Introduction
Pharmaceutical production requires high precision, reliability and compliance with strict hygiene standards. Cleanrooms used for drug production have limited temperature, humidity and contamination levels. In these conditions, the use of reliable and certified components is critical to ensure the smooth operation of the equipment.
Critical components
The Telemecanique GV2AE11 series is an important element in management and control systems in pharmaceutical facilities. These components function as sensors and measurement modules that ensure data accuracy and compliance with ISO 14644-1:2015 and EN 14644-1:2015 standards.
In addition, the following components are used in pharmaceutical production: the UNITEC-D E-Catalog series includes pressure sensors, thermostats, reducers and modular control systems. They ensure compliance with DSTU 3023-95, EN 60947-5-1:2016 and ISO 9001:2015.
Typical production plan
The pharmaceutical production line includes several stages: distribution of raw materials, mixing, filling, drying and packaging. GV2AE11 series components are used in temperature and humidity control systems. They are installed in control systems that ensure stable conditions in clean rooms.
Also used are ventilation control components that comply with EN 13779:2017 and ISO 14644-2:2015 standards. These systems ensure compliance with the requirements of the Hygienic Standard ISO 14644-1.
Failure modes and impact on downtime
Failure of components such as the GV2AE11 can cause temperature and humidity control in cleanrooms to fail. This can cause production line failure, resulting in product loss and room cleaning costs.
The average cost of downtime in the pharmaceutical industry is €3,500 per hour. This includes the cost of production shutdown, the cost of cleaning and restoring the systems.
Preventive and predictive maintenance
Preventive maintenance involves regular inspection and replacement of components before failure occurs. Predictive maintenance uses sensors and monitoring systems to identify potential problems.
The mean time between failures (MTBF) for the GV2AE11 series components is 50,000 hours. Predictive maintenance can increase MTBF to 70,000 hours, reduce repair costs and reduce the risk of failure.
Use case
In the pharmaceutical workshop, the temperature sensor installed on the cleanroom control system failed. This resulted in a temperature change of 2°C, which caused production to stop. The company used components from the UNITEC-D E-Catalog to replace the sensor and restore the system.
Repair costs were €1,200, and production recovery time was 4 hours. The use of GV2AE11 series components ensured compliance with ISO 14644-1 and EN 60947-5-1. standards
Management of spare parts
Effective spare parts management in pharmaceutical manufacturing requires analysis of component usage and cost forecasting. The use of inventory management systems (WMS) allows you to reduce storage costs and ensure the availability of components.
It is recommended to have a stock of GV2AE11 series components for 30% of the total usage. This will ensure smooth operation of production and reduce production costs.
Conclusion and call to action
The use of Telemecanique GV2AE11 series components in pharmaceutical production ensures high accuracy, reliability and compliance with standards. Compliance with DSTU, EN and ISO standards guarantees product safety and quality.
For more information on GV2AE11 series components and other pharmaceutical products, visit the UNITEC-D E-Catalog.
Sources
- ISO 14644-1:2015 - Classification of clean rooms
- EN 14644-1:2015 - Requirements for clean rooms
- DSTU 3023-95 - Electrical equipment standards
- EN 60947-5-1:2016 - Standards for sensors
- ISO 9001:2015 - Quality standards
