Blog

Medistri Announces its Second Sterilization Line in Hungary

27 March 2026
Back

(Download: Medistri Announces its Second Sterilization Line in Hungary in PDF by Medistri)

Expanding Sterilization Capacity in Hungary
Medistri is expanding its sterilization infrastructure with the addition of a second EO sterilization chamber at its facility in Székesfehérvár, Hungary. This expansion increases available capacity and strengthens supply chain reliability for healthcare manufacturers operating across development and industrial production phases.

Project Overview
The project represents 18 months of engineering, development, and preparation, supported by an investment of over $10 million.
More than 40 experts were involved on site during the chamber’s arrival and positioning. Installation and qualification phases will follow. This additional capacity reduces dependency on single-site availability and improves planning flexibility for sterilization scheduling.

Integrated Within Controlled Operations
The system is integrated with Medistri’s Gas Treatment System and operates under ISO 14001 environmental standards. Sterilization cycle development will follow ISO 13485 requirements, ensuring that processes are developed, controlled, and documented in line with regulatory expectations.

This integration supports repeatability, traceability, and compliance across both validation and routine sterilization activities.

Designed for Operational Requirements

  • Up to 16 pallets per cycle, 32 Double Stacked Pallets
  • 240 cm chamber height

These specifications allow the system to accommodate a wide range of product types, packaging configurations, and load structures. This is particularly relevant for products with complex geometries or multi-layer packaging, where process consistency and gas penetration must be carefully controlled.

Positioning Within Medistri’s Infrastructure
This is the second EO sterilization line in Hungary and the 8th sterilization chamber across Medistri’s infrastructure in Switzerland and Hungary.

The chamber is integrated within Medistri HU and connected to MyMedistri, enabling centralized visibility and coordination of orders across sites. This multi-site infrastructure allows for more flexible allocation of capacity depending on project requirements and timelines.

Operational Impact
The addition of this second chamber introduces tangible improvements in how sterilization capacity can be accessed and managed:

  • Increased access to sterilization capacity
  • Improved scheduling reliability
  • Reduced risk of bottlenecks during scale-up

This is particularly relevant for products transitioning from validation to routine production, where delays in sterilization can directly impact time-to-market and supply continuity.

Medistri is committed to work closely with our clients and partners needs and following strict sterilization guidelines to ensure the highest level of safety and effectiveness.

To learn more about our services, please visit our website at www.medistri.com or directly contact our team at contact@medistri.com.

– The Medistri Team

#Medistri

Frequently Asked Questions

1. What does the addition of a second EO sterilization chamber in Hungary represent?
The new chamber represents an expansion of sterilization capacity within Medistri’s infrastructure. It strengthens operational flexibility and supports growing demand across development and industrial production phases.

2. Why is increasing sterilization capacity important for healthcare manufacturers?
Increased capacity improves access to sterilization services and reduces the risk of delays during critical production stages. This is particularly important for products transitioning from validation to routine manufacturing, where timing directly impacts supply continuity.

3. How is the new sterilization chamber integrated into existing operations?
The chamber is connected to Medistri’s infrastructure and operates under established quality and environmental standards. Integration with centralized systems ensures consistent process control, traceability, and coordination across sites.

4. When will the new sterilization capacity become fully operational?
Following the arrival and positioning of the chamber, installation and qualification phases will be completed. Full operational readiness is achieved once validation confirms that the system performs consistently under defined conditions.

5. How does Medistri ensure reliable sterilization performance across its multi-site infrastructure?
Medistri applies standardized processes aligned with ISO requirements and integrates digital tools for centralized visibility and coordination. By combining infrastructure in Switzerland and Hungary, Medistri supports flexible capacity allocation, consistent performance, and reliable scheduling for its customers.

Back