Architecture, Block Capabilities, and Integration Guidelines for PCS 7 BioChem Library

The SIMATIC PCS 7 Industry Library - BioChem (IL BioChem V01.00) is an industry-specific expansion package engineered for pharmaceutical, biotechnology, and fine chemical applications, designed for integration with PCS 7 V8.1 SP1. Built upon the Advanced Process Library (APL) design principles, the BioChem Library provides pre-engineered technological function blocks, faceplates, and batch templates for complex operations such as bioreactor aeration, pH and dissolved oxygen control, nutrient dosage profiling, and automated Clean-in-Place (CIP) state machines. It complies with GAMP 5 and FDA 21 CFR Part 11 requirements. Official documentation and block libraries are delivered via the Siemens Industry Library product media and technical portal.

BioChem Library Positioning and Architectural Overview

The SIMATIC PCS 7 Industry Library (IL) - BioChem V01.00 addresses the stringent process control, regulatory compliance, and validation requirements of the life sciences sector (biotechnology, pharmaceuticals, cell culture, and fermentation). Standard process control blocks frequently require extensive custom programming to execute complex biological control tasks such as non-linear dissolved oxygen cascaded control or exponential nutrient dosing.

IL BioChem bridges this gap by providing pre-validated, standardized technological blocks that adhere fully to the APL Style Guide and ISA-88 Batch Architecture. It interfaces directly with SIMATIC BATCH for recipe execution and WinCC Route Control for automated transfer piping. Furthermore, all blocks are pre-engineered to generate comprehensive audit trail messages and electronic signature logs in compliance with FDA 21 CFR Part 11 and GAMP 5.

Key Technological Blocks and Process Capabilities

The BioChem Library introduces specialized technological algorithms tailored for biological unit operations:

Advanced Dissolved Oxygen Control (DO_Ctrl): Aerobic fermentation requires dissolved oxygen (DO) regulation under fluctuating oxygen uptake rates. The DO_Ctrl block coordinates split-range cascaded manipulation: first varying agitator RPM, followed by increasing airflow, and finally enriching inlet gas with pure oxygen (O2) injection.
Dynamic pH Control (pH_Ctrl): Manages high-precision titrations across non-linear neutralization curves by automatically switching gain scheduling between acid dosing pumps, base dosing valves, and CO2 sparging.
Nutrient Feed and Profile Dosing (Feed_Prof): Executes linear, exponential, or feedback-dependent feeding of glucose, substrate, and trace minerals to sustain optimal cell growth without inducing substrate inhibition.
Agitator and Impeller Management (Agit_L): Coordinates multiple impeller stages, managing shear-stress limitations for fragile cell cultures and monitoring torque/viscosity changes during high-density fermentation.
Clean-in-Place and Sterilization-in-Place (CIP_Ctrl / SIP_Ctrl): Implements automated temperature-hold and chemical contact time sequencing with guaranteed sensor validation before release.

BioChem Library Block Portfolio and Application Matrix

The following table summarizes core technological blocks, their functions, and faceplate components in IL BioChem:

Block Type NameFB NumberPrimary Process ApplicationWinCC Faceplate & ViewsDO_CtrlFB1410Dissolved oxygen cascade & split-range aeration@PG_DO_Ctrl.pdl (Cascade & Gas mix views)pH_CtrlFB1411Non-linear pH neutralization & gas dosing@PG_pH_Ctrl.pdl (Titration curve & limit views)Feed_ProfFB1412Exponential & substrate-demand dosing profiles@PG_Feed_Prof.pdl (Profile curve editor view)Agit_LFB1413Variable speed fermenter agitator & shear control@PG_Agit_L.pdl (Speed, torque & power views)SIP_CtrlFB1414Steam sterilization cycle & temperature holding@PG_SIP_Ctrl.pdl (F0 calculation & cycle phase)CIP_CtrlFB1415Multi-step caustic/acid wash & conductivity check@PG_CIP_Ctrl.pdl (Step status & rinse timer)

Step-by-Step Procedure to Integrate BioChem Blocks into PCS 7

To integrate the BioChem Library into a PCS 7 V8.1 SP1 project:

Install Prerequisites and Software Package:
- Ensure that SIMATIC PCS 7 V8.1 SP1 and PCS 7 Advanced Process Library (APL) are installed.
- Run the setup routine from the official SIMATIC PCS 7 Industry Library V8.1 installation media.
- Transfer the engineering and runtime licenses via Automation License Manager (ALM).
Import Blocks into the Master Data Library:
- In SIMATIC Manager, open your project's Master Data Library.
- Open the installed IL BioChem Library from the catalog.
- Copy the required function blocks (e.g., DO_Ctrl, pH_Ctrl), associated UDTs, and system blocks into the Master Data Library's Blocks folder.
- In SIMATIC Manager, execute Options -> Update Block Types to synchronize the blocks to all target CPUs.
Integrate WinCC Faceplates and Graphics:
- Copy the @PG_*.pdl faceplates and typicals from the BioChem installation directory (...\WinCC\GraCS\) into the OS project's GraCS folder.
- Open the project template @PCS7Typicals_Project.pdl and paste the BioChem block icons.
- Run the OS Project Editor in WinCC Explorer to register faceplate headers and scripts.
Instantiate and Compile in CFC:
- Drag the BioChem blocks into technological CFC charts (e.g., Bioreactor_01).
- Interconnect process variables (PV_In), control outputs, and module drivers.
- Execute Chart -> Compile -> Changes Only with module driver generation enabled.
- Compile the OS project and verify faceplate opening.

Verification

Verify BioChem library functionality:
1. In CFC, open the chart containing DO_Ctrl online; simulate a low DO reading and verify that the cascade sequentially commands agitation speed, air valve, and O2 enrichment.
2. Open the WinCC OS faceplate for DO_Ctrl; confirm that all cascade stages and operating modes (Aut/Man) respond to operator input.
3. Verify that operating actions trigger electronic signature dialogues and log user IDs to the WinCC audit archive.
4. Verify that SIMATIC BATCH phase parameters map correctly to the block inputs during recipe testing.

Limitations and Operational Precautions

Version Compatibility Bound: IL BioChem V01.00 is strictly compiled for PCS 7 V8.1 SP1. Deploying in older V7.1 or newer V9.0 environments without library update packages causes interface faults.
Licensing Requirements: Running BioChem blocks requires SIMATIC PCS 7 Industry Library AS Runtime and OS Runtime PO licenses in addition to base PCS 7 POs.
Validation Documentation: Life sciences plants must maintain the formal Siemens Manufacturer Declaration and execute Installation Qualification (IQ) / Operational Qualification (OQ) protocols.

Engineer FAQ

Where can I find the official documentation for the BioChem Library?

Documentation is supplied on the SIMATIC PCS 7 Industry Library installation media under the 'Manuals' directory and on the Siemens Industry Online Support portal.

Is the BioChem Library compatible with standard APL blocks?

Yes. The BioChem Library is built directly upon the APL architecture and shares identical look-and-feel, faceplate navigation, and status double-word mechanics.