Number of temperature mapping sensor in autocalve validation/ qualification

Validation
1

can you provide me the refernce details for using no. of the probes for temperature mapping in autoclave (Staem Sterilizer) and tunnel (Dry Heat Sterilizer)

2

HTM 2010 and PDA Technical Report No. 1 and 48

However for your further reading:
Ph. Eur. 6
• 5.1.1, Methods of Preparation of Sterile Products
• 5.1.2, Biological Indicators of Sterilisation
• 5.1.5, Application of the F0 Concept to Steam Sterilisation of Aqueous Preparations
USP 29
• <55> Biological Indicators - Resistance Performance Tests
• <1035> Biological Indicators for Sterilisation
• <1211> Sterilization and Sterility Assurance of Compendial Articles
GMP-Regulations
• EU-GMP-Guideline Part 1, Annexes 1, 15 & 17
• Code of Federal Regulations (CFR) 21, Part 210: Current Good Manufacturing Practice in Manufacturing, Processing, Packing of Holding of Drugs; General
• 21 CFR Part 211: Current Good Manufacturing Practice for finished Pharmaceuticals
• 21 CFR Part 11: Electronic Records; Electronic Signatures
FDA Guidance for Industry
• Sterile Drug Products Produced by Aseptic Processing
• Documentation for Sterilisation Process Validation European Medicines Agency (EMEA)
• CPMP/QWP/054/98 Corr., Decision Trees for the Selection of Sterilisation Methods
• CPMP/QWP/3015/99, Note for Guidance on Parametric Release

GAMP
• The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture, Vol. 4
• PDA Technical Reports
• PDA Technical Report No. 1, Validation of Steam Sterilisation Cycles
• HTM (Health Technical Memorandum)
• 2010; Sterilisation; Part 3: Validation and verification; NHS Estates; Department of Health; UK
• International, European and National Standards (ISO / EN /DIN) / Others
• EN 285, Sterilisation, Steam Sterilisation, Large Sterilisers
• DIN 58950, Sterilisation , Steam Sterilisers for Pharmaceutical Products
• EN 554, Sterilisation of Medical Devices

and also:

3

Dear All,

If I have moist heat sterilizers - lab autoclave of 200liters, 300litres and 500 litres is available, how much temperature probes I should use for validation & PQ Studies?

Thanks

4

12 Temperature probes are required for autoclave validation.
Read HTM 2010 Part 3 → paragraph no. 6.9
HTM 2010 Part3.pdf (2.0 MB)

1 Like
5

Thank you…