Lyophilizer,Low Refrigerator-Shanghai Toffon machinery equipment Co., Ltd.

Home > News > Industry News

Performance Test Of Aseptic Manufacturing System

Performance Test Of Aseptic Manufacturing System


(1)Experimental Purpose

   Drugs prepared with a pharmaceutical freeze dryer are called lyophilized drugs and usually are sterile drugs. It is unsafe if only the sterility test qualified of drug sampling is required. Especially, the entire manufacturing process is sterile and the freeze-dried products without moist hot sterilization are all the more so in the end. In order to ensure that the product has good quality, it is far from enough only to rely on sampling method if you want to make a sterile judgement on a batch of products. The detection rate of microbe obtained by the maximum probability method is very limited.

(2)Verification Method

   Usually, choosing tryptic soy broth medium, adding 1L injection water to every 30g according to the proportion, configuring a sufficient amount of filling medium, operating according to actual production process conditions and aseptic filling of required containers and filling volumes, in order to ensure sufficient amount of medium to contact the inner surface of the container and observe the growth of microorganisms conveniently.

(3)Sampling Principle

   Because the medium aseptic filling simulation experiment is the practical considerations of asepsis room production environment, equipment and utility facilities condition. In order to check the whole process of aseptic filling simulation experiment, sampling and carrying out random. If the filling process lasts for a full day, the sampling shall be divided into 4 periods: at the beginning in the morning, at the end in the morning, at the beginning in the afternoon, at the end in the afternoon.

(4)Judgment Standard

   The filling result of the medium is the basis for judging whether the aseptic process validation meets the requirements. The correct understanding of the verification standard is the key factor to make a scientific assessment of the verification results. The United States(USP24) has a definite requirement for the probability of contamination of sterile drugs.

Terminally sterilized drugs: The level of sterility shall not be less than 10^-6,that is ,the probability of contamination shall not exceed 1%.

Aseptic filling drugs: The level of sterility shall not be less than 10^-3,that is ,the probability of contamination shall not exceed 0.1%.

(5)Proposed revalidation type: According to the WTO GMP requirement, two times a year.

Shanghai Toffon Machinery Equipment Co.,Ltd.      Lyophilizer: www.tuffun.cn


Powered by MetInfo 5.3.19 ©2008-2021 www.metinfo.cn