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
蒸気滅菌プロセス
医療機器の無菌性を検証するために使用される耐熱性Geobacillusstearothermophilus胞子の不活化効率は、内部の微生物学研究所で調査することが可能です。
滅菌後の乾燥等
滅菌プロセスの後、EN285およびEN868-8に準拠したパッケージ化された医療機器の乾燥のバリデーションが実施可能です。
低温滅菌プロセス
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過酸化水素滅菌
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エチレンオキサイド滅菌
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過酢酸滅菌
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ホルムアルデヒド滅菌
滅菌アイテム
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滅菌バック
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滅菌パウチ
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不織布
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滅菌コンテナ
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.
Standards and guidelines
DIN EN 17665-1
DIN EN 285
DIN EN 13060
ISO 14937
EN 868-8
ISO 11607
