined with R&D scientists who work daily with our Quality Control systems, ensures that our solutions are both practical and scientifically rigorous. Additionally, we support a broad community of academic and industrial researchers through experimental studies and model development. The scientific expertise within the Pharma Technology Research team is a key driver of successful partnerships and Pharma Technology analyser key innovative solutions across the industry.
Conclusion
Reducing time to market for OSD pharmaceutical products is crucial to
- Minimize Material consumption during R&D
- Maximize patent life and revenue potential.
- Strengthen competitive positioning.
- Recover R&D investments efficiently.
- Meet urgent patient needs and align with regulatory priorities.