Top Ten Tips for writing a Moist Heat Steriliser Performance Qualification (PQ) Protocol

ABSTRACT

The purpose of this technical brief is to provide guidance on the top ten points to consider when preparing a moist heat steriliser Performance Qualification (PQ) protocol.

Throughout the document reference has been made to relevant GMP and regulatory guidelines as well as ISO standards to show the origin of requirements. It is hoped that this document can be used to help validation personnel prepare great qualification protocols or think about improvements to existing protocol templates.

KEYWORDS: Acceptance Criteria, Annex 1 2022, Application of Science, Aseptic Process, Bioburden, Biological Indicator (BI), Check Sheets, Complete Kill, Container Fluid, Control Procedures, D Value, Data Correlation, Data Logging, Deviation, Direct Inoculation, Dry Heat Sterilisation, Efficacy, EMEA, Guideline for sterilisation of medicinal product, EN285 , Equilibrium Time, EU GMP Annex 15, European Pharmacopoeia, Sterilisation- Large Sterilisers, FDA, Hard Goods, Healthcare, HTM2010 ISO, ISO11138-3, ISO17665, Lethality, Load Items, Load Patterns, Log Reduction, Minimum Log Reduction, Moist Heat Steriliser Performance Qualification Protocol, Monitoring, Partial Survivors, Performance Qualification (PQ), Pharmaceutical Manufacturing, Population Resistance, Porous Load, Product Lifecycle, Product Solutions, Qualification Tests, Quality Assurance, Risk Management, Scientific Rationale, Scientifically Valid, Slow Steam, Steam-in-Place, Sterilisation, Sterilisation Cycle, Sterility Assurance Level (SAL), Sterility Assurance Objectives, Temperature Sensors, Thermal, User Requirement Specification (URS), Validation Protocols, Worst-Case Challenges.

Further related information can be found in the following associated briefs:

1. Airborne particle counting using LSAPC – Technical Briefing (PDF)
2. Cleanroom Classification – Technical Briefing (PDF)
3. Cleanroom Testing – Technical Briefing (PDF)
4. High Efficiency Air Filters – Technical Briefing (PDF)
5. Cleanroom Airflow Visualisation – Technical Briefing (PDF)
6. Liquid and Gas Filtration – Technical Briefing (PDF)

More detailed information and explanation regarding sterilisation and associated topics are included in the following training courses:

1. Pharmaceutical Sterilisation: Principles in Practice®
2. Cleanrooms: Principles in Practice®
3. Critical Factors for Sterile Product Manufacturing
4. Aseptic Processing: Principles in Practice®