의약품

급변하는 현대에서는 지금까지 이상으로 경영 판단에는 속도와 정확성이 요구되고 있습니다. 의약품 업계에서도 ICT 기술을 활용한 패러다임의 변화 (Quality-by-Design, 연속 생산 등)가 일어나고, 그러한 흐름 속에서 어떻게 정보를 따라잡을 것인가가 기업의 과제입니다. Yokogawa는 원약, 제재, 바이오 분야에 1000개 이상의 시스템의 도입 실적을 바탕으로, 앞으로도 의약품 산업의 발전에 공헌하고자 합니다.

Customer Challenge

변화하는 시장에 적응
제약 회사들은 신흥 시장에서 일어나고 있는 저가 의약품으로의 전환과 아직 충족되지 못한 의학적 요구 (unmet medical needs)를 만족시키는 의약품에 대한 수요 증가와 같은 제약 시장의 변화에 보조를 맞추어야 한다는 압력을 받고 있습니다. 이윤을 창출하기 위해 제조업체는 효율성을 높이고 생산성을 향상시킬 수 있는 방법을 모색하고 있습니다. 

Our Solutions

Yokogawa의 최첨단 자동화 솔루션
Yokogawa의 솔루션은 제약 플랜트의 전반적인 통합 및 라이프 사이클 최적화를 가능하게 합니다. 다음은 전 세계 전문가 네트워크를 보유하고 있는 Yokogawa가 포괄적인 자동화 솔루션을 제공할 수 있는 제약 애플리케이션 리스트입니다.

 

다목적 플랜트 생산 관리 및 Batch 제어
원료 의약품(Active Pharmaceutical Ingredient, API) 생산에는 Batch 공정이 포함되며, 일부 공정은 다양한 목적을 위해 여러 제품을 생산합니다. 이를 위해서는 포괄적인 Batch 제어 시스템을 사용해야 합니다. CENTUM VP 통합 생산 제어 시스템은 ISA-88 배치 공정 제어 표준에 기초한 Batch 기능을 제공하며, FDA의 21 CFR Part 11 요건을 준수합니다.

 

21 CFR Part 11을 기반으로 한 Paperless 작업은 제약 산업에서 점점 더 보편화되고 있습니다.
SMARTDAC+® GX/GP 시리즈 Paperless 레코더는 Part 11의 요구 사항을 충족하는 전자 레코딩 기능을 지원합니다. 저장된 데이터에 전자 서명을 추가할 수 있습니다. Yokogawa가 모든 필수 검증 문서를 포함한 완벽한 설치를 제공할 수 있습니다.

제품 품질 보장을 위한 안정적인 제어
멸균, 동결 및 건조 공정은 제품 품질을 보장하기 위해 높은 해상도와 정확한 온도 제어가 필요합니다. FA-M3V, IT Macine 컨트롤러는 매우 빠른 처리 속도와 안정적인 제어 기능을 결합한 고성능 PLC입니다.  

Customer Challenge

글로벌 규정 및 가이드라인 준수
제약 회사는 글로벌 시장 표준에 따라 움직이고 있으며, PIC/S GMP 가이드 및 ICH 가이드라인과 같은 국제적인 이니셔티브를 준수하도록 요구됩니다. GMP 시설은 기존의 모범 사례를 따라야 하며, 자동화된 생산 설비 및 컴퓨터 시스템은 GAMP와 같은 현재의 컴퓨터 시스템 검증방식(CSV)을 채택할 것으로 예상됩니다.

Our Solutions

품질 의약품 생산 보장
Yokogawa는 수년간 GAMP (Good Automated Manufacturing Practice)를 준수하는 수많은 프로젝트를 성공적으로 수행했습니다. GAMP 가이드에 설명된 V 모델을 따르는 프로젝트 검증 계획(PVP)에 따라, 숙련된 Yokogawa 엔지니어가 기능 사양, 설계 사양, 실행, FAT 및 SAT를 수행합니다.

Customer Challenge

제품 품질을 보장하기 위한 보다 엄격한 접근 방식 필요
의약품의 경우, 제품 품질을 보장하기 위한 엄격한 과학적 접근법이 필요합니다. ICH 품질 가이드라인은 의약품 개발 및 제조 과정에서 QbD (quality-by-design) 접근법을 요구합니다. 제조 시설은 공정분석기술 (PAT) 과 같은 혁신적인 기술을 구현해야 하는 어려움에 직면해있으며, RTR (real-time release) 테스트를 도입할 것으로 예상됩니다.

Our Solutions

RTRT(Real Time Release Testing)에 대한 Yokogawa PAT 솔루션
Yokogawa의 공정분석기술(PAT) 솔루션 개발 방식은 린 제조방식(lean manufacturing)을 달성하기 위해 중요 품질 속성(CQA)의 실시간 모니터링을 통해 구현합니다. 온라인 품질 특성은 근적외선(NIR) 분석을 통해 직접 모니터링할 수 있습니다. 또 다른 접근법은 프로세스 상태를 모니터링하기 위해 프로세스 모델링 기술을 사용하여 프로세스 상태를 모니터링하는 것입니다. 

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

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

Overview:

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).

Overview:

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.

Overview:

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

Overview:

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.

Overview:

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. 

Overview:

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.

Overview:

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.

Overview:

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.

Overview:

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.

Overview:

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

Overview:

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.

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

Overview:

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

Overview:
  • 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
Overview:

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.

Overview:

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.

Overview:

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.

Overview:

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.

Application Note
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Overview:

 Ground water well level monitoring is needed.

Application Note
Overview:

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.

Overview:

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

Overview:

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.

Overview:

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.

Overview:

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.

Overview:

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.

Overview:

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.

Overview:

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.

Overview:

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. 

Overview:

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.

Overview:

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.

Overview:

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.

Overview:

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.

Overview:

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. 

Overview:

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.

기술 및 솔루션, 요꼬가와에 대한 자세한 정보를 찾고 계십니까?


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