How Medistri leverages its contract sterilization infrastructure to provide customised EO Sterilization Validation in 8 weeks.

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#MEDISTRI

Medistri continues to be at the forefront of regulatory requirements and quality proficiency.

Contract Sterilisation Company Medistri provides EO Sterilisation Validation Services to assist manufacturers in the development of a sterilization process that delivers the appropriate sterility assurance level and ensures repeatability for each product type developed.

Key points:

• Medistri’s specializes in ethylene oxide sterilization validations.

• Medistri’s customers are notified and regularly updated with the detailed outcomes of all stages of their validation project.

• Medistri’s Laboratory and combined resources & complete integration of expertise from our laboratory, sterilisation & quality team allow Medistri’s customers to fully integrate the EO Sterilisation Validation of their products within their existing workflow.

Prior to beginning routine ethylene oxide sterilisation, a product with a sterile claim needs to complete a validation process to ensure the Sterility Assurance Level claimed is met according to ISO 11135.

An Ethylene Oxide (EO) Sterilization Validation is designed to assist the manufacturer in the development of a sterilization process that delivers the appropriate sterility assurance level and ensures repeatability for each product type developed. All types of products, whether sterilized in-house or by a contract sterilizer, must be validated to ensure compliance with national and international standards. The requirements for an EO Sterilization Validation are outlined in ANSI/AAMI/ISO 11135. Various AAMI TIRs also offer guidance in meeting the requirements of the sterilization standard.

Medistri specializes in ethylene oxide sterilization validations,  thanks to their contract sterilization infrastructure, the company partner with its customers through the entire process from protocol generation to final report completion.

How Medistri’s EO Sterilisation Validation Flow works (in 8 weeks):

0 - Preparation of Validation protocol

All validation steps are documented in a protocol, which includes: :

• Objective

• Scope

• Normative references

• Definitions

• Responsibilities

• Equipment

• Procedures

• Acceptance criteria

1 - Preparation of Process Challenge Device

2 - Preparation of Bioburden Sample

3 - Preparation of Sterility Sample

4 - Preparation of Residual Sample

5 - Load Preparation

6 - Validation Cycles

• (1) Short-Cycles

• (4) Half-Cycles

• (2) Full-Cycles

7 - Final Validation Report

A final report is generated to:

• Document a review of the validation data

• Confirm the acceptability against the approved protocol for the sterilisation process

• Approve the process specification

Medistri continues its development in the EO sterilisation validation of pharmaceuticals and medical devices and continues to be at the forefront of regulatory requirements and quality proficiency.

Why customers benefit from Medistri’s Sterilisation Infrastructure:

• Sterilise Temperature-Sensitive products.

• Sterilise a wide range of products & materials.

• Allows for multiple packaging variations.

• Release your product directly after processing.

• Scalable solution for high growth companies.

• Fast.

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(Medistri is Europe’s largest independent contract sterilisation company. Medistri provides sterilisation & laboratory services for the global medical device & pharmaceutical companies. The company operates from Domdidier, Switzerland. )