Number of temperature mapping sensor in autocalve validation/ qualification

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)

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
• 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

• 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:

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?


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

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Thank you…