无菌采样
可靠的采样方法是实现稳定、高质量产出的关键。在制药和生物制药过程中采用无菌和无菌采样解决方案，可最大限度降低污染风险，实现准确、代表性的样品采集，从而实现可靠的工艺控制。我们的产品包括创新的手动无菌和自动无菌采样解决方案，旨在全程提高工艺步骤的效率和可靠性。
手动无菌采样
封闭式无菌采样可提供制造工艺采样所需的安全性。NovaSeptum® GO 无菌采样系统和 NovaSeptum® SURe 无菌采样组件是封闭式采样解决方案，可大幅降低交叉污染的风险，并为整个工艺全程提供代表性样品。此解决方案包括用于一次性制造工艺的 NovaSeptum® SURe 无菌采样组件，以及支持连接任意不锈钢运行装置的 NovaSeptum® GO 无菌采样系统。
- 封闭式设计： 保护您的工艺和样品的完整性
- 易于使用： 即插即用选项，可自选连接方式和一系列容器。
探索适用于不锈钢或多用途工艺的NovaSeptum® GO系统
自动无菌采样
自动采样系统便于频繁测定，上下游工艺都能最大限度提高效率，减少操作人员干预。我们的MAST®自动采样方案可实现近乎实时的在线分析，支持全面了解工艺和增强工艺控制。
- 高效： 提高采样频率，缩短周转时间，最大限度减少操作员接触机会
- 可靠： 确保样品快速转移和可追溯性，同时保持样品源的无菌性
Products
确保无菌制造工艺全程可靠采样
从生物反应器到最终灌装，NovaSeptum® 无菌采样系统可为生物制造商提供一致且具有代表性的样品，以便分析pH值、电导率、细胞活力、代谢物、生物负荷监测和内毒素水平。
通过采样进行pH、渗透压和电导率分析，实现对工艺参数的监测和调整。
通过添加无菌液体调整或补充工艺流体。
借助可轻松添加额外生物负荷监测步骤的串联连接支架，实现所有采样容器的极佳微生物回收
在保护昂贵的树脂免受污染的下一工艺步骤前，轻松监测生物负荷、内毒素和质量
通过取样证明无菌过滤有效性，并验证采样容器来确保对内毒素回收无影响，从而尽可能减小宝贵产品的样品体积
无缝整合至最终灌装工艺中，确保高水平的安全性并提供代表性的样品
如需针对工艺选择最适宜的一次性采样解决方案，请首先考虑首选的连接类型：热焊或无菌连接。然后，可通过 C-Flex® 连接管或 AsepticQuik® 连接器，预配置组件轻松将集成到您的工艺中。
然后根据样品体积、检测类型、储存条件和其他关键采样方案参数确定适当的采样容器。我们的NovaSeptum® SURe无菌采样组件是标准一次歧管系统，由三或五个容器组成，提供袋、瓶、注射器或锥形管供选。
选用适合于您的工艺的固定器：卡箍型(TC)、管道型或In-Gold®型。TC固定器也可预装于各种容器类型
从一系列瓶子、袋子、注射器和锥形管中进行选择。它们有多种尺寸和配置– 单次采样、歧管或预装。
确保整个过程的无菌性。采用Novaseptum®手动压接工具断开您的样品。
我们提供为了最大程度提高易用性而设计的配件，如袋架、端口插头和安全标签。
MAST®自动采样解决方案是一种先进的自动无菌采用工具，可提高生物制药工艺的效率和控制水平。这一多功能解决方案将从多个来源直接采集样品并运送到不同分析目的地，加快了周转时间，减少了操作员接触机会，最大限度降低了污染风险。它可与其他工艺分析技术(PAT)工具无缝集成，实现全面监控，并可根据不同工艺和规模进行配置。作为GMP合规解决方案，它可确保符合严苛的法规要求，同时可进行关键工艺参数在线近实时分析，实现高效的资源利用率。
相关视频
相关产品资源
- White Paper: Aseptic Process Sampling Risk Mitigation – A Regulatory Perspective
There are significant consequences associated with microbial contamination during biopharmaceutical manufacturing. Contamination increases risks for the operator, the company, and potentially the patient, all of which can result in significant negative impact.
- Application Note: Microbial Integrity of NovaSeptum® Sampling Systems upon Performance of Multiple Sampling Actuations
The NovaSeptum® and NovaSeptum® GO sampling systems are a family of products designed for singleuse sterile sampling throughout the biomanufacturing process.
- User Guide: NovaSeptum® and NovaSeptum® GO Sampling Units
This user guide provides installation and use instructions
- Datasheet: NovaSeptum® GO Sterile Sampling System
To demonstrate the safety and integrity of your product, you need a standard-setting sampling solution that provides the flexibility to sample throughout your entire process. I
- Datasheet: NovaSeptum® SURe Sterile Sampling Assemblies
NovaSeptum® SURe single-use sterile sampling assemblies are designed to protect your single-use process from potential cross-contamination ensuring representative samples.
- Brochure: NovaSeptum® GO Sterile Sampling System
Continuing to set the sampling standard, our NovaSeptum® GO sterile sampling system is equipped with additional features for even safer sampling throughout your entire process.
- Technical article: Enhance Bioprocess Sampling with MAST® Autosampling Solution
Explore the MAST® Autosampling Solution for efficient, automated sampling in bioprocesses, supporting higher measurement frequency and reduced process risk.
- Datasheet: MAST® Autosampling Solution
The MAST® Autosampling Solution is a versatile & modality-agnostic aseptic autosampling solution for reliable on-line and near real-time sample analysis.
- White Paper: Automated Aseptic Sampling for Accelerated Access to Process and Quality Data in Upstream Bioprocessing
This white paper focuses on PAT and the use of automated sampling technology to accelerate analytical and quality control methods and provide an approach for access to in-line data to monitor processes in real time.
- Application Note: Enabling Accelerated Raman Model Calibration for Seamless and Reproducible Real-Time Monitoring by Combining Raman and Automated Sampling Technologies
Explore how automated sampling can accelerate the integration of a Raman analyzer for a bioreactor application, speeding up the Raman model building phase, and facilitating in-line, real-time monitoring of critical process parameters (CPPs) and critical quality attributes (CQAs) during the manufacturing process.
- White Paper: Accelerate Process Development with Automated Aseptic Sampling
This whitepaper describes evaluation of the MAST® Autosampling Solution as part of an automated PAT system implemented by Takeda Pharmaceuticals.
如要继续阅读，请登录或创建帐户。
暂无帐户？