製藥

能否充分利用大型新興市場的機遇,是目前製藥行業面臨的重大挑戰。現在製藥公司比以往任何時候都更需要導入精益化生產技術,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

什麼是製藥 4.0?

製藥4.0是ISPE為製藥業規劃的路線圖,旨在導入“工業4.0”概念(也稱為智慧工廠)。
在工業4.0中,持續開發旨在提高產品品質和生產力、降低成本,並確保整個產品生命周期的穩定供應。這主要是利用IT創新和數位化改革業務流程來實現的。
此外,製藥4.0不僅需要滿足業務績效目標,還需要滿足政府針對製藥行業的法規中規定的義務。
換言之,製藥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藥品品質體系(PQS)準則的品質控制流程。
要實現製藥4.0,必須具備數位化的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。

為什麼仍然需要製藥4.0?

製藥業在為確保品質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,製藥4.0的實施將帶來絕大好處。
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,必須基於科學證據進行有效、高效和持續的品質改進工作(即POS)。
因此,製藥業為保證品質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,製藥業選擇加強工業自動化(即製藥4.0),並利用數位化和完全符合藥品監管標準來推動業務改革。
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Yokogawa橫河在製藥業中的業務目標

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,支援活性藥物成分(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】,利用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,將新型的共軛焦顯微鏡技術應用於藥物研發和前沿醫學研究領域。
利用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,以滿足製藥業的需求,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、品質檢測、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。
我們將這個產業的“世界觀”定義為 Bio Industrial Autonomy (BIA生物工業自治) ,並將其實現作為橫河製藥企業組織的使命。
我們將透過實施BIA為製藥4.0做出貢獻。
有關BIA的更多訊息, 請點此處

實施製藥4.0的效果

利用透過研究開發和製造收集的資訊接起來的先進網路,使各個部門的訊息互補利用,獲得多種積極的效果。
例如,品質源於設計(QbD)和連續生產的概念可以用於新藥開發和製造製程。這些可能會產生以下效果:
 

  • 利用數據分析,早期識别關鍵工業參數(CPP)和設計空間(DS)。
  • 利用製程分析技術(PAT)如軟傳感器,監控關鍵品質屬性(CQA)。
  • 利用關鍵品質監控促進中間體或成品的即時放行測試(RTRT)。
  • 透過累積的數據,增強對產品特性和製造製程的了解。
  • 提高數據的可訪問性,以及數據驅動的風險評估,對異常和偏差做出快速響應。
  • 利用反饋持續改善製程,並減少開發新藥和製造製程所涉及的時間和成本。

藉由通訊網路和周期增強競爭力,並促進業務持續增長。

 

橫河製藥4.0的整體解決方案

請參考以下專為製藥界客戶提供的解決方案,並能幫助客戶實現目標。

Smart GMP Factory

Zoom

 

Yokogawa Solution List

 
【Production scheduling】 FLEXSCHE
【Production, sales and cost management】 mcframe
【Quality management】 OpreX Laboratory Information Management System
【Environmental monitoring】 OpreX Environmental Monitoring System
【Equipment maintenance and management】 eServ
【Process database】 PI System
  Exaquantum
【Procedural automation】 Exapilot
【Production process monitoring and control】 CENTUM VP
  Field Instruments
【After-sales service business support】 ServAir

 

Environmental Monitoring System

環境監測符合藥品規定

OpreX環境監測系統收集、測量和儲存如溫度、濕度以及其他管理數據,以監控藥品生產區域、品質控制區域和儲存區域的環境。

主要特性

數據完整性

  • 符合 ALCOA+ 規定

數據收集與長期儲存

  • 將收集的數據長期儲存在符合FDA 21 CFR Part 11標準的記錄器中

即時數據監測

  • 使用監控軟體監控測量數據和報警

集中管理登錄用戶

利用Active Directory,網路伺服器集中管理用戶名和密碼。

  • 集中管理數據伺服器和記錄器的用戶名/密碼
  • 用戶登錄訪問控制

Major fratires

Package套裝組合

數據管理Package

集中管理數據記錄

存取控制

分組管理用戶,並根據不同群組授予不同存取權限。
限有被授權的用戶才能登錄系統並搜索和瀏覽數據。


Access control

稽核軌跡

授權用戶的所有操作都具有軌跡追蹤記錄

  • 文件操作(歸檔、刪除)
  • 備份和檔案還原



Audit trail

設定工具

管理員使用此工具設定數據管理包

  • 註冊新的記錄器
  • 註冊新用戶
  • License管理

GA10 即時監控軟體

數據的即時監控測量

  • 顯示測量值(趨勢顯示/數位顯示)
  • 螢幕顯示警報通知
  • 監控每個測量組的數據

GA10

通用檔案檢視器

瀏覽記錄數據的專用軟體

  • 顯示記錄數據
  • 支援最新的操作系統,絕佳觀看品質
  • 支援7種語言


universalviewer

無紙式記錄器

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
  • 全方位網路功能

先進的安全功能
電子數據記錄符合製藥法規

  • 邏輯安全
  • 軌跡追蹤功能
  • 二進制格式的安全數據儲存(防詐欺)
  • 用檢視軟體


universalviewer

客戶面臨的挑戰

Lean manufacturing

不斷變化的市場
製藥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。製造商不斷尋找提高效率和增加生產力的方法,確保獲利。精實化生產是關鍵。

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製藥廠實現全廠一體化及生命周期的優化。以下是一些製藥應用,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路服務。

API/Intermediates Process
 
Production Control System: CENTUM VP

多用途設備的生產管理和批次控制
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

21 CFR Part 11的無紙化操作在製藥業中變得越來越普遍
SMARTDAC+®GX/GP系列無紙記錄器支援符合 Part 11要求的電子記錄功能。可以將電子簽名添加到儲存數據中。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

確保產品品質的穩定控制
滅菌和冷凍乾燥工業需要高分辨率和精確的溫度控制,才能確保產品品質。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
製藥公司的市場遍及全球,鼓勵遵守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,並且採用當前的電腦化系統驗證(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)的專案。根據GAMP指南中描述的V模型專案驗證計劃(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品質
對於藥品,需要採用嚴格的科學方法來確保產品品質。ICH品質準則要求在藥物開發和制造階段採用品質源於設計(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,有望導入即時放行(RTR)檢測。

我們的解決方案

橫河用於即時放行檢測的PAT解決方案(RTRT)
橫河的開發製程分析技術(PAT)解決方案的方法是基於對關鍵品質屬性(CQA)的即時監控,來實現精益化生產。利用近紅外(NIR)分析儀可直接監測在線品質屬性。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:

日本千壽製藥選擇橫河電機的 Oprex EMS 確保優良的製藥品質。
EMS 有助於提高運營效率,同時符合 GMP 和其他標準。

摘要:

Kyowa Hakko Bio monitors vibration trends with Yokogawa's Sushi Sensors to prevent unexpected equipment failures.
By using eServ, sensor data and maintenance information are shared with everyone involved in manufacturing.

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:

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:

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:

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:

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:

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:

What if you could detect signs of abnormalities in bus ducts (bus bars) quickly during maintenance and inspection work and respond to them at just the right time? Yokogawa DTSX monitoring solution constantly monitors connections that tend to deteriorate over time and contributes by pinpointing abnormality locations and reducing workload of maintenance personnel, helping to ensure stability in plant operations.

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:

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:

With industrial and economic development comes increasingly large and advanced power plants and factories. Nevertheless, we find many cases where the original cables, cable tunnels, and other components of the power infrastructure have languished under continuous operation.

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:

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:

As a gateway to further expand Yokogawa's messaging as a One-stop Solution Business, Yokogawa has partnered up with INCIT, to introduce the S.I.R.I. framework. 

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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