EN product brochure (pharma)

PlantMaster

Manufacturing Execution System (MES)

BMS’s leading MES system for pharmaceutical and medical device manufacturers, PlantMaster monitors and synchronizes manufacturing activities from independent operations to globally distributed plants. PlantMaster is designed to seamlessly integrate with the company’s ERP system.

Using the Microsoft Windows® operating system and Oracle® database, PlantMaster offers a collaborative suite of application modules. PlantMaster meets the needs of pharmaceutical operations including tablet making, blister packaging and liquid filling lines. The system is also well established in pharmaceutical support industries such as the manufacturing of medical devices (e.g. Syringe moulding, needle manufacture etc).

The result is a powerful and flexible management tool providing managers with real-time visibility on all Key Performance Indicators (KPI), enabling them to achieve operational excel-lence and rapidly respond to changing conditions.

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TSDU/WDL

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Planning

Monitoring/reporting

Traceability

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Statistical Process &Quality Control

Windows server

Ethernet/OPC

DU8P/WDL

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Tablet compression

Encapsulation

Coating

Printing

Packaging

PlantMaster client-server concept

Networking the machinesPlantMaster supports both cabled and wireless networks to connect the machines to the central server. Machines are equipped with one of BMSvision’s Data Units for automatic as well as manual data collection or linked directly to the server through their Ethernet interface.

ERP system integrationPlantMaster is easily integrated with the customer’s ERP system. Through a standard interface, order and product data is transferred from the ERP system and imported in the PlantMaster database.

The integrated export functionality allows a straightforward upload of production data, calculated production schedules, work-in-progress and performance indicators from PlantMaster to the ERP system.

PlantMaster uses the standard TCP/IP protocols for integration with the host computer.

Connecting remote sitesPlantMaster supports the connection of multiple plants to one central server.

In the remote site, M-servers or WDl-servers, connected to a leased telephone line or the company’s Intranet, link the machines to the central computer system. A dedicated “multi-site consolidation module” on the central PlantMaster server allows integrated report-ing for all sites into one single reporting environment.

System requirementsOperating systems (32-bit):

• For the server: Windows Server 2003 or 2008.• For clients: Windows XP Professional SP3; Windows Vista Busi-

ness or Ultimate SP2; Windows 7 Professional, Enterprise or Business.

• Windows TSE or Citrix for remote connections.

Database: Oracle 10.2.0.

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DU8P: User friendly machine interface unit

The DU8P is BMS’s standard data collection terminal. This Data Unit automatically counts production, monitors cycle times or speeds, detects machine stops and allows operators to enter addi-tional information. Two serial interfaces allow direct connection to the machine’s microprocessor and measurement devices.

Nine user definable “quick entry” keys are available for fast entry of the most important stop reasons. All other data entry is conducted through software driven function keys. A large and configurable display allows the operator to view all production and planning information at the machine.

Connecting machines to PlantMaster

tsDU: Touch Screen Data Unit

BMS’s Touch Screen Data Unit serves as both a traditional monitor-ing Data Unit and an information point for the operator.

Using touch screen buttons, the operator can ask for information on quality control, process instructions, machine setup, … The need for printed documentation is reduced thus taking a big step towards “paperless” production.

Ethernet interfaceOPC and Euromap

The latest generation of production machines are often equipped with an Ethernet interface for host communication. These machines are connected by means of a standard Ethernet network (UTP5 cable or wireless). OPC as well as Euromap 63 are supported as communication protocols.

Overhead display

PlantMaster can be extended with scoreboards for quick and effec-tive communication in the plant. The scoreboard driver software allows flexible configuration of the displays, such as:

• Data to be displayed (selectable from the BMSvision PlantvieW data items)

• Text font/size/color• Machine filter• Update interval

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available time

loading time

operating time (availability)

net operating time (performance)

valuable operating time (quality)

planned down- time

down- time

losses

quality losses

speed losses

Real time machine monitoring

PlantMaster’s most important real time analysis tool is the Plant-vieW. In this color-coded layout of the plant, the machines are displayed in a number of colors, each color indicating a certain machine status or alarm condition.

The user selects the type of information to be displayed and user definable “filter sets” display only those machines which match a certain condition, for example all machines with OEE below 85%, machines producing too much waste, …

A “mouse click” on a specific machine or group of machines opens a window with detailed information for the selected machine(s).

Production visibility and analysis

Reporting

All data is stored in an Oracle relational database. By means of a powerful report and formula generator, users can define and configure their own calculations and reports.

Integrated graphics allow managers to build their own personalized “dashboards’ for a quick and transparent analysis and evaluation of all Key Performance Indicators (KPI).

With the “multi-site consolidation” module, managers can compare KPI’s and processes between sites, allowing operations to learn and optimize from the best performers.

OEE (Overall Equipment Effectiveness)

PlantMaster includes all the elements required for OEE monitoring and reporting. Information for availability, performance and quality is collected via easy to use BMSvision Data Units or directly from the machine.

Measurement and analysis of these important KPI’s can help drive improvements in performance with resulting beneficial cost savings.

User friendly reports and graphs identify problem areas, aiding the implementation of improvement agendas and plans.

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Real time job schedule

PlantMaster’s planboard lets you know within seconds whether you can meet customer’s requested delivery dates. Orders can be entered directly into the system or down loaded from the ERP system.

Based on the actual situation in the plant and technical restrictions stored in the system’s database, the system helps the planner in finding the optimum job sequence. Jobs can be rescheduled by simple “drag and drop” operations on the plan board. Jobs which are too late are automatically highlighted allowing the planner to take the necessary actions to get the situation under control again.

Managing job schedules

Kan Ban support

More and more manufacturers have switched from traditional order based planning (push) to Kan Ban planning (pull). PlantMaster supports this Kan Ban functionality.

In the Kan Ban philosophy, material or component requirements are triggered by the process that consumes this component. A “Kan Ban Card” is sent to the work center that produces this component. This bar coded card contains the product code, tool and quantity required. Scanning this card at the machine automatically generates a “production job” in the PlantMaster database.

Planning reports

Once the jobs are scheduled, a set of reports is available for planning, production and set up crew. They allow the managers to organize the necessary raw materials, operators and other resources.

Based on the scheduled machine load and the production calen-dar, the system also generates the tool and color change forecast reports, allowing efficient planning of change-overs.

Schedule adherence

PlantMaster offers a powerful tool to compare the progress of the current production plan with a target. Once the planning team create the schedule for the day (or week) it can be automatically downloaded into the PlantMaster system. As the products are manufactured, their progress is monitored and real-time reports can be created to compare the actual production performance versus planned performance. This provides live schedule adher-ence information to the planner as to whether orders are running as expected (expressed as a number of hours above or below target).

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Integrating traceability with monitoring

Product traceability has never been more important than today. Originally, traceability requirements were restricted to security parts in the automotive industry, but now it has become an obligation in various other domains like pharmaceuticals, food, cosmetics, medical devices, …

The traceability module within BMSvision’s PlantMaster system uses the hardware already in place for monitoring purposes. The Data Units at the work centers are extended with barcode scanners to allow identification of operators, raw materials and components. This significantly reduces administrative work and customer complaints due to incorrect deliveries, coding etc.

The system supports electronic signatures as required by 21CFR11 compliance and can be utilized in an FDA regulated environment.

Tracing from raw material to finished product

Process routing

In the process routing module, the user defines a “routing” for each product, containing all necessary production steps. For each step in the process, the machine or workstation is defined as well as all data to be collected.

Typical traceability data includes operators, lot numbers, compo-nent numbers and process and quality parameters. This allows the system to check in real time if indeed all data is collected during production.

The traceability system will automatically generate alarms (activate a lamp for example) in case certain data is forgotten or is incor-rectly entered.

Traceability reports

A powerful reporting module offers reports for forward and backward tracking per product, component and raw material and the search for causes in case of customer complaints.

For each individual product shipped, the system stores and reports raw materials and components used in each production step, process parameters, results of quality checks and operators that manufactured the product.

Information can be retrieved for as long as ten years in the past.

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The inspection plan

The PlantMaster sPC module keeps your process within the speci-fications required for optimum product quality and generates the documentation your customers demand for their quality assurance programs.

For every product, the user defines the quality and process control plan including the parameters to be monitored, the sampling strat-egy as well as calculations to be used. This way, the user configures the sPC package to fit his needs.

A link with the PlantMaster scheduling software assures an auto-matic generation of inspection orders at the start of the production order. Production orders for which the “quality checks” are overdue are automatically highlighted by the system.

Statistical Process Control (sPC)

Data collection for sPC/sQC

The system samples and stores process parameters as well as part related data and attributes. Process parameters are collected automatically using the Data Units at the machines (serial interface with the machine microprocessor or analog inputs) while part related information is sampled directly from measurement devices such as scales and calipers or entered manually through a PC connected to the system.

A special sPC touch screen terminal is available for convenient entry of sample data on the production floor.

sPC reporting and quality certificates

The PlantMaster sPC software offers an extensive set of sPC reporting tools: control charts for variables and attributes, normal-ity testing, histograms and process capability calculations. For variables, the user can choose between X-R and X-S charts. P, NP as well as pareto charts are available for attributes. The software automatically calculates alarm and warning limits.

The system is set up in such a way that the user himself can define how the calculations need to be done (FORD Q101, DGQ), which sPC rules need to be applied (check for trends, runs, etc.) and which type of control charts should be made. These settings can be modified for every single product.

An integrated editor allows the user to generate “quality certificates” at the end of each production run.

© Belgian Monitoring SystemsMember of the Savio group

www.bmsvision.com

Vlamingstraat 16, 8560 Wevelgem, BelgiumTel. +32 56 262 611 - Fax +32 56 262 690 - sales.bv@visionbms.com

Capricorn Park, Blakewater Road, Blackburn, Lancashire, BB1 5QR, UKTel. +44 1254 662 244 - Fax +44 1254 267 100 - sales.bla@visionbms.com

4420 Taggart Creek Road, Suite 112, Charlotte, North Carolina 28208, USATel. +1 704 392 9371 - Fax +1 704 399 5588 - sales@visionbmsusa.com

BMS bvba

BMS Vision Ltd

BMSVision LLC

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Operator tracking

Operator tracking allows both direct and indirect operators to log on/off at a machine via the BMSvision Data Unit. This can be done in a number of ways:

• The operator simply types in a number (operator ID) • RFID proximity device (tag reader)• Barcode slot reader• CCD scanner

Operators can be categorized into those that only need to log on at the machine (automatically logged off at the end of a shift) and those such as supervisors, quality operatives and maintenance people who need to both log on and log off. The operator tracking software stores all recorded informa-tion by operator code. Reports can be generated showing e.g. production, scrap, machine speed, downtime and efficiencies by operator.

Other optional modules

Typical PlantMaster installations Plastic molding Plastic extrusion

Engineering Packaging