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。

Details

什麼是制藥4.0?

制藥4.0是ISPE為制藥行業規劃的路線圖,旨在引入“工業4.0”概念(也稱為智能工廠)。
在工業4.0中,持續開發旨在提高產品質量和生產力、降低成本,並確保整個產品生命周期的穩定供應。這主要是通製IT創新和數字化改革業務流程來實現的。
此外,制藥4.0不僅需要滿足業務績效目標,還需要滿足政府針對制藥行業的法規中規定的義務。
換言之,制藥4.0可被視為在整個產品生命周期內,利用IT建立基於ICH-Q10藥品質量體系(PQS)準則的質量控制流程。
要實現制藥4.0,必須具備數字化的IT實施技術和清晰的目標,包括對藥品法規(包括PQS)的詳細了解。

為什麼仍然需要制藥4.0?

制藥業在為確保質量合規而不斷增加成本和創造利潤的需求之間進退兩難。
為了克服這一障礙,制藥4.0的實施將帶來巨大的好處。
根據ICH-Q12產品生命周期管理(PLCM)準則的規定,在整個藥品生命周期內,基於科學證據進行有效、高效和持續的質量改進工作是必要的(即POS)。
因此,制藥業為保證質量合規而產生的成本還將不斷增加。
與此同時,藥物研發回報率不斷惡化的行業環境迫使人們越來越需要提高生產力,而這往往包括藥物生產製程。
為了解決這一問題,制藥業選擇加強工業自動化(即制藥4.0),並通製數字化和完全符合藥品監管標準來推動業務改革。

橫河在制藥業中的業務目標

自20世紀80年代以來,一直以測量、成像、分析、診斷和集成為戰略重點;橫河提供了生產控制系統和眾多儀器,支持活性藥物成分(API)、藥物配方和生物技術應用的藥物生產製程。
自20世紀90年代以來,我們一直致力於生產【工業自動化】,通製將分散在工廠設備上的大量訊息聯系起來,提供各種生產管理解決方案供使用,來實現安全高效的生產。
大約在同一時期,橫河也開始提供活細胞成像解決方案,將新型的共聚焦顯微鏡技術應用於藥物研發和前沿醫學研究領域。
通製整合和深化我們的核心技術和經驗,橫河正在開發更安全、更高效的自主生產系統,以滿足制藥行業的需求,讓專業人士有更多機會將創造性和創新等獨特的人類能力應用到工作場所。
自主生產系統還將減少在藥品生產、質量檢測、文件編制和發布決策等方面對人類判斷的依賴,從而為工作人員集中精力提高生產力提供更多的一致性和時間。
我們將這個行業的“世界觀”定義為生物工業自治(BIA),並將其實現作為橫河制藥企業組織的使命。
因此,我們將通製實施BIA為制藥4.0做出貢獻。
有關BIA的更多訊息,請點擊此處

實施制藥4.0的效果

將研究、開發和制造中獲得的訊息連接起來的先進網絡,通製使各個部門的訊息得到互補利用而提供各種積極的效果。
例如,質量源於設計(QbD)和連續生產的概念可以用於新藥開發和制造製程。這些可能會產生以下效果:

  • 通製數據分析,早期識别關鍵工業參數(CPP)和設計空間(DS)。
  • 通製使用製程分析技術(PAT)如軟傳感器,監控關鍵質量屬性(CQA)。
  • 通製關鍵質量監控促進中間體或成品的實時放行測試(RTRT)。
  • 基於累積的數據,增強對產品特性和制造製程的了解。
  • 通製提高數據的可訪問性,基於數據驅動的風險評估,對異常和偏差做出快速響應。
  • 通製反饋持續改進工業,並減少開發新藥和制造製程所涉及的時間和成本。

這種通訊網絡和周期增強了競爭力,並促進業務持續增長。

 

橫河制藥4.0的整體解決方案

請參考以下產品組,這些產品組為制藥公司客戶的問題提供解決方案,並能幫助客戶實現目標。

橫河解決方案列表

 
【生產調度】 FLEXSCHE
【生產、銷售和成本管理】 mcframe
【質量管理】 OpreX Laboratory Information Management System
【環境監測】 OpreX Environmental Monitoring System
【設備維護管理】 eServ
【流程數據庫】 PI System
  Exaquantum
【程序自動化】 Exapilot
【生產製程監控】 CENTUM VP
  Field Instruments
【售後服務業務支持】 ServAir

Environmental Monitoring System

環境監測符合藥品規格

OpreX環境監測系統收集、測量和存儲如溫度、濕度以及其他管理數據,以監控藥品生產區域、質量控制區域和存儲區域的環境。

主要特性

數據完整性

  • 符合ALCOA +要求

數據採集與長期存儲

  • 將收集的數據長期存儲在符合FDA 21 CFR Part 11標準的記錄器中

實時數據監測

  • 使用監控軟件監控測量數據和報警

集中管理登錄用戶

通製Active Directory,使用網絡上的服務器集中管理用戶名和密碼。

  • 集中管理數據服務器和記錄器的用戶名/密碼
  • 用戶登錄訪問控制

Major fratires

套餐

數據管理套餐

集中管理數據記錄

訪問控制

用戶被分組,並根據他們所屬的組授予訪問權限。
隻有被授權的用戶才能登錄系統並搜索和瀏覽數據。


Access control

軌跡追蹤

授權用戶的所有操作都被軌跡追蹤記錄

  • 文件操作(歸檔、刪除)
  • 備份和恢複



Audit trail

配定工具

管理員使用此工具配定數據管理包

  • 注冊新的記錄器
  • 注冊新用戶
  • 許可證管理

GA10實時監控軟件

數據的實時監控測量

  • 顯示測量值(趨勢顯示/數字顯示)
  • 在屏幕上的警報通知
  • 監控每個測量組的數據

GA10

通用檢視

用於瀏覽記錄數據的專用查看軟件

  • 顯示記錄數據
  • 支持最新的操作系統,觀看體驗好
  • 支持7種語言


universalviewer

無紙記錄

SMARTDAC+系列

測量並記錄各種數據

  • 根據需要增加I/O模組
  • 多種強大的顯示功能
  • 全方位的網絡功能

先進的安全功能
電子數據記錄符合制藥法規

  • 邏輯安全
  • 軌跡追蹤功能
  • 二進制格式的安全數據存儲(防欺詐)
  • 專用檢視器軟件


universalviewer

客戶面臨的挑戰

Lean manufacturing

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。

API/Intermediates Process
 
Production Control System: CENTUM VP

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。

Formulation Process
 
SMARTDAC+® GX/GP Series Paperless Recorders

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。

FA-M3V IT Macine Controller

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

Good manufacturing practice (GMP)

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。

Validation V-Model

客戶面臨的挑戰

Scientific Quality Assurance

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。

Real-Time Release Testing (RTRT)

參考

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:

Wide and Clear
Confocal Scanner Unit

摘要:
  • 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.
摘要:

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.

摘要:

Faster, Brighter, and More Versatile Confocal Scanner Unit

摘要:
  • Colony Formation
  • Scratch Wound
  • Cytotoxicity
  • Neurite Outgrowth
  • Co-culture Analysis
  • Cell Tracking
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:

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.

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:

SMARTDAC+ GX series 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:

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:

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

摘要:

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.

摘要:

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

摘要:
  • 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
摘要:

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.

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:

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

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:

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.

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. 

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摘要:

憑借在IT、操作和控制技術方面的豐富知識和經驗,橫河電機旨在建立管理人員皆可利用的先進改進周期,最終與客戶攜手實現制藥工業4.0。

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