Technical Services
Testing Capability
Our new Technical Services Division has extensive experience in the sterilisation and scientific support industry, which means we can offer a unique insight into the services required to meet the regulatory needs of the medical device industry.The services offered include the below:
Bioburden Analysis
Validation Protocols, execution and reports in accordance with ISO 11737
Product testing – Total Viable Counts via membrane filtration
Microbial Identification
Ethylene Oxide Analysis
Product batch release analysis for residue EtO
Validation Protocol, execution and reports in accordance with ISO 10993-7
Biological Indicator analysis—ISO 11135
Environmental Monitoring
Cleanroom monitoring—Settle and contact plates
Water TVC analysis
Disinfection Qualification
Working towards compliance with ISO 14644
Consultancy and Training
Microbiological Auditing
Bespoke customer training days
Project Management
Problem Solving
Cleaning and Disinfection Studies
Accelerated Aging
Endotoxin Detection via Chromogenic analysis
Our Technical Services team are always
available to discuss your specific testing requirements.
To contact us please click here
Ethylene Oxide Sterilisation
The treatment of medical devices by ethylene oxide (EtO) has been the principle method of sterilisation and has become industry standard.
Ethylene oxide processing involves products being exposed to the gas under vacuum in a sealed chamber. This is achieved in three phases:
Phase 1 Preconditioning
Products are placed in a preconditioning cell that is designed to raise the core temperature, typically to 40-50 degree centigrade and controlled humidity. This is the first step to optimise the sterilisation process efficiency.
Phase 2 Processing
Products are moved by automatic transfer into the main chamber where the ethylene oxide gas is introduced under vacuum for a predetermined dwell time. This validated process is designed to deliver the required sterility assurance level in accordance with ISO11135.
Phase 3 Heated Aeration
In the final stage, the product is moved by automatic transfer into a preheated cell which uses circulated air to remove residual ethylene oxide within the products.
Ethylene Oxide Sterilisation
As a leading provider of medical products including custom procedure packs, Unisurge International has the experience and capability of meeting your requirements for sterilisation processing.
Validation process studies
Technical consultancy services
Flexible solutions
Comprehensive laboratory services
Pallet cycle of 1–48 dedicated or mixed cycle process capability
Distribution and logistic network
“All at the most cost effective prices”
The Unisurge Vision
To offer each and every customer the same high standard of service whether incubating a simple environmental settle plate through to a complex Ethylene Oxide process validation.
