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Summary of quality problems of medical plastic packaging

Aug 01,2021

Source: Link Testing Instruments Co.,Ltd.

What are the packaging forms of plastic medical packaging?

(1) Infusion bottle: mainly made of LDPE (low-density polyethylene) and PP (polypropylene), with good chemical stability, barrier properties, sealing properties and compatibility with drugs, light weight, and not easy to break. However, the introduction of air during the infusion can easily cause the pollution of the liquid medicine, the transparency is low, the PP bottle is not resistant to low temperature, and the PE bottle is not resistant to high temperature.

(2) Co-extrusion infusion bag: There are three layers and five layers. Three-layer co-extrusion is the main form. Most of them are formed by co-extrusion of polyethylene, polypropylene, modified olefin, and polyester. It has high barrier properties, good compatibility with drugs, easy heat sealing, good heat and cold resistance, no need to introduce outside air during infusion, to avoid air pollution, but the film material and packaging costs are high.

(3) Plastic bottle: It can be used for oral liquid, solid medicine and external liquid medicine packaging. The main material is HDPE (high density polyethylene), PP, PET (polyethylene terephthalate), which is light in weight and not easy to break. , Good sealing and moisture-proof.

•HDPE bottle-can pack most of the solid and liquid medicines except oily, volatile, and easily oxidized.

•PP bottles-especially suitable for high-temperature disinfection and sterilization, but the transparency and cold resistance are poor, and they are brittle at low temperatures. In order to reduce the brittleness, a certain proportion of PE and other raw materials can be added to ordinary PP materials. At present, most liquid medicine bottles are mainly made of PP.

• PET bottles-better barrier properties, physical and mechanical properties and chemical resistance, often used for larger bottles.

(4) Composite film bags: divided into paper-plastic composite film, plastic composite film, paper-aluminum-plastic composite film, aluminum-plastic composite film, aluminized composite film and other categories, used for tablets, capsules, pills, granules, powders and other medicines package of.

(5) Rigid sheet: used for blister packaging, common materials are PVC (polyvinyl chloride), PVC/LDPE, PVC/PVDC (polyvinylidene chloride), Al/PE, PVC/PE/PVDC, PA (polyvinyl chloride), PVC/LDPE Amide)/Al/PVC, etc. In view of the toxicity of monomers and plasticizers in PVC, the use of PVC has been restricted or banned abroad.

  • Sealing gasket: After the aluminum-plastic composite film is bonded to the cardboard, it is used for heat sealing of medical plastic bottles. Common materials are PET/Al/PE, PET/Al/PP, PET/Al/PET, which are used for heat sealing of PE, PP, and PET bottles respectively.
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What should we do if the powder medicine packaged in the vial appears agglomerated?

Quality issues:

The powder medicine packaged in vials appeared agglomerated after being stored for a period of time.

Cause Analysis:

(1) The drug itself

• High moisture content-if the powder is not fully dried and its own moisture content is high, it is prone to agglomeration. It can be verified by testing the moisture content of the drug.

(2) Packaging materials

• Poor airtightness-if the fit between the cap and the mouth of the vial is poor, such as the fit is not tight, the cap is loose, etc., or the opening force is low, and the tightness is poor, it is easy to cause external water vapor to enter the vial Inside, it caused agglomeration of the packaged powder medicine. It can be verified by opening force, fit and sealing performance (negative pressure method).

• Poor heat resistance-If the bottle cap has poor heat resistance and deformation during the sterilization process, it will easily lead to poor compatibility with the vial, which will lead to air leakage and cause agglomeration of packaged powdered medicines. It can be verified by sterilization test.

Expert advice:

——Focus on the moisture test of medicines.

——Pay attention to the monitoring of the main performance of the opening force of the packaging bottle cap, the sterilization resistance test, the compatibility of the cap and the vial, and the sealing performance (negative pressure method).

Typical quality case:

——Test sample: a vial of powdered medicine (the customer reported that the drug powder packaged in the vial was agglomerated, but the moisture content test of the drug powder itself showed that it was qualified).

—— Targeted testing items: opening force, sterilization resistance test, compatibility, sealing performance (negative pressure method).

——Test result: The opening force, sterilization resistance and compatibility of the bottle cap can meet the requirements, but in the sealing performance (negative pressure method) test, at -35.4 KPa, the surrounding area of ​​the cap appears The phenomenon of air leakage is avoided, and the high-quality vial with good airtightness will not leak under the pressure of -90 KPa. Therefore, the poor tightness of the cap and the vial is an important reason for the agglomeration of the packaged drug powder.

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What are the key focus items of glass containers for pharmaceutical packaging?

(1) Heat resistance—verify by heat stability test or heat resistance test. For glass containers that require high-temperature heat sterilization, if the heat resistance is poor, the bottle body is likely to crack or even break after heating.

(2) Breaking performance-mainly refers to the performance of the ampoule, which is verified by the breaking force test to ensure that the breaking force of the ampoule is within an appropriate range, and to prevent the breaking force from being too large or too small, which may cause the ampoule to be difficult to open or fail. It is easy to break during use or transportation.

(3) Volume deviation-verified by marking line volume and full mouth volume test. For glass containers with capacity requirements, through the detection of volume deviation performance, it can prevent the packaging of drugs from appearing due to large volume deviations The problem of underdose or overdose.

(4) Convenience of use—verified by tests such as puncture force, airtightness and puncture retention, opening force, tearing force, etc. For the stopper or lid of the glass container that needs to be punctured, it needs to have a suitable puncture force , Such as injection bottles sealed with rubber stoppers; for non-one-dose or inverted medical packaging after puncture, the puncture site should also be well sealed, such as the stopper of the infusion bottle; for the need to remove the bottle Containers with stoppers or bottle caps need to have suitable opening or tearing forces, such as aluminum caps, according to the different opening methods.

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