Environmental monitoring of clean areas in pharmaceutical factories

Environmental monitoring of clean areas in pharmaceutical factories, Total:152 items.

The international standard classification for "Environmental monitoring of clean areas in pharmaceutical factories" includes: Medical Sciences and health care facilities in general , Workplace atmospheres , Power stations in general , Geology. Meteorology. Hydrology .

The Chinese standard classification for "Environmental monitoring of clean areas in pharmaceutical factories" includes: Marking, packaing, transport and storage , Industrial dust and gas prevention technology , Medical apparatus and devices in general , Pharmaceutical in general , Industrial construction engineering , , Oceanographic instrumentation .

Professional Standard - Pharmaceutical Packaging

YBB 00412004-2015 Test methods for clean rooms (areas) of pharmaceutical packaging material production plants
YBB 0041-2004 Yaopinbaozhuangcailiao Shengchanchangfang Jiejingshi(qu) de Ceshifangfa Test methods for clean room to produce pharmaceutical packing materials

Group Standards of the People's Republic of China

T/CQAP 2003-2024 Prepared media plate for clean environment microbial monitoring
T/ZMDS 50004-2023 Medical device - validation for cleanroom and related controlled environments monitoring system
T/CASME 319-2023 Technical specification for operation and maintenance of clean workshop in pharmaceutical industry
T/SZCA 2-2021 Technical specification for cleanroom environment on-line monitoring
T/CECS 805-2021 Design standards for clean workshops in the veterinary drug industry
T/JSCA 001-2024 Clean room environment cleaning service specifications
T/SICCA 017-2023 Sandwich panel for cleanroom and associated controlled environments
T/CNIA 0144-2022 Nitrile gloves for semiconductor clean environment
T/ZAPA 0001-2021 TECHNICAL SPECIFICATION FOR OPERATION AND MAINTENANCE OF PHARMACEUTICAL CLEAN WORKSHOP

General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China

GB/T 25915.12-2021 Cleanrooms and associated controlled environments—Part 12: Specifications for monitoring of air cleanliness by nanoscale particle concentration
GB/T 16292-1996 Test method for airborne particles in clean room(area)the pharmaceutical industry
GB/T 25915.7-2010 Cleanrooms and associated controlled environments—Part 7:Separative devices (clean air hoods,gloveboxes,isolators and minienvironments)
GB/T 25915.13-2022 Cleanrooms and associated controlled environments—Part 13: Cleaning of surfaces to achieve defined levels of cleanliness in terms of particle and chemical classifications
GB/T 16294-2010 Test method for settling microbe in clean room(zone) of the pharmaceutical industry
GB/T 36527-2018 Cleanroom and associated controlled environments—Guideline of energy saving
GB/T 36066-2025 Cleanrooms and associated controlled environments—Technical requirements and application of testing
GB/T 25915.3-2010 Cleanrooms and associated controlled environments—Part 3:Test methods
GB/T 25915.2-2021 Cleanrooms and associated controlled environments—Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration
GB/T 16294-1996 Test method for settling microbe in clean room(area)the pharmaceutical industry
GB/T 16293-1996 Test method for airborne microbe in clean room(area)the pharmaceutical industry
GB/T 16292-2010 Test method for airborne particles in clean room(zone) of the pharmaceutical industry
GB/T 25915.3-2024 Cleanrooms and associated controlled environments—Part 3: Test methods
GB/T 16293-2010 Test method for airborne microbe in clean room(zone) of the pharmaceutical industry
GB/T 25915.16-2024 Cleanrooms and associated controlled environments—Part 16：Energy efficiency in cleanrooms and separative devices
GB/T 25915.1-2010 Cleanrooms and associated controlled environments—Part 1:Classification of air cleanliness

Professional Standard - Medicine

YY 0141-1993 Test methods for suspended particles in clean rooms and clean areas of the pharmaceutical industry

Ministry of Housing and Urban-Rural Development of the People's Replublic of China

GB 50457-2019 Code for design of pharmaceutical industry clean room
GB 50457-2008 Code for Design of Pharmaceutical Industry Clean Room

Henan Provincial Standard of the People's Republic of China

DB41/T 1381-2017 Electric chain hoist for clean workshop

Professional Standard - Machinery

JB/T 14201-2022 Bridge cranes for clean environment
JB/T 14200-2022 Electric hoists for clean environment

未注明发布机构

IEST RP-CC046.1 2013 Controlled Environments (Aerospace, Non-cleanroom)

Anhui Provincial Standard of the People's Republic of China

DB34/T 4510-2023 Intravenous medication compounding center clean area management specifications

Professional Standard - Energy and Power Planning

DL/T 382-2010 Norm for environmental monitoring manage of thermal power plants
DL 414-1991 Technical Specifications for Environmental Monitoring in Thermal Power Plants
DL/T 414-2022 Norm for environmental monitoring of thermal power plants
DL/T 414-2004 Norm for environmental monitoring of thermal power plants
DL/T 382-2022 Norm for environmental monitoring manage of thermal power plants
DL/T 414-2012 Norm for environmental monitoring of thermal power plants

Professional Standard - Nuclear Industry

EJ 382-1989 Environmental Radiation Monitoring Regulations for Nuclear Power Plants
EJ/T 1131-2001 Regulations for environmental radiation monitoring of nuclear power plant

Professional Standard - Energy

NB/T 20246-2013 Specification for Environmental Radiation Monitoring of Nuclear Power Plants

Jiangsu Provincial Standard of the People's Republic of China

DB3204/T 1068-2024 Changzhou Food and Pharmaceutical Industry Clean Room (Area) Management Specification

Shaanxi Provincial Standard of the People's Republic of China

DB6103/T 03-2019 Rural living environment clean and tidy village requirements

Professional Standard - Ocean

HY/T 091-2005 environmental buoy

Shandong Provincial Standard of the People's Republic of China

DB37/T 3547-2019 Technical specifications for environmental monitoring during construction of nuclear power plants

Association Francaise de Normalisation

NF EN ISO 14644-2:2016 Clean rooms and related controlled environments - Part 2: monitoring the maintenance of clean room performance for particulate air cleanliness
NF X44-101-2*NF EN ISO 14644-2:2016 Cleanrooms and associated controlled environments - Part 2 : monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration
NF EN ISO 14644-8:2022 Clean rooms and related controlled environments - Part 8: assessment of chemical air cleanliness
NF EN ISO 14644-7:2004 Salles propres et environnements maîtrisés apparentés - Partie 7 : dispositifs séparatifs (postes à air propre, boîtes à gants, isolateurs et mini-environnements)
NF EN ISO 14644-1:2016 Clean rooms and related controlled environments - Part 1: classification of particulate air cleanliness
NF EN ISO 14644-3:2019 Salles propres et environnements maîtrisés apparentés - Partie 3 : méthodes d'essai
NF X44-107*NF EN ISO 14644-7:2004 Cleanrooms and associated controlled environments - Part 7 : separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
NF X44-101-9*NF EN ISO 14644-9:2022 Cleanrooms and associated controlled environments - Part 9: Assessment of surface cleanliness for particle concentration

UNKNOWN

YY/T 0141-1993 Test methods for suspended particles in clean rooms and clean areas of the pharmaceutical industry

British Standards Institution (BSI)

BS 5295-1:1976 Environmental cleanliness in enclosed spaces-Specification for controlled environment clean rooms, work stations and clean air devices
BS 5295-1:1989 Environmental cleanliness in enclosed spaces-Specification for clean rooms and clean air devices
BS EN ISO 14644-2:2015 Cleanrooms and associated controlled environments. Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration
BS ISO 14644-12:2018 Cleanrooms and associated controlled environments - Specifications for monitoring air cleanliness by nanoscale particle concentration
BS EN ISO 14644-3:2019 Cleanrooms and associated controlled environments - Test methods
16/30348371 DC BS ISO 14644-12. Cleanrooms and associated controlled environments. Part 12. Specifications for monitoring air cleanliness by nanoscale particle concentration
BS 5295-2:1976 Environmental cleanliness in enclosed spaces-Guide to the construction and installation of clean rooms, work stations and clean air devices
BS EN ISO 14644-5:2025 Cleanrooms and associated controlled environments - Operations
BS 5295-2:1989 Environmental cleanliness in enclosed spaces-Method for specifying the design, construction and commissioning of clean rooms and clean air devices
BS EN ISO 14644-16:2019 Cleanrooms and associated controlled environments - Energy efficiency in cleanrooms and separative devices
BS EN ISO 14644-1:2015 Cleanrooms and associated controlled environments. Classification of air cleanliness by particle concentration
BS EN ISO 14644-7:2004 Cleanrooms and associated controlled environments - Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
BS EN ISO 14644-5:2004 Cleanrooms and associated controlled environments - Operations
BS 5295-3:1989 Environmental cleanliness in enclosed spaces-Guide to operational procedures and disciplines applicable to clean rooms and clean air devices
BS 5295-4:1989 Environmental cleanliness in enclosed spaces-Specification for monitoring clean rooms and clean air devices to prove continued compliance with BS 5295:Part 1
BS EN ISO 14644-2:2000 Cleanrooms and associated controlled environments - Specifications for testing and monitoring to prove continued compliance with ISO 14644-1
BS EN ISO 14644-9:2012 Cleanrooms and associated controlled environments. Classification of surface cleanliness by particle concentration
BS EN ISO 14644-3:2019(2020) Cleanrooms and associated controlled environments Part 3 : Test methods
BS EN ISO 14644-3:2005 Cleanrooms and associated controlled environments - Test methods
BS EN ISO 14644-8:2013 Cleanrooms and associated controlled environments. Classification of air cleanliness by chemical concentration (ACC)
BS EN ISO 14644-1:1999 Cleanrooms and associated controlled environments - Classification of air cleanliness
BS 5295-3:1976 Environmental cleanliness in enclosed spaces-Guide to operational procedures and disciplines applicable to clean rooms, work stations and clean air devices

Gosstandart of Russia

GOST R ISO 14644-12-2020 Cleanrooms and associated controlled environments. Part 12. Specifications for monitoring air cleanliness b nanoscale particle concentration
GOST R ISO 14644-3-2007 Cleanrooms and associated controlled environments. Part 3. Test methods
GOST R ISO 14644-3-2020 Cleanrooms and associated controlled environments. Part 3. Test methods
GOST R ISO 14644-16-2023 Cleanrooms and associated controlled environments. Part 16. Energy efficiency in cleanrooms and clean air devices
GOST R 56060-2014 Industrial environmental monitoring. Monitoring of the state and pollution of the environment on the territories of waste disposal facilities

German Institute for Standardization

DIN EN ISO 14644-2:2016-05 Cleanrooms and associated controlled environments - Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration (ISO 14644-2:2015); German version EN ISO 14644-2:2015
DIN EN ISO 14644-2 E:2014-11 Cleanrooms and associated controlled environments Part 2: Using particle concentration monitoring to provide evidence of cleanroom performance related to air cleanliness (draft)
DIN EN ISO 14644-2 E:2010-12 Cleanrooms and associated controlled environments Part 2: Using particle concentration monitoring to provide evidence of cleanroom performance related to air cleanliness (draft)
DIN EN ISO 14644-2 E:2014 Draft Document - Cleanrooms and associated controlled environments - Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration (ISO/DIS 14644-2:2014); German version prEN ISO 14644-2:2014
DIN EN ISO 14644-2:2016 Cleanrooms and associated controlled environments - Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration (ISO 14644-2:2015); German version EN ISO 14644-2:2015
DIN EN ISO 14644-7:2005-01 Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) (ISO 14644-7:2004); German version EN ISO 14644-7:2004
DIN EN ISO 14644-1:1999-07 Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness (ISO 14644-1:1999)
DIN EN ISO 14644-3:2020-08 Cleanrooms and associated controlled environments - Part 3: Test methods (ISO 14644-3:2019, Corrected version 2020-06); German version EN ISO 14644-3:2019
DIN EN ISO 14644-7:2005 Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) (ISO 14644-7:2004); German version EN ISO 14644-7:2004

European Committee for Standardization (CEN)

EN ISO 14644-2:2015 Cleanrooms and associated controlled environments - Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration

International Organization for Standardization (ISO)

ISO 14644-2:2015 Cleanrooms and associated controlled environments - Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration
ISO 14644-1:1999 Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness
ISO 14644-2:2015 Plus Redline Cleanrooms and associated controlled environments - Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration (includes Redline Version)
ISO 14644-12:2018 Cleanrooms and associated controlled environments - Part 12: Specifications for monitoring air cleanliness by nanoscale particle concentration
ISO 14644-3:2019/Amd 1:2020 Cleanrooms and associated controlled environments — Part 3: Test methods
ISO 14644-7:2004 Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)

Standard Association of Australia （SAA）

AS ISO 14644.2:2017 Cleanrooms and associated controlled environments, Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration
AS ISO 14644.3:2021 Cleanrooms and associated controlled environments, Part 3: Test methods

Danish Standards Foundation

DANSK DS/EN ISO 14644-2:2016 Cleanrooms and associated controlled environments – Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration
DS/EN ISO 14644-1:1999 Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness
DANSK DS/ISO 14644-12:2018 Cleanrooms and associated controlled environments – Part 12: Specifications for monitoring air cleanliness by nanoscale particle concentration
DANSK DS/EN ISO 14644-7:2004 Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
DS/EN ISO 14644-7:2004 Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
DANSK DS/ISO 14644-9:2022 Cleanrooms and associated controlled environments – Part 9: Assessment of surface cleanliness for particle concentration

Korean Agency for Technology and Standards (KATS)

KS I ISO 14644-2-2022 Cleanrooms and associated controlled environments — Part 2:Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration
KS I ISO 14644-2-2017(2022) Cleanrooms and associated controlled environments — Part 2:Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration
KS I ISO 14644-1:2017 Cleanrooms and associated controlled environments－Part 1：Classification of air cleanliness
KS I ISO 14644-1:2007 Cleanrooms and associated controlled environments－Part 1：Classification of air cleanliness
KS I ISO 14644-12:2020 Cleanrooms and associated controlled environments —Part 12: Specifications for monitoring air cleanliness by nanoscale particle concentration
KS I ISO 14644-12-2020 Cleanrooms and associated controlled environments —Part 12: Specifications for monitoring air cleanliness by nanoscale particle concentration
KS I ISO 14644-7:2005 Cleanrooms and associated controlled environments-Part 7:Separative devices(clean air hoods, gloveboxes, isolators and mini-environments)
KS I ISO 14644-2:2017 Cleanrooms and associated controlled environments — Part 2:Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration
KS I ISO 14644-2-2017 Cleanrooms and associated controlled environments — Part 2:Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration

Spanish Association for Standardization (UNE)

UNE-EN ISO 14644-2:2016 Cleanrooms and associated controlled environments - Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration (ISO 14644-2:2015)
AENOR UNE-EN ISO 14644-2:2016 Cleanrooms and associated controlled environments - Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration (ISO 14644-2:2015)
UNE-EN ISO 14644-1:2000 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS. PART 1: CLASSIFICATION OF AIR CLEANLINESS (ISO 14644-1:1999)
UNE-EN ISO 14644-3:2021 Cleanrooms and associated controlled environments - Part 3: Test methods (ISO 14644-3:2019, Corrected version 2020-06)
UNE-EN ISO 14644-7:2005 Cleanrooms and associated controlled environments. Part 7: Separative enclosures (clean air hoods, gloveboxes, isolators, mini-environments) (ISO 14644-7:2004)

Japanese Industrial Standards Committee (JISC)

JIS B 9920-2:2019 Cleanrooms and associated controlled environments -- Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration

Association of German Mechanical Engineers

VDI 2083 Blatt 3.1-2011 Cleanroom technology - Metrology and test methods - Monitoring
VDI 2083 BLATT 3.1-2012 Cleanroom technology — measurement technology in cleanroom air — monitoring
VDI 2083 Blatt 16-2009 Cleanroom technology - Separated clean environments (isolators@ mini-environments@ separative devices) - Effectiveness and certification
VDI 2083 Blatt 16-2-2021 Cleanroom technology Mini environments Requirements
VDI 2083 BLATT 3.1-2012 Cleanroom technology — measurement technology in cleanroom air — monitoring
VDI 2083 Blatt 12-1998 Cleanroom technology - Safety and environmental aspects
VDI 2083 BLATT 12-2000 Cleanroom technology — safety and environmental protection aspects
VDI 2083 BLATT 16.2-2021 Clean room technology - barrier systems - minienvironments
VDI 2083 BLATT 16.2-2015 Reinraumtechnik - Barrieresysteme - Mini-Environments

US-FCR

FCR NAV MIL-HDBK-1028/5 REV A-1994 ENVIRONMENTAL CONTROL - DESIGN OF CLEAN ROOMS

Standards Norway

NS-EN ISO 14644-2:2015 Cleanrooms and associated controlled environments — Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration (ISO 14644-2:2015)
NS-EN ISO 14644-1:1999 Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness (ISO 14644-1:1999)

CZ-CSN

CSN 12 5310-1984 Clean rooms and clean workplaces with checked dustfree envíronment. Terminology and definitions. Classification of cleanness classes

Swedish Institute for Standards

SS-ISO 14644-12:2018 Cleanrooms and associated controlled environments - Part 12: Specifications for monitoring air cleanliness by nanoscale particle concentration (ISO 14644-12:2018, IDT)
SS-EN ISO 14644-9:2022 Cleanrooms and associated controlled environments - Part 9: Assessment of surface cleanliness for particle concentration (ISO 14644-9:2022)
SS-EN ISO 14644-16:2019 Cleanrooms and associated controlled environments - Part 16: Energy efficiency in cleanrooms and clean air devices (ISO 14644-16:2019)

PH-BPS

PNS ISO 14644-12:2021 Cleanrooms and associated controlled environments - Part 12: Specifications for monitoring air cleanliness by nanoscale particle concentration

American Society for Testing and Materials (ASTM)

ASTM E2352-04 Standard Practice for Aerospace Cleanrooms and Associated Controlled Environments-Cleanroom Operations
ASTM E2352-04(2010) Standard Practice for Aerospace Cleanrooms and Associated Controlled Environments-Cleanroom Operations
ASTM E2352-19 Standard Practice for Aerospace Cleanrooms and Associated Controlled Environments—Cleanroom Operations

Institute of Environmental Sciences and Technology

IEST RP-CC046.1-2013 Controlled Environments (Aerospace, Non-cleanroom)

Ente Nazionale Italiano di Unificazione

UNI EN ISO 14644-2:2001 Cleanrooms and associated controlled environments - Specifications for testing and monitoring to prove continued compliance with ISO 14644-1.
UNI EN ISO 14644-7:2005 Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
UNI EN ISO 14644-3:2019 Cleanrooms and associated controlled environments - Part 3: Test methods
EC 1-2020 UNI EN ISO 14644-3:2019 Cleanrooms and associated controlled environments - Part 3: Test methods
UNI EN ISO 14644-3:2006 Cleanrooms and associated controlled environments - Part 3: Test methods

Lithuanian Standards Office

LST EN ISO 14644-1:2003 Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness (ISO 14644-1:1999)

American National Standards Institute （ANSI)

ANSI/IEST/ISO 14644-9-2022 Cleanrooms and associated controlled environments — Part 9: Assessment of surface cleanliness for particle concentration

Australian/New Zealand Standard (AU-AS/NZS)

AS/NZS 14644.3:2009 Test methods for clean rooms and related controlled environments (ISO 14644-3:2005 MOD)

Others: