開課講師｜劉錦誠
課程資訊｜2025.10.18-4
報名方式｜線上報名
課程介紹｜
為確保組織庫中人體組織的保存效能與長期穩定性，所有接觸人體組織的操作程序皆應使用無菌耗材，以有效降低微生物污染風險。於執行耗材無菌確認與滅菌確效時，可依據國際標準（如 ISO 11737-1、ISO 11737-2 及 USP <71>）程序，結合實務經驗，建立一套科學且具重現性的驗證流程。
對關鍵耗材（如移植用敷料、導管、組織保存容器等），首先進行生物負荷量（Bioburden）測試，以掌握產品製程中可能存在的微生物負載，作為後續滅菌條件設計的依據。滅菌確效方面，依據耗材材質與用途選擇適當的滅菌方式（如環氧乙烷、輻射或濕熱），並執行滅菌劑量確認、生物指示劑選擇與分布測試，以確保達到無菌保證水準（SAL ≤ 10⁻⁶）。
對於無法進行最終滅菌的耗材，則採用無菌製程控制，並透過直接接種法進行無菌性驗證，搭配方法適用性試驗以排除抑菌性干擾。在實務操作中，依樣品特性設計適當的處理與培養條件，包含14天觀察期、雙培養基系統（TSB與FTM）應用，以及操作環境潔淨度的嚴格控管。
透過完整的滅菌確效與無菌試驗流程，SGS可協助建立符合TFDA等法規要求的驗證資料，確保耗材於人體組織應用中的安全性與有效性，進一步提升組織庫的保存品質與後續應用的可靠性。
To ensure the effectiveness and long-term stability of human tissue preservation in tissue banks, all procedures involving human tissue must utilize sterile consumables to minimize the risk of microbial contamination. During the sterility verification and sterilization validation of these consumables, SGS follows international standards such as ISO 11737-1, -2 and USP <71>, integrating practical experience to establish a scientific and reproducible validation process.
For critical consumables—such as graft dressings, catheters, and tissue storage containers—bioburden testing is first conducted to assess the microbial load introduced during manufacturing. This data serves as the basis for designing appropriate sterilization parameters. Depending on the material and intended use, suitable sterilization methods (e.g., ethylene oxide, radiation, or moist heat) are selected. Sterilization dose verification, biological indicator selection, and distribution studies are then performed to ensure a Sterility Assurance Level (SAL) of ≤ 10⁻⁶ is achieved.
For consumables that cannot undergo terminal sterilization, aseptic processing is implemented. Sterility testing is conducted using direct inoculation methods, along with method suitability testing to eliminate any antimicrobial interference.
In practice, sterility testing is performed on randomly sampled sterile consumables using standardized procedures. Appropriate handling and incubation conditions are established based on sample characteristics, including a 14-day observation period, dual-media systems (TSB and FTM), and strict control of cleanroom environments.
Through comprehensive sterilization validation and sterility testing processes, SGS supports to generate regulatory-compliant validation data that ensures the safety and effectiveness of consumables used in human tissue applications—enhancing the reliability of tissue bank preservation and subsequent application
講師介紹｜
