63° SIMPOSIO AFI – DIGITAL WORKSHOP EMME 3 – Package Integrity: Industry Standards and Measurement Principles
L'evento
The presentation explores the complex world of pharmaceutical manufacturing standards and regulations, with a specific focus on the integrity testing of containers for sterile medicinal products. It discusses the evolution of Annex 1 guidelines, highlighting the importance of container closure integrity testing, especially for containers closed through fusion methods. The emphasis is on the shift to more stringent testing requirements, stressing the need to assess, manage, and monitor parameters that impact seal integrity during operations.
Additionally, the presentation dives into the intricacies of primary barrier packaging standards established by ASTM, underscoring the role of package design and development in guaranteeing the integrity of pharmaceutical products. It touches on various testing methods used, from vacuum decay to vacuum deflection, each essential in upholding the quality and safety of parenteral bags, vials, ampoules, and blister packs.
Essentially, the presentation acts as a detailed guide to the precise procedures involved in container closure integrity testing, merging aspects of GMP regulations, ASTM standards, USP1207, and Annex guidelines to maintain the highest standards of quality and safety in the production of sterile medicinal products.
GENERAL INFORMATION
Participation is free of charge upon registration to be made by the day before the webinar.
INFORMATION TO PARTICIPATE IN THE WEBINAR WILL BE SENT AUTOMATICALLY VIA E-MAIL. WE RECOMMEND ALSO CHECK YOUR JUNK MAIL BOX AND CONTACT THE ORGANIZATIONAL SECRETARIAT IN CASE OF FAILURE TO RECEIVE IT.
ORGANIZERS
SEPHA, part of TASI group, was founded in 1980 and has established a global reputation for innovationand development of specialised, high quality equipment for use in the manufacture of pharmaceuticalblister packs, medical device and healthcare products. Our products enable customers to create highquality blister packs, to accurately detect leaks and weak seals in packaging, and to recover high valueproducts from blister packs.
EMME3 was founded in 1980 to offer only the best of scientific instrumentation to laboratories in the main fields of research and industry. We specialize in the marketing and service of laboratory and scientific instruments and their accessories and materials. The instruments we propose have always been distinguished by their high technological content. To achieve this goal, Emme 3 uses a direct and exclusive communication channel with the main manufacturers to be able to offer its customers only the best instrumentation on the market.
For further information, please contact the Organizing Secretariat:
New Aurameeting Srl
Via Rocca d’Anfo, 7 – 20161 Milano
Tel. 0039 02 6620 3390
eventi@newaurameeting.it – www.newaurameeting.it