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By Dave Harrold
Do you know what you get when you mix S88, S95, B2MML, M2Pack, BatchML, MES, OPC, JETT, OMAC and PAT together? No, it’s not alphabet soup. What you get is a collection of tools that, when used in combination, provide proven, well-documented ways to create a flexible, robust production environment that fulfills manufacturers’ long-time desire to obtain near real-time production visibility.
Greyssi Campos, a control systems engineer with Wyeth-Ayerst Lederle in Carolina, Puerto Rico, knows firsthand what S88 can provide. “Before we implemented S88, each recipe change required new code, new graphics and validation of both, in addition to validation of the recipe,” says Campos. “S88 has saved us a tremendous amount of time and money by eliminating code and graphic validation when recipes are changed.”
An Internet search for S88, S95, B2MML, M2Pack, BatchML, MES, OPC, JETT, OMAC and PAT returns thousands of hits for books, articles, whitepapers and tutorials describing these standards, templates and initiatives, but you’ll find very little on why using them makes savvy business sense—until now.
In his book, Management Challenges for the 21st Century, business guru Peter Drucker explains it’s best to focus on the meaning of the information and not on the technology that collects and delivers it. Drucker’s sage advice is exactly why using this collection of standards, templates and initiatives can help:
While this structure represents production, S95 supports its easily being adapted and applied to maintenance, quality, or inventory information
Certainly an Internet search on these individual tools will provide significantly more detail about each. However for our purposes, the following simple definitions are adequate to understand why using them together can improve the visibility of executives into production processes.
Standards and templates. S88 defines the terminology as well as the physical and functional hierarchy for recipe management and process segmentation. Use of S88 encourages development and reuse of pretested software modules designed to match the capabilities of equipment and processing units. Originally developed for batch processes, S88 has proven to be an equally effective automation development model for continuous processes.
S95 consists of terminology and models that can be used to develop an efficient information exchange between a variety of business systems, such as sales, finance, quality, production, maintenance and logistics. S95 encourages use of the standard business system information exchange language, or unified modelling language (UML).
Manufacturing execution systems (MES) are defined in S95 as systems that control “level 3-” related activities, such as resource allocation, production dispatching, collection of product production activities, quality assurance management, document management, labor management and more.
Communications. B2MML is a set of XML schemas developed by a World Batch Forum working group. Using the eXtensible Markup Language (XML) schema definition language, B2MML schemas are available as royalty-free, ready-to-use templates designed to make implementation of the S95 standard easy.
Batch markup language (BatchML) provides explanatory information about developing XML schemas that may be used to exchange information about recipes, equipment and batch lists per the data models and attributes defined in the S88 standard.
OPC is an open communication protocol for industrial automation and the enterprise systems that support industry. Interoperability is assured through creation and maintenance of open standards specifications. Based on fundamental standards and technology of the general computing market, OPC Foundation adapts and creates specifications that fill industry-specific needs.
Initiatives Underway. The Joint Equipment Transition Team (JETT) is a consortium of healthcare industry manufacturers, equipment suppliers and consultants seeking to improve communications between users and suppliers to more effectively meet the validation requirements of the healthcare industries as defined in version 4.0 of the ISPE’s Good Automated Manufacturing Practice Guide.
Make2Pack is a joint effort by several industry groups to harmonize similar standards and produce a common framework of terminology and models that supports automation strategies across the entire manufacturing landscape—batch and continuous processing, fill-finish and packaging.
S88 enables reuse of pretested software modules that match capabilities of devices and processing units.