ETO Sterilization

AurSterilization Mgmtum Healthcare is a medical device specialist in Ethylene Oxide (ETO) Sterilisation. We provide regulatory compliant and cost effective ETO sterilisation solutions for the healthcare industry. The treatment of medical devices by Ethylene Oxide (ETO) is the principal method of sterilisation in the healthcare industry. With technological advancements and the increasing regulatory demands, the requirements for a stable, reliable and compliant partner is critical. 

 

 

sterilzationAurum Healthcare provides the most reliable and cost-effective ETO Sterilisation services. Our state-of-art ETO Sterilisation facility is used to sterilize medical and pharmaceutical products that cannot support conventional high temperature steam sterilization – such as devices that incorporate electronic components, plastic packaging or plastic containers. ETO gas infiltrates packages as well as products to kill micro-organisms that are left during production or during the packaging processes.

 

sterilzation1Safety of personnel is an important issue due to the harmful effects of ETO on humans. Polluted areas need to be alarmed using gas detectors set up at different locations to monitor any leak. Our facility provides excellent visual monitoring and audio alarm systems to provide proactive management in the event of any leakages.

 

 

Dependable Service and

Reliable Expertise

 

Aurum Healthcare operates in accordance to the Good Manufacturing Practices. Our ETO facilities are certified to international standards such as the ISO9001 and the ISO13485. Our ETO Sterilisation process is operated in accordance and compliance to the ISO 11135-1 and we are audited by renowned British Standard Institute Group (BSI) for “Provision of Ethylene Oxide Sterilisation Services of Medical Products in accordance with EN ISO 11135-1:2007”.

 

As Asia’s leading sterilization specialist, we have more than 20 years’ experience in providing safe and effective sterilization and decontamination. We have expanded significantly and has invested in one of the state-of-the-art ETO Sterilisation facility at the heart of the most dynamic part of Malaysia’s Regional Economic Corridor, Iskandar, Johor.

 

Competitive Edge and Significant Benefits

 

  • HealthcareRegulatory Compliance with Full Certification
  • Flexible solutions to meet any volumes
  • Reliable and Trained Staff
  • Cost Effective
  • Service Quality Commitment
  • State-of-the-Art ETO Sterilisation facility
  • Unrivalled Technical & Regulatory expertise
  • Deep Domain Knowledge in Sterilisation Validation Protocols
  • Safe and Environmentally Friendly Facility
  • Affordable and most cost effective
  • Reliable Pick Up and Delivery Service

 

Environmentally Safe and

Highly Efficient Processes

ETO Control

  • Accurate Temperature Control
  • Availability of the Control System
  • Accurate Pressure and Vacuum Control
  • Easy Displays of Process Phases
  • Auto-Batching Release through Tolerance Tests
  • System Report on Validation Protocols
  • Security Interlocks between Actuators
  • Security Alarm and Shut Down Strategies
  • Audit Trail Facilities

 

 

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