制药

能否充分利用大型新兴市场的机遇,是目前制药行业面临的重大挑战。现在制药公司比以往任何时候都更需要引入精益化生产技术,以提高盈利能力。作为全球知名工业自动化供应商,横河电机致力于为客户的优化生产实践提供卓越的解决方案。

详细介绍

什么是制药4.0?

制药4.0是ISPE为制药行业规划的路线图,旨在引入“工业4.0”概念(也称为智能工厂)。
在工业4.0中,持续开发旨在提高产品质量和生产力、降低成本,并确保整个产品生命周期的稳定供应。这主要是通过IT创新和数字化改革业务流程来实现的。
此外,制药4.0不仅需要满足业务绩效目标,还需要满足政府针对制药行业的法规中规定的义务。
换言之,制药4.0可被视为在整个产品生命周期内,利用IT建立基于ICH-Q10药品质量体系(PQS)准则的质量控制流程。
要实现制药4.0,必须具备数字化的IT实施技术和清晰的目标,包括对药品法规(包括PQS)的详细了解。

为什么仍然需要制药4.0?

制药业在为确保质量合规而不断增加成本和创造利润的需求之间进退两难。
为了克服这一障碍,制药4.0的实施将带来巨大的好处。
根据ICH-Q12产品生命周期管理(PLCM)准则的规定,在整个药品生命周期内,基于科学证据进行有效、高效和持续的质量改进工作是必要的(即POS)。
因此,制药业为保证质量合规而产生的成本还将不断增加。
与此同时,药物研发回报率不断恶化的行业环境迫使人们越来越需要提高生产力,而这往往包括药物生产过程。
为了解决这一问题,制药业选择加强工业自动化(即制药4.0),并通过数字化和完全符合药品监管标准来推动业务改革。

横河在制药业中的业务目标

自20世纪80年代以来,一直以测量、成像、分析、诊断和集成为战略重点;横河提供了生产控制系统和众多仪器,支持活性药物成分(API)、药物配方和生物技术应用的药物生产过程。
自20世纪90年代以来,我们一直致力于生产【工业自动化】,通过将分散在工厂设备上的大量信息联系起来,提供各种生产管理解决方案供使用,来实现安全高效的生产。
大约在同一时期,横河也开始提供活细胞成像解决方案,将新型的共聚焦显微镜技术应用于药物研发和前沿医学研究领域。
通过整合和深化我们的核心技术和经验,横河正在开发更安全、更高效的自主生产系统,以满足制药行业的需求,让专业人士有更多机会将创造性和创新等独特的人类能力应用到工作场所。
自主生产系统还将减少在药品生产、质量检测、文件编制和发布决策等方面对人类判断的依赖,从而为工作人员集中精力提高生产力提供更多的一致性和时间。
我们将这个行业的“世界观”定义为生物工业自治(BIA),并将其实现作为横河制药企业组织的使命。
因此,我们将通过实施BIA为制药4.0做出贡献。
有关BIA的更多信息,请点击此处

实施制药4.0的效果

将研究、开发和制造中获得的信息连接起来的先进网络,通过使各个部门的信息得到互补利用而提供各种积极的效果。
例如,质量源于设计(QbD)和连续生产的概念可以用于新药开发和制造过程。这些可能会产生以下效果:

  • 通过数据分析,早期识别关键工艺参数(CPP)和设计空间(DS)。
  • 通过使用过程分析技术(PAT)如软传感器,监控关键质量属性(CQA)。
  • 通过关键质量监控促进中间体或成品的实时放行测试(RTRT)。
  • 基于累积的数据,增强对产品特性和制造过程的了解。
  • 通过提高数据的可访问性,基于数据驱动的风险评估,对异常和偏差做出快速响应。
  • 通过反馈持续改进工艺,并减少开发新药和制造过程所涉及的时间和成本。

这种通信网络和周期增强了竞争力,并促进业务持续增长。

 

横河制药4.0的整体解决方案

请参考以下产品组,这些产品组为制药公司客户的问题提供解决方案,并能帮助客户实现目标。

横河解决方案列表

 
【生产调度】 FLEXSCHE
【生产、销售和成本管理】 mcframe
【质量管理】 OpreX Laboratory Information Management System
【环境监测】 OpreX Environmental Monitoring System
【设备维护管理】 eServ
【流程数据库】 PI System
  Exaquantum
【程序自动化】 Exapilot
【生产过程监控】 CENTUM VP
  Field Instruments
【售后服务业务支持】 ServAir

Environmental Monitoring System

环境监测符合药品规格

OpreX环境监测系统收集、测量和存储如温度、湿度以及其他管理数据,以监控药品生产区域、质量控制区域和存储区域的环境。

主要特性

数据完整性

  • 符合ALCOA +要求

数据采集与长期存储

  • 将收集的数据长期存储在符合FDA 21 CFR Part 11标准的记录器中

实时数据监测

  • 使用监控软件监控测量数据和报警

集中管理登录用户

通过Active Directory,使用网络上的服务器集中管理用户名和密码。

  • 集中管理数据服务器和记录器的用户名/密码
  • 用户登录访问控制

Major fratires

套餐

数据管理套餐

集中管理数据记录

访问控制

用户被分组,并根据他们所属的组授予访问权限。
只有被授权的用户才能登录系统并搜索和浏览数据。


Access control

轨迹追踪

授权用户的所有操作都被轨迹追踪记录

  • 文件操作(归档、删除)
  • 备份和恢复



Audit trail

配置工具

管理员使用此工具配置数据管理包

  • 注册新的记录器
  • 注册新用户
  • 许可证管理

GA10实时监控软件

数据的实时监控测量

  • 显示测量值(趋势显示/数字显示)
  • 在屏幕上的警报通知
  • 监控每个测量组的数据

GA10

通用检视

用于浏览记录数据的专用查看软件

  • 显示记录数据
  • 支持最新的操作系统,观看体验好
  • 支持7种语言


universalviewer

无纸记录

SMARTDAC+系列

测量并记录各种数据

  • 根据需要增加I/O模块
  • 多种强大的显示功能
  • 全方位的网络功能

先进的安全功能
电子数据记录符合制药法规

  • 逻辑安全
  • 轨迹追踪功能
  • 二进制格式的安全数据存储(防欺诈)
  • 专用检视器软件


universalviewer

客户面临的挑战

Lean manufacturing

紧跟不断变化的市场
制药企业面临很多应对变化的压力,例如新兴市场转向低成本药物,以及有效应对医疗用药的需求。为了盈利,制造商正在寻找提高效率和增加生产力的方法。精益化生产是关键。

我们的解决方案

横河电机卓越的自动化解决方案
横河的解决方案可以帮助制药厂实现全厂一体化及生命周期的优化。以下是一些制药应用,横河电机提供全面的自动化解决方案,并为客户提供全球专家网络服务。

API/Intermediates Process
 
Production Control System: CENTUM VP

多用途设备的生产管理和批量控制
活性药物成分(API)的生产涉及批量处理,其中一些流程用于不同用途的多种产品。这需要使用完备的批量控制系统。CENTUM VP(综合生产控制系统)提供基于ISA-88批处理控制标准的批处理功能,并符合FDA的21 CFR Part 11要求。

Formulation Process
 
SMARTDAC+® GX/GP Series Paperless Recorders

基于21 CFR Part 11的无纸化操作在制药行业中变得越来越普遍
SMARTDAC+®GX/GP系列无纸记录仪支持符合 Part 11要求的电子记录功能。可以将电子签名添加到存储数据中。横河电机可提供包含所有必要验证文件的全套安装。

FA-M3V IT Macine Controller

确保产品质量的稳定控制
灭菌和冷冻干燥工艺需要高分辨率和精确的温度控制,才能确保产品质量。FA-M3V和IT Macine控制器是一种高性能可编程逻辑控制器(PLC),具有处理速度快、控制稳定等特点。

客户面临的挑战

Good manufacturing practice (GMP)

遵守全球标准的法规和准则
制药公司在全球市场中运营,鼓励该行业遵守PIC/S GMP规定和ICH准则等国际倡议。GMP设备需要遵循既定的良好作业规范,使生产设备自动化,并且让计算机系统采用当前的计算机化系统验证(CSV)规范,例如GAMP。

我们的解决方案

确保优质药品的生产
多年来,横河电机已成功实施了许多符合良好自动化制造规范(GAMP)的项目。根据GAMP指南中描述的V模型项目验证计划(PVP),经验丰富的横河电机工程师为功能规格、设计规格、实施、工厂测试和现场验收测试阶段交付结果。验证和测试结果,其中包括安装和操作资格(IQ/OQ),将作为确定是否满足项目要求的客观指标。

Validation V-Model

客户面临的挑战

Scientific Quality Assurance

需要更严格的方法确保产品质量
对于药品,需要采用严格的科学方法来确保产品质量。ICH质量准则要求在药物开发和制造阶段采用质量源于设计(QbD)的系统方法。制造工厂面临着实施创新技术的挑战,诸如过程分析技术(PAT)等,有望引入实时放行(RTR)检测。

我们的解决方案

横河电机用于实时放行检测的PAT解决方案(RTRT)
横河电机的开发过程分析技术(PAT)解决方案的方法是基于对关键质量属性(CQA)的实时监控,来实现精益化生产。通过近红外(NIR)分析仪可直接监测在线质量属性。另一种方法是采用过程建模技术来监控过程的健康状况。

Real-Time Release Testing (RTRT)

参考

概述:
  • 尖端生物制药工厂使用CENTUM,VP Batch,Exaquantum和PRM。
  • 大型生物科技生产设施的整体系统集成。
概述:
  • 通过FAST / TOOLS监控不间断生产医用氧气。
  • 定期进行审核,要求可追溯性并保留所有批量生产活动的历史记录。
概述:
  • Yokogawa provides CENTUM VP with Batch Recipe Management Package for new fine chemical plant.
  • Yokogawa's CENTUM VP complies with the requirement of Good Automation Manufacturing Practices(GAMP).
概述:
  • RotaMASS was chosen to work with weight measurements and/or differential pressure transmitters for extremely accurate measurements.
  • The customer recognized the product's advantages: reliability, accuracy, guaranteed draining system, easily cleaned system, no moving parts, directly built into the pipelines, low pressure losses.
概述:
  • Implementation of control system supported by global maintenance, service, engineering, and technical support capabilities
  • Improved stability and safety of plant operation
概述:
  • Pharmaceutical automation solution delivered through commitment to local expertise
  • Enhanced process reliability and consistency leading to greater assurance of product quality
概述:

Cell stage categorized using FucciTime lapse imaging of Fucci-added Hela cells was conducted over 48 hrs at 1 hr intervals. Gating was performed based on the mean intensities of 488 nm and 561 nm for each cell. They were categorized into four stages, and the cell count for each was calculated.

概述:
  • For remote monitoring (of temperature, pressure, and flow volume), installing the SMARTDAC+ GM in the plant and the SMARTDAC+ GX in the office provides for a scalable, pc-free on-site data monitoring solution.
  • You can centralize management of large quantities of data by automatically transferring acquired data to a FTP server.
概述:

Wide and Clear
Confocal Scanner Unit

概述:

Faster, Brighter, and More Versatile Confocal Scanner Unit

概述:

Eliminating the wire using wireless transmitter is the perfect solution for rotating equipment. It establishes data collection between the transmitter and the gateway by reliable communication even though the dryer was rotating.

概述:

SMARTDAC+ GX series records the clean room temperature, humidity, atmospheric pressure, door openings and closings, etc.

概述:

This introduces a system that uses Ethernet communications to acquire measured values, target values, and control output values from a controller installed on site into a PLC at high speed (ten units' worth within one second).

概述:

In semiconductor manufacturing processes, a deficient clean room environment can lead to defects and wasted resources, making a strictly controlled clean room indispensable. Maintaining the environment in the clean room requires control of air filters, HVAC systems, room temperature, humidity, airborne particles, and other factors.

概述:

In the plants of food and beverage manufacturers, there are times when monitoring and recording of production equipment is necessary inside clean rooms. This is an introduction to monitoring and recording in clean rooms using paperless recorders.

概述:

Performing control while changing the set point temperature moment by moment is called running a program pattern (or simply running a program). Sterilization and pasteurization require maintaining specific temperatures for specific durations. 

概述:

The paperless recorder DX series automatically calculate the Fo value from the heating temperature and are useful in managing the sterilization process by displaying and recording the value together with the heating temperature.

概述:

In the manufacturing process of Pharmaceutical, Chemical and Food & Beverage industries, the cleaning and sterilization of tanks and piping are done with various cleaning solutions, fresh or hot water and steam after manufacturing products. Clean-In-Place (CIP) is the system designed for automatic cleaning and disinfecting.

概述:

The discharge of improperly treated industrial chemicals and fuel gas can have a major impact on the environment, posing a serious threat to public health. Concurrent with the global growth of manufacturing operations to keep pace with market trends, many countries are taking measures to deal with environmental problems.

概述:

For the management of raw materials in the pharmaceutical and cosmetics industries, a manual titration method presents many difficulties. Yokogawa developed the NR800 FT-NIR Analyzer, and with this system, measurements are reliable and stable. It is much easier to control quality.

概述:

By using the Multibatch function (an option added with SMARTDAC+), you can efficiently record data from multiple devices onto a single SMARTDAC+.

概述:

Using the custom display function that comes standard with DXAdvanced means that you can combine the recorders, displays, and switches used in various kinds of equipment.

概述:

Using the batch name + lot number system, past measured data can be recalled for reference by batch name.

概述:
  • Universal inputs provide support for thermocouple, RTD, voltage, and a variety of other input signals.
  • Lineup of models for up to 450 inputs.
    Allows multipoint monitoring and recording on a single unit.
  • Easily enables network-based data management. 
    file transfers, Web monitoring, and alarm e-mail
概述:

By using the computation function of the SMARTDAC+ series Paperless recorder GX/GP, computation option computes the "F-value," or sterilizing value for the sterilization process, so that the computation results can be recorded in the form of data.

概述:

The sterilization temperature prior to the filling process is monitored in the field or office. The temperature data is recorded in an external storage medium.

概述:

 Ground water well level monitoring is needed.

概述:

Blending plays a key role in industries such as food, healthcare and chemicals etc. Temperature and vacuum measurements are very important in minimizing the moisture content to ensure the quality of the final product. Strictly maintaining them throughout the process ensures the final product yield.

概述:

One of the primary applications for high purity water is for boiler feed water. The measurement of pure water pH can be one of the quickest indicators of process contamination in the production or distribution of pure water. Effective chemical treatment of the feed water is vital in maintaining the useful operating life and minimizing maintenance costs of the boiler.

Industry:Power, Pharmaceutical, Common

概述:

This technical white paper will discuss Yokogawa's CENTUM VP DCS (Distributed Control System) product, hereafter referred to as "CENTUM VP", and the extent of its compliance with Part 11 of Title 21 of the Code of Federal Regulations, (21 CFR Part 11), the Electronic Records / Electronic Signatures Rule.

概述:

The worlds of process automation and production management have been converging for some time. What once used to be islands of automation and production management functionality connected through highly proprietary integration schemes that were costly to maintain have developed into integrated platforms that provide seamless data exchange between the world of automation and the plant floor, the functions of production and operations management, and integration with business level systems.

概述:

The world of process automation is governed by procedures. While we like to refer to the process industries as being largely "continuous", this could not be further from the truth. Process manufacturing is constantly in flux.

概述:

From engineering to installation, commissioning, operations, and maintenance, FOUNDATION fieldbus offer significant cost reductions of 30 percent or more versus conventional analog systems. Many of these cost reductions come from the advanced functions that fieldbus offers versus analog technology.

概述:

The automation suppliers that will be successful in the long term will be those that effectively address application or industry specific problems for end users with a value proposition that cannot be ignored. These problems exist throughout the process industries today, and they won't be solved by simply offering a product, but through a combination of hardware, software, services, application expertise, and knowledge.

概述:

In ARC's view, customers need a compelling business value proposition to justify investment in any kind of automation. Vigilance and VigilantPlant were created with this in mind. Yokogawa's vision with VigilantPlant is to create an environment where plant personnel and operators are well informed, alert, and ready to take action. 

概述:

Yokogawa has come a long way in making its message clear to the world of process automation. Last year, the company embarked on a full-scale global marketing campaign to make customers aware of the company's focus on system reliability, security, dependability, and robustness. Dubbed "Vigilance", the campaign created a unified message for the company and greatly helped expand awareness of the Yokogawa brand and corporate philosophy.

概述:

Process automation end users are under more pressure than ever to do more with less. The current economic climate means that many automation capital projects are on hold. With capital budgets tighter than ever, users instead focus on operational budgets (where cost cutting is also a key concern), or on automation investments with a very rapid return on investment.

概述:

In today's dynamic industrial marketplace, the only constant is change. Raw material costs, energy costs, market demands, environmental and safety regulations, technology, and even the nature of the labor force itself are constantly changing, and not always in predictable directions.

概述:

This document describes the operation and data flow of the Yokogawa Print Wave software using the DX-P Reporter. It will provide a detailed explanation of the Advanced Alarm Reporter functions. The functions described in this paper were first released in Print Wave version 5.5.

概述:

The first stage in creating next-generation production control system that achieves innovative plant operation is providing "Visualized operation". "Visualized operation" for the customer means that he can reliably access and visualize plant data regardless of plant location and time.

概述:

Lonza's Riverside plant manufactures bulk active ingredients for the pharmaceutical industry. A new, fully automated multipurpose reactor train was installed in early 1996. The train includes ten 500 to 1500 gallon vessels used for reaction, distillation, phase separation, and crystallization; two centrifuges for isolating finished products; and two dryers. 

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概述:

通过采用环境监测系统,我们能够在细胞存储设施中创建一个可以控制质量的环境,保持高水平的安全性。

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