GB/T 15692.1-1995Pharmaceutical machinery - Terms (English PDF)
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Issued by
State Administration for Market Regulation, China National Standardization Administration
Level / Type
National · Recommended
Issue date
May 28, 2024
Implementation date
December 1, 2024
Scope
GB/T 15692.1-1995 (Pharmaceutical machinery - Terms) is available as an English-translated PDF.
GB/T 15692.1-1995 — This document defines the terms and definitions for pharmaceutical machinery and equipment: This document applies to the design, manufacture, circulation, use and supervisory inspection of pharmaceutical machinery and equipment:
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Document preview — GB/T 15692.1-1995
National Standard of the People's Republic of China
- ICS
- 11.120.30
- Classification
- C 90
Issued by: State Administration for Market Regulation, China National Standardization Administration
Contents
- Preface
- 1 Scope
- 2 Normative references
- 3 General terms
- 4 API machinery and equipment
- 4.1 Reaction equipment
- 4.2 Tower equipment
- 4.3 Crystallization equipment
- 4.4 Separation machinery and equipment
- 4.5 Extraction equipment
- 4.6 Extraction and concentration equipment
- 4.7 Evaporation equipment and concentration equipment
- 4.8 Distillation equipment
- 4.9 Heat exchanger
- 4.10 Drying machinery and equipment
- 4.11 Storage equipment
- 4.12 Sterilization equipment
- 5 Preparation machinery and equipment
- 5.1 Granule Machinery
- 5.2 Tablet machinery
- 5.3 Capsule machinery
- 5.4 Powder injection machinery
- 5.5 Small volume injection machinery and equipment
- 5.6 Large volume injection machinery and equipment
- 5.7 Pill machinery
- 5.8 Suppository machinery
- 5.9 Ointment machinery
- 5.10 Oral liquid preparation machinery
- 5.11 Aerosol and spray machinery
- 5.12 Ophthalmic preparation machinery
- 5.13 Pharmaceutical film machinery
- 6 Medicinal grinding machinery
- 6.1 Mechanical pulverizer
- 6.2 Airflow mill
- 6.3 Grinding machinery
- 7 Decoction pieces machinery
- 7.1 Cleaning machinery
- 7.2 Cutting machinery
- 7.3 Roasting machinery
- 7.4 Medicinal material drying machinery
- 8 Water, gas (steam) equipment for pharmaceutical processes
- 8.1 Pharmaceutical process water equipment
- 8.2 Gas (steam) equipment for pharmaceutical processes
- 9 Pharmaceutical packaging machinery
- 10 Drug testing equipment
- 11 Other pharmaceutical machinery and equipment
- 11.1 Conveying machinery and equipment
- 11.2 Auxiliary machinery
- References
- Index
Foreword
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1: Structure and drafting rules for standardization documents" Drafting:
This document replaces GB/T 15692-2008 "Pharmaceutical Machinery Terminology": Compared with GB/T 15692-2008, except for the structural adjustment and compilation in addition to logical changes, the main technical changes are as follows:
--- Deleted the new product design confirmation, design confirmation, verification, installation confirmation, operation confirmation, performance confirmation, and standards for pharmaceutical machinery (equipment) 7 terms in operating procedures (see 2.2 to 2:8 of the:2008 edition);
---Deleted in-situ detection, fully automatic machine, semi-automatic machine, multi-function machine, integrated machine, linkage line, medicine, pharmaceutical excipients, lump materials, medicine 12 terms for packaging, pharmaceutical packaging, and filling (see 2.11 to 2:22 of the:2008 edition);
--- Deleted the five terms of sealing, bundling, printing, processing and mothering (see 2.25 to 2:29 of the:2008 edition);
--- Fluidized bed reactors, tower reactors, membrane reactors, tubular reactors, microtubular reactors, microchannel reactors and cell 7 terms for culture bioreactors (see 4.1:5 to 4:1:11);
--- Added three terms: bottle transfer machine, oscillator, and fermenter (see 4.1:12:2 to 4:1:12:4);
--- Deleted mechanical self-priming fermentation tank (see 3.1:5:4 of the:2008 edition);
--- Added fermentation system (see 4.1:12:5);
--- Deleted the terms immobilized cell fluidized bed fermenter and culture tank (see 3.1:5:11 and 3:1:5:12 of the:2008 edition);
--- Added two terms: packed tower and alcohol recovery tower (see 4.2:6, 4:2:7);
--- Deleted the terms random packed tower and structured packed tower (see 3.2:5 and 3:2:6 of the:2008 edition);
--- The internal circulation crystallizer has been changed (see 4.3:1:5, 3:3:1:4 of the:2008 edition);
--- Added centrifuge (see 4.4:1);
--- Deleted three-column centrifuge, upper unloading three-column centrifuge, lower automatic unloading three-column centrifuge, direct-connected three-column centrifuge 4 terms for machine (see:2008 edition, 3:4:1:1, 3:4:1:1:1~3:4:1:1:3);
--- Added centrifugal screening machine (see 4.4:1:1:4);
--- Changed the horizontal piston pusher centrifuge (see 4.4:1:1:5, 3:4:1:5 of the:2008 edition);
--- Added horizontal spiral unloading concentrating filter centrifuge (see 4.4:1:1:10);
--- Added magnetic suspension centrifuge (see 4.4:1:1:13);
--- Deleted three-column sedimentation centrifuge (see 3.4:2:1 of the:2008 edition);
--- Deleted refrigerated centrifuge (see 3.4:2:6 of the:2008 edition);
--- Deleted centrifugal separation machinery and equipment, manual slag butterfly separator, nozzle slag butterfly separator, ring valve slag butterfly separator Machine (see 3.4:3, 3:4:3:2~3:4:3:4 of the:2008 edition);
--- Added the term filter-washer-dryer (three-in-one) machine (see 4.4:2:3:1);
--- Deleted horizontal open flow plate and frame filter press, horizontal undercurrent plate and frame filter press, vertical undercurrent plate and frame filter press (see:2008 edition 3:4:4:3:2~3:4:4:3:4);
--- Added adsorption extrusion solid-liquid separator (see 4.4:2:3:4);
--- Deleted the three terms of rotary drum vacuum filter, rotary drum pressure filter and adsorption type rotary drum filter (see the:2008 edition 3:4:4:4:1~3:4:4:4:3);
---Added chromatography separation system, chromatography column, disposable chromatography system, liquid chromatography system, supercritical fluid chromatography system, continuous chromatography Spectral system, crystal filter 7 terms (see 4.4:2:7, 4:4:2:7:1~4:4:2:7:5, 4:4:2:8);
--- Deleted microporous membrane filter, ultrafine filter, nano filter, cartridge filter, vacuum cartridge filter, pressurized cartridge filter Element filter, vacuum cartridge filter, pressurized cartridge filter, other separation equipment, bag filter, sintered tube Dust collector, wire mesh dust collector 12 terms (see 3.4:4:6:1~3:4:4:6:3, 3:4:4:7, 3:4:4:7:1~3:4:4:6:3 :::
3:4:4:7:4, 3:4:5, 3:4:5:4~3:4:5:6);
--- Added 6 terms: vibrating screen, ultrasonic vibrating screen, circular vibrating screen, swing screen, rotary screen, horizontal air flow screen (see 4.4:3:1, 4:4:3:1:1, 4:4:3:1:2, 4:4:3:2, 4:4:3:4, 4:4:3:5);
--- Deleted the crushing vibrating screen (see 3.4:6:1 of the:2008 edition);
--- Added two terms: rotating distillation bed and detoxification system (see 4.4:9~4:4:10);
---Added static extraction tank, multifunctional extraction tank, basket extraction tank, continuous dynamic extraction tank, continuous countercurrent extraction unit, multi-stage countercurrent extraction unit, Reflux extraction unit, external circulation extractor, reflux extraction concentration unit, ultrasonic extraction concentration unit, as well as microwave and supercritical extraction 10 terms (see 4.6:1, 4:6:1:1, 4:6:1:2, 4:6:2:1 to 4:6:2:3, 4:6:2:5, 4:6:5, 4:6:6, 4:6:7);
--- Deleted the circulating fluidized bed adsorption device (see 3.5:4:2 of the:2008 edition);
--- Changed the shell and tube evaporator (see 4.7:1:1:2, 3:7:1:2 of the:2008 edition);
--- Added rotary tube evaporator (concentrator) (see 4.7:1:3:4);
--- Deleted heat pump evaporator (see 3.7:10 of the:2008 edition);
---Added thermal vapor recompression evaporator, mechanical vapor recompression evaporator, MVR falling film evaporator, MVR forced circulation evaporator 4 terms for transmitters (see 4.7:1:10, 4:7:1:11, 4:7:1:11:1, 4:7:1:11:2);
---Added double-effect external circulation concentrator, single-effect concentrator, double-effect concentrator, multi-effect concentrator, hot reflux concentrator, ultra-low temperature concentrator 7 terms for membrane concentrator and membrane concentrator (see 4.7:2:2 to 4:7:2:8);
--- Deleted external floating head heat exchanger and internal floating head heat exchanger (see 3.6:2:2:1 and 3:6:2:2:2 of the:2008 edition);
--- Added spiral tube heat exchanger (see 4.9:2:5);
--- Deleted coil heat exchanger, immersed coil heat exchanger, spray coil heat exchanger, umbrella plate heat exchanger, jacket heat exchanger 5 terms (see 3.6:4, 3:6:4:1, 3:6:4:2, 3:6:5:3, 3:6:5:4 of the:2008 edition);
--- Deleted air flow dryer, horizontal multi-chamber (continuous) fluidized bed dryer, internal heating fluidized bed dryer, vacuum vibration fluidized bed dryer Dryer, inert particle fluidized bed dryer, centrifugal spray dryer, pressure spray dryer, disc dryer, belt flap dryer 9 terms for dryers (see 3.9:1:1, 3:9:1:2:1, 3:9:1:2:2, 3:9:1:2:4, 3:9:1:2:5, 3:9:1:4:1, 3:9:1:4:2, 3:9:1:6:3, 3:9:1:6:4);
--- Deleted vertical flat bottom flat cover container, vertical flat cover no folded edge conical bottom container, vertical flat bottom conical cover container, vertical no folded edge spherical 6 terms: head container, vertical 90° folded conical bottom elliptical head cover container, vertical elliptical head container (see:2008 Version 3:10:1:1~3:10:1:6);
--- Deleted the four terms horizontal non-folded spherical head container, horizontal elliptical head container, vacuum storage container and thermal insulation storage container (see 3.10:2:1, 3:10:2:2, 3:10:3, 3:10:4 of the:2008 edition);
--- Added sterilizing filter (see 4.12:10);
--- Added weighing batching system, gravity mixer, hot melt extruder granulator, twin screw granulator, powder removal screen, stearic acid spraying device 8 terms (see 5.1:1, 5:1:2:2, 5:1:3:10, 5:1:3:11, 5:2:1:5, 5:2:1:6, 5:3:1:2, 5:5:5:2);
--- Changed the rock mixer (see 5.1:2:2:4, 4:1:1:2:3 of the:2008 edition);
--- The universal mixer has been changed (see 5.1:2:2:5, 4:1:1:2:4 of the:2008 edition);
--- The intermittent cannula-type hard capsule filling machine has been changed (see 5.3:1:1:1, 4:3:1:1:2 of the:2008 edition);
--- Changed the continuous cannula type hard capsule filling machine (see 5.3:1:1:2, 4:3:1:1:3 of the:2008 edition);
--- Changed the plugging type hard capsule filling machine (see 5.3:1:1:3, 4:3:1:1:4 of the:2008 edition);
--- The pulse cutting soft capsule (pill) manufacturing machine has been changed (see 5.3:2:5, 4:3:2:4:2 of the:2008 edition);
--- Changed the hot air circulation tunnel sterilization and drying machine for antibiotic glass bottles (see 5.4:1:2, 4:4:1:2 of the:2008 edition);
--- Changed the ampoule water injection sterilizer (see 5.5:1:6, 4:5:2:5 of the:2008 edition);
--- Changed the small volume injection water bath sterilizer (see 5.5:1:6:1, 4:5:2:5:1 of the:2008 edition);
--- Changed the steam sterilizer for ampoule water injection (see 5.5:1:6:2, 4:5:2:5:2 of the:2008 edition);
--- Changes have been made to the antibiotic glass bottle water injection machinery (see 5.5:2, 4:5:3 of the:2008 edition);
--- The antibiotic glass bottle water injection linkage line has been changed (see 5.5:2:2, 4:5:3:8 of the:2008 edition);
--- Changed the cartridge water injection machinery (see 5.5:3, 4:5:4 of the:2008 edition);
--- The cartridge water injection linkage line has been changed (see 5.5:3:2, 4:5:4:4 of the:2008 edition);
--- Changed the pre-filled injection machinery (see 5.5:5, 4:5:6 of the:2008 edition);
--- Changed the pre-filled injection filling machine (see 5.5:5:1, 4:5:6:3 of the:2008 edition);
---Added non-PVC film soft bag nozzle injection molding machine, non-PVC film soft bag nozzle cleaning machine, non-PVC film soft bag making machine, large honey pill Cooling pill machine, solid dripping pill machine, medicine bottle boiling water washing and sterilizing machine, spray capping and sealing machine, spray valve rolling machine 8 terms (see 5.6:3:1~5:6:3:3, 5:7:1:8, 5:7:2:1, 5:10:2:9, 5:11:2:1, 5:11:2:2);
--- Changed the glass oral liquid bottle washing machine (see 5.10:2:1, 4:10:2:1 of the:2008 edition);
--- Changed the aerosol filling machine (see 5.11:1:1, 4:11:1 of the:2008 edition);
--- Changed the aerosol valve rolling machine (see 5.11:1:1:1, 4:11:1:2 of the:2008 edition);
--- Changed the propellant press (see 5.11:1:1:2, 4:11:1:3 of the:2008 edition);
--- Changed the liquid dispensing equipment (see 5.12:1:1, 4:12:1:1 of the:2008 edition);
--- Deleted planetary cone mixer, wet granulator, rotary fluidized bed granulator, cyclone fluidized bed granulator, granulation coating machine, Centrifugal granulator coating machine, cyclone fluidized bed granulator coating machine, fluidized spouted bed granulator coating machine, multi-kinetic granulator 9 terms (see 4.1:1:3, 4:1:2:1, 4:1:2:3:1, 4:1:2:3:2, 4:1:3, 4:1:3:2~4:1:3:4, 4:1:5 of the:2008 edition);
--- Deleted the five terms of mixing machine, granulating machine, granulating machine, perforated coating machine and non-perforated coating machine (see 4.2:1~2008 edition) 4:2:3, 4:2:5:2:1, 4:2:5:2:2);
--- Deleted semi-automatic hard capsule filling machine, gelatin liquid equipment, soft capsule batching equipment, soft capsule conveyor, soft capsule washing machine, net Six terms for rubber crusher (see 4.3:1:1:1, 4:3:2:1, 4:3:2:2, 4:3:2:5, 4:3:2:7, 4:3:2:9 of the:2008 edition);
--- Deleted the track-type antibiotic glass bottle washing machine, vertical antibiotic glass bottle washing machine, column-type antibiotic glass bottle washing machine, Hot air circulation tunnel sterilization dryer, far infrared radiation tunnel sterilization dryer, rotating cage medicinal rubber stopper cleaning machine, Functional medicinal rubber stopper cleaning machine, liquid preparation equipment, antibiotic glass bottle cleaning machine, antibiotic glass bottle tunnel sterilization and drying machine, antibiotic 14 terms for plain glass bottle capping machine, medicinal rubber stopper cleaning machine, medicinal aluminum cap cleaning machine, medicinal aluminum-plastic composite cap ozone sterilizer (See 4.4:1:1:1~4:4:1:1:3, 4:4:1:2:1, 4:4:1:2:2, 4:4:1:6:1, 4:4:1:6:2, 4:4:2:1~ 4:4:2:3, 4:4:2:7~4:4:2:10);
--- Removed the liquid preparation equipment, concentrated preparation tank, diluted preparation tank, ampoule cleaning machine, horizontal ampoule cleaning machine, vertical ampoule cleaning machine, and small capacity ampoule Injection steam rapid cooling sterilizer, antibiotic glass bottle washing machine, antibiotic glass bottle tunnel sterilization dryer, antibiotic glass Glass bottle capping machine, medicinal rubber stopper cleaning machine, medicinal aluminum cap cleaning machine, medicinal aluminum-plastic composite cap ozone sterilizer, cassette glass sleeve Cleaning machine, tunnel sterilizing and drying machine for glass sleeve of cartridge bottle, piston cleaning machine for cartridge bottle, aluminum cap cleaning machine for cartridge bottle, pre-filling machine Liquid syringe glass needle cleaning machine, pre-filled liquid syringe glass needle tunnel sterilization drying machine, pre-filled liquid syringe piston cleaning 20 terms for machines (see 4.5:1, 4:5:1:1, 4:5:1:2, 4:5:2:1, 4:5:2:1:3, 4:5:2:1:4, 4:5:2:5:3, 4:5:3:1, 4:5:3:2, 4:5:3:4~4:5:3:7, 4:5:4:1, 4:5:4:2, 4:5:4:5, 4:5:4:6, 4:5:6:1, 4:5:6:2, 4:5:6:4);
--- Removed the liquid preparation equipment, concentrated preparation tank, diluted preparation tank, glass infusion bottle negative pressure filling machine, glass infusion bottle pressure time filling machine, medicine 7 terms for rubber stopper cleaning machine and pharmaceutical aluminum cap cleaning machine (see 4.6:1, 4:6:1:1, 4:6:1:2, 4:6:2:3:3, 4:6:2:3:4, 4:6:2:11, 4:6:2:12);
--- Deleted the colloid mill, pipe seat chain rotary metal hose filling machine, pipe seat chain rotary metal composite pipe filling machine, pipe seat chain rotary Plastic hose filling machine, disc rotary metal hose filling machine, disc rotary metal composite pipe filling machine, disc rotary 7 terms for plastic hose filling and sealing machines (see 4.9:2:4, 4:9:3:1~4:9:3:6 of the:2008 edition);
--- Deleted the track-type glass oral liquid bottle washing machine, vertical glass oral liquid bottle washing machine, column-type glass oral liquid bottle washing machine, Rotary glass oral liquid bottle washing machine, hot air circulation tunnel sterilization drying machine, far infrared radiation tunnel sterilization drying machine Machine, linear glass oral liquid bottle filling machine, rotary glass oral liquid bottle filling machine 8 terms (see the:2008 edition 4:10:2:1:1~4:10:2:1:4, 4:10:2:2:1, 4:10:2:2:2, 4:10:2:3:1, 4:10:2:3:2);
--- Deleted the terms "liquid filling machine" and "pressure stabilizing tank" (see 4.11:1:1 and 4:11:1:4 of the:2008 edition);
--- Deleted the eye drop bottle cleaning machine, eye drop bottle inner mouth (plug) cleaning machine, plastic eye drop bottle forming and filling machine, paste batching tank, Paste machine, pipe seat chain rotary metal hose filling machine, pipe seat chain rotary metal composite pipe filling machine, disc rotary metal hose Filling machine, disc rotary metal composite pipe filling machine 9 terms (see 4.12:1:2, 4:12:1:3, 4:12:1:5,:2008 edition 4:12:2:1, 4:12:2:2, 4:12:2:3:1 to 4:12:2:3:4);
--- Added the terms hammer dust-free mill and hammer granulator (see 6.1:2:1, 6:1:2:2);
--- Added pulse dust removal water-cooled pulverizer unit, water-cooled Shibata pulverizer unit, granulation water-cooled pulverizer unit, multi-stage pulverizer, super 7 terms for micro-pulverizer, eddy current pulverizer unit, and needle pulverizer (see 6.1:3:1 to 6:1:3:6, 6:1:4);
--- Added three terms: turbine self-cooling pulverizer, frozen wall-breaking micro-powder machine, and extrusion crusher (see 6.1:5:1, 6:1:7, 6:1:10);
--- Deleted the pressure grinding mill (see 5.1:5 of the:2008 edition);
--- Added three terms: fluidized bed jet mill, pin-type nano sand mill, and dual-drive nano sand mill (see 6.3:4 to 6:3:6);
--- Deleted five terms: vertical air separator, horizontal separator, blowing air separator, suction air separator, and variable frequency air separator (see 6.1:2:1~6:1:2:5 of the:2008 edition);
--- Added the terms bubbling cleaning machine and cleaning and peeling machine (see 7.1:2:3, 7:1:2:4);
--- Deleted the polygonal tube dry cleaning machine (see 6.1:7:2 of the:2008 edition);
--- Added two terms: peeling machine and steaming machine (see 7.1:5:4, 7:2:1:3);
--- Deleted the terms rotary tablet cutting machine and rotary tablet cutting machine (see 6.2:2:2:1 and 6:2:2:2:2 of the:2008 edition);
--- Six more terms have been added: dicing machine, steaming medicine box, Chinese medicine decoction machine, Chinese medicine automatic decoction system, air flow stirring decoction pot, and frosting machine (See 7.2:2:4, 7:3:1:2~7:3:1:4, 7:3:1:4:1, 7:3:2);
--- Deleted the terms steam-type medicine box and electric-heating medicine box (see 6.3:1:2 and 6:3:1:3 of the:2008 edition);
--- Added three terms: electromagnetic medicine frying machine, electromagnetic sand scalding production line, and electromagnetic stirring medicine frying pot (see 7.3:3:4~7:3:3:6);
--- Deleted hot air circulation oven (see 6.4:2:1 of the:2008 edition);
--- Added 6 techniques: sand filter, cation exchanger, anion exchanger, mixed bed ion exchanger, microporous filter, ultrafiltration equipment Language (see 8.1:1:1, 8:1:1:3:1~8:1:1:3:3, 8:1:1:5, 8:1:1:6);
--- Changed the terms of electrodialysis equipment and reverse osmosis equipment (see 8.1:1:2, 8:1:1:7, 7:2:1, 7:2:3 of the:2008 edition);
--- Added two terms: medicinal oxygen concentrator and ozone generator (see 8.2:2, 8:2:3);
--- Changed the terms of medicinal nitrogen generator and steam generator (see 8.2:1, 8:2:4, 7:1:1, 7:1:2 of the:2008 edition);
--- Deleted the inflator, direct drug packaging machinery, bottle container plugging machinery, bottle container sealing machinery, multifunctional medicinal bottle packaging Filling machine, micro-pellet bottling machine, small pill bottling machine, tube bottle tablet bottling machine, glass bottle packaging linkage line, plastic bottle packaging linkage line 10 terms (see 7.1:3, 8:1, 8:1:2:3, 8:1:2:4, 8:1:2:5, 8:1:2:5:1~8:1:2:5:3, 8:1:2:6:1, 8:1:2:6:2);
--- Changed the counting and filling machine (see 9.2:2, 8:1:2:2 of the:2008 edition);
--- Added three terms: electronic weighing bottle filling machine, desiccant inserting machine, powder filling screw (rolling) capping machine (see 9.2:4, 9:2:10, 9:2:14);
--- Deleted the terms strip packaging machine, aluminum-plastic blister packaging machine, aluminum-aluminum blister packaging machine, aluminum-plastic-aluminum blister packaging machine (see 8.1:3:5, 8:1:4:1, 8:1:4:2, 8:1:4:3 of the:2008 edition);
--- Added three terms: Chinese medicine decoction packaging machine, large honey pill shelling machine, and shelling and wax dipping machine (see 9.3:6, 9:3:9:1, 9:3:9:2);
--- The blister and cartoning machine linkage lines have been changed (see 9.3:8:4, 8:1:4:4 of the:2008 edition);
--- Added 4 new functions: automatic dispensing system for Chinese herbal medicine slices, dispensing equipment for Chinese herbal formula granules, metering and filling machine, and closed metering and filling machine Language (see 9.3:10:4, 9:3:10:5, 9:3:11, 9:3:12);
--- Deleted the outer packaging machinery for pharmaceutical packaging (see 8.2, 8:2:1~8:2:8 of the:2008 edition);
--- Deleted pharmaceutical packaging material manufacturing machinery (see 8.3, 8:3:1~8:3:4 of the:2008 edition);
--- Changed the hardness tester (see 10.1, 9:1 of the:2008 edition);
--- Changed the degasser (see 10.3, 9:3 of the:2008 edition);
--- Changed the brittleness tester (see 10.5, 9:5 of the:2008 edition);
--- Changed the tablet/capsule visual inspection machine (see 10.6, 9:6 of the:2008 edition);
--- Deleted the thickness tester (see 9.7 of the:2008 edition);
--- Deleted the tablet comprehensive tester (see 9.8 of the:2008 edition);
--- The capsule weight sorting machine has been changed (see 10.10, 9:12 of the:2008 edition);
--- Added metal detector (see 10.13);
--- Deleted particle size analyzer (see 9.16 of the:2008 edition);
--- Added 5 more instruments including water quality analyzer, online monitor for ozone and residual chlorine in water, dissolved oxygen meter, residual chlorine meter, and total organic carbon analyzer Terminology (see 10.15, 10:15:1 to 10:15:4);
--- Changed the clarity tester (see 10.16, 9:17 of the:2008 edition);
--- Added endotoxin gel assay instrument (see 10.19:1);
--- The vibration instrument and osmotic pressure tester have been changed (see 10.20, 10:21, 9:21, 9:22 of the:2008 edition);
--- The bacteria collector has been changed (see 10.22, 9:23 of the:2008 edition);
--- Deleted the medicinal material hardness tester (see 9.26 of the:2008 edition);
--- Added Raman spectrometer (see 10.29);
--- Deleted the following items: ampoule injection foreign body inspection equipment, ampoule injection foreign body inspection instrument, ampoule injection foreign body semi-automatic inspection machine, ampoule injection foreign body inspection instrument, Automatic inspection machine for foreign matter in vials of injection, semi-automatic inspection machine for foreign matter in glass infusion bottles of large-capacity injections, and large-capacity injection machines for plastic infusion bottles:
7 terms including injection leak detector, non-PVC film soft bag large volume injection leak detector (see 9.31, 9:31:1~2008 edition) 9:31:3, 9:32~9:34);
--- Added injection foreign body detector, oral liquid foreign body detector, light inspection machine, clarity tester, injection electronic leak detector, 7 terms including bacteria handling glove leak detector, filter integrity tester, etc: (see 10.30~10:36);
---Added capsule wall thickness tester, polarimeter, mass spectrometer, gas chromatograph, liquid chromatograph, nuclear magnetic resonance analyzer, Abbe refractometer 9 terms including color measuring instrument, drug solution color measuring instrument, melting point measuring instrument, etc: (see 10.39~10:47);
--- Deleted mechanical conveyor, flat chain conveyor, belt conveyor, screw conveyor, vibrating conveyor, air flow conveyor, suction conveyor Air conveyor, pressure conveyor, liquid conveying machinery, centrifugal pump, axial flow pump, vortex pump, gear pump, screw pump 14 technologies (See 10.1:1, 10:1:1:1~10:1:1:4, 10:1:2, 10:1:2:1, 10:1:2:2, 10:1:3, 10:1:3:1~10:1:1:4 of the:2008 edition) 10:1:3:5);
---Added fixed lifting feeder, mobile lifting feeder, mobile telescopic lifting feeder, interlayer lifting machine, vacuum feeder, 6 terms for dust feeders (see 11.1:2 to 11:1:7);
---Added automatic unpacking feeder, batching tank, online liquid preparation equipment, injection liquid preparation system, automatic liquid preparation system, isolation operator, Aseptic transfer cabin, UV disinfection transfer cabin, ozone disinfection transfer cabin, hydrogen peroxide aseptic transfer cabin, temperature control unit, hopper cleaning machine, Medicinal rubber stopper cleaning machine, medicinal aluminum cap cleaning machine, hydrogen peroxide sterilizer, medicinal aluminum plastic composite cap ozone sterilizer, tablet picking machine, 18 terms for dust collectors (see 11.2:1~11:2:6, 11:2:6:1~11:2:6:4, 11:2:7, 11:2:9~11:2:14, 11:2:17):
1 Scope
This document defines the terms and definitions for pharmaceutical machinery and equipment:
This document applies to the design, manufacture, circulation, use and supervisory inspection of pharmaceutical machinery and equipment:
2 Normative references
This document has no normative references:
3 General terms
Production machinery and equipment used to complete and assist in the completion of pharmaceutical processes:
3.1.1
Use physical and chemical methods to biologically or chemically transform animals, plants or minerals or change their shapes and properties to produce raw materials machinery and equipment:
3.1.1.1
Reaction equipmentreactionequipment Under certain conditions, a device that uses biological and chemical methods to achieve transformation between substances and generate new substances:
3.1.1.2
Tower equipment columnreactor Under certain conditions, the unit operation process of distillation, absorption, desorption, extraction, medium cooling, gas purification, drying, humidification, etc:
Tower equipment:
3.1.1.3
A device that allows solutes to precipitate and crystallize by cooling or evaporating a saturated solution to form a supersaturated solution:
3.1.1.4
Machinery and equipment for classifying and separating suspensions, emulsions, aerosols and solid particle sizes:
3.1.1.5
Extraction equipmentextractingequipment Equipment that uses the different solubility of different substances in the same solvent to separate the effective components in the material:
3.1.1.6
Equipment that has both extraction and concentration functions:
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 63 pages — is available in the English PDF.
Referenced standards
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GB/T 10003-2026 — Biaxially oriented polypropylene (BOPP) film
GB/T 10007-2026 — Rigid cellular plastics - Determination of shear properties
GB/T 10009-2026 — Acrylonitrile-butadiene-styrene (ABS) plastic extruded sheets
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GB/T 15692.1-1995
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