Panbu Electric
Pharmaceutical Biotechnology

Clean Process Control & Monitoring: Safeguarding Drug Quality

The pharmaceutical and biotechnology sectors prioritize hygiene classification, measurement accuracy, response speed, and data compliance. Pharmaceutical water processing involves filtration, reverse osmosis, distillation, and thermal storage; injection-grade distilled water must be stored at a minimum of 70°C, with conductivity adhering to pharmacopeial limits. In sterilization processes, temperature, pressure, and time are interdependent parameters; recorded data must be tamper-proof and comply with FDA 21 CFR Part 11. Biopharmaceutical fermentation, separation, and homogenization are sensitive to pH, pressure, and contamination, requiring constant pressure to ensure reproducible production of active substances. Drying operations include lyophilization and spray drying, where certain areas pose explosion risks necessitating intrinsically safe sensors. Cleanrooms and isolator systems must maintain renewable climatic conditions for pressure, temperature, and humidity. CIP/SIP online cleaning requires wide-range conductivity measurements to determine the cleaning endpoint. Supporting 316L stainless steel sanitary temperature sensors, high-precision pressure and differential pressure transmitters, four-electrode conductivity cells, multi-measurement module instruments, multi-channel process controllers, and paperless recorders compliant with regulatory standards ensures process stability and product quality while meeting hygiene and compliance requirements.

Industry Challenges

Water for Injection must be stored hot at a minimum temperature of 70 °C, with strict monitoring requirements for temperature and liquid level.
In sterilization processes, temperature, pressure, and time are interdependent. Recorded data must be tamper-proof and comply with regulatory documentation requirements.
Biopharmaceuticals are sensitive to pH, pressure, and contamination. Consistent pressure during separation and homogenization is essential to ensure reproducible production of active substances.
Cleanrooms must maintain constant pressure, temperature, and humidity while monitoring total suspended particles and microbial counts.
CIP/SIP online cleaning requires wide-range, precise conductivity measurement to determine the endpoint and conserve resources.

VALUE

Energy Savings Value

Accurate measurement records are traceable and meet cleanroom process and compliance documentation requirements.

Reduce consumption

Energy Efficiency Improvement

Boost Efficiency

Stable performance

COMBINATION

Product Bundle Compatibility

Combine01

Temperature Sensors and Thermal Resistors

1

Combine02

Pressure and Differential Pressure Transmitters

2

Combine03

Paperless Recorder and Process Regulator

3

Combine04

Water Quality Analysis and Conductivity Measurement

4

AUTOMATION & SOLUTIONS

Recommended Solutions

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制药及生物技术行业测量与控制解决方案

Pharma & Biotech Measurement Control

制药及生物技术行业测量与控制解决方案

面向制药及生物技术行业的测量与控制解决方案,基于久茂 JUMO 卫生型温度传感器、压力与差压变送器、电导率电极与水质分析变送器、多通道过程调节器与无纸记录仪,覆盖医药用水、医药产品灭菌消毒、生物制药发酵与产出、干燥、精致添加剂制粒包衣、无尘室与手套式操作箱、CIP/SIP 清洗七类工艺环节,实现温度压力液位电导率精确测量、工艺数据防篡改记录与合规文档管理。

Use Cases

制药厂与生物技术企业的注射用水与纯化水系统、蒸汽与气体灭菌设备、发酵罐与分离均质系统、冷冻干燥与喷雾干燥设备、制粒与包衣机组、无尘室与手套式操作箱、CIP/SIP 在线清洗系统的新建配套与测量控制改造。

Solve pain points

医药用水生产是制药行业重要过程之一,水的质量是高质量产品的前提条件,过滤、反渗透、蒸馏与热存储各环节对电导率、温度与压力测量精度要求高反渗透前需通过过滤系统对水进行过滤以阻止渗透膜堵塞,缺乏差压监测手段时无法判断过滤器剩余使用寿命,造成滤芯过早更换或堵塞风险欧洲药典规定注射用蒸馏水需热存储且存储温度最低 70 摄氏度,温度与液位监测不到位将影响水质合规消毒工艺中温度、压力与时间参数相互依存并相互影响,测量仪器若反应迟缓或精度不足将影响灭菌效果

Solution Composition

差压与压力测量:JUMO delta p20Pro 差压变送器(型号 403522)根据差压增长情况精确测量过滤器剩余使用寿命,使过滤器得到充分利用;JUMO p20Pro 压力变送器测量元件由不锈钢材质制成,测量精度高且具备高安全性与高可靠性,适用于蒸馏过程压力监测与收集罐液体静压液位监测;JUMO DELOS S02 高精度压力变送器带触点开关、模拟量输出与 LCD 显示器,可显示过程压力及开关触点状态,其高品质不锈钢和无缝前冲洗测量系统特别适合应用在卫生敏感区域;JUMO dTRANS p30 压力变送器用于均质过程压力的可靠、安全与精确控制;JUMO dTRANS p32(型号 402051)用于监测手套式操作箱中气态的干燥介质,核心部位为高负载电阻压阻式测量元件 / 卫生型温度测量:专为高纯水系统特殊设计的温度传感器,材质为 316L 不锈钢,表面粗糙度不大于 0.8 微米,拥有快速的响应速度并可配卫生型过程连接(卡箍连接或焊接护套);用于蒸汽灭菌的插入式热电阻(型号 902830) / 记录与合规文档:JUMO LOGOSCREEN 700 高拓展无纸记录仪按照 FDA 测量数据记录标准设计,符合 FDA 21 CFR Part 11 认证,适用于所有制药工艺的文档管理,可记录生产工艺且防篡改,支持在线工艺数据可视化以及多种限值监测程序,发生故障时进行远程报警,可同时记录 3 组完全独立的处理过程数据,并可同时记录、显示并保存测量变量;发生故障和错误时可通过综合网络服务器快速知道问题所在 / 过程调节与控制:JUMO DICON touch 多通道过程调节器与多通道控制器,无论测量压力为低压还是高压均可满足需求,用户可配置的屏幕能在现场显示个人工艺设置,记录功能可确保重现整个过程,用于冷冻干燥工艺优化控制与包衣悬浮工艺的压力温度精确控制 / 水质分析与电导率测量:多种卫生型传感器与变送器用于监测反渗透生产工艺,电导率变送器提供符合 ASTM D1125-9 的温度补偿并满足 USP 水电导率 645 的限值控制;JUMO tecLine CR-4P 四极式电导率电极在整个测量过程中实现精确测量,测量范围 1 微西门子每厘米至 600 毫西门子每厘米,确保清洗过程迅速可靠;JUMO AQUIS touch S 多测量模块仪器可作为 CIP 清洁的新方法,可测量、控制、记录和显示酸碱浓缩液的设置以及所有箱体中的液位和流速,所有操作只需一个测量仪器完成,最大可测量和管理 4 种传感器模拟信号与多达 10 个测量单元 / 防爆与温湿度监测:JUMO Wtrans Ex 湿度及温度传感器(型号 700755)等符合 ATEX 本安防爆认证的传感器,用于存在潜在爆炸风险的干燥与溶剂场所 / 服务与支持体系:制造服务涵盖客户定制的传感器技术(RTD 热电阻、压力变送器、电导率电极、pH 或氧化还原电极)、电子模块与金属工艺(冲压成型技术、软金属片制造、浮法生产、焊接链接和装配技术、表面处理技术),并提供研发、设计、试验、大量试验设备、物料管理、生产、物流配送与售后服务;资料与培训提供研讨讲座、在线学习视频与技术文献;产品服务提供全球配送渠道、现场咨询与选型建议、服务热线、快速维修与 24 小时备件服务;维护与校准可前往客户现场或 DAkkS 认可校准室进行专业校准,并按 EN 10204 要求将检测结果记录于校验证书

Service Process

工艺勘测与测量点梳理 → 卫生型仪表与记录系统选型 → 安装集成与限值联锁调试 → 合规验证与校准维护

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