How to choose the sealing integrity evaluation method for injection product packaging system? What problems should be paid attention to in the application of integrity technology of drug packaging and sealing? How are CCIT container seal integrity positive samples applied on various packaging materials? How can pharmaceutical companies conduct sealing integrity research on injection packaging system according to relevant technical and regulatory requirements?
The forum of "Application of Drug Packaging Integrity under New Regulations" held by Zhonglin in 2021 will closely follow the CDE technical Guidelines on packaging sealing, highlight the typical application of packaging sealing integrity, case sharing and research practice, and provide strong guidance for the practical work of packaging sealing research.
Time
Time: 13:30-17:00, October 28
Location: Conference room EIII, Villa Lake Suzhou, Suzhou, Jiangsu province
Organizer: Shanghai Zhonglin Electromechanical Equipment Co., LTD(Zillion CCIT)
The chairmen of the Forum
Cai Rong
Vice director of Shanghai Food and drug Packaging Material Testing Institute
Zhao Xia
Director of Packaging Materials Room, Pharmaceutical Excipients and Packaging Materials Inspection Institute, China National Institute for Food and Drug Control
Agenda
Title: Study on container seal integrity of injection product packaging system
Speaker: Lu Weiyi
Lu Weiyi: Director of business Management Office of Shanghai Food and Drug Packaging Materials Testing Institute, engaged in the inspection and research of pharmaceutical packaging materials for many years, participated in the preparation and revision of national pharmaceutical packaging materials standards, and the research work of pharmaceutical packaging materials related standards and topics of national Bureau and Pharmacopoeia Commission.
Abstract: 1) Characteristics of injection products; 2) Injection product packaging system; 3) Selection of sealing integrity evaluation method for injection product packaging system; 4) Sealing integrity evaluation of injection product packaging system
Title: Application of integrity technology of drug packaging seal
Speaker: Xie Jun
Xie Jun: I have more than 7 years of practical experience in the research field of drug packaging sealability. For many years, I have been focusing on the research of packaging sealability. I once participated in drafting YY/T vacuum attenuation testing standard for pharmaceutical industry, and received special training on packaging sealability in internal training courses of FDA and PDA for many times. Familiar with various domestic and foreign laws and regulations related to packaging sealing validation of injection consistency evaluation, and have rich experience in CCIT research and practice.
Abstract: 1) Study on packaging integrity of headspace protection drugs; 2) Detection of MALL value aperture of sterile drugs; 3) Application of online leak detection technology in drug packaging; 4) Quality analysis of cILLIN bottle sealing.
Title: Practical introduction to CCIT positive samples: Case sharing at home and abroad, development trend of new technology, problem analysis
Speaker: Lu Gengfeng
Lv Gengfeng: Graduated from Aston University, he has worked for Johnson & Johnson, Corning, SC Johnson and other multinational companies. Currently, he is the Manager of micro machining Division of OpTek Systems China. Several invited presentations on CCIT container seal integrity at PDA Pharmaceutical Association international conferences.
Abstract: A comprehensive overview of CCIT container seal integrity positive samples, including the introduction of preparation methods (laser drilling, capillary, microporous plate, microdropper, copper wire, etc.), its advantages and disadvantages, the development trend of new technology in Europe and America, and the application of various packaging materials (glass, plastic, bubble cover, special bottle species, etc.). How to select the most suitable method of positive sample preparation according to different packaging materials and different experimental purposes.
Title: Research practice on sealing integrity of injection packaging system
Speaker: Xia Yu
Xia Yu: Manager of Yangzijiang R&D Management Center, director of Registration, responsible for registration regulations, project management, R&D QA and other related work; More than 10 years of research and development experience, has reviewed more than 50 sets of application materials, presided over and approved more than 30 generic drugs, consistency evaluation varieties.
Abstract: According to the relevant technical and regulatory requirements, combined with the company's strategy, product layout and technology platform, the enterprise carried out the idea of sealing integrity of injection packaging system. This paper focuses on the establishment and verification of methods based on vacuum attenuation method, and the association with microbial challenge method, as well as the main content and focus of method selection and verification.
Display Equipment
Vacuum decay packing leak detector
Positive sample (natural defect)
