Chemical Production of Pharmaceutical Substances API

Batch substance production control system with MES level production control system COMES.

Compas > Chemical Production of Pharmaceutical Substances API

The need for great flexibility is typical of the production of substances in the Saneca Company (former Zentiva and Slovakofarma). The company often manufactures only a few batches of the specific substance per year and the technology is adjustable both for fully-automated processes as well as processes with manual operations.

COMPAS automatizace reworked the dedicated software of the original supplier of the Simatic PCS7 process control system to a flexible recipe-oriented batch system. The project was assigned for the need of a change in the originally fixed programmed algorithms for a specific product into a multi-product system with simultaneous control of several production lines. After an analysis, we prepared programs for the individual production steps in the phase logic in compliance with the ISA S88 standard. The COMES Batch module allows operators to flexibly control the technological process and the technologist or the process engineer can freely configure the production regulations (procedures) and set their parameters. The solution is CFR part 11 compliant including the electronic batch record (EBR) and the option to generate a production report according to a template defined by the Client and configured in the COMES Modeller module. The COMES Historian module is used for the collection, archiving and analysis of technological quantities and reports.

The project uses the attributes and functions of the MES system COMES. The Client uses the control system for fully automated and semi-automated production procedures as well as for production with a large number of manual operations.

The COMES application was later extended for material management in production and for communicating with ERP SAP (material consumption etc.).

Automation Project

  • Modernization of the pharmaceutical substances process control system (API)

Engineering and Deliveries

  • Analysis of production steps (phases)
  • Control system design
  • Batch control SW development
  • Assembly
  • Commissioning
  • HW delivery

Control System and MES Architecture

  • Process control system SIEMENS Simatic PCS7
  • Operator stations Exi with HMI WinCC
  • COMES Batch
  • COMES Modeller
  • COMES Historian