SOP For Validation of Dry Heat Sterilizer

SOP For validation of Dry heat Sterilizer is described in this post which you can follow in the section of the Quality Assurance Department.

OBJECTIVE

The objectives of this process (Sterilization) validation study is to

Ensure and justify, through continuous process monitoring, and documentation, the precision and consistency in the output against the already established Acceptance Criteria.

Identify and solve the problem(s), if any, encountered during the process.

Establish confidence on existing sterilization operation.

Find ways and means to increase productivity and improve quality.

Assure that complete process is under control.

SCOPE

This protocol is intended to prove through documented evidence that the current process for sterilization as described in the relevant SOP is under control and capable of producing reproducible, reliable and consistent quality product.

To describe the phases of validation dealing with various stages of critical processes of sterilization, e.g., (depyrogenation, sterilization) to ensure that the sterilization process is up to the mark.

Validation Approach

Since the product is being manufactured for more than 10 years, therefore concurrent validation approach Will be adopted. Three consecutive commercial batches will be studied for the sterilization process.

Requirements

Procedure of the Sterilization of Glass Vials.

Challenge Test to check the performance of Sterilizer

Bio-Indicator Test (Geo-Bacillus-Stearothermophilus Spores)

Bacterial Endotoxin Test (BET)

PRECEDURE

The vials that can withstand temperature up-to 220°C are sterilized and Depyrogenated by dry heat in the hot air oven.

Wash the vials by washing machine and collect in S.S. trays in inverted position.

Shift the S.S. trays to the sterilization by placing them in the SS trolleys.

Temperature of the hot air oven is adjusted to 220°C and the time is adjusted to 2.5 hours for the sterilization and Depyrogenation cycle.

Fix the paper in the chart recorder and turn “ON” the oven. Information about the sterilization cycle is entered into the hot air oven record sheet.

Turn “OFF” the hot air sterilizer after the sterilization cycle is over.(Temperature Log Cards)

The activity in Sterilization is performed by Sterilization staff under the supervision of relevant section in-charge.

Activity should be in accordance with instructions mentioned in relevant Batch Manufacturing Record of the product and relevant Standard Operating Procedure of machines.

The Sterilization staff enters the activity performed in Batch Manufacturing Record and Logbook of relevant machines, the sterilized materials are then shifted to sterile area from the other door (that opens into sterile area) into the sterile area.

LOAD PATTERN DETERMINATION:

Description Max. Load Vials/tray Total vials /batch

BIOLOGICAL INDICATOR TEST

Challenge Test to check the performance of Sterilizer

For challenge test of dry heat oven following bio indicators are to be used.

Geo-Bacillus Stearothermophilus Spores.

Procedure:

Place bio indicator at different places in the hot air oven with the full load.

Run the sterilizer and after the completion of the sterilization cycle take out the bio indicators and transfer them to the microbiology lab for further processing.

Bacterial Endotoxin Test (BET)

Procedure

Dispense 100µl of the Endotoxin Standard in the number of Depyrogenated tubes required for validation.

Place the Endotoxin standard added tubes at different locations to check the Depyrogenation activity of the Hot Air Oven.

Run the load of Hot Air Oven for the required duration and after completion remove the tubes and add Lysate in each tube and incubate at 37°C for one hour.

Positive control is also run along with the test.

Identification of Responsible Personnel:
Name	Job Title	Signature
	Microbiologist
	Quality assurance inspector
	Deputy Manger production
	Maintenance Engineer.