ISO certified Ethylene Oxide (EtO) sterilisation services.
Created in 2006 Maurister, a subsidiary of NATEC Medical, offers outsourcing services for ethylene oxide sterilization of medical devices. Our processes have been streamlined to eliminate unnecessary delays and ensure substantial savings in time to market. We work with our clients, one on one, every step of the way to provide responsive, consistent and cost effective ethylene oxide sterilization.
It is accredited ISO 9001:2008, ISO 13485:2003 with ISO 11135-1:2007 certified by LNE/GMED.
The company’s main activities are:
- 4 europallet of simultaneous capacity,
- Pre-conditioning, gas exposure and dynamic desorption of the products in the same room to ensure sterilized lot integrity and homogeneity,
- On completion of the cycle, a series of vacuums and rinses with nitrogen and air are initiated, followed by dynamic desorption to remove a maximum of residual gas before transferring the pallets into the aeration room prior to shipment,
Ethylene Oxide Sterilisation
Ethylene Oxide (EtO) sterilization is a preferred and widely practiced method of sterilization. Being a cold process, it has low impact on physical characteristics of most products.
It is mainly 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.
Ethylene oxide characteristics: colorless gas, flammable and explosive. EtO is liquid at temperatures below 10.8oC.
Mode of action: Based on a gas diffusion process, EtO is capable of sterilizing and rendering products free of viable microorganisms. Sterility occurs when an EtO gas molecule reacts with critical molecules like microbial DNA or enzyme and destroys it. This reaction mechanism is called Alkylation.
The process requires the simultaneous control of four variable, but interdependent parameters:
- Gas concentration,
- Relative humidity
- Time of exposure.
EtO effectiveness depends on its ability to freely diffuse through a product and packaging. All products must be placed in breathable packaging that allows gas to penetrate the sterile barrier and reach all surfaces of the device or product.
EtO gas has a high penetrating power and passes through and sterilizes large packages of materials, bundles of cloth, and even certain plastics infiltrates packages as well as products themselves to kill microorganisms that are left during production or packaging processes.
Our EtO sterilization lines involve three different stages:
- Sterilization process
Salient features of EtO Service facility:
- Complete adherence to ISO 13485 quality systems and GMP
- EtO Sterilisation process is carried to ISO 11135: 2014 standards.
- Use of Biological Indicators as basis of product release.
- Periodic Validation of the sterilisation equipment is done to ensure consistent performance.
- Automatic sterilisation systems.
- Customised process parameters and customer-specific / Product specific Validation support is available from Natec’s team of experts.
The EtO process offers flexibility of choice, in terms of a wide range of compatible films and packaging material which is entirely customer-convenience-dependent:
The Sterilization facility is equipped with:
- A pre-conditioning room
- A sterilization chamber Sterox 04A (sterilization capacity: 10.3m3)
- An aeration chamber (capacity: 61.3m2, 153m3)
Packaging for sterilization:
Medical Devices and the like could be packed in multiple packaging:
- Primary: Pouches made from permeable films, like PE, PVC, PP, HMHD, etc., in which the individual device could be packed.
Medical grade peel-open pouches are also suitable.
- Secondary: Shelf-unit boxes.
- Tertiary: Cartons, corrugated boxes into which several individual boxes could be packed and shipped.
Bulk Products can be packed in: bags and cartons; typically, poly-lined-HDPE woven sacks / multi-ply craft paper bags / jute bags / cartons.
- Routine sterilization: as per customer requirements
- Sterilization validation: As efficacy of the sterilization process cannot be verified by visual inspection of the product, It has to be validated before use.
Natec Medical Ltd carries out periodic validation of medical devices and other healthcare products in accordance with the international standard ISO 11135 or as per the protocol for validation drawn out by customers.
Standard Quality System
Natec Medical is certified ISO 13485 – Medical Device
Safety and quality are non-negotiables in the medical devices industry. Regulatory requirements are increasingly stringent throughout every step of a product’s life cycle, including service and delivery. Natec wants to demonstrate their quality management processes and ensure best practice in everything they do.
ISO 13485, Medical devices – Quality management is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry.
Sterilizations are performed using ISO 11135: 2014 standard: ISO 11135:2014 specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both the industrial and health care facility settings.
Natec Quality system is accredited to ISO 13485:2016 with ISO 11135:2014 certified by LNE/GMED.
Guidelines ensuring process quality
Pre Conditioning Stage:
On time monitoring of temperature and humidity with calibrated data loggers
Then the load goes through a complex sterilization cycle.
Requirements of such a system are:
- Accurate temperature control.
- Availability of the control system.
- Accurate pressure and vacuum control.
- Easy displays of process phases
- Dedicated customer recipes.
- Auto batching release through tolerance tests.
- Security interlocks between actuators.
- Shut down strategies.
Once the cycle is started, the software monitor and show:
- The actual phase of sterilization
- All the key set points and tolerances as loaded by the recipe
- All the key process values for the auto batch release facility
- Control of vacuum and pressure.
- During execution of the sterilization process a batch report is generated. This report will include:
- Tolerance checks,
- Phase changes,
- Alarms, events and critical process values.
During the sterilization cycle if any abnormal condition occurs, the batch will be automatically stopped and condition(s) causing the stoppage will be identified.
When the batch is over an automatic print of the report can be performed. Batch logged files are also archived electronically for future review.
Batch logged files could be searched by the following:
- Batch ID
- Customer name
- Product type
- Start and stop time
Finally, products need to go through a degassing phase to remove any particle of EtO.
The batch load goes over a dwell time under a temperature controlled environment in our aeration chamber.