Drugs and packaging need to do compatibility test first, such as our product 10cc syringe for cockroach. When inspecting the drug packaging materials, the container made of three batches of packaging materials should be used for the compatibility test of a batch of drugs to be packaged: when inspecting the drugs, three batches of drugs should be selected for packaging with a batch of materials or containers to be packaged. After the compatibility test. When the compatibility test between the drug package and the drug is carried out, the test method can be established with reference to the quality standard of the drug and the packaging material or container.
I.llumination test
Strong light exposure tests shall be carried out on medicines packed in light-proof or light-shielding packaging materials or containers. Place the test sample in a light box equipped with a fluorescent lamp or other suitable light device, place it for 10 days, and illuminate the test. Place the test sample in a light box equipped with a fluorescent lamp or other suitable light device, and place it for 10 days. The illumination condition is: 45001x±5001x, sample on the 5th day and the 10th day, and check the items according to the key items.
2. Accelerated test
Place the test sample in a constant temperature and humidity chamber with a temperature of 40 °C ± 2 °C and a relative humidity of 90% ± 10% or 20% ± 5% for 6 months, respectively at 0, 1, 2, 3, and 6. Take out the month and test it. Temperature-sensitive drugs can be tested after being placed for 6 months at 25 °C ± 2 °C and relative humidity of 60% ± 10%. It is used to predict the effectiveness of packaging for drug protection and to estimate the expiration date of the drug.
3. Long-term test
The test sample was placed in a constant temperature and humidity chamber at a temperature of 25 ° C ± 2 ° C and a relative humidity of 60% ± 10%, and was placed for 12 months, and taken out at 0, 3, 6, 9, and 12 months for testing. After 12 months, it is still necessary to continue to investigate according to the relevant regulations, and take them out in 18, 24, and 36 months to conduct tests to determine the impact of packaging on the effective period of the drug. Temperature sensitive drugs can be placed at 6 °C ± 2 °C.
What should we pay more attention on choosing plastic pharma bottle
View More >How Can Plastic Vitamin Tube Keep Dry Environment
View More >Effervescent Tube with Spiral Desiccant Closure
View More >Copyright © Shijiazhuang Xinfuda Medical Packaging Co., Ltd. All Rights
MAKE AN ENQUIRY