PromasCS

A complete solution for the integration of all production areas
below the ERP-Level. Modular as SCADA, PLS and MES
FDA 21 CFR Part 11 compliant.

General information

  • Ready-to-use, comprehensive, configurable and easy-to-use complete solution for the practically-oriented integration and automation of all production areas
  • Tailored to production processes in the pharmaceutical, chemical, cosmetics and food sectors
  • Scalable from a simple machine control to a complete MES system
  • Combines MES- & PLS and SCADA-Functions in one system
  • Electronic recording and documentation (ERB) according to FDA 21 CFR Part 11
  • Ready-to-use software base guarantees a minimalized validation effort in the project
  • Developed from the experience and requirements of production and practice
  • Since 2005 worldwide with more than 1500 installations in productive use

Modules of PromasCS

BD - Raw Material Tanks

  • Fully integrated raw material tank management for reception and provision of raw materials
  • Quantity registration at truck unloading
  • Administration and monitoring of expiry dates
  • Fully automated cleaning control via VisualProcess
  • Monitoring states of cleaning and sterilization

BD – Central Dosing System

  • Fully integrated dosing system for central raw material supply to compounding lines or dosing/tapping stations
  • Coordination / prioritization of dosing requests
  • Monitoring and locking in accordance to the expiry date
  • Automatic interlock of raw materials tanks

WD / WM – Warehouse - Weighing - Dispensing

  • Considers variations of active ingredients
  • Considers the amount of ingredients based on previous weighing’s
  • Expiry date monitoring / prioritization
  • System guided calibration or working instruction
  • Workflow guided weighing process

CT – Confirmation Terminal

  • Integration of existing systems into the paperless documentation – without modification of the existing automation
  • Electronic procedures instructs the operator step by step
  • Execution is documented within the electronic batch record (EBR)
  • Confirmation of raw material via barcode to ensure the right combination of batch and material

BATCH – Compounding

  • Fixed size or scalable batching for reproducible processes
  • Fully automated control of production and cleaning processes by self-created MBR (Master Batch Records) with VisualProcess
  • Interlocking equipment in relation to the product & cleaning matrix
  • Status of equipment can be monitored or set within the process
  • Gap free documentation of all production steps (EBR)

BT – Bulk Tanks

  • Management to store batches into solid / mobile bulk tanks
  • Administration, calculation and monitoring of expiry dates
  • Fully automated cleaning control via Visual Process
  • Monitoring states of cleaning and sterilization

FP – Filling / Packaging

  • Full integrated bulk supply to filling lines
  • Automatic locking with quality release and cleaning state
  • Definition and identification (Barcode) of packaging materials
  • Identification of equipment (Barcode) for  setting up filling lines
  • Administration of electronic instructions for setting up, filling  or cleaning filling lines

PM – Preventive Maintenance

  • Administration of periodic tasks or operating counter based task to manage recurring services, maintenance or support tasks
  • Increase of industrial safety, optimization of replacement intervals and reduction of unscheduled shutdowns
  • Saving time and cost of materials
  • System based documentation of the executed task

ME – Manufacturing Equipment

  • Fully integrated equipment management to set and monitor states of manufacturing equipment
  • Online evaluation of equipment status inside batching process
  • Definition of machine independent workflows
  • Supports Equipment Identification  (e.g. Barcode, RFID)

MBR (Master Batch Record)

Creation of customized cleaning and production processes with the very useful support of HMI-flow charts and the flow diagram display to visualize the process. The simulation & plausibility checks while creating processes safes time and reduces errors.

EBR (Electronic Batch Record)

According to FDA 21 CFR Part 11 the One-Click batch report collects all relevant information of the selected batch. At a glance it can be seen whether the batch has deviations.

Track & Trace

Easy to follow graphical material tracking – from delivery of raw materials and packaging materials up to filling.

PA – Process Analysis (Golden Batch)

Display of deviations according to a reference batch. Supports the CIP (Continuous Improvement Process): Critical point analysis and process optimization. Detection of tendencies.

IPC / Labor - Quality

Assistance in the analysis of weighed and added LOTs, IPCs and laboratory results.

EI – Enterprise Integration

Interfaces to ERP systems based on different standard technologies like e.g.:

  • XML/SOAP Webservices
  • B2MML
  • Datenbanken
  • OPC
  • RFC / MII
  • CSV / TXT

Customer requirements

Special wishes? We implement additional modules into your overall system and adapt existing modules to your needs. No wish should be left open!