Study On Comparative Standard Technical Scheme Of Medicine Packaging Material

As an important part of medicines,medicine packaging accompanies the whole process of medicine production,circulation and using.Pharmaceutical glass containers,plastic containers and seals account for a large portion of pharmaceutical packaging materials.The paper selects ampoules,infusion bottles,injection bottles made of glass materials,infusion or injection containers made of plastic materials,and aluminum caps and aluminum-plastic composite cap used as seals for infusion bottles and injection bottles as the benchmark objects.The paper reviews and analyzes domestic and foreign standards of those products.The list of benchmark standards and technical solutions for those products are studied and determined based on international standards,foreign advanced standards and domestic standards.According to the searching criteria,it mainly conducts benchmark analysis on the performance indicators and specifications between ISO standards and YBB standards.The results are as follows:1.Ampoules: ISO 9187-1-2010,ISO 9187-2-2010 and domestic ampoules standard benchmark analysis.Nicked ampoules have a smaller breaking force by ISO standard;YBB standard has more performance requirements than ISO standard;annealing quality of ISO standard is not more than 50nm/mm and the YBB standard requires no more than 40nm/mm;there is a big gap between the outer diameter of specifications,height and thickness.2.Glass infusion bottles: ISO 8536-1-2011 and YBB standard benchmark analysis.Requirements for hydrolysis resistance,internal pressure resistance,thermal shock resistance and annealing treatment are the same between the two standards;Requirements for identification,stitching,scales,characters,marks,121?/ 98?particle water resistance,thermal stability,arsenic,antimony,lead,cadmium leaching amount are needed by YBB standard,however those are not needed by ISO standard;ISO standard adds the capacity of A-type bottle to be 125ml;the YBB standard adds requirements for the outer and inner diameter of the bottle mouth,the thickness of the bottle wall,the bottom thickness of the bottle and the quality.3.Glass injection bottles: piped injection bottle ISO 8362-1-2018,molded injection bottle ISO 8362-4-2011 and YBB standard benchmark analysis.Identification,121?particle water resistance and leaching amounts of arsenic,antimony,lead,cadmium are required by YBB standard and are not required by ISO standard;the specifications such as 4ml,6ml,50 ml and 100 ml are not found in the YBB standard,but there are specifications such as 5ml and 7ml in the YBB standard with the size difference compared with ISO standard;the molded glass injection bottle in ISO standard has higher hydrolysis resistance requirements compared with low borosilicate glass molded injections in the YBB standard.4.Plastic container: ISO 15747-2018 is benchmarked with YBB standard.YBB standard has more index requirements such as suspension force,oxygen and nitrogen permeability,tensile strength,heat sealing strength,light transmittance,endotoxin,biological test,storage and the clarity and color required in the dissolution test.5.Aluminum-plastics combination caps: ISO 8536-7-2009,ISO 10985-2009,ISO 8872-2003 and YBB00402003-2015 benchmark analysis,ISO 8362-6-2010,ISO 8362-7-2006 and YBB00372003-2015 benchmark analysis.The YBB standard does not need general requirements,materials requirements and processing quality;the YBB standard and the ISO standard have the same maximum plastic part removal force which belongs to standard opening forces,but the ISO standard does not require the minimum plastic part removal force and tearing force of tear piece;As for mechanical properties of aluminum parts,the ISO standard has more graded requirements;the size of the Aluminum-plastics combination caps for infusion bottles with a nominal size of 28 mm is different.The size of the aluminum-plastics combination caps for injection bottles differs only in the d₂max with a nominal size of 13 mm.6.Aluminum caps: ISO 8362-3-2001,ISO 8872-2003 and YBB00082005-2015 benchmark analysis,ISO 8536-3-2009 and YBB00092005-2015 benchmark analysis.ISO standard allows a small amount of residual lubricant in the appearance of the aluminum cover and YBB standard requires no residual lubricant;the opening force,size index and size of the aluminum caps for injection bottle are basically the same.The bridge breaking force and size of full opening force of aluminum cover used by infusion bottle are the same.The ISO standard requires the minimum force used to push the A-type into the F-type protective cap of the three-piece composite aluminum cover,which is not required by the YBB standard.The caps type of YBB standard is different from that of ISO standard.The size of the same caps type is different.YBB standard requires the specific values and ISO standard gives the range.