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Autoclave Validation Presentation

The document discusses autoclave validation. It begins by introducing autoclaves and their importance for sterilization in the pharmaceutical industry. It then outlines the aims of the presentation, which are to explain what an autoclave is, why they are used, how to validate one, and what to look for in an audit. The document provides details on how autoclaves work, the common types, factors that can impact sterilization, and defines key terms related to validation such as D-value and z-value. It also discusses the validation process, including establishing loading patterns through biological indicators and requalification frequency. Considerations for auditing an autoclave are provided.

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Ankur Bhatia
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1K views17 pages

Autoclave Validation Presentation

The document discusses autoclave validation. It begins by introducing autoclaves and their importance for sterilization in the pharmaceutical industry. It then outlines the aims of the presentation, which are to explain what an autoclave is, why they are used, how to validate one, and what to look for in an audit. The document provides details on how autoclaves work, the common types, factors that can impact sterilization, and defines key terms related to validation such as D-value and z-value. It also discusses the validation process, including establishing loading patterns through biological indicators and requalification frequency. Considerations for auditing an autoclave are provided.

Uploaded by

Ankur Bhatia
Copyright
© Attribution Non-Commercial (BY-NC)
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPT, PDF, TXT or read online on Scribd
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Autoclave Validation

Presented by Paul Yeatman BSc. Microbiologist

www.yeatmandesign.com.au

Introduction
Introduce self. Whats in it for you?
If we did not have autoclaves (or steam in place), life would be different for the pharmaceutical industry. Sterilisation would involve fire (or heat), chemicals, filtration or radiation. Microbiological media would have a shorter shelf life and there would be a greater risk of contamination. Autoclave means auto lock. Interesting info: The man credited with initiating the project which lead to the invention of the autoclave was Charles Chamberland. He worked with Louis Pasteur and also invented a vaccine for chicken cholera by accident.

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Presentation Aims/Outcomes
What is an autoclave Why we use autoclaves Identify the two main types used by us Detail how to validate an autoclave (including loading patterns) What to look for in an audit

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What is an Autoclave?
How do they work
In general In order to sterilize

Types common to us Why use an autoclave What may affect sterilization Steam penetration

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Hows Does An Autoclave Work?


Steam enters the chamber jacket, passes through an operating valve and enters the rear of the chamber behind a baffle plate. It flows forward and down through the chamber and the load, exiting at the front bottom. A pressure regulator maintains jacket and chamber pressure at a minimum of 15 psi, the pressure required for steam to reach 121C (250F). Overpressure protection is provided by a safety valve.

(from S.S. Block, Disinfection, Sterilization and Preservation, 2nd ed., Philadelphia, lea & Febiger, 1977)

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Hows Does An Autoclave Sterilize?


Steam held at elevated temperature and pressure for time is used to transfer moist heat. Steam has much greater heat transfer than boiling water. 80 calories to boil water, 540 calories to produce steam. Heat acts to denature proteins, effectively killing all cells present.
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Common Types
Production autoclave.
Usually large Loads one side, unloads the other Used to sterilize production equipment May be used to sterilize filled product (can have one opening) If faulty, potential impact on sterile core or batch disposition

Microbiology Laboratory Autoclave


May be large or small Usually loads and unloads from same side - Sterilized items do not unload directly into production environment Used to sterilize equipment as well as media. Also used to decontaminate materials before disposal

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Why Use Autoclaves?


Easiest way to sterilise large volumes of heat tolerant materials.
More effective than dry heat Not as messy as chemicals No need for radiation shielding

Once validated, simple indicators used to tell autoclaved and non autoclaved material apart the temp/time/pressure trace is used to confirm sterilization occurred.

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What may affect Sterilization


Sterilization is dependant on:
initial bioload microbe sensitivity to heat time A/C held at sterilizing temperature Ability of steam to penetrate items being sterilized Steam Penetration: As steam is used to transfer heat, tightly wrapped items, or long tubing may not be properly penetrated. Would represent worse case for validation

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What is Validation?
Validation shows that a process (or item of equipment) does what it is claimed to do. Why validate?
Need to show that sterile equipment is being taken into sterile core - do not want to contaminate production (which could lead to adulterated product) For micro testing (both bacteriological and Viable Environmental Monitoring), using sterile equipment helps reduce false positives. Need to show that decontamination cycles are effective

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How To Validate
The usual URS. IQ, OQ, PQ.
This discussion will focus on PQ.

IQ: does equipment meet the URS requirements? Is everything that was on the box, in the box? Is the unit installed properly. Are support programs in place for ongoing operation of A/C? OQ: does the A/C operate properly? Does the unit hold temp and pressure correctly? PQ: validation of autoclave cycles and loading patterns need to show sterilization.

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PQ of Autoclave
PQ: validation of autoclave cycles and loading patterns. What SAL do you need?
Need to show a 10-6 reduction of microbes (WWQC 11.1.10).

What is your starting bioload?


Spore strips have >106 CFU.

What is the microbes D value?


For Geobacillus stearothermophilus, this is around 1-1.5

Can use physical, chemical or biological indicators. As microbiologist, tend to use BIs (spore solution or impregnated strip). How does this all fit together?

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D-Value, Z-Value and Fo


What is D value?
refers to decimal reduction time - The time required at a certain temperature to kill 90% (eg reduce population by log 1) of the organisms being studied. Thus after an organism is reduced by 1 D, only 10% of the original organisms remain. Dependant on microbe and initial numbers. Eg D value of 1.5 = 1CFU left after 10 .5 mins.

What is Z value?
Refers to the temperature change required to produce a 1 log reduction in D value.

What is F0?

The number of minutes to kill a specified number of microbes with a Z value of 10oC at a temp of 121.5oC. Often confused with the time the chamber is held at elevated temperature and pressure and in practice is the same thing.

Overkill
Use many more microbes than would find on items typically autoclaved. Negates the need to test sample for bioload before running the cycle. Use a sterilisation time exceeding what is necessary to kill a large number of microbes. Negates the need to determine D value of microbe.

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Loading Patterns
Why important?
Sterilization relies on steam penetration. This may not occur in all cases Very important to show what you put in an autoclave comes out sterile When to use spore strips and when to use solutions

How to validate?
3x successful runs each loading pattern Place BI with each item in worse case spot. Place thermocouple next to BI, but not touching item.

How often re qualify?


Directive says annually 11.1.10 for terminal sterilisation. For Micro A/Cs depends on use. If used as part of sterility testingis used for EM samplingis used for decon cycles

Loading patterns should be adhered to.


Worse case validated can use less but not more equipment

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Audit Considerations
What to look for in an audit

When auditing, look at:


Was validation conducted? I would look mainly at PQ only if the unit is >15 years of age. If newer, the whole validation package. Also want to see a preventative maintenance program, SOPS, leak rate test data Are all expiry dates current? Cycle time is it sufficient for tested D values? Was validation equipment within calibration (pre and post use for thermocouples) Temperature traces for validation and most recent cycle Compare. Discrepancies? Are vacuum cycles used appropriately? Are the coolest and warmest positions clearly stated in the validation report? Examine largest (bulkiest) loading pattern. Was the validation acceptable. Is anything thing not listed on the loading pattern present in the autoclave? Is there enough room for steam to circulate through the chamber? Were there any deviations from the protocols. Are conclusions valid and justified? *Can the site show that the product that has been terminally sterilized has retained efficacy? *Could also check that the steam system is validated and that dye bathing (or some other integrity checking) occurs post sterilisation

*Not exactly on A/C audit scope.

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Conclusion
You now know:
What is an autoclave and how it works Why we use autoclaves What the main autoclaves are used by microbiologists in the pharmaceutical industry The basics behind autoclave validation What to look for in an audit

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Questions

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