RSD has developed a specific control system for industrial ethylene oxide sterilizers
The ETO sterilization proces
s requires a high level of safety to be optimal, safe and reliable for the personnel, the equipment, until the products that have to be sterilized.
Given the fact that the ethylene oxide gas is explosive, flammable and toxic properties, it is important to have an adequate and reliable control system.The advantages of our control system
RSD has developed its own control system based on SCADA technology and safety PLC
(the “brain” of the process).
The PLC is based on high-quality technology using Siemens/Allen Bradley brands, and SIL certified as per IEC 61508. To meet the safety requirements, the PLC and the SCADA are programmed in accordance with the HAZOP analysis and SIL definition for each project, always fulfilling the 21 CFR Part 11.The characteristics of our SCADA:
Use of Intouch, worldwide known as a most, to develop the SCADA according to each customers needs and fulfilling the GAMP 5 recommendations.
- The data of the sterilization cycles are saved in a database (including backups) and are protected by a password.
- The system manages the whole installation interlocks.
- Possibility to use an audit trail.
- 6 levels of users are proposed (operator, supervisor, director, maintenance, administrator and calibration) without users limitation. According to the user level some actions will be available or not.
- The whole software is validated.
- Flexible recipes.
- The inflammable diagram is automatically calculated for each new recipe to keep the process in the safe zone.
- Screen availability for calibration operations.
- Availability for manual / automatic modes to operate the process.
- Automatically generation of final reports.
- User friendly screens: synoptics, graphs, alarms, …
Strict validation protocols are executed:
- PLC certified according to SIL normative (IEC 61508) and installed in the main electrical cabinet.
- The SAFETY PLC has safe modules to control any critical inputs and outputs of the installation, and standard functions are configured for the non-critical operations
- Well-known brands: Siemens or Allen Bradley.
Strict quality protocols are performed, in order to ensure that the equipment and the operations are safe and reliable. Our control department takes care of the following protocols:
- SDS (Software and Design Specifications).
- SMDS (Software Module Design Specifications).
- SMTS (Software Module Test Specifications).
In addition, and thanks to its huge experience and skilled personnel, our control department defines the appropriate application of every single customized project.
The risk analysis of the project is taken into account on the software application, as well as the GAMP 5 and 21 FCR part 11 aspects. In such a way, the customer is ensured to buy a safe, efficient and reliable control system.
As manufacturer of ETO sterilization solutions
, we offer programming services as well as a validated control system for any ETO sterilization equipment
Come to see us in our booth Hall 12 / A68
and find out our bespoke services for pharmaceutical and medical device industries.