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The test of sterility and abnormal toxicity of preperfusion syringes
Author:Admin Source: Time:20-04-17 21:55:52 Views:

The syringe is composed of a needle tube, a cap, a push rod or a piston. The test of sterility and abnormal toxicity of preperfusion syringes are two important indexes.


The test of sterility and abnormal toxicity of preperfusion syringes

Prefill the syringe


Test method for sterility of prefilling and sealing syringe:

(after sterilization) Take an appropriate amount of this product, add 1/2 of the labeled capacity of sodium chloride injection, cover the piston and tube cap, oscillate for 1 minute, and combine the extract. The extracted liquid was inoculated into 2 tubules (9ml per tube) of thioglycolate fluid medium (TG), 0.2ml per tube. One was cultured at 35 ~ 37℃ and the other at 23 ~ 25℃. Another TSB tube (7ml per tube) was inoculated with 0.2ml, cultured at 23-25 ℃, and checked by sterility test (Appendix 3306, Part 3, 2015 Edition of Veterinary Pharmacopoeia of the People's Republic of China), which should meet the requirements.

Abnormal toxicity test of prefilling and sealing syringe:

Take this play, only after the needle cleaned with water, cut up, take 500 cm2 (surface area) within, add sodium chloride injection 50 ml, buy high pressure steam sterilizer 110 ℃ after 30 minutes, cooling backup, do blank with each batch of sodium chloride injection, intravenous injection, inspection in accordance with the law (the law of the People's Republic of China veterinary drug Canon "general principles of the 2015 edition of 1111), should comply with the rules.

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