制藥

能否充分利用大型新興市場的機遇,是目前制藥行業面臨的重大挑戰。現在制藥公司比以往任何時候都更需要引入精益化生產技術,以提高盈利能力。作為全球知名工業自動化供應商,橫河電機致力於為客戶的優化生產實踐提供卓越的解決方案。

客戶面臨的挑戰

緊跟不斷變化的市場

制藥企業面臨很多應對變化的壓力,例如新興市場轉向低成本藥物,以及有效應對醫療用藥的需求。為了盈利,制造商正在尋找提高效率和增加生產力的方法。精益化生產是關鍵。

我們的解決方案

橫河電機卓越的自動化解決方案

橫河的解決方案可以幫助制藥廠實現全廠一體化及生命周期的優化。以下是一些制藥應用,橫河電機提供全面的自動化解決方案,並為客戶提供全球專家網絡服務。

 

多用途設備的生產管理和批量控制

活性藥物成分(API)的生產涉及批量處理,其中一些流程用於不同用途的多種產品。這需要使用完備的批量控制系統。CENTUM VP(綜合生產控制系統)提供基於ISA-88批處理控制標準的批處理功能,並符合FDA的21 CFR Part 11要求。

 

基於21 CFR Part 11的無紙化操作在制藥行業中變得越來越普遍。

SMARTDAC+®GX/GP系列無紙記錄儀支持符合 Part 11要求的電子記錄功能。可以將電子簽名添加到存儲數據中。橫河電機可提供包含所有必要驗證文件的全套安裝。

確保產品質量的穩定控制

滅菌和冷凍干燥工業需要高分辨率和精確的溫度控制,才能確保產品質量。FA-M3V和IT Macine控制器是一種高性能可編程邏輯控制器(PLC),具有處理速度快、控制穩定等特點。

客戶面臨的挑戰

遵守全球標準的法規和準則

制藥公司在全球市場中運營,鼓勵該行業遵守PIC/S GMP規定和ICH準則等國際倡議。GMP設備需要遵循既定的良好作業規範,使生產設備自動化,並且讓計算機系統採用當前的計算機化系統驗證(CSV)規範,例如GAMP。

我們的解決方案

確保優質藥品的生產

多年來,橫河電機已成功實施了許多符合良好自動化制造規範(GAMP)的項目。根據GAMP指南中描述的V模型項目驗證計劃(PVP),經驗豐富的橫河電機工程師為功能規格、設計規格、實施、工廠測試和現場驗收測試階段交付結果。驗證和測試結果,其中包括安裝和操作資格(IQ/OQ),將作為確定是否滿足項目要求的客觀指標。

客戶面臨的挑戰

需要更嚴格的方法確保產品質量

對於藥品,需要採用嚴格的科學方法來確保產品質量。ICH質量準則要求在藥物開發和制造階段採用質量源於設計(QbD)的系統方法。制造工廠面臨著實施創新技術的挑戰,諸如製程分析技術(PAT)等,有望引入實時放行(RTR)檢測。

我們的解決方案

橫河電機用於實時放行檢測的PAT解決方案(RTRT)

橫河電機的開發製程分析技術(PAT)解決方案的方法是基於對關鍵質量屬性(CQA)的實時監控,來實現精益化生產。通製近紅外(NIR)分析儀可直接監測在線質量屬性。另一種方法是採用製程建模技術來監控製程的健康狀況。

摘要:
  • Highlyadvanced biopharmaceutical plant uses CENTUM, VP Batch, Exaquantum and PRM.
  • Total system integration for large-scale biotech production facility.
摘要:
  • Uninterrupted Medical Oxygen Production with FAST/TOOLS Monitoring.
  • Audits are performed periodically, requiring traceability and the keeping of historical records for all batch production activities.
摘要:
  • 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).
摘要:
  • 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.
摘要:
  • Implementation of control system supported by global maintenance, service, engineering, and technical support capabilities
  • Improved stability and safety of plant operation
摘要:
  • Pharmaceutical automation solution delivered through commitment to local expertise
  • Enhanced process reliability and consistency leading to greater assurance of product quality
摘要:
  • For remote monitoring (of temperature, pressure, and flow volume), installing the MW100 in the plant and DXAdvanced in the office provides for a scalable, pc-free on-site data monitoring solution.
  • You can centralize managment of large quantities of data by automatically transferring acquired data to a FTP server.
摘要:

DXAdvanced records the clean room temperature, humidity, atmospheric pressure, door openings and closings, etc.

摘要:

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).

摘要:

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.

摘要:

MW100 Data Acquisition/Data Logging System with PR300 Power and Energy Meters

摘要:

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.

摘要:

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. 

摘要:

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.

摘要:

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.

摘要:

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.

摘要:

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.

摘要:

By using the Multibatch function (an option added with DXAdvanced R3), you can efficiently record data from multiple devices onto a single DXAdvanced.

摘要:

Using the custom display function that comes standard with DXAdvanced R3 means that you can combine the recorders, displays, and switches used in various kinds of equipment.

摘要:

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

摘要:

Alarm contact output (optional) connected to abnormality alarm device:
Operations managers are notified in turn of the alarm by telephone.

摘要:
  • Universal inputs provide support for thermocouple, RTD, voltage, and a variety of other input signals.
  • Lineup of models for up to 48 inputs.
    Allows multipoint monitoring and recording on a single unit.
  • Easily enables network-based data management. 
    file transfers, Web monitoring, and alarm e-mail
摘要:

Remote measurement of sterilization temperatures at each stage using the DX2000+MW100 The DX2000's external input function (/MC1) lets you add up to 240 external input channels.

摘要:

A 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 analog data.

摘要:

DAQWORX Data Acquisition Software Suite helps the administrative department collect and monitor data on each section of the factory, including data on the usage of chemicals, gas, and electricity.

摘要:

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.

摘要:

 Ground water well level monitoring is needed.

摘要:

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.

摘要:

The DXAdvanced R4 touch screen model makes traditional key operations more intuitive and easy, raising efficiency for on-site operators.

摘要:

The DXAdvanced Paperless Recorder (hereinafter, the DX) lets you write arbitrary messages on the trend display screen that are useful for writing comments or memos. Moreover, with a combination of the DX touch screen model (DX1000T/2000T) and the custom display function, you can write messages, start/stop recording, and perform a variety of other tasks at the touch of a button.

摘要:

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.

摘要:

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.

摘要:

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.

摘要:

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.

摘要:

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.

摘要:

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. 

摘要:

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.

摘要:

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.

摘要:

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.

摘要:

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.

摘要:

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. 

摘要:

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.

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