This indicator is not enough,medicines are contaminated every minute

Medicine is an indispensable item in daily life and has high requirements for microbial limits. If drugs are contaminated, it will inevitably cause certain economic losses to pharmaceutical companies. Therefore, the microbiological limit test of drugs is very important. As high-density polyethylene bottles in common pharmaceutical packaging, the microbial limit test cannot be ignored.

hdpe bottle for pharmaceutical

The Chinese Pharmacopoeia stipulates that in addition to the sterility inspection of injection preparations and infusions, other non-specified sterilized preparations and their raw and auxiliary materials have a certain limit of microbiological inspections, and it is stipulated that there must be no control bacteria. High-density polyethylene bottles are widely used in pharmaceutical packaging, mainly for the packaging of solid or liquid preparations. If the microbiological limit of the pharmaceutical packaging does not meet the requirements, it is easy to cause drug contamination.

According to the 2015 edition of the Chinese Pharmacopoeia General Rules 1105 and 1106, the high-density polyethylene bottle adopts the following detection method: take a number of samples, add chlorinated injection of 1/3 of the labeled volume, close the cap tightly, and shake for 1 minute. The test solution. After the test solution is subjected to membrane filtration, it shall be inspected in accordance with the law. The number of bacteria must not exceed 1000 cfu per bottle, the number of molds and yeasts must not exceed 100 cfu per bottle, and each bottle of Escherichia coli must not be detected.

The microbial limit of child proof bottles is related to whether medicines will be contaminated. If medicines are contaminated by microorganisms, their active ingredients will be destroyed and their effectiveness will be lost. If contaminated drugs flow into the hands of patients, it will cause serious consequences, and the image of pharmaceutical companies will also be affected. Therefore, pharmaceutical companies must pay attention when choosing drug packaging.