An Expertise Within An Expertise
Process control engineering is a specific expertise blending knowledge of industrial processes, programming, software, and instrumentation.
S88
ANSI/ISA-88 (S88) provides a consistent set of standards and terminology for batch control. Utilizing the S88 standard simplifies code development and provides a more elegant package with consistent methodology and terminology across multiple platforms.
GAMP / GMP
Regulated industries such as pharmaceuticals must adhere to GAMP (Good Automated Manufacturing Practice), a globally recognized framework, to ensure that systems, instruments, and data comply with regulatory requirements and meet its operational requirements reliably.
Robust Configuration for Improved Maintainability
How well you structure the sequence interactions can greatly affect the process controllability, quality, and cycle time.
Our Batch Experts will analyze the structure of your process by considering the following questions:
Key Process and Equipment Considerations for Batch Control Analysis
Working process knowledge is critical when planning key elements of process steps that the batch sequence must address. In addition, expertise around equipment such as reactors, crystallizers, centrifuges, dryers, and batch filters all have their own unique elements and concerns.
Our Process Engineers will analyze the process in the context of the following considerations:
Operator Interactions With Batch Processes
Batch processes will have varying degrees of manual operator interaction. A batch operation is more likely to require operator assistance, whether through manual raw material additions, field verifications, or triggering specific process actions.
The following should be considered regarding operator interaction:
Our Team Will Guide You Through The Entire Process
Planning
Our Team integrates front end planning as a foundational phase in the project lifecycle. This phase aligns business needs with project execution strategies and includes a feasibility study to determine if the project is within the acceptable capital budget, develop a detailed scope definition, and perform a project risk assessment. Our Team will also provide proper documentation, including a Functional Design Specification (FDS), to capture your requirements and check the program.
Implementation
Batch programming enables precise control over sequential operations, ensuring that each step in a recipe or process occurs in the correct order and under the right conditions. It also allows facilities to manage multiple product recipes on shared equipment, adapt to changes in ingredients or process paths, and maintain traceability and compliance with standards like ISA-8812. Our Team also offers onsite testing and post startup support.
As a vendor-agnostic system integrator, we work with a variety of Platforms.
Electronic Batch Records
A Shift to Digital
Batch records that document a manufactured product can assist with tracking lots and preparing for audits. There is a push in the manufacturing industry to shift to digital records – Electronic Batch Records (EBR) – and track information electronically.
Benefits of Electronic Batch Records
Considerations Before EBR Implementation
Implementation Complexity
Full EBR requires integration of a number of your production platforms including enterprise resource planning (ERP), laboratory information management system (LIMS), manufacturing execution systems (MES), industrial control systems (ICS/DCS/PLC), and OT/Cybersecurity. With unique processes, up-front planning is critical.
EBR Life Cycle Commitments
After validation is complete, system upsets can still occur, so it’s important to plan and execute preventative maintenance programs regularly, including maintaining hardware and software. Routine checks should be outlined and scheduled to help keep the system up and running.
Plan For Support
More systems incorporated into your processes means more support to maintain interconnectivity and reduce downtimes. Without the proper support, you can incur gaps in your records or lose production time. Build your organization to mitigate and address these issues and plan your support into your operations budget.
Cybersecurity & Data Integrity
With vital pieces of information being stored and passed between systems, routine cybersecurity audits can help identify vulnerabilities and ensure that both hardware and software systems are up to date and secure. Unfortunately, secure systems are still at risk without proper procedures in place to maintain data integrity, ensuring consistency and quality of the products manufactured. Our Team can design, configure, and maintain your systems so your data involved can’t be manipulated outside of an audit trail.
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