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Rockwell Automation has released its Factorytalk Pharma Suite 2.1 software, incorporating electronic batch recording (EBR) capabilities to meet the needs of pharmaceutical and biotech manufacturers.

The new release extends the capabilities of the Pharma Suite by supporting a ‘review by exception’ methodology.

With Pharma Suite 2.1, exceptions during batch recording can be reviewed and addressed in real time, not after the fact as is typical for paper-based or ‘paper-on-glass’ workflows.

The exception handling during the EBR execution occurs during the manufacturing process, allowing the operator on the shop floor to address exceptions as the manufacturing rules are enforced in real time.

This reduces wasted time, money and materials.

Usability capabilities also allow quality personnel to start investigating process deviations as they occur on the shop floor, rather than wait for batch completion.

Collected exceptions are the starting point for the batch review process.

The online batch record review capability allows quality control personnel to more efficiently judge the documented deviations and to close out the review process more quickly and with fewer process deviations.

The EBR capability reduces the amount of time spent on batch review after completion of the batch, which means the finished products spend less time warehoused waiting for the release.

This is said to reduce inventory costs, increases turnover and allows the product to spend more time in the distribution channel before its shelf life expires.

All quality-related processing information is compiled in a holistic batch record based on the ISA S88 standard.

Pharma Suite also provides the capability to render batch record information in different publishing formats, such as PDFs, HTML, XML and classic paper-based reports.

In Pharma Suite, recipes are modelled graphically and aligned with the ISA S88 standard.

Visual tools and intelligent search mechanisms help ensure that all information required for recipe design can be accessed quickly and easily.

Recipes are assembled from reusable parameterised building blocks that represent standard functions such as adding material to a process or checking equipment against requirements.

Pharma Suite also allows the re-use of preconfigured building blocks to accelerate recipe design, reduce errors and speed validation, resulting in faster deployment.

The recipe execution client of Pharma Suite maximises operator efficiency by focusing on the operator’s main workflow.

The system guides the operator through the complex processes and helps ensure that all tasks are completed according to the recipe.

Deviations are handled by the built-in exception management that delivers important input for review by exception.

Pharma Suite is based on the Factorytalk Productioncentre manufacturing operations platform.

It leverages a service-orientated orientated architecture for cost-effective, flexible deployment, as well as integration with business and automation systems.

Its object-oriented design makes it easier and faster to build, modify and systematically deploy applications across multiple sites.

Rockwell Automation

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