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In-line liquid concentration measurements

for pharmaceutical drug manufacturing and biotechnology processes: Increase yield, produce on-spec products always and lower production costs

药物开发和制造受到高度监管，以确保安全性，有效性和质量。FDA的过程分析技术（PAT）是提高创新和支持效率的一项重要倡议。它是创新药物开发，制造和质量保证的框架。PAT鼓励在制药制造中使用最新的科学优势和技术，以及在处理过程中连续的实时质量保证。连续制造（CM）是一种新的行业趋势，与传统基于批处理的制造相比，许多鉴定出的好处。成功实施PAT或CM需要实时传感器和测量设备。


VAISALA K-PATENTS®Pharma折光仪是专门为药物和生物技术工艺设计的，可为广泛的应用提供可靠的，连续的在线浓度测量，例如活性药物成分（API），维生素，草药，基于草药的药物，疫苗，青霉素，苯甲基素蛋白质，素食，以及医疗防护服，伤口敷料和医疗植入物制造。

设计的质量，安全性和功效

The reliable measurement and data provided by the Vaisala K-PATENTS Pharma Refractometer help to understand critical process parameters (CPP), process conditions, and elevate process understanding and fully supports continuous manufacturing. Importantly, this refractometer can help to meet the regulatory requirements for validating, quality, and controlling the manufacturing processes.

In addition, continuous in-line measurements, and provided data help to reduce production cycle times, increase production capability, prevent rejects, abolish human errors in manufacturing and provide high quality and safe products with minimum variability. In drug manufacturing, this technological innovation can be used from laboratory-scale to pilot batches that are used in process development to the production-scale batches needed to support commercialization. In the R&D phase, using the Vaisala K-PATENTS Pharma Refractometer can reduce drug development time.

连续准确的在线测量

Vaisala K-Patents药物折射率提供了与工艺分析技术（PAT）制造方法对齐的应用的连续，准确，可重复和可重复的测量。
• Process data for every batch or lot via Ethernet.
• Aids in compliance with cGMP (Current Good Manufacturing Practice)
• Sanitary 3-A and EHEDG certified.
•审核跟踪和访问控制21 CFR第11部分合规性。
•可追溯的校准和验证。
• IQ/OQ documentation for validation.

Applications in pharmaceuticals manufacturing

Active Pharmaceutical Ingredients (API) production and pharmaceuticals processing at all scales in small molecules medicines manufacturing, and throughout the manufacturing line from reaction monitoring to downstream processes such as crystallization and filter cake washing.

下载我们的申请说明以获取更多信息。

Production of Active Pharmaceutical Ingredients (API)

Real-time concentration measurements during reaction, crystallization, separation and purification, filter cake washing, solvent swap and solvent exchange for the development and production of APIs.

Solvent swap or solvent exchange

Monitor your solvent swap operation during API production by measuring the concentrations of the original and swap solvents.

Pharmaceutical crystallization

在API生产过程中，确定确切的播种点并仅产生高质量的晶体。

Filter cake washing

通过测量数据获得深入的过程理解，开发独特的洗涤曲线，并找到最合适的洗涤溶剂，以增加产量和最大洗涤结果。

Aspirin crystallization

测量阿司匹林（乙酰水杨酸）结晶中的液相，并控制您的结晶过程。

Pharmaceutical extraction: herbal-based medicine

始终在固定液体提取过程中达到目标提取物浓度（浸出）。

生物技术过程中的应用

Timely measurements for the development and monitoring of biopharmaceuticals processing such as fermentation, cell culture, protein buffer solutions and concentration.

下载我们的申请说明以获取更多信息。

Pharmaceutical fermentation

Measurement solutions for standardizing and automating processes. From fermentation profile design to scale-up and for determining the endpoint of fermentation instantly and reliably with no deviations on full-scale production.

疫苗生产

Collect only the virus fraction with correct density for best yield in purification operations/downstream processes.

Protein concentration and filtration

Control retentate concentration for good permeability even with the smallest of particles.

Penicillin production

测量原始青霉素的浓度，监测发酵过程并在生产过程中保持高收率的最佳条件。

L-Lysine evaporation process

Control your evaporation process with an industrial process refractometer.

血浆中间超过滤

安全地内联和实时测量蛋白质浓度，可精确地控制保留浓度，以获得最佳渗透率

医疗应用

Wound dressing, medical implants manufacturing and medical protective wear.

下载我们的申请说明以获取更多信息。

藻酸盐伤口敷料和织物

监测湿旋旋溶液和凝结浴浓度的湿旋，以进行最佳纤维质量。

Medical implants and device surface treatments

监测和控制酸（例如硝酸HNO3) during medical parts passivation to meet product specifications.

浸泡在橡胶和医疗手套制造中

通过测量液态乳胶，氮，乙烯基或合成聚异丙烯浸泡浴中的总溶解固体（TD），确保保护服的临界最终质量和耐用性。

博客s, webinars and success stories

Vaisala K-PATENTS process refractometers for pharmaceutical manufacturing

Refractive index for pharmaceutical and biotechnology manufacturing

Ensure safe, consistently high-quality products with minimal variability with Vaisala's robust measurement technology. In-line, real-time measurement is the prerequisite for PAT. Read from our eBook how manufacturers can monitor critical quality attributes, prevent rejects and ensure high-quality products with minimum variability.

下载电子书
Fast and efficient viral vaccines purification by sucrose density gradient

Fast and efficient viral vaccines purification by sucrose density gradient

In this 30-minute webinar (+ 15 minutes for Q&A), Vaisala's Liquid Measurements pharmaceutical experts will explain the benefits of the refractive index technology and how it helps downstream processes during purification of viral vaccines manufacturing.

观看网络研讨会
K-Patents Webinar: The Benefits of Refractive Index (RI) in Development and Production of Active Pharmaceutical Ingredients (APIs)

Refractive index in development and production of Active Pharmaceutical Ingredients (APIs)

从真实的客户案例中学习如何将折射率用作PAT工具
standardizing and scaling-up APIs production.

观看网络研讨会
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液体浓度测量

Vaisala offers a wide range of products tailored to liquid measuring needs of different industries. Learn more about the refractometer technology and its applications, and visit the library of product related assets.

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