Validation of Moist Heat Sterilizer by its best method

Validation of Moist Heat Sterilizer; Purpose

To validate Moist Heat Sterilizer by Biological Indicator.

Validation of Moist Heat Sterilizer; Scope

This SOP applies for validation of Moist Heat Sterilizer in Sterile Processing area and Microbiology Laboratory at XX Pharmaceuticals Limited.

Definitions/Abbreviation

Validation

Validation is the process to establish documented evidence, which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications & quality attributes.

Biological Indicator

Biological Indicator is a defined preparation of viable spores made from Bacillus stearothermophillus & Bacillus subtilis & has a particular spore count per indicator of not less than 10⁴ and not more than 10⁹ spores which is used to monitor the efficacy of sterilization process.

• BI: Biological Indicator
• ATCC: American Type Culture Collection
• NCTC: National Type Culture Collection

Responsibilities

The roles and responsibility is as follows

Executive/ Senior Executive, Microbiology

Preservation of Biological Indicator, perform Moist Heat Sterilizer validation and report preparation.

Manager, Microbiology

Ensure Moist Heat Sterilizer Validation, documentation and application of sound technical information.

Head of Quality Assurance

Take initiative to Approval of this SOP

Procedure

Instructions

• Biological Indicator is usually non-pathogenic but all microorganisms are unscrupulous pathogen. So before handling it, wear protective items such as sterile wear sterile latex free gloves, laboratory coat & eye protection (if required).
• Discard all items after autoclave.
• At the end of work, leave all used items at designated containers safely.
• Make sure that all personal ornaments, cell phone are left to prevent unauthorized contamination, before entrance into the test room.

Handling of Biological Indicator

• Check expiry date of Biological Indicator (Bacillus stearothermophilus, ATCC-7953).
• Discard it after autoclaving if expiry date is exceeded
• Observe Certificate of Analysis of Biological Indicator.
• Ensure that the paper strip is fully intact.
• Preserve always BI at 25⁰C or as per manufacturer instructions.
• Do not preserve it at freezer.

Validation Frequency

Perform the validation once in six months interval.

Exposure of Indicator:

• Carry out validation as per test schedule.
• Map the chamber with most critical area for exposure of Biological Indicator.
• Define location & label on each Biological Indicator.
• Place spore strip of Biological Indicator of Bacillus stearothermophilus (ATCC 7953) at 8 points as per chamber mapping, table-1.
• Complete sterilization cycle along with product to be sterilized or empty sterilizer.

Analysis of Indicator

After sterilization, Cut cover paper aseptically & transfer paper strip into separate test tube containing 9 ml of sterile Tryptone Soya Broth including a positive control & negative control.

 

 

Incubation of Indicator:

Incubate all strips including positive & negative control at [50 to 55]⁰C for 7 days.

Interpretation of Result

Observe indicator strip after 7 days for growth. Turbidity of culture media indicates positive growth. Sterilizer is valid if the following criteria are met:

• No growth found in exposed all indicator strip
• No growth found in negative control indicator strip.
• Growth found in positive control indicator strip.

Repeat validation if following result is found

• Growth found in one or more than one exposed indicator strip
• Growth found in negative control indicator strip.
• No growth found in positive control strip.

The sterilizer is invalid if the following result are found

• Growth found in one or more than one exposed indicator strip
• No growth found in negative control indicator strip.
• Growth found in positive control indicator strip.

Correction Action:

• If growth found in anyone indicator strip in repeat test, inform test result to concerned department and Engineering Department for corrective action.
• After corrective action, Engineering Department shall inform to Microbiology Lab. for the repeat test.
• Microbiology Section shall perform the complete test.

Report Preparation

Report the validation in Moist Heat Sterilizer Validation Report, Annexure-I.

Download Annexure Here:

Annexure I Moist Heat Sterilizer Validation Report