Detection of relevant raw materials before printing of aluminum foil for drug packaging
relevant raw materials for aluminum foil printing for drug packaging include: aluminum foil for drug packaging, ink, solvent and adhesive for aluminum foil printing, PVC hard sheet for drug packaging, etc. The quality of these materials is related to the product quality of aluminum foil after printing. As the manual dispensing valve is used as the control element, the raw materials should be inspected according to the national, industrial and enterprise standards before printing. There is no need for substandard products, and the pre printing quality should be well controlled
inspection of medicinal aluminum foil materials
aluminum foil can be said to be a very thin printing substrate made of high-purity aluminum by multiple calendering. Aluminum foil used for drug packaging is divided into hard aluminum foil (blister packaging of tablets or capsules) and soft aluminum foil (generally used as composite flexible packaging material). The thickness of hard aluminum foil is 20 ~ 25 m, and the thickness of soft aluminum foil is 7 ~ 91 M
before rolling the rolled aluminum foil, clean it with a large amount of low boiling point organic solvent and clean the lubricating oil on the surface of the aluminum foil. If the aluminum foil is rolled up without treatment, it is called hard aluminum foil. Put the hard aluminum foil into the annealing furnace and anneal at a pressure of 0.0133pa and a high temperature of 350 ~ 500 ℃. The lubricating oil remaining on the surface of the aluminum foil is removed, and the hard aluminum foil becomes soft. After hard aluminum foil turns into soft aluminum foil, its surface cleanliness can be improved, which is conducive to printing and bonding
the barrier property of aluminum foil is very good, which is light tight, moisture permeable and breathable. However, the purity of aluminum and the calendering environment will affect the quality of aluminum foil. Pinholes often appear when aluminum foil is rolled below 10 m. The more pinholes, the larger the aperture, the greater the permeability and the worse the barrier. The purity of aluminum used for calendering aluminum foil should be higher than 99.5%. The calendering workshop should ensure that there is no dust, the air should also be purified, and the workshop is in a positive pressure state
the pinhole standard of medicinal aluminum foil is: no more than 1 pinhole of ¢ 0.3mm per cubic meter. Test method: use a wooden box of 800mm, 600mm, 300mm or appropriate volume. The wooden box is equipped with a 30W fluorescent lamp. On the wooden box, put a piece of glass plate lined with ink paper, and leave a 400mm 250mm opening. Take 10 400mm 250mm samples from the finished products, place them on the pinhole inspection table one by one, and check whether the pinholes meet the requirements of the standard in the dark
aluminum is an active metal, which is prone to surface oxide film. The oxide film is relatively stable, which can protect the internal aluminum from oxidation and make its surface more conducive to bonding and printing. Aluminum foil is extremely thin, with low mechanical strength and easy to tear and break. The requirements for the physical and mechanical properties of aluminum foil are: the breaking strength is greater than 90kpa, the tensile strength is 98mpa, the thickness is 0.02mm, the surface is clean and flat, and there is no wrinkle, indentation, damage, or flake of fluorescent substances. The label should be fixed in a correct position, flat, solid, and not inclined. The detection methods are:
(1) determination of aluminum foil rupture strength
take three 40mm and 40mm samples from the finished product, put them into the rupture strength meter one by one, and turn on the oil pump to make the rupture strength value on the pressure gauge not less than 90kpa
(2) determination of fluorescence on the surface of aluminum foil
take 5 pieces of 100mm l00mm samples from the finished product, and use an ultraviolet analyzer with a wavelength of 24 ~ 365nm to observe that the fluorescence on the surface of the finished product should not be flaky
(3) tensile strength measurement
take a certain specification of aluminum foil sample, clamp the sample on the upper and lower grippers of the full-automatic tension machine, start the tension machine and record the test data to see whether it is greater than the standard requirements of 98mpa
(4) Cleanliness Measurement
the cleanliness of aluminum foil is divided into four levels: A, B, C and D. The best grade A is almost free of oil stain, and the worst grade D indicates oil stain and low elongation. The measurement method is: prepare four levels of measuring liquid a, B, C and D, and the level a liquid is 100% distilled water; Class B liquid is composed of 10% absolute ethanol and 90% distilled water; Grade C liquid is composed of 20% absolute ethanol and 80% distilled water; Grade D liquid is composed of 30% absolute ethanol and 70% distilled water. Spread the aluminum foil to be tested on a board with 45 corners, and spray it with four levels of liquid a, B, C and D. if the surface of one aluminum foil is evenly wet into a liquid film, it does not shrink into blocks or dots, and there are no water or liquid beads, the aluminum foil corresponds to the level of the liquid
detection of ink and solvent materials
special ink for aluminum foil printing is mainly composed of pigments, fillers, synthetic resins and solvents. The quality standard is: the color should be similar to the standard color sample (scraped sample visual inspection), the coloring rate is 95% ~ 110% compared with the standard sample, the fineness is 25 m, and the viscosity is 20 ~ 27s measured with No. 4 cup at 25 ℃
the solvents used in aluminum foil printing inks mainly include ketones and esters. The detection method of solvent is based on GB, and the water content of its main indicators shall not exceed 0.2%, and the purity shall not be less than 99%
testing of adhesives
the quality of adhesives for aluminum foil is mainly tested and evaluated from the appearance of adhesives, bonding strength, residual solvents and residual monomers. Its uses are different, and the detection indicators are also the same
(1) solid content determination method
use the hot water weight loss method to test the content of nonvolatile matter in adhesives. Take 2 clean and dry containers, put 5g of adhesive into them, record it as M1, bake them in a drying oven at 80 ℃ for 2 ~ 3H, weigh it as m2, and the ratio of two weighings (m2/M1) 100% is the solid content
(2) viscosity measurement method
use a rotary viscometer to measure the viscosity: keep the adhesive at a constant temperature of 25 ℃ for 0.5h, and then select an appropriate rotary viscometer to measure according to the viscosity provided by the manufacturer
(3) binder acidity
can be measured with a glass electrode pH meter, or its pH value can be detected with a precision test paper. Put the dissolved glass electrode into the sample adhesive and titrate to the end point to obtain the acidity value
(4) NCO value of adhesive
according to the detection method of polyisocyanate, the NCO value of curing agent is detected by chemical titration. ① Prepare reaction solution, analyze pure dihydropyridine, acetone =1:50; ② Take 2G curing agent and put it into a conical flask with 10ml acetone added in advance; ③ Add 25ml of reaction solution and let it stand for 15min; ④ Then add 20ml absolute ethanol and 7 drops of bromophenol blue indicator; ⑤ Titrate with 0.5mol/L ethanol to the end point; ⑥ At the same time, the blank experiment was carried out to obtain the NCO value
inspection of PVC for blister packaging
rigid PVC sheets are mainly used for blister packaging of solid drugs. It is a transparent medicinal PVC sheet made of sanitary PVC resin as the main raw material by plastic refining and calendering
(1) physical property test
① the tensile strength is greater than 450kgf/cm. The test method shall be in accordance with GBL "plastic tensile test method"
② the damage rate of falling ball impact is less than 40%. Take 10 pieces of 50mm l50mm aluminum sheets, fasten the test pieces on the testing machine, keep the span of 100mm and the height of 600mm, start the instrument, make the steel ball fall freely, and check the damage rate in the test
③ the heating expansion rate should be controlled at 7%. Cut two square test pieces with a width of 120mm from the PVC hard piece, place them on the glass, place them in the test chamber at (100 1) ℃ for 10min, take them out, cool them to room temperature, then measure the length of each piece of segment, calculate the average value, and calculate the longitudinal and transverse expansion rates
④ the water vapor permeability is less than 2.5g/(M 24h). Take a round piece with an inner diameter of 40mm and a height of 25mm, cover it on the mouth of the dish, seal it with a molten mixture of paraffin and rosin, weigh it, put it into a dryer containing water, place it at a temperature of (252) ℃ for 24h, take it out, wipe the water vapor, put it to room temperature, weigh it, and calculate the water vapor permeability. The water vapor permeability = (a-b)/(R), a is the weight gain of the glass dish after the test of the test piece, and R is the radius of the glass dish
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