C92 制药加工机械与设备 标准查询与下载

JB/T 20149-2012 抗生素玻璃瓶/安瓿两用洗烘灌封联动线

本标准规定了抗生素玻璃瓶/安瓶两用洗烘灌封联动线的标记，要求，试验方法，检验规则，标志、使用说明书、包装、运输和储存。 本标准适用于抗生素玻璃瓶/安瓶两用洗烘灌封联动线（以下简称联动线）。

Synchronized combi-filling line for antibiotic vial and ampoule

JB/T 20030-2012 多效蒸馏水机

本标准规定了多效蒸馏水机的标记，要求，试验方法，检验规则，标志、使用说明书、包装、运输和储存。 本标准适用于以蒸汽为热源的列管式多效蒸馏水机（以下简称：蒸馏水机）。

Multi-effect water distiller

ASTM D7709-12 医药瓶和泡罩水蒸气透过率(WVTR)测量的标准试验方法

The purpose of these test methods is to obtain reliable values for WVTR that can be used to discriminate among barrier packages for pharmaceutical products. These test methods will establish a WVTR value that represents the water vapor transmission of the container closure system being evaluated. They are intended for use in evaluating or comparing, or both, the water vapor barrier performance of alternative packages for use in packaging of pharmaceutical products. While these methods were developed for a specific, limited application, they should be suitable for most types and sizes of consumer packages.1.1 The three test methods described herein are for measurement of water vapor transmission rates (WVTRs) of high-barrier multiple-unit containers (bottles), high-barrier single-unit containers (blisters), and quasi-barrier single-unit containers used for packaging pharmaceutical products. The containers are tested closed and sealed. These test methods can be used for all consumer-sized primary containers and bulk primary containers of a size limited only by the dimensions of the equipment and the weighing capacity and sensitivity of the balance. 1.2 These test methods are intended to be of sufficient sensitivity and precision to allow clear discrimination among the levels of barrier packages currently available for pharmaceutical products. 1.3 There are three methods: Method A is for bottles, Method B is for formed barrier blisters, and Method C is for formed quasi-barrier blisters. Methods B and C can be adapted for use with flexible pouches. 1.4 These test methods use gravimetric measurement to determine the rate of weight gain as a result of water vapor transmission into the package and subsequent uptake by a desiccant enclosed within the package. The packages are exposed to environments typical of those used for accelerated stability testing of drug products in the package (typically 40°C/75 % relative humidity [RH]). 1.5 For these methods, balance sensitivity, amount of desiccant, number of blisters per test unit, and weighing frequency were developed in an experiment based on Test Methods E96/E96M. 1.6 Test Methods E96/E96M gives specific instruction on the interactions among weighing frequency, number of data points necessary to establish steady state, minimum weight gain in a weighing period, and balance sensitivity. 1.7 The test methods in this standard were developed specifically for pharmaceutical bottles and blisters as closed container-closure systems. The experiment from which the methods were developed provided an inter-laboratory study from which the precision and bias statement was written. The packages in the study were small bottles and blisters used regularly for pharmaceutical solid oral dosage forms. 1.8 In spite of the specific nature of their application, the test methods in this standard should be suitable for other pharmaceutical packages and most types and sizes of other consumer packages. 1.9 The values stated in SI units are to be regarded as the standard. No other units of measurement are included in this standard. The units of measure for bottles are milligrams per bottle per day (mg/bottle-day) and for blisters, milligrams per blister cavity per day (mg/cavity-day). These units may be used for both standard and referee testing. 1.10 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and ......

Standard Test Methods for Measuring Water Vapor Transmission Rate (WVTR) of Pharmaceutical Bottles and Blisters

JB/T 20140-2011 电加热多效蒸馏水机

本标准规定了电加热多效蒸馏水机的标记、要求、试验方法、检验规则和标志、使用说明书、包装、运输、储存。 本标准适用于电加热多效蒸馏水机。

Electric heating multiple effect distillation

JB/T 20001-2011 注射剂灭菌器

本标准规定了注射剂灭菌器的术语和定义、分类和标记、要求、试验方法、检验规则、标志、使用说明书、包装、运输和贮存。 本标准适用于需要最终灭菌的液体类注射剂灭菌器。

Sterilizer of parenteral

JB/T 20142-2011 玻璃输液瓶洗灌塞封一体机

本标准规定了玻璃输液瓶洗灌塞封一体机的型号和标记、要求、试验方法、检验规则和包装、使用说明书、标志、运输、储存。 本标准适用于50mL-500mL的集玻璃输液瓶的精洗、灌装、塞封于一机的玻璃输液瓶洗灌塞封一体机。

Integrated machine of washing,filling and sealing for glass infusion bottle

JB/T 20002.2-2011 安瓿立式超声波清洗机

JB/T 20002的本部分规定了安瓿立式超声波清洗机的标记、要求、试验方法、检验规则和标志、使用说明书、包装、运输、储存。 本部分适用于安瓿立式超声波清洗机。

Ampoule vertical ultra-sonic cleaning machine

JB/T 20002.3-2011 安瓿隧道式灭菌干燥机

JB/T 20002的本部分规定了安瓿隧道式灭菌干燥机的型号标记、要求、试验方法、检验规则和标志、使用说明书、包装、运输、储存。 本部分适用于安瓿隧道式灭菌干燥机。

Ampoule tunnel sterilizing dryer

JB/T 20002.4-2011 安瓿灌装封口机

JB/T 20002的本部分规定了安瓿灌装封口机的型号标记、要求、试验方法、检验规则和标志、使用说明书、包装、运输、储存。 本部分适用于安瓿灌装封口机。

Ampoule filling and sealing machine

JB/T 20014-2011 药用流化床制粒机

本标准规定了药用流化床制粒机的分类和标记、要求、试验方法、检验规则和标志、使用说明书、包装、运输、储存。 本标准适用于药用流化床制粒机。

Fluid bed granulator for pharmaceutics

JB/T 20072-2011 离心式制粒包衣机

本标准规定了离心式制粒包衣机的术语和定义、分类和标记、要求、试验方法、检验规则和标志、使用说明书、包装、运输、储存。 本标准适用于离心式制粒包衣机，也适用于离心式制丸机。

Centrifugal granulating and coating machine

JB/T 20141-2011 电加热纯蒸汽发生器

本标准规定了电加热纯蒸汽发生器的标记、要求、试验方法、检验规则和标志、使用说明书、包装、运输、储存。 本标准适用于电加热纯蒸汽发生器。

Electric heating ultra-pure pyrogen-free steam generater

JB/T 20002.1-2011 安瓿洗烘灌封联动线

JB/T 20002的本部分规定了安瓿洗烘灌封联动线的型号标记、要求、试验方法和检验规则。 本部分适用于安瓿洗烘灌封联动线。

Ampoule cleaning-drying and filling-sealing production line

JB/T 20135-2011 安瓿注射液异物自动检查机

本标准规定了安瓿注射液异物自动检查机的标记、要求、试验方法、检验规则和标志、使用说明书、包装、运输、储存。本标准适用于检测安瓿注射液中粒径或长度大于或等于50μm可见异物的安瓿注射液异物自动检查机(以下简称检查机)。

Automatic ampoule injection impurity detecting machine

JB/T 20016-2011 滚筒式包衣机

本标准规定了滚筒式包衣机的分类和标记、要求、试验方法、检验规则和标志、使用说明书、包装、运输、储存。本标准适用于对片剂、丸剂包衣的滚筒式包衣机(以下简称包衣机)。

Rotary-drum coating machine

JB/T 20138-2011 药用高纯度制氮机

本标准规定了药用高纯度制氮机的术语和定义、标记、要求、试验方法、检验规则和标志、包装、使用说明书、运输、储存。本标准适用于采用分子筛变压吸附法,制取含氮量不低于99.999%纯度氮气的药用高纯度制氮机(以下简称制氮机)。

Medical high-purity nitrogenerator

JB/T 20133-2010 中药煎药机

本标准规定了中药煎药机的术语和定义、型号和标记、要求、试验方法、检验规则和标志、使用说明书、包装、运输与储存。 本标准适用于设计压力小于0.1MPa的中药煎药机(以下简称煎药机),也适用于煎药和包装一体机的煎药部分。

Decocting machine of Chinese herbal

JB/T 20134-2010 药用料斗提升机

本标准规定了药用料斗提升机的术语和定义、型号标记、要求、试验方法、检验规则、标志、使用说明书及包装、运输和储存。 本标准适用于提升质量小于1000 kg的药用料斗提升机(以下简称提升机)。

Pharma popper lifter

DB35/T 1010-2010 卷式膜过滤设备

本标准适用于食品饮料、制药等行业，对经过预处理、颗粒粒径不大于25μm的澄清料液，采用卷 式膜进行分离纯化、脱色、脱盐或浓缩的处理设备。

Roll membrane filtration equipment

JB/T 20027-2009 滚模式软胶囊压制机

本标准规定了滚模式软胶囊压制机的术语和定义、分类与标记、要求、试验方法、检验规则、标志、使用说明书、包装、运输和储存。 本标准适用于滚模式软胶囊压制机(以下简称"软胶囊机")。

Film rolling soft capsule encapsulating machine