Process Validation

Validation and Compliance Services for EO Sterilization of Medical Devices and In-vitro Diagnostics

European CE and US FDA regulations require thorough validation documentation for medical devices and in-vitro diagnostics labelled 'sterile'. For Manufacturers wishing to operate their own ETO sterilizers we provide comprehensive service including installation qualification, cycle development, process validation, product testing and regulatory compliance documentation. Manufacturers that cooperate with contract sterilizing companies can be supported by a full package of process validation and product testing including regulatory submissions.

Validation Services for Ethylene Oxide Sterilization

Our validation services guarantee compliance with latest applicable international sterilization standards as well as with international regulatory requirements. Our validation services include:

Document Preparation

	Validation master plan preparation and review
	IQ/OQ/PQ protocols and summary reports
	Standard operating
	Calibration procedures
	Acceptance testing protocols

Validation Execution

	System commissioning
	Performance qualification
	Process validation (physical)
	Microbiological qualification
	Summary reports

Customer Support Services

	Project management
	Product testing
	Microbiological tests
	Audit of sterilization process and testing labs
	Cycle development
	Cycle optimization tests

Validation Services

Sterilization validation is based on product specifications and customer needs. Our experienced validation team of engineers and scientists is capable to develop a complete sterilization validation package which provides assurance that your system or process is under control. We develop sterilization validation protocols according to AAMI/ANSI/ISO 11135 and EN 550 standards thus guaranteeing acceptance for CE or FDA submission. Our validation program includes e.g.:

	ETO/EG/ECH residual testing
	Microbiological testing
	Bioburden
	Sterility testing
	Packaging validation

We work closely with our customers to customize our services to your specific needs and to guarantee maximum flexibility and fastest access to the regulated health care market.