The shift toward single-use technology in bioprocessing represents one of the most significant changes in pharmaceutical manufacturing methods. While disposable components have become commonplace in many aspects of production, measurement instrumentation has traditionally relied on fixed, reusable equipment. This limitation created a persistent weak point in otherwise sterile processes. The Kemtrak single-use optical measurement cell system addresses this gap with an approach that aligns absorbance and turbidity measurement capabilities with modern manufacturing needs.
Why Bioprocessing Is Moving to Single-Use Technology
Personalized Medicine Drives Single-Use Adoption
Several key factors have accelerated the adoption of single-use measurement technology in bioprocessing. The growth of personalized medicine, particularly CAR T-cell therapy and cell-based immunotherapies, requires pristine processing conditions for patient-specific treatments. Each therapy batch uses the patient’s own cells, making cross-contamination prevention absolutely critical to successful treatment outcomes. Major biopharmaceutical companies have recognized this shift, increasingly adopting single-use components in their manufacturing processes.
Cross-Contamination Risks in Traditional Systems
Traditional fixed measurement systems, despite rigorous cleaning protocols, carry inherent risks of cross-contamination between production runs. Regulatory standards for product purity continue to tighten across all bioprocessing applications. This regulatory landscape, combined with the need for manufacturing flexibility, has exposed the limitations of conventional measurement approaches. Single-use components eliminate cleaning validation requirements and reduce the risk of batch rejection due to contamination issues.
Advanced Features of Single-Use Measurement Systems
The technological response to these industry demands has produced measurement systems that combine precision with practicality. The key advancement centers on achieving zero dead volume, ensuring sharp peak detection crucial for both fractionation control and filtration applications. Measurement capabilities now span from 4.5 to 90 OD, accommodating everything from small-scale research to full production environments.
Material science plays a crucial role in this evolution. Cells manufactured from medical-grade poly-phenylsulfone (PPSU) provide the durability and chemical compatibility required for bioprocessing applications. Each cell features color-coding for optical path length identification, while the quick-release mechanism and robust cell dock design ensure reliable positioning in the optical light path. Sterilization flexibility — through either autoclaving or irradiation — allows integration into existing workflows without compromising standard operating procedures.
Single-Use Cell Specifications for Bioprocessing
The adaptability of Kemtrak’s single-use measurement cells stems from their range of available configurations. Cell sizes span from 1/8″ to 1″, with internal diameters ranging from 2 mm to 20.83 mm.
Path Length Options
- 0.5 mm to 10 mm range enables measurement optimization
- Smaller path lengths (0.5-2 mm) suit high-concentration protein measurements
- Longer path lengths (5-10 mm) provide enhanced sensitivity for dilute solutions
- Standardized optical configurations ensure measurement consistency across scales
Integration Features
- Standard SMA905 fiber optic connectors ensure compatibility
- Spring-loaded cell retainer maintains precise optical alignment
- Available mounting options for both laboratory and plant installation
- Maximum operating temperature of 174°C supports standard sterilization protocols
Applications in Bioprocess Manufacturing
The versatility of single-use measurement cells has expanded their implementation across multiple bioprocessing operations. These systems now handle critical measurements in:
- Protein Concentration Monitoring: Precise measurement across a wide range of concentrations, from dilute solutions to high-concentration formulations, enabling optimal process control
- Chromatographic Separation: Zero dead volume enables precise peak detection and fraction collection, while multiple path length options optimize resolution across different protein concentrations
- Medicine Formulation: Accurate measurement capabilities support critical quality attributes during formulation, ensuring consistent drug product characteristics
- Filtration Monitoring: Real-time measurement capabilities track protein concentration through various filtration stages, from initial clarification to final sterile filtration
- Process Development: Small-volume options support early-stage work where sample conservation is crucial, allowing seamless transfer of measurement parameters to larger scales
GMP Compliance and Validation for Single-Use Systems
The validation burden in bioprocessing traditionally involves extensive documentation, time-consuming protocols, and complex risk assessments. Kemtrak’s single-use measurement cells reduce this complexity through several key features:
Material and Design Compliance
- USP Class VI and FDA certified materials meet biocompatibility requirements
- EN 10204 documentation provides complete material traceability
- Comprehensive certification package supports GMP implementation
Risk Mitigation Features
- Color-coded optical path lengths prevent selection errors
- Quick-release mechanism ensures consistent cell positioning
- No cleaning validation requirements between batches
- Single-use nature eliminates cross-contamination risks
Future of Single-Use Measurement Technology
Meeting Manufacturing Challenges
The integration of single-use measurement cells represents more than a temporary solution to current manufacturing challenges. As biomanufacturing continues its evolution toward flexible, modular processing, measurement systems must adapt without compromising data quality or process reliability.
Scalability Across Development Stages
The scalability of these systems, from research and development through clinical trials to commercial production, eliminates the need for multiple measurement approaches throughout a product’s lifecycle. This consistency in measurement methodology streamlines process validation and tech transfer activities.
Supporting Emerging Therapeutic Needs
Beyond the immediate benefits in current applications, these measurement systems anticipate future needs in bioprocessing. The ability to handle high-concentration protein formulations, combined with the range of available path lengths, positions this technology to support emerging therapeutic modalities and manufacturing approaches.
Final Word
The advancement of single-use measurement technology has removed a significant barrier in bioprocess manufacturing. As the industry pushes toward more flexible, efficient production methods — particularly in cell therapy applications — the ability to maintain measurement precision while eliminating cross-contamination risk becomes increasingly valuable. The combination of simplified validation, robust measurement capabilities, and adaptable configurations positions this technology as an integral component in modern bioprocessing operations.
Contact South Fork Instruments
For detailed specifications or to discuss your specific application requirements, contact us at info@southforkinstruments.com or call 925-461-5059. You can also reach out via our website. How can we help?
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