CTBS Sterilization Methods 5

Question 1

What is the purpose of the 'overkill' approach in sterilization validation?

Accepted Answer

Achieving at least 12-log reduction regardless of initial bioburden

Answer

The overkill approach targets a 12-log reduction of highly resistant organisms, providing a large safety margin independent of measured bioburden.

Question 2

Which regulatory agency requires tissue establishments to validate their sterilization processes and maintain process records?

Accepted Answer

FDA (21 CFR Part 1271)

Answer

The FDA, under 21 CFR Part 1271, requires tissue establishments to validate processing steps including sterilization and maintain comprehensive records.

Question 3

A tissue bank uses supercritical CO₂ (scCO₂) for sterilization. Which advantage does this method offer over gamma irradiation?

Accepted Answer

Preservation of sensitive biological molecules at low temperatures

Answer

scCO₂ operates at low temperatures and near-neutral conditions, preserving growth factors and collagen structure better than high-dose radiation.

Question 4

In radiation sterilization, what is the 'dose audit' conducted for?

Accepted Answer

Verifying that each product lot received a dose within the validated minimum and maximum range

Answer

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.

Question 5

What sterilization challenge is unique to prion-contaminated tissue and cannot be addressed by standard terminal sterilization methods?

Accepted Answer

Prions are resistant to all known chemical sterilants and standard radiation doses

Answer

Prions (misfolded proteins) are extraordinarily resistant to heat, radiation, and chemical sterilants, making donor screening the primary risk mitigation strategy.

(CTBS) Certified Tissue Bank Specialist Practice Test

(CTBS) Certified Tissue Bank Specialist Practice Test

CTBS Sterilization Methods 5