{"product_id":"engineering-framework-for-risk-based-autoclave-prasantha-laxman-pujari-9798905101595","title":"Engineering Framework for Risk-Based Autoclave Steam Sterilization Cycle Design: A GMP Validation Methodology for Complex Mixed Loads in ADC Biopharma","description":"\u003cp\u003eMost autoclave validation programs document that a cycle passed. An FDA Pre-Approval Inspection asks something harder: why was it designed this way, and what happens when conditions change?\u003c\/p\u003e\u003cp\u003e\u003c\/p\u003e\u003cp\u003eEU GMP Annex 1 (2022) and ISO 17665-1:2024 both require science-based sterilization cycle development for complex mixed loads. Neither provides a reproducible engineering method. The peer-reviewed literature confirms this gap is real and consequential - sterilization failures from residual non-condensable gases and inadequate air removal remain among the least visible risks in sterile drug manufacturing.\u003c\/p\u003e\u003cp\u003e\u003c\/p\u003e\u003cp\u003eThis manual is the method those documents do not provide. It covers thermodynamic mapping, pressure-temperature correlation as an air-detection diagnostic grounded in Dalton's law, master load design, wireless individual item mapping, edge-of-failure testing, and F₀ lethality analysis each step explained with its engineering basis, not just its procedure. The author developed and applied this framework at a biopharmaceutical oncology facility producing an FDA-approved drug product. It went through a federal inspection.\u003c\/p\u003e\u003cp\u003eIt held up the method works on any GMP autoclave, at any facility. Built for engineers who need to defend their decisions, not just report their results.\u003c\/p\u003e\u003cbr\u003e\u003cbr\u003e\u003cb\u003eAuthor:\u003c\/b\u003e Prasantha Laxman Pujari\u003cbr\u003e\u003cb\u003eISBN-13:\u003c\/b\u003e 9798905101595\u003cbr\u003e\u003cb\u003ePublisher:\u003c\/b\u003e Notion Press\u003cbr\u003e\u003cb\u003eLanguage:\u003c\/b\u003e English\u003cbr\u003e\u003cb\u003ePublished:\u003c\/b\u003e 06\/05\/2026\u003cbr\u003e\u003cb\u003ePages:\u003c\/b\u003e 40\u003cbr\u003e\u003cb\u003eFormat:\u003c\/b\u003e Paperback\u003cbr\u003e\u003cb\u003eWeight:\u003c\/b\u003e 0.19lbs\u003cbr\u003e\u003cb\u003eSize:\u003c\/b\u003e 9.00h x 6.00w x 0.10d","brand":"Prasantha Laxman Pujari","offers":[{"title":"Paperback","offer_id":50546507088127,"sku":"9798905101595","price":28.8,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0662\/2982\/9887\/files\/img_c18e4019-6ef4-4092-b718-68c4edbaecbc.jpg?v=1790537661","url":"https:\/\/www.whiterainbookhouse.com\/products\/engineering-framework-for-risk-based-autoclave-prasantha-laxman-pujari-9798905101595","provider":"WR Book House","version":"1.0","type":"link"}