a system for designing, analyzing, and controlling manufacturing
through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in-process
materials and processes with the goal of ensuring final product quality.
Optek offers tools needed to develop processes that can consistently ensure a predefined quality at the end of manufacturing. Developing procedures consistent with the basic tenet of quality by design can reduce risks to quality and regulatory concerns while improving efficiency.
More specifically, optek provides process analyzers and validation tools that deliver reliable real-time, inline measurements without process interruption. Through process characterization, the user gains a better understanding of the process, leaving them one step away from realizing improved process control.
Process Characterization Challenges
Some manufacturers will face extreme challenges when attempting to characterize and define process parameters using inaccurate or unreliable process data from dated methods or poorly qualified process analyzers.
Unreliable data
Poor understanding of the process
Inability to Characterize the Process
Cell Culture and Fermentation
optek cell density analyzers provide powerful growth trend information to eliminate manual sampling operations and real-time monitoring helps achieve a new level of productivity and process control.
Separation and Filtration
optek dual channel absorbance and scattered-light analyzers precisely measure clarity and concentration in a variety of separation and filtration applications. Commonly installed inline, upstream and downstream to the separation equipment; integrity and performance of the separation is measured to improve process balance and control.
Purification
With an extremely wide measuring range, dual-wavelength sensors can reliably monitor your entire elution peak with excellent resolution, even at the lowest protein concentrations.
Reliable Solutions
Optek provides its clients with process analyzers that deliver reliable real-time in-process measurements, empowering them to gain further understanding of their processes:
Real-time Data = Real-time Decisions
Proven Technology
Superior Repeatability
Measurements correlate directly to specific product attributes
Cell Culture and Fermentation 19 mm Cell Density Probes:ASD19 probes and the optek Fermenter Control converter are designed for real-time cell growth characterization for mammalian, bacterial, yeast and other cell lines. Autoclavable: Ideal for all laboratory bioreactors and fermentors.
25 mm Cell Density Probes:AS16 probes are designed for continuous cell growth analysis and fermentation applications to optimize control. NIST-traceability. Installs in standard 25 mm Ingold and safety ports.
Separation and Filtration Centrifugation Performance: Dual mode technology sensor TF16N Turbidity Meter
provides inline centrifugation measurements using scattered-light and near infrared absorption (NIR). Extreme precision improves separation performance for process control and maximizes recovery for all types of host cells.
Purification Dual Wavelength UV Absorption:AF46 sensors offer real-time absorbance measurements at two separate UV wavelengths using a certified optical path. Captures entire elution peak with high resolution at all concentrations for the most precise control of a fractionating pool. With a fixed optical bench, setup is easy and maintenance is virtually nonexistent. Factory calibration is available.
Measurement Confidence
Confidence in the data delivered by a high-precision process analyzer can only be gained through proven performance and measurement reliability, batch after batch, day after day. optek offers a comprehensive set of performance verification (validation) tools to validate measurements without process intrusion. One set of NIST-traceable standards can calibrate all optek analyzers within a facility, delivering measurement uniformity and absolute confidence in the process data received.
Fast verification of measurement accuracy
Measurement Uniformity - One set of standards is used in all optek analyzers
Knowledge Gained
By receiving real-time process data through the use of reliable process analyzers with validated performance, the user can begin to characterize the process and identify critical parameters, define acceptable tolerances and learn to control the process.
Reliable process data delivers improved understanding and allows process characterization
Identification of process upsets and deviations
Reliable real-time data provides the basis to predict manufacturing performance
Knowledge Applied
Optek has experience with a wide variety of applications. By applying your increased process knowledge, your company is just one step away from realizing improved process control.
Defines optimal processing parameters based on reliable statistics
Allows for real-time control and decisions
Real-time assessment of quality and process performance
PEAK Results
By the knowledge gained from process analyzers with proven performance, the user can develop, and confidently apply improved control strategies that have been statistically proven to yield high quality with optimized production efficiency.
Reliable statistical data
Increased Process Knowledge = reduced risk potential
Accurately and Reliably predict product quality and yield
Assured QA / QC
Reduced / Controlled Process Variability
Improved process efficiency
Reduced manufacturing costs
Continuous Improvement through statistical data
Cell Culture and Fermentation
The result: Improved yields, identify control points and efficacy.
Separation and Filtration
The result: Consistent throughput, peak recovery and improved purity.
Purification
The result: Improved recovery, yield and purity.
Bottom Line
Optek delivers analytical results that can only come from quality engineering and the solid experience of an industry leader. By implementing optek at strategic points in your processes, you are one step away from gaining powerful process knowledge with proven results.
