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Table 1 Raw material and formula for raw materials for polyethylene injection blown hollow bottles (part) Polyethylene (5006S) 100 Calcium carbonate filler 5 Masterbatch (titanium dioxide) 1 (0.8) Zinc stearate 1 Medicinal The main technical indicators of plastic bottles Currently there is no national standard for the production of plastic bottles as a guide, usually followed by the pharmaceutical industry standard ---- "solid pharmaceutical polyolefin plastic bottles", this standard applies to non-aromatic packaging, Non-greased, non-volatile and easily oxidized solid drugs (tablets, capsules, and preparations) plastic bottles, the main technical indicators are as follows:
Appearance quality requirements: the appearance of medicinal plastic bottles should have a uniform milky white color, there must be no obvious color difference, the bottle surface should be smooth, smooth, does not allow deformation and obvious scratches, does not allow any trachoma, oil bubbles, bottles The mouth should be smooth and smooth.
Physical performance requirements: See Table 2 for the main technical specifications of the physical properties of medicinal plastic bottles.
Item Index Sealability No Leakage Oscillation Allowed Leakage Water Vapor Permeability 100mg/24h L
Chemical performance requirements: Chemical properties of medicinal plastic bottles Main technical indicators Table 3 Chemical properties Main technical indicators Item index Reduced substance consumption O.02mol/L Potassium permanganate solution <1.0 ml Othmium heavy metal ≤ 1.0 ppm Water immersion fluid ≤ 12.0 Mg ethanol leaching solution ≤50.0Mg hexane leaching solution ≤75.0Mg
Bacteria test index: The total number of bacteria in plastic bottles less than 100 ml shall not exceed 1500/bottle, and the total number of moulds shall not exceed 150 pcs/bottle. 100 to 250 ml plastic bottles The total number of bacteria shall not exceed 3,000/bottle More than 250 mL of plastic bottles The total number of bacteria shall not exceed 3500/bottle, the total number of moulds must not exceed 350/bottle. All specifications of plastic bottles must not be detected E. coli abnormal toxicity: medicinal plastic bottles need no abnormal toxicity.
Plastic bottle material, formula and technical indicators
The main raw materials and formulas of plastic medical bottles are generally. A variety of thermoplastic plastics such as PE, PP, Pc, etc. can be used as raw materials for injection blown hollow medicine bottles. However, the current production is mostly polyolefin plastic bottles for solid drug packaging. The bottle is made of high-density polyethylene resin or polypropylene, and is made by adding masterbatch (or titanium dioxide), calcium carbonate filler, and zinc stearate. Taking high-density polyethylene resin (5000S) as an example, its main raw materials and recipes are shown in Table 3.