能否充分利用大型新興市場(chǎng)的機(jī)遇，是目前制藥行業(yè)面臨的重大挑戰(zhàn)?，F(xiàn)在制藥公司比以往任何時(shí)候都更需要引入精益化生產(chǎn)技術(shù)，以提高盈利能力。作為全球知名工業(yè)自動(dòng)化供應(yīng)商，橫河電機(jī)致力于為客戶的優(yōu)化生產(chǎn)實(shí)踐提供卓越的解決方案。

制藥企業(yè)面臨很多應(yīng)對(duì)變化的壓力，例如新興市場(chǎng)轉(zhuǎn)向低成本藥物，以及有效應(yīng)對(duì)醫(yī)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(chǎn)力的方法。精益化生產(chǎn)是關(guān)鍵。

橫河的解決方案可以幫助制藥廠實(shí)現(xiàn)全廠一體化及生命周期的優(yōu)化。以下是一些制藥應(yīng)用，橫河電機(jī)提供全面的自動(dòng)化解決方案，并為客戶提供全球?qū)＜揖W(wǎng)絡(luò)服務(wù)。

 

活性藥物成分（API）的生產(chǎn)涉及批量處理，其中一些流程用于不同用途的多種產(chǎn)品。這需要使用完備的批量控制系統(tǒng)。CENTUM VP（綜合生產(chǎn)控制系統(tǒng)）提供基于ISA-88批處理控制標(biāo)準(zhǔn)的批處理功能，并符合FDA的21 CFR Part 11要求。

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(chǔ)數(shù)據(jù)中。橫河電機(jī)可提供包含所有必要驗(yàn)證文件的全套安裝。

滅菌和冷凍干燥工藝需要高分辨率和精確的溫度控制，才能確保產(chǎn)品質(zhì)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(wěn)定等特點(diǎn)。

制藥公司在全球市場(chǎng)中運(yùn)營(yíng)，鼓勵(lì)該行業(yè)遵守PIC/S GMP規(guī)定和ICH準(zhǔn)則等國(guó)際倡議。GMP設(shè)備需要遵循既定的良好作業(yè)規(guī)范，使生產(chǎn)設(shè)備自動(dòng)化，并且讓計(jì)算機(jī)系統(tǒng)采用當(dāng)前的計(jì)算機(jī)化系統(tǒng)驗(yàn)證（CSV）規(guī)范，例如GAMP。

多年來，橫河電機(jī)已成功實(shí)施了許多符合良好自動(dòng)化制造規(guī)范（GAMP）的項(xiàng)目。根據(jù)GAMP指南中描述的V模型項(xiàng)目驗(yàn)證計(jì)劃（PVP），經(jīng)驗(yàn)豐富的橫河電機(jī)工程師為功能規(guī)格、設(shè)計(jì)規(guī)格、實(shí)施、工廠測(cè)試和現(xiàn)場(chǎng)驗(yàn)收測(cè)試階段交付結(jié)果。驗(yàn)證和測(cè)試結(jié)果，其中包括安裝和操作資格（IQ/OQ），將作為確定是否滿足項(xiàng)目要求的客觀指標(biāo)。

對(duì)于藥品，需要采用嚴(yán)格的科學(xué)方法來確保產(chǎn)品質(zhì)量。ICH質(zhì)量準(zhǔn)則要求在藥物開發(fā)和制造階段采用質(zhì)量源于設(shè)計(jì)（QbD）的系統(tǒng)方法。制造工廠面臨著實(shí)施創(chuàng)新技術(shù)的挑戰(zhàn)，諸如過程分析技術(shù)（PAT）等，有望引入實(shí)時(shí)放行（RTR）檢測(cè)。

橫河電機(jī)的開發(fā)過程分析技術(shù)（PAT）解決方案的方法是基于對(duì)關(guān)鍵質(zhì)量屬性（CQA）的實(shí)時(shí)監(jiān)控，來實(shí)現(xiàn)精益化生產(chǎn)。通過近紅外（NIR）分析儀可直接監(jiān)測(cè)在線質(zhì)量屬性。另一種方法是采用過程建模技術(shù)來監(jiān)控過程的健康狀況。

Highlyadvanced biopharmaceutical plant uses CENTUM, VP Batch, Exaquantum and PRM. Total system integration for large-scale biotech production facility.
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.
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).
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.
Implementation of control system supported by global maintenance, service, engineering, and technical support capabilities Improved stability and safety of plant operation
Pharmaceutical automation solution delivered through commitment to local expertise Enhanced process reliability and consistency leading to greater assurance of product quality
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.

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

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).

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.

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

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.

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. 

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.

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.

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.

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.

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

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.

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

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

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

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.

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.

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.

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.

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.

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

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.

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.

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.

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.

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.

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.

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. 

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.

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.

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.

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.

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. 

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.