How do you validate sterilization process?

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 autoclave principle?

Autoclave Principle/ Working The autoclave works on the principle of moist heat sterilization where steam under pressure is used to sterilize the material present inside the chamber. The high pressure increases the boiling point of water and thus helps achieve a higher temperature for sterilization.

What is Sterilisation validation?

A radiation sterilization validation determines the appropriate radiation sterilization dose for a product that requires a sterile label claim. If a sterile label claim is required and the sterilization method will be radiation, a validation is required to determine the appropriate sterilization dose.

What are the FDA recommended methods for sterilization?

Established sterilization methods, which FDA believes “have a long history of safe and effective use,” include dry heat, moist heat or steam, radiation, and ethylene oxide in a fixed, rigid chamber.

What is DF and z-value?

The D-value of an organism is the time required in a given medium, at a given temperature, for a ten-fold reduction in the number of organisms. While the D-value gives the time needed at a certain temperature to kill 90% of the organisms, the z-value relates the resistance of an organism to differing temperatures.

What is Z-value in autoclave?

The z-value is defined as the temperature coefficient of microbial destruction, i.e. as the number of degrees of temperature which causes a 10-fold variation of D (or, more generally, of the sterilization rate).

What is the autoclave validation requirement?

Autoclave Validation Requirements. Autoclave Validation / Qualification is mandatory for all machines used for biological sterilization, in the biomedical and pharmaceutical industries within the FDA, MHRA, WHO & EU controlled areas. Sterilization can be accomplished by either physical or chemical means.

What is a qualified sterilization process in an autoclave?

Sterilization process in the pharmaceutical industry in an autoclave will be considered qualified for consistent and reliable performance (validated) on successful completion of the following tests– • Bowie-Dick Test for steam penetration (3 trails).

What is autoclave?

Autoclave (Steam Sterilizer) Validation Autoclave is used for sterilization of various articles in microbiology laboratory as well in sterile manufacturing.

How to use the autoclave data logger for sterilization?

4.0 Operate the steam sterilizer and also start the autoclave data logger to record actual temperature within the sterilization chamber with respect to time. 5.0 When the sterilization cycle completes, 1) Collect printout of the sterilizer and preserve as Annexure. 2) Download the data-analysis and printing.