Process analytical technology in the pharmaceutical industry
Increase process control in pharmaceutical manufacturing and ensure final product quality
In the traditional off-line quality control, samples are taken at various process stages and transported to a quality lab for analysis. It may take hours until the results are available, resulting in a delay, making result-based process control impossible. In a PAT-based approach the pharmaceutical manufacturing process and the analytical instrument, such as a spectrometer, acquire in-line measurement results in real time. This real-time data can improve both process control and product quality.
> 1500
Kaiser Raman units installed worldwide
How we can help
We can help you achieve advanced process control through in-line measurement of your critical quality parameters. You can get the analysis results in seconds instead of hours. From time consuming sample analysis to real-time monitoring of critical process parameters or critical quality attributes. With our optical technologies, such as Raman and UV spectroscopy, you can monitor and control the concentration or composition of your process media or final product in real time. Your benefits are:
improved process control leading to optimized production and increased yield and quality
elimination of contamination risks and time savings thanks to in-line process monitoring without the need for sampling
complete packaged solutions for upstream and downstream process
simplified scale-up with probes for all scales and technologies (i.e. glass, stainless steel, single-use plastic)
Applications
Optimized process control in bioreactors
In a bioreactor it is important to keep the dissolved oxygen and pH at an optimal level at all times. Cell density and metabolites should also be monitored for a better insight into the process. Concentration of metabolites is typically measured off-line with time consuming techniques and therefore require sampling with the associated risks.
Chuyên môn của chúng tôi trong lĩnh vực
Raman spectroscopy is an ideal solution for fast and non-destructive measurement. Our Raman solutions can monitor several parameters simultaneously with one single probe installed directly in-line. The complete upstream package enables real-time and optimized control of the process leading to reduced time between batches, limited risk of contamination and increased yield.
Glucose is the main energy source of cells during the upstream process. The concentration of glucose is a critical process parameter (CPP) because excessive glucose can lead to metabolic inefficiency and subsequent toxic lactate and glucose accumulation. Traditionally, a sample must be taken from the cultivation and analyzed in the lab to determine the amount of glucose that needs to be supplied to the bioreactor.
Chuyên môn của chúng tôi trong lĩnh vực
Direct in-line monitoring of glucose concentration provides a better understanding and control of the fermentation or cell culture process. Continuous glucose measurements using Raman analyzers not only offer important bioprocess information for better process understanding but also bring huge potential for optimization. For example, with Raman-based glucose control in a mammalian cell bioprocess, titer increase of up to 85% has been realized.
Kaiser Raman technology is easily integrated into bioreactor controllers, and is a proven PAT solution able to provide real-time process control and quality assurance
As a pharmaceutical manufacturer, you strive for highest possible yield and purest product in your downstream process. Improving chromatography and the purification of your product mixture is a key aspect in achieving this goal. To achieve a maximum purification degree with minimum loss, you need precise and sensitive UV absorption with fast and reliable protein detection.
Chuyên môn của chúng tôi trong lĩnh vực
With our UV absorption photometer, we bring the sensor and the measurement right into the process, by measuring the protein concentration in-line. For signal processing we use our well-known transmitter platform Liquiline. Using only one Liquiline CM44P transmitter, you can add pH and conductivity sensors, making it the perfect package for chromatography control.
The OUSAF44 UV sensor monitors the concentration of your product in process liquids and is suitable for sterile processes (CIP/SIP)
The low-volume flow cell OUA260 for the process photometers enables fast measurement and ensures optimum product yield. For pH and conductivity, the flow cell CYA680 is the right choice
With the fully encapsulated Easycal system you get a safe and liquid-free on-line calibration of our UV sensors that is traceable to NIST
The chromatography process map with all relevant measurement points
Lợi ích
With inline spectrometers a measurement frequency in the range of seconds can be achieved, thus enabling real-time advanced process control (APC) in pharmaceutical manufacturing. The move to process analytical technology (PAT) can help you develop processes that generate higher quality products and improve efficiency through increased automation, reduction in cycle times and uninterrupted batch/continuous processing.
35
fermentation batches until ROI of a single channel Kaiser Raman Rxn system
10x
lower maintenance costs of a Raman measurement compared to a chromatography system
90%
less time spent calibrating one UV sensor with Easycal
Nước, đồ uống, sản phẩm sữa, hóa chất hoặc dược phẩm phải được phân tích hàng ngày. Chọn thiết bị phù hợp với nhu cầu nhất từ danh mục sản phẩm toàn diện của chúng tôi.
Lưu lượng kế
Lưu lượng kế
Nước, khí tự nhiên, hơi nước, dầu khoáng, hóa chất là một số chất lỏng phải được đo đạc mỗi ngày. Chọn lưu lượng kế phù hợp nhất với nhu cầu quy trình.
Mức
Mức
Đo mức liên tục và theo dõi điểm đo mức trong chất lỏng và khối chất rắn
Áp suất
Áp suất
Thiết bị mạnh mẽ để đo áp suất quy trình, chênh áp, mức và lưu lượng.
Phần mềm
Phần mềm
Bên cạnh việc cung cấp các công nghệ về hệ thống và đo lường, chúng tôi cũng cung cấp các phần mềm phù hợp cho tất cả các ngành giúp tối ưu tiềm năng cho các quy trình vận hành.
Sản phẩm hệ thống
Sản phẩm hệ thống
Ứng dụng Applicator
Đo nhiệt độ
Đo nhiệt độ
Nhiệt kế và thiết bị truyền tín hiệu cho ngành quy trình
Instrumentation Services
Instrumentation Services
Maximize plant performance, minimize OPEX, increase uptime, all with compliance. Partner with Endress+Hauser instrumentation services.
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