Source: Link Testing Instruments Co.,Ltd.
What are the packaging forms of plastic medical packaging?
(1) Infusion bottles: mainly LDPE (low-density polyethylene) and PP (polypropylene). They have good chemical stability, barrier properties, sealing properties and compatibility with drugs. They are light and not easy to break. However, air is introduced during infusion, which can easily cause drug contamination. They have low transparency. PP bottles are not resistant to low temperatures, while PE bottles are not resistant to high temperatures.
(2) Co-extruded infusion bags: There are three-layer and five-layer types, with three-layer co-extrusion being the main type. They are mostly formed by co-extrusion of polyethylene, polypropylene, modified olefins and polyester. They have high barrier properties, good compatibility with drugs, are easy to heat seal, and have good heat and cold resistance. There is no need to introduce outside air during infusion to avoid air pollution, but the cost of film materials and packaging is high.
(3) Plastic bottles: They can be used for packaging oral liquids, solid drugs and external liquid drugs. The main materials are HDPE (high-density polyethylene), PP and PET (polyethylene terephthalate). They are light, not easy to break, have good sealing properties and are moisture-proof. •HDPE bottles - can be used to package most solid and liquid drugs except those that are oily, volatile, and oxidizable. •PP bottles - particularly suitable for high-temperature sterilization, but with poor transparency and cold resistance, and very brittle at low temperatures. To reduce brittleness, a certain proportion of PE and other raw materials can be added to ordinary PP materials. At present, most liquid medicine bottles are made of PP as the main material. •PET bottles - better barrier properties, physical and mechanical properties, and chemical resistance, and are often used for bottles with larger capacity.
(4) Composite film bags: divided into paper-plastic composite films, plastic composite films, paper-aluminum-plastic composite films, aluminum-plastic composite films, and aluminum-plated composite films, and are used for the packaging of tablets, capsules, pills, granules, powders, and other drugs.
(5) Hard tablets: used for blister packaging, common materials include PVC (polyvinyl chloride), PVC/LDPE, PVC/PVDC (polyvinylidene chloride), Al/PE, PVC/PE/PVDC, PA (polyamide)/Al/PVC, etc. In view of the toxicity of monomers and plasticizers in PVC, the use of PVC has been restricted or banned abroad.
(6) Sealing gasket: After the aluminum-plastic composite film is bonded to the paperboard, it is used for heat sealing of medical plastic bottles. Common materials include PET/Al/PE, PET/Al/PP, and PET/Al/PET, which are used for heat sealing of PE, PP, and PET bottles respectively.
How to test the content of headspace gas in vials?
Drugs packaged in vials are often packaged in a gas-filled form, that is, a certain volume of nitrogen or other gases is filled into the vial to extend the shelf life of the packaged drugs. However, due to the influence of factors such as the purity of the gas source, the gas filling process, or the barrier and sealing properties of the packaging, the gas concentration in the vial often changes. How to monitor the gas concentration in the bottle, the headspace gas analyzer came into being.
The headspace gas analyzer is a detection instrument used to test the content of gas components inside the package. The specific operation process is: use a gas sampling device dedicated to the container to extract a certain amount of gas from the vial, and the extracted gas is analyzed by the oxygen and carbon dioxide gas sensors inside the headspace gas analyzer to test the content of oxygen and carbon dioxide in the vial. For common gas-filled packaging, the gases in the packaging are mainly oxygen, carbon dioxide, and nitrogen. The content of other gases can be ignored, so the concentration of oxygen and carbon dioxide is subtracted from 100%, which is the concentration of nitrogen in the vial.
What should I do if the powder medicine packaged in the vial clumps?
Quality problem: The powder medicine packaged in the vial clumps after being stored for a period of time.
Cause analysis:
(1) The drug itself has a high moisture content - If the drug powder is not fully dried and has a high moisture content, it is easy to clump. This can be verified by testing the moisture content of the drug.
(2) Packaging material • Poor sealing - If the fit between the vial cap and the bottle mouth is poor, such as loose fit, loose cap, etc., or the opening force is low and the sealing is poor, it is easy for external water vapor to enter the vial, causing the packaged powder medicine to clump. This 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 deforms during the sterilization process, it is easy to cause poor fit with the vial, and then leakage occurs, causing the packaged powder medicine to clump. This can be verified by sterilization resistance test.
Expert advice: - Pay attention to the moisture test of the drug. ——Pay attention to the monitoring of the main performance of the packaging bottle cap, such as the opening force, sterilization resistance test, compatibility between the bottle cap and the vial, and sealing performance (negative pressure method).
Typical quality case:——Test sample: vial for packaging powder medicine (the customer reported that the powder of the medicine packaged in the vial was agglomerated, but the moisture content test of the powder itself was qualified). ——Targeted test items: opening force, sterilization resistance test, compatibility, sealing performance (negative pressure method). ——Test results: The opening force, sterilization resistance and compatibility of the bottle cap with the bottle mouth can meet the requirements, but in the sealing performance (negative pressure method) test, at -35.4 KPa, the bottle cap had air leakage around it, while the high-quality vial with good sealing performance would not leak at a pressure of -90 KPa. Therefore, the poor tightness between the bottle cap and the vial is an important reason for the agglomeration of the packaged drug powder.
What are the key areas of focus for glass containers used in pharmaceutical packaging?
(1) Heat resistance - verified through thermal stability test or heat resistance test. For glass containers that need to be sterilized by high temperature heating, if the heat resistance is poor, the bottle body is prone to cracks or even rupture after heating.
(2) Breaking performance - mainly refers to the performance of ampoules, which is verified through breaking force test to ensure that the breaking force of ampoules is within an appropriate range to prevent the breaking force from being too large or too small, which makes the ampoules difficult to open or prone to breakage during use or transportation.
(3) Capacity deviation - verified through marked capacity and full mouth capacity tests. For glass containers with capacity requirements, the detection of capacity deviation performance can prevent the problem of insufficient or excessive doses of the packaged drugs due to large capacity deviation.
(4) Ease of use - verified through tests such as puncture force, sealing and puncture device retention, opening force, and tearing force. For glass container stoppers or caps that need to be punctured, they need to have appropriate puncture force, such as injection bottles sealed with rubber stoppers. For pharmaceutical packaging that is not a single dose or needs to be inverted after puncture, the puncture site should also be well sealed, such as the bottle stopper of an infusion bottle. For containers that need to remove the stopper or bottle cap, they need to have appropriate opening force or tearing force depending on the opening method, such as aluminum caps.
For more details please visit www.linktesting.org
