What is terminal sterilization validation?

In the world of medical devices, “sterilization” is defined as a “validated process used to render product free from viable microorganisms.” Terminal sterilization is defined as the “process whereby product is sterilized within its sterile barrier system.” (10) The terminal sterilization process is considered a …

How do you validate sterilization?

Verification activities used to monitor and control the sterilization process may include: bioburden testing, Biological Indicator (BI) testing, Chemical Indicator (CI) testing, process control record review, sterilant residue testing, and endotoxin testing.

What is a terminal sterilization?

2.54 Terminal sterilization: A process whereby a product is sterilized in its final container or packaging, which permits the measurement and evaluation of quantifiable microbial lethality.

What is difference between autoclave and terminal sterilizer?

A sterilizer is a general term for any piece of equipment that can sterilize. An autoclave falls under this category of equipment. Autoclaves use only steam to disinfect, while other sterilizers might use high pressure, irritation, chemicals, filtration or a combination of processes to sterilize a surface.

What is F0 in sterilization?

F0 value is used to determine the exposure time of material for sterilization at a particular temperature. F0 value is the time in minute for the specified temperature that gives the same thermal lethality as at 121 °C in one minute.

What is the easiest method of sterilization?

Filtration is the quickest way to sterilize solutions without heating. This method involves filtering with a pore size that is too small for microbes to pass through. Generally filters with a pore diameter of 0.2 um are used for the removal of bacteria.

What are the qualification requirements for terminal sterilization?

moist heat (autoclaving) is the most common process used for terminal sterilization product must not be affected by heat container/closure integrity must be established items being sterilised must contain water (if sealed) or material must allow for removal of air and penetration of steam for steam (moist heat) sterilization

How is terminal sterilization used to preserve biological function?

First, the product must be delivered to surgery in a sterile format. This is achieved either by aseptic processing, often employed to preserve biological function, or through terminal sterilization. Second, products are expected to be biocompatible, eliciting a minimal or acceptable inflammatory or immunological response.

What is the standard for validation of sterility?

Validation of sterility to sterility assurance levels of 1:106 is based on a statistical approach and may supplement or replace other methods such as using aseptic control of the production environment.

How is validation of moist heat sterilization performed?

The validation of moist heat sterilization processes may be performed using any of the three strategies outlined below. The approach selected should be appropriate and adequately supported.