{"product_id":"pre-filled-syringes-and-aseptic-processing-ian-bruce-9798315610786","title":"Pre-filled Syringes and Aseptic Processing","description":"\u003cp\u003e\u003ci\u003ePre-Filled Syringes and Aseptic Processing\u003c\/i\u003e is a comprehensive technical guide for pharmaceutical professionals, engineers, and quality experts involved in the development, manufacturing, and regulation of injectable drug delivery systems. With the increasing shift toward patient-centric therapies and biologics, pre-filled syringes (PFS) have become a cornerstone in modern parenteral drug delivery-offering convenience, safety, and dose accuracy.\u003cbr\u003eThis book dives deeply into the science, engineering, and regulatory landscape that underpins the lifecycle of pre-filled syringe systems. From raw materials and component design to aseptic processing and advanced barrier technologies, each chapter builds a rich understanding of how PFS systems are conceptualized, validated, and brought to market in compliance with global standards such as ISO 11040, ISO 15378, and cGMP.\u003cbr\u003eReaders will explore intricate aspects of glass and elastomer selection, plunger-syringe compatibility, and the nuanced mechanical forces (like glide and breakloose) that affect performance. With discussions on protein aggregation, lifecycle testing, container closure integrity, and automation through SCADA-integrated isolator lines, the book spans both the micro-level chemical interactions and the macro-level facility and regulatory considerations.\u003cbr\u003eSpecial attention is paid to isolator technologies and ready-to-use (RTU) components that have redefined aseptic processing, enabling cleaner, more efficient, and scalable sterile filling lines. The integration of clean utilities, sterility assurance strategies, and automated inspection systems is also covered in depth, with practical examples and visual illustrations that enhance understanding.\u003cbr\u003eKey Topics\u003c\/p\u003e\u003col\u003e\n\u003cli\u003eISO 15378 and QMS for Primary Packaging Materials\u003c\/li\u003e\n\u003cli\u003eISO 11040 Series - Glass and Plastic Syringe Standards\u003c\/li\u003e\n\u003cli\u003ePlunger Materials and Elastomeric Closures\u003c\/li\u003e\n\u003cli\u003eContainer Closure Integrity (CCI) Testing\u003c\/li\u003e\n\u003cli\u003eGlide Force and Breakloose Force Testing\u003c\/li\u003e\n\u003cli\u003eFunctional Testing for Needle Shields and Tip Caps\u003c\/li\u003e\n\u003cli\u003eSiliconization Techniques and Lubrication Challenges\u003c\/li\u003e\n\u003cli\u003eProtein Aggregation and Drug-Container Interaction\u003c\/li\u003e\n\u003cli\u003eMaterial Compatibility and Extractables\/Leachables\u003c\/li\u003e\n\u003cli\u003eFluoropolymer Coatings in Plungers\u003c\/li\u003e\n\u003cli\u003eDesign Control and Quality by Design (QbD) Approaches\u003c\/li\u003e\n\u003cli\u003eLifecycle and Fluid Leakage Testing\u003c\/li\u003e\n\u003cli\u003eAutomation and Robotic Integration in PFS Lines\u003c\/li\u003e\n\u003cli\u003eAseptic Filling with RTU Syringe Tubs\u003c\/li\u003e\n\u003cli\u003eIsolator Technology and VPHP Decontamination\u003c\/li\u003e\n\u003cli\u003eVision Inspection Systems and Data Integrity (21 CFR Part 11)\u003c\/li\u003e\n\u003cli\u003eSterility Assurance and Environmental Monitoring\u003c\/li\u003e\n\u003cli\u003eClean Utilities - WFI, Compressed Air, Clean Steam\u003c\/li\u003e\n\u003cli\u003eRegulatory Standards - ISO 13408, EU GMP Annex 1\u003c\/li\u003e\n\u003cli\u003eDevice Development and Design Verification for PFS\u003c\/li\u003e\n\u003c\/ol\u003e\u003cp\u003e\u003c\/p\u003e\u003cbr\u003e\u003cbr\u003e\u003cb\u003eAuthor:\u003c\/b\u003e Ian Bruce\u003cbr\u003e\u003cb\u003eISBN-13:\u003c\/b\u003e 9798315610786\u003cbr\u003e\u003cb\u003ePublisher:\u003c\/b\u003e Independently Published\u003cbr\u003e\u003cb\u003eLanguage:\u003c\/b\u003e English\u003cbr\u003e\u003cb\u003ePublished:\u003c\/b\u003e 03\/27\/2025\u003cbr\u003e\u003cb\u003ePages:\u003c\/b\u003e 248\u003cbr\u003e\u003cb\u003eFormat:\u003c\/b\u003e Paperback\u003cbr\u003e\u003cb\u003eWeight:\u003c\/b\u003e 0.74lbs\u003cbr\u003e\u003cb\u003eSize:\u003c\/b\u003e 9.00h x 6.00w x 0.52d","brand":"Ian Bruce","offers":[{"title":"Paperback","offer_id":47136588955903,"sku":"9798315610786","price":26.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0662\/2982\/9887\/files\/img_b47912dd-96c4-4e11-b20d-a088b36b001e.jpg?v=1755023806","url":"https:\/\/www.whiterainbookhouse.com\/products\/pre-filled-syringes-and-aseptic-processing-ian-bruce-9798315610786","provider":"WR Book House","version":"1.0","type":"link"}