nutritional supplement bottle

The compatibility test between the nutritional supplement bottle and the health care product is an experiment conducted to investigate whether migration or adsorption between the health care product bottle and the health care product occurs, thereby affecting the quality of the drug.

First, Establishment of compatibility test method When investigating health care product bottles, three batches of health care product bottles should be used to conduct compatibility tests on a batch of drugs to be packaged; when inspecting drugs, three batches of drugs should be used. The compatibility test is carried out after packaging in a batch of materials or containers to be packaged. When conducting a compatibility test between a health care product bottle and a drug, a test method can be established by referring to the quality standard of the drug and the health care product bottle or container.

PET transparent bottle for supplements

Second, the conditions of the compatibility test 1, the light test The use of light-proof or light-shielding health care products bottles or containers of drugs should be subjected to strong light exposure test. Place the test sample in a light box equipped with a fluorescent lamp or other suitable light device, and place it for 4 days under the condition of 4500 lx±500 lx. Sample on the 5th day and the 10th day, and focus on compatibility. Project, testing.

2. Accelerated test The test sample is placed at a temperature of 40 ° C ± 2 ° C, relative humidity of 90% ± 10% or 20% ± 5% for 6 months, respectively, at 0, l, 2, 3, 6 Take out and test for months. The temperature-sensitive drug can be tested after being placed for 6 months at a temperature of 25 ° C to 2 ° C and a relative humidity of 60% ± 10%. For drugs packaged in semi-permeable containers, to predict the effectiveness of the package for drug protection, the drug's expiration date is presumed.

3. Long-term test The test sample is placed in a constant temperature and humidity chamber with a temperature of 25 °C ± 2 °C and a relative humidity of 60% ± 10%. It is placed for 12 months, at 0, 3, 6, 9, and respectively. Take out the month and test it. After 12 months, it is still necessary to continue the investigation according to the relevant regulations, and take them out at 18, 24, and 36 months to test to determine the impact of packaging on the drug's expiration date. Temperature-sensitive drugs can be placed at 6 ° C at 2 ° C.

healthcare bottle

4, special requirements to place the test sample at a temperature of 25 ° C ± 2 ° C, relative humidity of 20% ± 5% or temperature of 25 ° C ± 2 ° C, relative humidity of 90% ± 10%, placed 1, 2, 3 , 6 months. The main objects of this test are liquid preparations such as eye drops, injections, suspensions, etc., and solid preparations of aluminum-plastic blister packs, to check whether moisture will escape or penetrate into the packaging container. 5. Process requirements Throughout the test, the drug and drug packaging containers should be in full contact and simulate actual use. 6. When necessary, the compatibility of the use process should be examined.