Source: Link Testing Instruments Co.,Ltd
How to solve the problem that the stopper of an infusion bottle or infusion bag is difficult to puncture?
Quality problem:
The mouth of some infusion bottles or bags is not easy to puncture, which affects the use. Cause analysis:
(1) Packaging material • The puncture resistance of the bottle stopper or bag mouth is too strong - the hardness or thickness of the bottle stopper or bag mouth material is too high, which may cause excessive puncture resistance, resulting in excessive puncture force, affecting normal use.
(2) Injection needle • Poor puncture ability of the injection needle - The injection needle used has poor rigidity, is easy to bend, or the sharpness of the needle tip is poor (there are burrs or hooks and other undesirable phenomena), resulting in difficulty in puncture.
Expert advice:
- Pay attention to the monitoring of the main performance such as the puncture force of the bottle stopper or bag mouth and the puncture force of the needle tip of the injection needle.
- On the basis of ensuring sealing and anti-drop properties, choose bottle stopper or bag mouth materials with appropriate hardness and good elasticity. - Improve the firmness of the injection needle and the sharpness of the needle tip. The needle tip should not have burrs or hooks and other quality problems.
Typical quality cases:
- Test samples: polypropylene bottles for infusion (a manufacturer of anti-inflammatory liquid medicine reported that the mouth of its infusion bottle was not easy to puncture).
- Targeted test items: puncture force at the puncture site of the infusion bottle.
- Test results: The puncture force at the mouth of the infusion bottle was 88.23N (using a metal puncture device). The results showed that this puncture force exceeded the puncture force index requirements for polypropylene bottles for infusion in the national drug package standard, affecting later use. It is recommended to reduce the hardness of the bottle mouth by improving the process to increase its elasticity and softness.
Why do hard sheets used in blister packaging delaminate?
Quality issues:
The composite hard sheets used in blister packaging often delaminate during use. Cause analysis:
- Packaging materials • Adhesive has poor heat resistance
- If the heat resistance of the adhesive used in the composite hard sheet is poor, delamination is likely to occur when heat-sealed with the pharmaceutical aluminum foil. • Improper control of the production process of blisters
- Different materials have different tensile properties, especially the tensile properties of aluminum foil and plastic film are quite different. The elongation of aluminum foil is low, while the elongation of plastic film is high. If the production process of blisters on hard sheets is not properly controlled, delamination is likely to occur due to the elongation of each layer of material.
Expert advice: -- Pay attention to the monitoring of the peel strength performance of composite hard sheets. -- Reasonably adjust the production process of composite hard sheets.
What should I do if medicines packaged in plastic composite film have an odor?
Quality problem:
Drugs wrapped in plastic composite film packaging bags have a pungent odor that is not the drug itself.
Cause analysis:
—Packaging materials • Improper control of the brushing process-When printing, the ink needs to be dissolved in an organic solvent (alcohols, ketones, esters, benzene) before printing. If the printing process is not properly controlled, the organic solvent is not fully volatilized and remains in the packaging material. After being used to package drugs, it slowly migrates into the drugs, causing the drugs to have odors. • Improper control of the composite process
—Before packaging composite, the adhesive needs to be dissolved in an organic solvent and then composited, and then the organic solvent is volatilized through subsequent processes. If the composite process is not properly controlled, some solvents will remain in the packaging bag, which will cause drug contamination after being used to package drugs. • Poor quality of raw materials
—The quality of the raw material resin or small molecular substances added for packaging is poor, and the content of small molecular substances with odor is high. • Poor quality of adhesive
—If the quality of the composite adhesive is poor, it is easy to produce toxic substances such as toluene diamine under high temperature conditions.
Expert advice: - Pay attention to the monitoring of the hygienic properties of packaging materials such as solvent residue, toluene diamine content, and non-volatiles. - Select appropriate inks (such as solvent-free inks) and adhesives, and adjust the volatilization and drying process parameters during printing and lamination.
Typical quality cases: - Test samples: a plastic composite film for granule packaging (customers reported that they smelled a strange smell when opening the package after heat sealing). - Targeted test items: solvent residue. - Test results: The total amount of solvent residue in the composite film was 6.8 mg/m2, of which benzene solvents were 1.2 mg/m2. The total amount of solvent residue and the amount of benzene solvents were both high. The odor was mainly caused by the high amount of solvent residue.
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