You are here: HomeNews
News Video

The standard of HDPE bottle

Carrie Apr 08,2019 Share this post:

HDPE bottle refers to a medicinal high-density polyethylene bottle produced by a blow molding process using polyethylene as a main raw material. The quality standards can refer to the quality standards of oral solid pharmaceutical high-density polyethylene bottles and oral liquid pharmaceutical high-density polyethylene bottles.

HDPE bottle

The quality standards for hdpe bottles are as follows:

1. Appearance The color is uniform and uniform, no obvious color difference; the surface is smooth, the voucher, the pentagon and the obvious scratches; no blisters, oil stains, air bubbles; the bottle mouth is smooth and smooth.

2, sealing, immersed in water, vacuumed to 27 kPa, maintained for 2 minutes, no water or bubbling in the bottle

3, the burning residue Take this product 2.0g, according to the law (Chinese Pharmacopoeia 2015 version of the General Rules 0841), the residual residue should not exceed 0.1% (the residual residue of the bottle containing sunscreen should not exceed 3.0%).

4. Microbial limit The number of bacteria should not exceed 1000cfu per bottle. The number of mold and yeast should not exceed 100cfu per bottle. Escherichia coli should not be detected.

5, abnormal toxicity can not be detected According to the law (Chinese Pharmacopoeia 2015 Edition General 1141), should comply with the regulations.

Previous: The stability test way of horse syringe

Next: Polyethylene bottles and polyethylene classification

We're here to help!