Validation of autoclaves - autoclave loads and cycles

Sample Document

Table of Content

  1. Purpose
  2. Scope
  3. Responsibilities
  4. Validation
  5. Quality Assurance
  6. Quality Control
  7. Engineering
  8. Production / Development
  9. Definitions
  10. Safety And Process Specific Information
  11. Safety
  12. Process
  13. F0 Calculation Theory and Data Analysis
  14. Procedure – Validation of An Autoclave and/or Autoclave Installation
  15. Prerequisites
  16. Equipment Verification (EV) Protocol
  17. Acceptance Criteria
  18. Procedure – autoclave and load cycle validation – preparation
  19. Documentation
  20. Cycle and Load Performance Review
  21. Cycle Development and Assessment
  22. Instrumentation Calibration Requirements and Data-Logger Preparation
  23. Number of Thermocouples
  24. Pressure Transmitters
  25. Autoclave load and cycle validation – acceptance criteria
  26. Dry Cycle Acceptance Criteria (Dry Porous Loads – without liquid content)
  27. Wet Cycle Acceptance Criteria (Liquid Containing Loads)
  28. Procedure – autoclave and load cycle evaluation – empty chamber performance check
  29. Procedure – autoclave and load cycle evaluation – execution
  30. Dry Cycles (Dry Porous Loads)
  31. Wet Cycles (Liquid Loads)
  32. Procedure – autoclave and load cycle evaluation – reporting
  33. Deviation Reports
  34. Conditional Release
  35. Cycle Reporting
  36. Summary Reporting
  37. Re-validation approach
  38. Production use of autoclaves during “tag-out” for validation
  39. Usage conditions

Sample Content

A.   PURPOSE

This standard operating procedure outlines the validation approach for autoclaves, autoclave loads and autoclave cycles a GMP site.

B.   SCOPE

This document describes the validation and re-validation approach to sterilisation activities conducted utilising autoclaves a GMP site.

C.   RESPONSIBILITIES

The department responsibilities in regards to validation of the autoclave, cycle and loads are outlined below.

  • Validation
    • Prepare, approve and execute protocols in accordance with this SOP.
    • Develop validation program and re-validation plans.
    • Review and approve validation test results.
    • Ensure only fully validated load configurations and cycle parameters are documented in the relevant operational SOPs.
  • Quality Assurance
    • Ensure compliance with this SOP with specific regard to Installation, Operational and Performance Qualification and Re-validation activities.
    • Ensure compliance with current corporate policy and regulatory requirements.
    • Ensure operational compliance to local Department of Agriculture requirements.
  • Quality Control
    • Review and approve validation protocols and test documentation.
    • Provide access to equipment and resources to allow for validation work to be carried out.
    • To ensure SOPs contain only current and accurate load patterns and associated autoclave cycles
    • To generate change controls for autoclave cycle/load additions/changes
    • Perform Biological Indicator (BI) analysis.
  • Engineering
    • Review and approve validation protocols and test documentation.
    • Ensure compliance with this SOP with specific regards to Maintenance, Calibration and Change Controls.
    • Ensure that autoclave equipment utilities and sensors are compliant with operating limits
    • Ensure autoclave cycle programs, PLCs and chart recorders are up to date, correct and operational
  • Production / Development
    • Review and approve validation protocols and test documentation
    • Provide access to equipment and resources to allow for validation work to be carried out
    • To ensure SOPs contain only current and accurate load patterns and associated autoclave cycles
    • To generate change controls for autoclave cycle/load additions/changes

D.  DEFINITIONS

  • BI – a biological indicator is a spore strip/ ampoule or inoculated item with a population of spores of no less than 106 Geobacillus stearothermophilus with known D and Z values.
  • Control BI – A BI of the same lot as those used for testing, but one that was not exposed to the sterilisation cycle.
  • Chamber – The part of the steriliser that the load is placed in.
  • Load – A specified combination of the type and number of items and their distribution within the autoclave chamber.
  • Autoclave Cycle: An operating program which defines the phases, critical parameters and conditions utilised for conducting sterilisation of a given load configuration.
  • Autoclave Phase: A stage in operation of an autoclave cycle. e.g. holding of the chamber at a vacuum state for 2 minutes.
  • Conditional Approval – Approval to resume production use of an autoclave prior to the final re-qualification report approval based on specified requirements and conditions.
  • Equilibration Time – The period that elapses between the attainment of the sterilisation temperature of 121°C in the sterile chamber and the attainment of the sterilisation temperature at all test points within the load.
  • Exposure Time – An equipment based parameter that is the time at which the autoclave is held at the desired operating temperature.
  • D-value – The D value is defined as the time in minutes at a given set of parameters required to reduce the population of a biological indicator (BI) by one log.
  • F0 Value – Calculated sterilisation time (equivalency value) at the observed temperature and time equivalent to the sterilisation time at the base temperature at 121°C. The calculation is as follows:

F0 = ∆t∑10(T-121)/z

Where T is the actual temperature in oC at time (t)

∆t is the measurement interval (minutes)

  • Z value is defined as the number of degrees of temperature change required for a one log or a 90% change in the D-value (°C)
  • Heat Penetration (study): Refers to the measurement of the temperature of the load during evaluation of an autoclave cycle (for the given load)
  • Heat Distribution (study): Refers to the measurement of the temperature of the autoclave chamber during operation of a load containing autoclave cycle evaluation.
  • Holding Time -Period for which the temperature at all points within the steriliser is held within the sterilisation temperature band.
  • Liquid Load – The sterilisation of liquids in containers.
  • Porous Load – A load which requires the air to be removed from the equipment or product for effective sterilisation to occur.
  • Stabilisation Period – Initial Period up to and after the attainment of the chamber temperature set point that a controller may require before achieving steady state temperature control and uniformity.
  • Sterilisation Band – This is defined as the acceptable sterilisation temperature fluctuation range.
  • Department of Agriculture – Regulatory body responsible for management of quarantine regulations

E.   SAFETY AND PROCESS SPECIFIC INFORMATION

F.   F0 CALCULATION THEORY AND DATA ANALYSIS

G.  PROCEDURE – VALIDATION OF AN AUTOCLAVE AND/OR AUTOCLAVE INSTALLATION

H.  PROCEDURE – AUTOCLAVE AND LOAD CYCLE VALIDATION – PREPARATION

I.     AUTOCLAVE LOAD AND CYCLE VALIDATION – ACCEPTANCE CRITERIA

J.    PROCEDURE – AUTOCLAVE AND LOAD CYCLE EVALUATION – EMPTY CHAMBER PERFORMANCE CHECK

K.   PROCEDURE – AUTOCLAVE AND LOAD CYCLE EVALUATION – EXECUTION

L.    PROCEDURE – AUTOCLAVE AND LOAD CYCLE EVALUATION – REPORTING

M. RE-VALIDATION APPROACH –

N.  PRODUCTION USE OF AUTOCLAVES DURING “TAG-OUT” FOR VALIDATION

Sample Document