All projects of Suphatec complies with verification protocols in each phase.
Suphatec get inmersed from the study of the client’s URS to the Product Qualification (PQ), where the client must verify the efficiency between the installed equipment and the product and its reproducibility.
From the beginning, Suphatec takes the compromise in deeply studying the client’s needs and to apply all its experience, with the unique purpose of getting a succesful project.
After a personalised study and always keeping the specific client’s requirements, Suphatec will look for the best option, allways complying with environmental and security regulations, and under the indications established in UNE EN-1422:2014.
Once the URS have been approved, DQ documents are given to the client to be verified, along with an exhaustive risks analysis realized by competent and qualified staff, keeping in mind to look for the adaptation of the design in order to preserve the environment, and searching the most adecuate surrounding for the location of the installation.
All this will be planned by a Plan Manager in order to make the project and the installation a success.
During the manufacturing phase, laser tchnology cutting, bending, welding and assembly steps are carried out by working with each piece in detail, and always according to the requirements specified in the DQ document.
Our production processes are respectful with the Enviroment and Security and Safe regulation, by maximizing the correct waste management consequential of the manufacturing phase.
Our team is specialized and certified under the strict internal prodecures for welding, currently homologated by ENAC.
The manufacturing process is verified according to our Quality procedures, in which we realize, among other trials, Hydraulic pressure tests, vaccume resistivity tests, leak tests and quality measurement of the materials.
All the equipment will be pre-assembled in our facilities in order to realize the FAT (factory Acceptance test) in the presence of the customer. In this test, real operation conditions will be simulated. The test ends by realizing a complete sterilization cicle inside the empty chamber, and by verifying DQ specifications.
After the FAT is approved by the client, all the equipment will be fitted to be sent. Our specialized team will visit your facilities to arrange the installation and the starting up phases. Then, the staff in charge or the qualification phase will realize the SAT (Site Acceptance Test).
This final SAT proof is vital important to ensure the succesful qualification of the installation within the shortest possible time.
After the SAT begings the qualification phase, already planned to comply with the EN 1422:2014 and ISO 11135:2015 regulations. Suphatec has an especialized team in IQ and OQ execution of protocols.
The IQ (Installation Qualification) has as purpose to documentally verify that the equipment and the peripheral installations involved in the study process are manufactured and installed according to the original design. To prove that, every layout and P&ID plans are checked, every certification for each material used is revised as well as every maintenance plan. After the IQ approval, the protocol OQ (Operation Qualification) execution is carried out in order to verify the correct operational performance of the whole installation together. In this step are verified the calibration certificates for each measurement and registration instrument; it is also realized the sealing test and another test to verify the homogeneity of the temperature inside the sterilization chamber and also to thoroughly verify the control software, checking all the alarms and warnings of the system, obtaining all the information of the PC printed in a process report.
The OQ culminates with the test of three complete cycles inside the empty chamber to check the reproducibility of the cycle without incident.
As a previous step to the PQ phase, Suphatec take is as a norm to carry out a microbiological test, according to ISO 11135: 2015, which allows us to obtain a complete qualification and give way to the PQ.
Due to its extensive knowledge of sterilization of disposable products, Suphatec can advise the customer throughout the whole development of the PQ, helping to establish the ideal parameters for the sterilization cycle. The study of these parameters is vital in order to ensure the correct sterilization of the product or set of surgery, achieving an effective process. Suphatec will search to obtain the minimum exposure time to economize and to speed up the streamline the production chain, without any detriment in quality.
We help you, based on our extensive experience to perform an analysis of your product and design the best cycle, teaming with you.
In the last term, Suphatec offers specific and specialized formation given by highly qualified and experimented staff, after the installation at the client’s facilities, with the purpose to train the responsible team of the installation.
This training consists of a part focused on technical maintenance staff, another for the technical team responsible for production and a final part focused on the technical team responsible for validation and batch release.
This training is taught in the client’s own facilities, taking as an example the experience in real cases; and the planning is tailored to the needs of the client.