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Common pharmaceutical packaging quality problems monitoring solution

May 18,2021

Source: Link Testing Instruments Co.,Ltd

The roll film used for pharmaceutical packaging often has deviations or poor unwinding during bag making.

Cause Analysis:

(1) Packaging materials

• The friction coefficient is not suitable-if the friction coefficient of the packaging material roll film is low or uneven, it is easy to cause deviation and slippage during unwinding and bag making; if the friction coefficient of the roll film is too high, it is easy to cause It is not easy to draw the roll, unwinding is not smooth, and even the packaging material is stretched.

(2) Production equipment

• The surface performance of the unwinding reel and other equipment is not suitable-if the surface of the unwinding reel and other bag-making equipment used for the pharmaceutical packaging film is not smooth, uneven, it is easy to cause problems such as non-smooth drawing or deviation.

Expert advice:

——Pay attention to the monitoring of the friction coefficient performance of packaging materials.

——Adjust the amount of additives such as opening agent, slip agent, etc.; improve the stiffness of the surface; regularly check the unwinding bag making equipment.

Typical quality case:

——Test sample: granule packaging roll film (customers report prone to slippage during bag making).

——Targeted test items: friction coefficient.

——Test results: The static friction coefficient of the packaging film is only 0.123, and the dynamic friction coefficient is only 0.094, which is far lower than the average value of similar products in the market. Therefore, the low friction coefficient is the main reason for the slippage of the roll film.

Coefficient of Friction Tester LTCOF-05A

What is the reason for the rupture of the plastic infusion bag?

Quality issues:

Plastic infusion bags are prone to breakage when they are squeezed or dropped.

Cause Analysis:

--Packaging Materials

• Poor flexibility of the packaging material-if the packaging material has poor flexibility and high brittleness, it will easily occur during the transportation or storage of the infusion bag due to mutual squeezing, stacking or falling of the infusion bag Broken bag. It can be verified by tests such as tensile strength, burst pressure, pressure resistance, and drop resistance.

• The temperature resistance of the packaging material is poor—for infusion bags, the liquid preparations packaged may undergo heat sterilization or low-temperature storage as required. If the temperature resistance of the packaging material is poor, it will After the high temperature or low temperature environment, the performance will be greatly deteriorated, and the bag will be broken when subjected to external force. It can verify the burst pressure after temperature treatment, temperature adaptability (that is, test pressure resistance after temperature treatment), drop resistance and other tests.

Expert advice:

——Pay attention to the monitoring of the tensile strength, burst pressure, pressure resistance, and drop resistance of packaging materials that have not undergone temperature treatment.

——Pay attention to the monitoring of the burst pressure, temperature adaptability, and drop resistance of the packaging bags after temperature treatment.

——Adjust the packaging process to improve the toughness of the bag body.

Typical quality case:

——Test sample: three-layer co-extruded plastic infusion bag (customers report that the infusion bag is prone to breakage during transportation and stacking).

—— Targeted testing items: Burst pressure and pressure resistance of packaging bags before and after temperature treatment.

——Test results: Before the temperature treatment, the packaging bag did not leak or break in the pressure resistance test, and the burst pressure was 84.3 KPa; according to the information provided by the customer, the infusion bag was subjected to corresponding temperature treatment. Liquid leakage occurred during the pressure performance test, and the burst pressure dropped to 60.5 KPa. Therefore, the poor temperature resistance of the three-layer co-extruded film infusion bag is an important reason for its stacking and breaking of the bag.

Intelligent Sealing Instrument LTMFY-06S(burst tester)

What are the key performance characteristics of the rigid sheet for blister packaging?

Physical and mechanical properties

• Heat resistance—verified by heating expansion rate test. After the medicine is packaged by the rigid film and heat-sealed with the medicinal aluminum foil, if the heat resistance of the rigid film is poor and the size changes after being heated, the blister package will easily be deformed, which will seriously affect the product image.

• Composite fastness—verified by peel strength test. For composite hard sheets, especially those made of aluminum foil and plastic film, aluminum foil is the main barrier material. If delamination occurs, the aluminum foil layer is easy to be The damage causes the barrier properties of the entire hard film to be greatly compromised, and at the same time reduces the quality image of the medicine.

• Heat sealing effect-verified by heat sealing strength test to prevent air leakage of a single blister due to the low heat sealing strength of the blister package.

• Sealing performance-the test is carried out through the sealing performance (negative pressure method) test, mainly to detect the tightness of the finished package, so as to find the location of the blister package that is easy to leak.

LTH-H3 Heat Seal Tester

What are the key performances of the infusion bag?

Physical and mechanical properties

• Heat-sealing effect—verified by heat-sealing strength test. If the heat-sealing effect of the infusion bag is poor, it is prone to leakage or rupture at the heat-sealed place if it is squeezed by external force or impacted by the liquid medicine.

• Flexibility-through the input verification of tensile strength, burst pressure, pressure resistance, drop resistance and other tests, it can prevent the bag body of the infusion bag from rupturing due to the poor flexibility of the packaging material.

• Temperature resistance-verified by temperature adaptability and drop resistance test to prevent the poor high temperature resistance of the infusion bag. After high temperature sterilization, the performance will decrease, and the bag will break when it is squeezed or dropped.

• Easy puncture performance-verified by puncture force test, if the puncture force at the mouth of the infusion bag is too large, it will cause inconvenience to the infusion process.

• Sealing performance-through the sealing performance (negative pressure method), injection point tightness, puncture retention and insertion point impermeability test to verify, the negative pressure method sealing performance test is to prevent the leakage of the infusion bag before infusion , The last three tests are to prevent the leakage of the medicine along the puncture part of the infusion bag after the puncture point appears in the infusion bag.

• The mechanical performance of the lifting ring is verified by the suspension force test. If the lifting ring of the infusion bag has poor mechanical performance, the suspension force that can be sustained is low and the time is short, and it is easy to break during the infusion.

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