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Microbial Limit Testing of Effervescent Tube Caps

Sep 26 , 2022

Effervescent tube is a kind of packaging form with special structure design. It consists of two parts: a cover and a tube body. It is mostly used for tablets, capsules and other drugs that need moisture-proof preservation. In the quality standard of packaging, the microbial limit is an important test item.

Requirements for the moisture content of the desiccant in the effervescent tube

144mm*29mm effervescent tube packaging

Requirements for the moisture content of the desiccant in the effervescent tube

caps for effervescent tube

The quality standard for effervescent tube caps is based on the "YBB00172004-2015" standard for oral solid medicinal low-density polyethylene moisture-proof combined bottle caps. The standard has a detailed description of the detection method of microbial limit, as follows:

Take a few pieces of this product, in a sterile environment, slightly dampen a sterile cotton swab with sodium chloride injection, wipe the bottle cap, wipe each bottle cap with 2 cotton swabs, and cut each cotton swab immediately after wiping (or Burn off), put it into a test tube containing 10ml of sodium chloride injection, shake and mix well, and then get the test solution. Take the test solution for membrane filtration and check according to the law (General Rules 1105 and 1106 of the Chinese Pharmacopoeia 2015 Edition). The cover cannot be detected.

The above is the microbial limit test of the lid of the effervescent tube. The main purpose of controlling this indicator is to prevent the microorganisms in the package from contaminating the drug and bringing the risk of medication to the patient.

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