Technical requirements for plastic bottles for medicinal use

Technical requirements for plastic bottles for medicinal use. Pharmaceutical plastic bottles are generally made of PE, PP, PET and other materials, which are not easily damaged, good sealing performance, moisture-proof, sanitary, and meet the special requirements of drug packaging. They can be directly used for drug packaging without cleaning or drying, and are excellent pharmaceutical packaging containers. Widely used for oral solid drugs (such as tablets, capsules, granules, etc.) and oral liquid drugs (such as syrup, tincture of water, etc.) packaging, compared with other plastic hollow packaging containers for medicinal plastic bottles have many special places.

Medical plastic bottle

1. Appearance quality of medical plastic bottles: Oral solid medical bottles are generally white.

Oral liquid medicine bottles are generally brown or transparent, and can also be produced according to customer requirements of other colors of products, color should be uniform, no obvious color difference, surface should be smooth, smooth, no obvious deformation and scratches, no trachoma, oil, air bubbles, bottle mouth should be smooth.

2, identification (1) infrared spectrum: the infrared spectrum of the material used in the product should be consistent with the control map. (2) Density: The density of medical plastic bottles is: oral solid and liquid high-density polyethylene bottles should be 0.935 ~ 0.965 (g/cm³) Oral solid and liquid polypropylene bottles should be 0.900 ~ 0.915 (g/cm³) Oral solid and liquid polyester bottles should be 1.31 ~ 1.38 (g/cm³)

3, sealing: vacuum to 27KPa, maintain for 2 minutes, no water or bubbling in the bottle.

4. The weight loss of oral liquid medicine plastic bottles shall not exceed 0.2% according to the test conditions; the water vapor permeability of oral solid medicine plastic bottles shall not exceed 1000mg/24h · L according to the test conditions.

5. The fall resistance falls naturally to the horizontal rigid smooth surface according to the test conditions, and shall not be broken. This test is limited to oral liquid pharmaceutical plastic bottles.

6. Shock test This test is limited to oral solid medicinal plastic bottles, which should be qualified according to the test conditions.

7, burning residue according to the test method (Pharmacopoeia of the People’s Republic of China, 2000 edition, Appendix ⅷ N, Part II) test, residual residue shall not exceed 0.1% (bottle containing sunscreen burning residue shall not exceed 3.0%).

8, acetaldehyde as determined by gas chromatography (Pharmacopoeia of the People’s Republic of China, 2000, Appendix VE), acetaldehyde must not exceed 2 parts per million, this test is limited to polyester plastic bottles for medicinal purposes.

9. Dissolution test preparation of dissolution test solution according to the requirements of the standard, oral liquid pharmaceutical plastic bottles for solution clarity, heavy metals, PH change, UV absorption, easy oxides, no volatile substances test, the results should meet the standard requirements; Oral solid medicinal plastic bottles should only be tested for easy oxides, heavy metals and no volatiles, and the results should also meet the requirements of the standard.

1O, decolorization test colouring bottle should be tested according to the standard requirements, the color of the immersion solution shall not be painted on the blank solution.

11, microbial limit according to the standard requirements and microbial limit method (Pharmacopoeia of the People’s Republic of China 2000 version ⅺ Appendix J1 determination, oral liquid medicinal plastic bottles of bacteria, mold, yeast each bottle shall not be more than 100, Escherichia coli shall not be detected; The number of bacteria in plastic bottles for oral solid medicine shall not exceed 1000, the number of mold and yeast shall not exceed 100, and the number of Escherichia coli shall not be detected.

12, abnormal toxicity according to the standard and according to the law (Pharmacopoeia of the People’s Republic of China 2000 version II Appendix ⅺ C) test, should be in accordance with the provisions. The above items according to the standard provisions of the inspection rules, and the matching bottle cap can be selected according to the needs of different materials, according to the standard in the dissolution test, abnormal toxic community project test, and should comply with the provisions under the relevant. The project shall be tested and shall comply with the provisions under the relevant item.