Pharmaceutical Industry

Automation of support systems

Automation of ventilation and air conditioning (HVAC)so called BMS solutions, solutions for control of clean rooms so called EMS solutions, solutions for production and distribution media (hot and cold water, purified and deionized water, etc..) solutions FOR control of energy consumption.

All Metronik solutions follow the recommendations of GMP and GEP and are made in accordance with GAMP 5 and according to customer needs ensure compliance with 21 CFR Part 11.

Metronik solutions are based on industrial automation equipment (SCADA iFix, GE Intelligent Platform or OPTO 22 PLC) and are therefore very reliable, open and flexible and provide high functionality.

Solutions for process control

Solutions for complex batch-oriented chemical processes in the segment of substances production, which requires a compromise between a high level of automation and flexibility of the process. To these challenges Metronik approaches with dedicated tools for the batch control (Proficy Batch Execution)which supports the development of recipes and implementation of the process in accordance with S88 standard.

Metronik offers also solutions for less demanding processes in the production segment of substances, and more demanding pharmaceutical technologies segment (a sterile solution preparing process, production of ampoules and pellets), where the complexness of process doesn’t require use of dedicated tools for batch management. For such cases Metronik has developed custom tools to support the recipe control process in compliance with standard S88.

Compliance with the pharmaceutical regulatory in such process control solutions is crucial, therefore Metronik solutions strictly follow the recommendations of GMP and are made in accordance with GAMP5, and normally also ensure compliance with 21 CFR Part 11.

Solutions for production managment

Metronik MES solution (Manufacturing Execution System) MePIS-LS(Life Science) includes following features:

Creation of master recipes (MBR),

Implementation of recipes and production management in accordance with the work flow (which stands for Workflow),

Control of material flow,

Creating of electronic records in production (EBR).

MePIS-LS follows the recommendation of GMP and can be implemented in segments (selected manufacturing Islands), or horizontally across the entire production. One of the important Metronik solutions is also efficiency control module (OEE), which significantly contributes to reducing of production shut downs and higher utilization of equipment. One of the important features of Metronik efficiency solution segment is using real time data from production and powerful analytics to support managing decisions. A set of our IT solutions for production support also include solutions for control and analysis of GMP relevant parameters.

Pharmaceutical Industry

ADDED VALUE FOR PHARMACEUTICAL COMPANIES:

Increased reliability of production processes
Secure energy supply for production
Increased repeatability and process efficiency
Use of pharmaceutical standards and recommendations (GAMP 5, 21 CFR Part 11)
Flexible recipe system
Implementation of paperless production
Reduced number of production shut downs
Efficient use of production resources
Optimal use of energy and lower management costs
Validated Solutions

OUR PARTNERS:

Metronik solutions are implemented in all bigger Slovenian pharmaceutical companies and abroad: Krka, Lek-Sandoz, Hemofarm-Stada, Pliva-Teva, Belupo, Zdravlje-Actavis, Bosnalijek, Pharmaswiss, Pharma nova.