Sterilization process validation
Sterilization Process Validation
Moist Heat | Low-Temperature | Drying | Validation of Packaging Processes and Sterile Barrier Systems
Sterilization process test provided by SMP GmbH of Germany
バイオフィルム
緑膿菌バイオフィルムの培養およびバイオフィルムの不活化および除去手順の有効性の評価。
製造工程後の清浄度評価
インプラント等
R＆D
洗浄剤の開発段階の試験、テストソイルの開発等
Evaluation of steam sterilization process
SMP GmbH has introduced DIN EN 285 and DIN EN 13060 compliant steam sterilizers to carry out process validation of medical device sterilization by moist heat according to DIN EN 17665-1, quality assurance measures and process control of these. Equipped with technical equipment for.
Evaluation of cold sterilization process
SMP GmbH works with certified partners to validate sterilization processes for industrial and medical devices using ethylene oxide, hydrogen peroxide, formaldehyde, peracetic acid and more.
The newly developed sterilization method is also tested and evaluated by SMP GmbH according to ISO 14937.
Evaluation of various sterilization items
DIN EN ISO 11607 and the DGKH, DGSV, and AKI mutual guidelines for sterile packaging require the use of quality-guaranteed and validated processes and certified materials for the packaging of sterile medical devices.
Investigate the airtightness of packaging material leaks, the impact on successful sterilization, and the storability of sterile packages containing sterile containers and their filters, clear sterile pouches (hot-sealed foil paper pouches) and non-woven fabrics.