Introducing the Stream Sampling Kit (SSK)
We are excited to launch our latest innovation designed to enhance pharmaceutical quality assurance.
Now Available from CIS International LLC!
About the Product:
The Stream Sampling Kit (SSK) is a patented sampling interface (US Patent 10,520,400) designed to ensure blend content uniformity by enabling real-time quality monitoring and control during powder manufacturing.
Developed and supported by Rodolfo J. Romañach, Ph.D. and Rafael Méndez, Ph.D. from the University of Puerto Rico – Mayagüez Campus, licensed by the Puerto Rico Science, Technology and Research Trust (PRSTRT), and exclusively manufactured by CIS International with the direct support of Dr. Carlos Conde, the SSK is backed by multiple peer-reviewed publications (2020–2024, International Journal of Pharmaceutics).
Traditional sampling methods rely on laboratory testing that is often slow, complex, and prone to biases due to particle behavior. In contrast, the SSK functions as a real-time sampling interface, integrating directly into the process stream and working seamlessly with PAT tools such as NIR and Raman analyzers.
How it Works:
- Powder flows from a hopper or a continuous mixer to the Stream Sampling Kit
- Powder is confined within paddles (designed to eliminate the wave pattern)
- NIR, Raman spectra, or other PAT tools monitor quality in real-time
- Powder leaves the system, avoiding recirculation (different from what occurs in most feed frames)
The system ensures:
- Gentle powder dynamics for minimum attrition
- Consistent flow
- Unbiased and representative sampling for better quality measurements
Intended for:
- Pharmaceutical manufacturing (batch or continuous)
- Biopharmaceutical production
- Powder blending, homogenization, granulation, and compression processes
SSK Benefits:
- Enables true real-time quality monitoring and decision-making
- Eliminates sampling biases from traditional “thieving” methods
- Supports faster time to product introduction (great for NPI)
- Improves process understanding and knowledge
- Strengthens process control and reliability
- Avoids particle rearrangement, attrition, and recirculation
- Ensures equal sampling probability (Fundamental Sampling Principle)
- Works with PAT tools for immediate quality measurement, adjustments, and control
- Tested with multiple formulations (e.g., Ibuprofen/Lactose/MCC blends, etc.)
- Demonstrated stable NIR spectra during continuous operation
- Supported by extensive scientific literature (2020–2024 studies)
- Supported by SMEs from the Academia and CIS International
Our Value Proposition:
Technical Summary
- The stream sampler with an approximate capacity between 8 - 100 kg/h
- Wide range of material properties studied (Carr’s Index between 21 and 40)
- Wide range of API concentrations (0.7 – 80% w/w)
- Easy to clean and small in size
- Avoid complex flow dynamics of the feed frame (avoids recirculation)
- No need to install NIR or Raman inside the feed frame or use a long fiber optic probe
- Adaptability to granulators, blenders, and multiple tablet compression machines, regardless of the feed frame
- Variographic analysis – Sampling & Error.
SSK product (equipment)
- SSK hardware and components (piping fully customizable, optics, motor, electronics, and sensors)
- Supported and compatible with most PAT tools (e.g., NIR, Raman, etc.)
- Support with different chemometrics software and data acquisition software
- Accessories and Documents: Installation Manual, BOM, Designs, URS, IOPQ package, SOP, warranty, etc.
- Reference literature
Featured Integrations:
The SSK is designed for seamless integration across processes and analytical systems:
Process Integration
- Continuous mixing and blending
- Roller compaction
- Granulation and drying
- Lubrication and compression
- Tablet press operations
Compatible Analyzers:
- VIAVI MicroNIR (PAT-U & PAT-W)
- Bruker Matrix-F II Process FT-NIR
- Sentronic SentroProbe DR LS
- Thermo Fisher MARQ Raman
- Additional analyzers under testing
