The pharmaceutical industry currently faces a major challenge in taking full advantage of the opportunities presented in large emerging markets. Now, more than ever, pharmaceutical companies need to introduce lean manufacturing techniques that will enhance profitability. As one of the world's leading industrial automation suppliers, Yokogawa is committed to delivering the best possible solutions for your best manufacturing practices.
Keeping up with a changing marketplace
Pharmaceutical manufacturers are under pressure to keep up with changes such as the shift to low-cost drugs in emerging markets and the demand for drugs that effectively satisfy unmet medical needs. To operate at a profit, manufacturers are looking for ways to improve efficiency and increase productivity. Lean manufacturing is the key.
Yokogawa's Leading-Edge Automation Solutions
Our solutions enable plantwide integration and lifecycle optimization at pharmaceutical plants. Here are some pharmaceutical applications for which Yokogawa provides comprehensive automation solutions and has a global network of experts at your service.
Production Management and Batch Control for Multipurpose Plant
The production of active pharmaceutical ingredients (API) involves batch processes, some of which produce multiple products for a variety of purposes. This necessitates the use of a comprehensive batch control system. The CENTUM VP, Integrated Production Control System supplies batch functions based on the ISA-88 batch process control standard and complies with the FDA's 21 CFR Part 11 requirements.
Paperless operations based on 21 CFR Part 11 are becoming more common in the pharmaceutical industry.
The SMARTDAC+® GX/GP Series Paperless Recorders supports electronic recording functions that meet the requirements of Part 11. Electronic signatures can be added to the stored data. Yokogawa can offer complete installations with all essential validation documents
Stable control for product quality assurance
The sterilization and freeze drying processes require high resolution and accurate temperature control in order to assure product quality. The FA-M3V, IT Macine Controller is a high-performance programmable logic controller (PLC) that combines very high processing speeds with stable control features.
Compliance with globalized regulations and guidelines
Pharmaceutical companies operate in a global marketplace and the industry is encouraged to comply with international initiatives such as the PIC/S GMP Guide and the ICH Guidelines. GMP facilities need to follow established best practices and automated production equipment and computer systems are expected to adopt current computerized system validation (CSV) practices such as GAMP.
Assuring the Production of Quality Pharmaceutical Products
Over the years, Yokogawa has successfully realized numerous projects in compliance with Good Automated Manufacturing Practice (GAMP). Under a project validation plan (PVP) that follows the V model described in the GAMP guide, experienced Yokogawa engineers deliver outcomes for the functional specification, design specification, implementation, factory testing, and site acceptance testing phases. The verification and test results, including the installation and operational qualifications (IQ /OQ), serve as objective indicators for determining if project requirements have been met.
Need for a more rigorous approach to ensure product quality
With pharmaceuticals, a rigorous scientific approach is needed to ensure product quality. The ICH quality guidelines call for a quality-by-design (QbD) approach in pharmaceutical development and manufacturing. Manufacturing facilities face the challenge of implementing innovative technologies such as process analytical technology (PAT) and are expected to introduce real-time release (RTR) testing.
Yokogawa PAT Solution to Real-Time Release Testing (RTRT)
Yokogawa's approach to the development of process analytical technology (PAT) solutions relies on real-time monitoring of critical quality attributes (CQA) to achieve lean manufacturing. Online quality attributes can be directly monitored by means of near infrared (NIR) analysis. Another approach is the use of process modeling technology to monitor process health.
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.
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.
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.
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.
Ground water well level monitoring is needed.
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.
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.
Discovering your Baseline with OT Security Risk Assessment
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.
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.
- For improved agility in implementing control system projects -
- Optimizes the supply chain and operations by enabling plant personnel to work more efficiently -
- For improved efficiency in drug discovery and biological and medical research through the uniform management of microscopic images -
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