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The sealing integrity of drug packaging materials is a mandatory physical indicator written into the drug packaging
material standards and national drug use standards, and it is also a concern for pharmaceutical manufacturers and
drug packaging material enterprises. Because the sealing performance of drug packaging materials is related to the
quality and safety of drugs. If the sealing performance does not meet the standard, external moisture and other
substances will enter the packaging material and come into contact with the internal drugs, causing the drugs to
become damp, ineffective, or even spoiled, endangering the patient's health. Therefore, drugs must have intact sealed
packaging throughout their entire shelf life, and drug packaging materials must undergo professional and rigorous
sealing performance testing. Testing the sealing performance of drug packaging materials is to test the sealing reliability
of flexible packaging, packaging bottles, etc. Through this test, it can ensure that the entire product packaging is sealed
completely without leakage. In the pharmaceutical industry, it is essential to conduct sealing tests on the packaging of
various drugs produced, which will directly determine whether the quality of the drugs meets the standards and whether
they will pose a threat to human safety.
So, what are the materials that need to be tested for sealing in drug packaging?
There are many drugs in the pharmaceutical industry that need to be tested for packaging sealing, and the common ones
are the following three categories:
Sealed containers: penicillin bottles, ampoules, syringes, oral liquids, sterile bags, infusion bags/bottles, water injections,
powder injections, BFS bottles, API bottles, BPC bottles, FFS bottles, and other sealed containers of any shape, material, or size.
2. Bubble wrap packaging: Samples of powders, tablets, capsules, contact lenses, etc. packaged in bubble wrap form.
3. Small headspace packaging: Packaging with extremely small headspace, such as granule packaging and low-dose powder
packaging.
In addition, there are sterile products and cooking bags in the field of medical equipment.
With the increasing standardization of drug packaging material management, the sealing of drug packaging materials must
refer to relevant national drug packaging material testing standards, such as: GB/T 15171、ASTM D3078、GB/T 27728、
YBBOOl12002-2015、YBB00122002-2015、YBB00262002-2015, Use professional pharmaceutical packaging sealing testing
equipment.
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