EO sterilisation machines and equipment
Sterilisation is the most crucial step in any medical and surgical device production process. Over the years, the use of a gas such as ethylene oxide has become paramount, as it performs exceptionally well even at low temperatures. This makes it perfect for the sterilisation of single-use medical products with plastic or heat-sensitive components and products used in the chemical, pharmaceutical and medical sectors in general.
We design and manufacture two types of autoclaves: atmospheric (ATM Series) and pressurised (P Series); both can operate individually or in innovative “in-line” systems.
EO IN-LINE STERILISATION SYSTEM
Any process involving sterilisation using a gas such as ethylene oxide also requires:
A pre-conditioning chamber essential for preparing goods before processing;
A degassing chamber used for the disposal of post-sterilisation gas residues.
This is where Ser.Com’s ingenuity comes into play by combining all three steps in one sequence: EO in-line sterilisation is born. The pre-conditioning chamber, the sterilising autoclave and the degassing chamber are thus combined in a continuous chain, interconnected by fully automated internal and intermediate handling systems.
By means of software, which also communicates with pre-existing management systems, an operator can handle entire pallets of products by feeding them directly into the pre-conditioning system and can monitor every aspect, ensuring that process settings are maintained.
The combination of these steps has led to results that not only make the entire job more efficient but also ensure that operators can perform their tasks in complete safety.
Download the full layout of an inline sterilisation plant in PDF.
Phase 1
PRE-CONDITIONING
The packaged goods enter the chamber and are prepared for sterilisation according to pre-set temperature and relative humidity levels. Once the aforementioned levels have been reached, the second door is opened, and the pallets are fed into the autoclave.
Phase 2
STERILISATION
Using the internal handling system, the goods enter the dual-door autoclave, which, once sealed, proceeds to load the mixture of ethylene oxide and CO2, which sterilises any bacteria in the product.
Phase 3
DEGASSING
At the end of the software-controlled cycle, the third step starts in the degassing chamber; the air is treated and sent to the blast chiller, which will lower the residual gas level to a minimum.
Phase 4
STORAGE
After degassing, the pallets are automatically positioned in the final part of the line, called the unloading bay, ready to be picked up and stored again as finished goods.
ATM Series sterilisation autoclaves
Ethylene oxide sterilisation autoclaves operating under atmospheric pressure are designed and manufactured to optimise the combined use of essential sterilisation factors, such as the concentration of the EO gas mixture, the material exposure time, the temperature and the relative humidity in the chamber. These vacuum machines operate at atmospheric pressure levels (not suitable for pressurised operation) and are not required to comply with PED.
To optimise the process, we equip our machines with cycle handling equipment and control software that ensure total autoclave automation and monitoring, reading and logging of all data.
Each chamber incorporates an automatic load handling system, an essential function that ensures the sterilisation of entire pallets without having to handle them and with complete operator safety.
- Internal walls lined with AISI304 steel;
- Operating pressure: vacuum/atmospheric;
- Door with manual or motorised opening;
- Pneumatic release and securement system;
- Internal pallet handling system;
- Electrical panels;
- Supervision and control software (PLC and SCADA);
- Insulation layer;
- Parallelepiped shape;
- Fully customisable volume and dimensions.
The equipment complies with European standards UNI EN ISO 11135:2014 – Ethylene oxide: Requirements for the development, validation and routine control of a sterilisation process for medical devices; 2014/35/EC (Low Voltage); 2014/30/EC (EMC); 2006/42/EC (MD).
They do not need to be assessed for compliance with the 2014/68/EU PED Directive because they are non-pressurised vessels.
P Series sterilisation autoclaves
The P Series autoclaves are pressurised chambers used for sterilisation using an ethylene oxide mixture. They are constructed in AISI 304 steel and are equipped with an airtight sliding door.
The closure system has been designed to be easy to manoeuvre, and, for special goods handling requirements, a second door can be fitted that can open right or left in line with the chamber’s orientation.
The advantage of pressurised autoclaves is that they favour a greater speed of penetration of the sterilising gas into the packaging, thus enabling a greater number of sterilisation cycles to be performed.
- Operating pressure: vacuum/+2 bar (relative);
- Internal plating in AISI304 steel;
- Hermetically sealed sliding door;
- Possibility of adding a second door;
- Internal pallet handling system;
- CE and PED certification;
- Electrical panels;
- Supervision and control software (PLC and SCADA);
- Insulation layer;
- Parallelepiped shape.
The equipment complies with European standards UNI EN ISO 11135:2014 – Ethylene oxide: Requirements for the development, validation and routine control of a sterilisation process for medical devices; 2014/35/EC (Low Voltage); 2014/30/EC (EMC); 2006/42/EC (MD); and 2014/68/UE (PED).
The P-Series autoclaves are pressure vessels that must comply with a verified and approved design procedure according to current regulations. Hence, Ser.com offers a range of machines that can be chosen according to production requirements.
SCOPE OF APPLICATION
Both ATM Series and P Series autoclaves are widely used in the following applications:
