This part of JB / t20002 ampoule Pharmaceutical filling and sealing machine revises JB 20002.4-2004 ampoule filling and sealing machine according to the requirements of "good manufacturing practice for drugs" and GB / T l.l-2009 "guidelines for standardization Part 1: structure and compilation of standards".
JB / T 20002 "ampoule washing, drying, filling and sealing linkage line" consists of the following four parts:
—JB / T 20002.1 "ampoule washing, drying, filling and sealing linkage line";
—JB / T 20002.2 "vertical ultrasonic cleaning machine for ampoules";
—JB / T 20002.3 "ampoule tunnel sterilization dryer";
—JB / T 20002.4 ampoule filling and sealing machine.
This part is the fourth part of JB / T 20002.
This part replaces IB 20002.4-2004 ampoule filling and sealing machine.
Compared with JB 20002.4-2004, the main changes are as follows:-
—The original standard is edited and modified according to GB / T 1.1-2009;
—The qualified rate of ampoule sealing increased from 98% to 99%;
—The 100 level laminar flow velocity of the filling and sealing machine is changed from 0.35 RN / s to 0.36 M / s-0.54 M / s;
—The requirement of filling accuracy is increased.
This part is proposed by China Pharmaceutical Equipment Industry Association.
This part is under the jurisdiction of SAC / TC356.
Drafting unit: Shanghai Far East Pharmaceutical Machinery Co., Ltd.
The main drafters of this part are Huang chenyin and Yu Aiying.
The previous versions of the standards replaced by this part are as follows:
Range of ampoule Pharmaceutical filling and sealing machine
This part of JB / T 20002 specifies the type marking, requirements, test methods, inspection rules and marks, operation instructions, packaging, transportation and storage of ampoule filling and sealing machine.
This part is applicable to ampoule filling and sealing machine (hereinafter referred to as filling and sealing machine)