مشخصات کتاب

Extractables and Leachables for Pharmaceutical Products 2010 14-15 September 2010 London, UK 3rd International Conference

ویرایش:  
 
سری:  
ISBN (شابک) : 9781847355539 
ناشر: iSmithers Rapra Publishing 
سال نشر: 2010 
تعداد صفحات: 198 
زبان: English 
فرمت فایل : PDF (درصورت درخواست کاربر به PDF، EPUB یا AZW3 تبدیل می شود) 
حجم فایل: 7 مگابایت 

در صورت تبدیل فایل کتاب Extractables and Leachables for Pharmaceutical Products 2010 14-15 September 2010 London, UK 3rd International Conference به فرمت های PDF، EPUB، AZW3، MOBI و یا DJVU می توانید به پشتیبان اطلاع دهید تا فایل مورد نظر را تبدیل نمایند.

توجه داشته باشید کتاب مواد قابل استخراج و قابل شستشو برای محصولات دارویی 2010 14-15 سپتامبر 2010 لندن ، سومین کنفرانس بین المللی انگلستان نسخه زبان اصلی می باشد و کتاب ترجمه شده به فارسی نمی باشد. وبسایت اینترنشنال لایبرری ارائه دهنده کتاب های زبان اصلی می باشد و هیچ گونه کتاب ترجمه شده یا نوشته شده به فارسی را ارائه نمی دهد.

توضیحاتی در مورد کتاب مواد قابل استخراج و قابل شستشو برای محصولات دارویی 2010 14-15 سپتامبر 2010 لندن ، سومین کنفرانس بین المللی انگلستان

19 مه 2010 SHROPSHIRE، UK (19 مه 2010) - iSmithers، که قبلاً گروه اطلاعاتی در Smithers Rapra Technology Ltd.، یک شرکت تابعه از سازمان مستقل آزمایش، تحقیق و مشاوره مستقر در ایالات متحده، The Smithers Group، میزبان سومین کنفرانس بین المللی خود در مورد Extractables خواهد بود.

توضیحاتی درمورد کتاب به خارجی

19 May 2010 SHROPSHIRE, UK (May 19, 2010) - iSmithers, formerly the information group within Smithers Rapra Technology Ltd., a subsidiary of U.S.-based independent testing, research and consulting organisation, The Smithers Group, will host its third international conference on Extractables & Leachables for Pharmaceutical Products, September 14-15 2010, in London. This high profile event has been developed to support the safe use of polymers in the pharmaceutical and medical device industries - something that Smithers Rapra's pharma consultants are truly passionate about. In recent years there has been an increasing importance placed on the examination of leachables and extractables that may arise from components used in, for example, primary container and closure systems, self-adhesive labels or secondary packaging materials, Smithers Rapra officials stated. "As the regulatory pressure increases and evolves there is a greater need for pharmaceutical companies to investigate the possible interaction between dosage and the components of the primary closure and transfer system," said Keith Scott, commercial manager, pharmaceutical solutions at Smithers Rapra. "Companies must have reliable methods of product testing and quality control in place - from the initial design, material choice, product testing and the understanding of regulations. More and more, our technical consultants are being asked to formulate testing strategies for drug delivery devices such as pMDI, DPI and nasal spray devices, as well as elastomeric closures for containers (stoppers, plungers etc) for injectables, to address regulatory requirements from the EMEA and FDA. The two-day conference will feature an expert speaker panel with case studies from world-class companies, such as Boehringer Ingelheim Inc., Pfizer Inc., GlaxoSmithKline, Novo Nordisk, Novartis Pharmaceuticals and AstraZeneca as well as regulatory updates from the MHRA, Health Canada and the FDA. Extractables are defined are "compounds that can be extracted from elastomeric, plastic compounds or coatings of the container and closure systems when in the presence of appropriate solvents under vigorous conditions". Leachables are defined as "compounds that leach from elastomeric, plastic compounds or coatings of the container and closure system as a result of direct contact with the formulation during the shelf-life of the product". As specialists in polymers and polymer products utilised in the pharmaceutical industry Smithers Rapra offers a complete analysis service on leachables and extractables that exist in various delivery systems. For example: DPI's, pMDI's, nebulizers, elastomeric closures, stents and topical creams. For more information on the Extractables & Leachables conference, contact Sharon Garrington sgarrington@ismithers.net and view forthcoming conferences at www.ismithers.net/conferences. To discuss testing and analysis requirements please contact Keith Scott kscott@rapra.net

فهرست مطالب

Contents......Page 4
Paper 01 - ORIGINS OF EXTRACTABLES AND LEACHABLES FROM
POLYMER PRODUCTS......Page 6
Paper 02 - REGULATORY EXPECTATIONS FOR SAFETY QUALIFICATION
OF EXTRACTABLES AND LEACHABLES IN MEDICINAL
PRODUCTS......Page 24
Paper 03 - ACCEPTABLE VARIABILITY AND FOCUSED TESTING ON
CONTAINER CLOSURE SYSTEM FOR REGULATORY
FLEXIBILITY......Page 28
Paper 04 - LEACHABLES IN PARENTERAL DRUG PRODUCTS AND
RESPONSES TO THESE FROM HEALTH AUTHORITIES......Page 30
Paper 05 - THRESHOLDS AND BEST PRACTICES IN PARENTERAL AND
OPHTHALMIC DRUG PRODUCTS......Page 42
Paper 06 -THRESHOLDS AND BEST PRACTICES IN PARENTERAL AND
OPHTHALMIC DRUG PRODUCTS......Page 44
Papers 7-11 - THE EXTRACTABLES AND LEACHABLES SAFETY
INFORMATION EXCHANGE (ELSIE): DEVELOPMENT OF AN
EXTRACTABLES AND LEACHABLES DATABASE......Page 70
Paper 12 -ADVANCING QUALITY OF MATERIALS THROUGH
COLLABORATION WITH THE SUPPLY CHAIN: THE WORK OF
THE IPAC-RS OINDP MATERIALS WORKING GROUP......Page 76
Paper 13 -BPSA CONSENSUS RECOMMENDATIONS FOR
EXTRACTABLES TESTING OF SINGLE-USE PROCESS
EQUIPMENT......Page 84
Paper 14 - ROUTINE METHOD DEVELOPMENT: PERILS, PITFALLS AND
TRIUMPHS......Page 108
Paper 15 -HOW TO SPEED UP EXTRACTABLE AND LEACHABLE
TESTING TO ACHIEVE QUALITY BY DESIGN......Page 114
Paper 16 - COMPARISON OF THE APPLICATION OF A RISK-BASED
APPROACH TO THE DESIGN OF AN EXTRACTABLES AND
LEACHABLES PROGRAMME FOR THE STUDY OF A
BIOPHARMACEUTICAL AND DRY POWDER INHALER
PRODUCT......Page 124
Paper 17 - THE ROLE OF EXTRACTABLE & LEACHABLE TESTS WITHIN
A RISK MANAGEMENT FRAMEWORK......Page 134
Paper 18 - APPLICATION OF QUALITY BY DESIGN (QBD) PRINCIPLES TO
EXTRACTABLES/LEACHABLES ASSESSMENT:
ESTABLISHING A DESIGN SPACE FOR TERMINALLY
STERILIZED AQUEOUS DRUG PRODUCTS STORED IN
PLASTIC PACKAGING SYSTEM......Page 140
Paper 19 - EXTRACTABLES & LEACHABLES - A CONVERTER'S VIEW......Page 152
Paper 20 - DEVELOPMENT OF MATERIALS FOR ORALLY INHALED AND
NASAL DRUG PRODUCTS (OINDPS) BASED ON KNOWLEDGE
REGARDING EXTRACTABLES – COMPARISON WITH
TRADITIONAL PACKAGING DEVELOPMENT......Page 162
Paper 21 - A PHARMACEUTICAL RUBBER FORMULATION BASED ON AN
UNCONVENTIONAL ELASTOMER – EXTRACTABLES
BEHAVIOUR BEFORE AND AFTER GAMMA IRRADIATION......Page 170
Paper 22 - CLEAN AND EFFECTIVE CURING VITAL FOR ELASTOM......Page 186

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