Sterilization Methods Flashcards
7 cards from real CTBS practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Sterilization Methods flashcards as text
What is the purpose of the 'overkill' approach in sterilization validation?
Answer: Achieving at least 12-log reduction regardless of initial bioburden
The overkill approach targets a 12-log reduction of highly resistant organisms, providing a large safety margin independent of measured bioburden.
Which regulatory agency requires tissue establishments to validate their sterilization processes and maintain process records?
Answer: FDA (21 CFR Part 1271)
The FDA, under 21 CFR Part 1271, requires tissue establishments to validate processing steps including sterilization and maintain comprehensive records.
A tissue bank uses supercritical CO₂ (scCO₂) for sterilization. Which advantage does this method offer over gamma irradiation?
Answer: Preservation of sensitive biological molecules at low temperatures
scCO₂ operates at low temperatures and near-neutral conditions, preserving growth factors and collagen structure better than high-dose radiation.
In radiation sterilization, what is the 'dose audit' conducted for?
Answer: Verifying that each product lot received a dose within the validated minimum and maximum range
A dose audit verifies that actual radiation doses received by each production lot fall within the minimum (sterility) and maximum (tissue integrity) validated dose limits.
What sterilization challenge is unique to prion-contaminated tissue and cannot be addressed by standard terminal sterilization methods?
Answer: Prions are resistant to all known chemical sterilants and standard radiation doses
Prions (misfolded proteins) are extraordinarily resistant to heat, radiation, and chemical sterilants, making donor screening the primary risk mitigation strategy.
When revalidating a sterilization process after a significant equipment change, which element is NOT required?
Answer: Full re-IQ of unaffected auxiliary systems
Revalidation focuses on the changed system; components unaffected by the change do not require re-Installation Qualification (IQ) unless the change could logically affect them.
Which sterilization method is considered MOST compatible with maintaining the viability of living cellular tissue grafts?
Answer: Aseptic processing without terminal sterilization
Living cellular grafts (e.g., viable bone marrow or certain skin grafts) cannot withstand terminal sterilization and require rigorous aseptic processing to preserve cell viability.