sidelights on infusion packaging development forum 2012
infusion packaging: safety is the first important affair
——sidelights on infusion packaging development forum 2012
deep concern cannot separate from material, process, use and standard:
“infusion packaging development forum 2012” hosted by china pharmaceutical packaging association was held in qingdao on 6 september and 7 september. on the forum, over 300 visitors actively participated in 24 keynote speeches arranged by the sponsor and they cherished this scarce “charging” opportunity.
drug safety is always the focus which the global pays attention to. however, infusion products with highest risk receive more attention from drug administration department in various countries and pharmaceutical industry. “infusion packaging safety therefore becomes key field which pharmaceutical industry continuously explores. safety is the first important affair.” cai hong as secretary general of china pharmaceutical packaging association expressed.
material, process, use and standard cannot lose concern.
data on the forum shows that recently large infusion market capacity in china amplifies continuously for implementation of medical insurance policy such as the new rural cooperative medical care system. used quantity of large infusion in the whole country was 6.1 billion bottles (bags) in 2006. the number greatly rose to 8.05 billion bottles (bags) in 2009. sales volume of large infusion in the whole country reached 11.487 billion bottles (bags) in 2011. therein, market share ratio among glass bottle, plastic bottle and soft bag is 2:5:3.
with capacity expansion of infusion market and changes of product structure, drug supervision departments, relevant test institutions and industries in china have expanded concern on infusion packaging products to the whole process of infusion industry chain. on “infusion packaging development forum 2010”, the topic of “new material application and its raw material-various aggregates” attracted everyone. situation for this time is not an exception. representatives coming from enterprises such asｌｇchemistry shanghai technical center, anhui huafeng pharmaceutical rubber co., ltd., kraton polymers shanghai co., ltd., senju pharmaceutical co.,ltd. fukusaki plant, renolit group and shinva medical respectively introduced design of medical polypropylene, thermoplastic elastomer and pp/tpe combined cover, application ofｃarflextm ir on direct contact physic liquor, proposal of new oxygen insulation packaging material, application of foreign multi-chamher bag and present situation and prospect for instant prepared powder solution with double chamber infusion soft bag technology in detail.
“appearance of drug ｇｍｐin version 2010 put forward higher standard for production quality of sterile drug for large infusion. as main components of large infusion, there are more and more attentions paid to product quality of drug packaging material by everyone.” gao shuping as deputy general manager of shijiazhuang no. 4 pharmaceutical co., ltd. shows that the enterprise shall start with omnibearing efforts including basic research and construction of software and hardware facilities, implement research on material science and research on technical equipment level promotion, effectively control various pollutants which may exist, implement overall management of production process from raw and supplemental materials, packaging material to finished products and effectively control introduction of new pollutants. in addition, some advanced production technology also attracts participants’ attention. dr.ｓtefan puller of plümat maschinenbau introduced welding technology of multi-chamber bag. dr.ｔhorsten leopold of ｗ＆ｈcompany introduced breakthrough production efficiency ofａｑｕａｒｅunder blowing water cooling production line in the field of infusion bag film; dr. folker steden of schott tubing introduced basic control points of direct contact drug packaging material.
in our country, security problems of infusion packaging in the link of using seem not to make society pay close attention to it. therefore, the industry worries about it. wang shaohua as director of pharmaceutical department qingdao municipal medical group implements analysis on common problems of infusion (including injection) in clinical use and put forward corresponding processing method and solution. miao yan as quality chief inspector of china otsuka pharmaceutical co., ltd. put forward quality control determined safety of large infusion in the whole process of production and use. therefore, production enterprises shall pay attention to the influence of products on patient safety and reduce medical errors through products design.
relevant chief of registration division in state food and drug administration (sfda) said formulation, revision and implementation of supervision laws and relevant products and technical standards played crucial role in guaranteeing drug safety. on the forum, relevant chief of chinese pharmacopoeia commission introduced drafting situation of chinese pharmacopoeia in version 2015. pharmacopoeia in new version involved in content of large infusion and injection and development trend of chinese pharmacopoeia. desmond hunt as senior scientific affairs contact of standard development department in the united states pharmacopoeia convention entrusted tao qiaofeng as assistant dean of zhejiang institute for food and drug control to introduce standard of drug packaging, storage and distribution. relevant chief of national institutes for food and drug control implemented interpretation and answering of 21 guiding principles such as evaluation and review technique guiding principle of application data for drug packaging material (opinion soliciting draft). relevant chief of sfda center for drug evaluation introduced guiding principle of compatibility research technology of chemical injection and plastic packaging material which is going to be issued and implemented interpretation of some key contents which enterprises concerned.
learning, exploration, practicing and expansion are propelled step by step.
“at present, compatibility research on drug and packaging material in china is still in starting and exploration stage. relevant chief of sfda center for drug evaluation points out drug packaging has become important part of drug quality control system. china develops compatibility research on drug and packaging material for a short period. therefore, the basis is weak. besides, it lacks relevant technical requirements. there are a few research institutions. drug research and development and production enterprises do not involve in this field.
however, what makes us feel delighted is that compatibility research on drug and packaging material in china has been started. with the support of sfda, china pharmaceutical packaging association has held seminar for many times and actively promotes compatibility research technology guide of drug and packaging material in china. guiding principle of compatibility research technology of chemical injection and plastic packaging material which is going to be issued is the first compatibility research technical guide in china. it is reported that sfda center for drug evaluation will issue relevant technical guide principles successively.
many representatives present at the meeting said international experts of relevant field who were invited to participate in the forum brought current international latest research and dynamic of laws and regulations, which clears the way of thinking for developing relevant research in future.
dr. jacqueline a. kunzler coming from baxter medical supplies company brought “infusion packaging toxicology research” which opened field of vision for domestic the same industry. according to his introduction, foreign safety research on drug packaging material includes two parts. one is chemical research; the other is pharmacology and toxicology. “although there are many international guide principles such as ｉｃｈ ｑ３ｃ andｉｓｏ 10993, pharmaceutical enterprise still need to implement comprehensive research on safety of drug and packaging material.” dr. kunzler as expert of toxicology working committee said packaging container seriously influenced drug safety. that was because preparation and packaging material are not inert. generally they would interact. in order to understand these influences, researchers need to implement analysis on migrated substance and implement evaluation of safety risk. the research purpose of toxicology is to guarantee extract can be controlled and it is relatively safe. kunzler also introduced the latest situation of suction type drug safety, changes of safety evaluation on extract of pharmaceutical preparation and rules of using classic material in simple procedure or having exemption test.
as member of chemistry groupｐｑｒｉ, group leader of pda, member ofｉｓｏ/ｔｃ７６, edward smith introduced optimal extract standard of injection products, relation between amount of extractable substance, additive amount and leaching quantity through emphasis.
as a matter of fact, domestic enterprises and testing organizations perform continual exploration and practices in infusion packaging safety. baxter qiaoguang healthcare (guangzhou) co., ltd. contributes a lot in the compatibility research. its development manager huang qihong shared the research case on compatibility between high-capacity injection and multilayer extrusion film infusion bag with the participants in the seminar. cai rong as the deputy director of shanghai food and drug packaging material control center indicated that they also deepened the exploration in the influence of rf label rfid on the injection products. “rfid is mainly used for drug counterfeiting. we research the influence of rf label on the cefradine for injection and recombinant human insulin injection for the purpose to reach the adaptability of this technology in the drug application. ”
“comparing with international research, research on drug and packaging material safety and compatibility in china still has a distance with international research. parts of work have been developed. there is still a long way to go in this year.” aexpert who participated in the seminar said.
china pharmaceutical news reporter jiang heng