Quality Analysis And Research Of Composite Film For Pharmaceutical Packaging

The “biaxially oriented polypropylene/aluminum/polyethylene pharmaceutical packaging film”(abbreviated as BOPP/Al/PE composite film)is a pharmaceutical packaging material approved by the State Food and Drug Administration and its product quality is based on the composite film YBB standard.Product registration approval is based on the company's corporate standards,which makes the material have some differences in the quality control indicators.In order to solve this problem,this paper mainly studied the applicability of the YBB compound film general rules and method standards in the National Standard for Pharmaceutical Packaging Materials,and provided the reference for the industry standards for making and modifying the material in the next step.The main research contents of the paper are as follows:1.Carry out quality analysis and research of BOPP/Al/PE composite membranes,including:(1)The heat transfer method,film method,thermal cracking method,ATR method and micro-infrared method recommended in the "Infrared Spectrometry Method for Packaging Materials"(YBB00262004-2015)were compared by theoretical analysis and experiments in BOPP.The application characteristics of the quality of the Al/PE composite film and the ATR method were finally selected to verify the applicability of the method in the composite film studied.The results show that the ATR method is simple,fast,and informative,and can be used for the quality identification of BOPP/Al/PE composite membranes.(2)The test methods for the barrier properties,peel strength and heat sealing strength of the BOPP/Al/PE composite film were studied.The results showed that:(1)In the cup method,gravimetric method and infrared detection method,the water vapor ‘s penetration is preferably measured by an infrared detector method,and the high-barrier film is measured by this method,which has a high detection accuracy(reaches 0.005 g/(m2·24h),which is 100 times that of the cup method)and whose operation is fully automatic.(2)Compared with differential pressure method,the coulometric method is more suitable for testing the oxygen permeation of composite membranes with low oxygen permeation,such as BOPP/Al/PE.3 The vertical and horizontal peel strength of the membrane is not lower than 2.5 N/.The actual condition of the 15 mm which accords with the situation of BOPP/Al/PE composite film can be used as the peeling strength control index of this type of film.(4)The heat sealing conditions of the composite film have some influence on the heat seal strength,but the effect is not very obvious in the temperature range of 150-170 °C and pressure 0.2-0.3 MPa.If the BOPP/Al/PE film studied under this condition range,the heat seal strengths are all above 12 N/15 mm,which indicates that this value can be used as the standard limit of BOPP/Al/PE film heat seal strength.At the same time,the experimental results also show that the physical performance indicators of the 16 batches of samples studied in this article meet the qualification requirements.(3)The feasibility of the determination of residual solvents in BOPP/Al/PE composite membranes by headspace gas chromatography was studied in Method for Determination of Residual Solvent Content of Packaging Materials(YBB00312004-2015).Through the investigation of the specificity,reproducibility and precision of the method,it was found that this method can meet the requirements for the detection of solvent residues in BOPP/Al/PE composite membranes,and it might be used as a standard method for the detection of residual solvents in BOPP/Al/PE composite membranes in the future.According to the test results of the detection method,and compared with the standard requirements of "General Requirements for Pharmaceutical Packaging Composite Membrane and Bags"(YBB00132002-2015),the residues of the solvents in the 16 batches of samples studied in this article were qualified.(4)Validation of the detection method(titration method)of easy oxides specified in "General Requirements for Composite Films and Bags for Pharmaceutical Packaging"(YBB00132002-2015),non-volatile detection methods(gravimetric method)and heavy metal detection methods(The colorimetric method)were used to test the feasibility of oxides,non-volatiles and heavy metals in the BOPP/Al/PE composite membranes.The results show that these methods are suitable for the detection of related content in BOPP/Al/PE composite membranes.From the test results of 16 products,there are certain differences in the dissolution products of different companies,but all meet the YBB00132002-2015 limit requirements.However,the experiment also found that this standard sets too large a limit for the non-volatile content of water and 65% ethanol.It is recommended that it can be adjusted downwards when it is later modified.(5)The applicability of the microbial limit and abnormal toxicity test method in the BOPP/Al/PE composite membrane was verified in the YBB00132002-2015 standard.The results show that the relevant methods can be used for the inspection of BOPP/Al/PE composite membranes,and the biological tests of the samples studied in this article are all in line with the requirements.2.The application of three different methods to determine the mechanical properties of aluminum materials in the "Aluminum Lids for Infusion Bottles"(YBB00092005-2015)was compared in the determination of the tensile strength and elongation of the composite film aluminum.The results show that the accuracy of method 1 in the standard is highly dependent on the operation.Although the automated procedure and precision of the method 3 have been improved,the measured data is obviously low,which is not suitable to use aluminum for injection bottle.The indicators in the cover "YBB00082005-2015" are used to determine the quality,and the method is used to determine the quality judgment standards.Only the method 2 is not only quick and convenient,but also the measured data is consistent with the quality indicators in YBB00082005-2015.