Steri24 is a brand of CertoClav Sterilizer GmbH (CertoClav).
CertoClav is a company specialized in the production and trade of equipment for instrument reprocessing. CertoClav performs the organization of the mandatory initial validation as well as the recurring performance verification (revalidation) of washer-disinfectors.
Certified CertoClav Service Partners are specially trained in issues related to the validation of Steri24 equipment reprocessing processes and have received appropriate training in accordance with the guidelines of the German Society for Hospital Hygiene (DGKH), the German Society for Sterile Supply (DGSV) and the Robert Koch Institute (RKI). Validation and performance testing are carried out using the latest EDP programs and calibrated measurement technologies, with all process parameters being recorded. Data loggers from EBRO and Valitech, which comply with DIN EN ISO 15833:6.2, are used to record the process parameters. Chemical-biological processes are evaluated by an external laboratory to ensure better traceability.
We summarize and assess the results in a report that complies with the guidelines. Internal supervision ensures high-quality reporting.
Validation (installation, operation and performance qualification) as well as revalidation (renewed performance qualification) are carried out on the basis of the relevant parts of the DIN EN ISO 15883 standard as well as the current guidelines of the DGKH, DGSV and RKI for the validation and routine monitoring of automated cleaning and disinfection processes as well as the guidelines for steam sterilization and sealing processes. The respective current recommendations of the Commission for Hospital Hygiene and Infection Prevention (KRINKO) at the Robert Koch Institute (RKI) and the Federal Institute for Drugs and Medical Devices (BfArM) "Requirements for hygiene in the reprocessing of medical devices" are also taken into account.
|
Validation Small Steam Sterilizer
|
Initial validation
3 Test Batches
|
Revalidation
1 Test Batch
|
2 Year Validation Contract
|
|
Initial validation
3 Test Batches
|
Revalidation
1 Test Batch
|
|
Working time and travel within 50 km
|
✓
|
✓
|
✓
|
✓
|
|
Installation qualification (IQ)
|
✓
|
|
✓
|
|
|
Operational qualification / Process qualification (PQ)
|
✓
|
|
✓
|
|
|
Performance qualification (LQ)
(based on the guidelines of DGKH, DGSV and RKI)
- Conductivity determination of the water used
- Vacuum test with cold device
- Vapor Penetration Test / Bowie-Dick Test
- Test of temperature and pressure distribution with empty chamber
- Three tests of temperature and pressure distribution with usual operator loading (worst-case loading)
|
✓
|
✓
|
✓
|
✓
|
|
Fixed price for 2 years
|
|
|
|
✓
|
|
Creation of overall documentation / validation report
|
✓
|
✓
|
✓
|
✓
|
|
Travel costs for total distance over 50 km 0,35 €/km charged seperately
|
✓
|
✓
|
✓
|
✓
|
|
Price:
|
799,-
|
699,-
|
759,-
|
659,-
|
How is the validation contract concluded?
Immediately after ordering a maintenance contract, a CertoClav employee will contact you by e-mail to conclude the contract with you and clarify any open questions. Of course, you also have the possibility to contact us in advance at any time by phone or via the contact form.
