New biopharmaceutical equipment

New biopharmaceutical equipment, Total:179 items.

The international standard classification for "New biopharmaceutical equipment" includes: Energy and heat transfer engineering in general , Solid fuels , Starch and derived products , Animal husbandry and breeding , Pharmaceutics .

The Chinese standard classification for "New biopharmaceutical equipment" includes: Biomass energy , Pharmaceutical, safety machinery and tool in general , Other fermented goods , Domesticate animal , Cement and cement product equipment .

Professional Standard - Agriculture

884兽药质量标准2017年版 Biological Products Volume 1 Veterinary Drug Quality Standard Inactivated Newcastle Disease Vaccine (La Sota Strain)
798兽药质量标准2017年版 Biological Products Volume 1 Veterinary Drug Quality Standard Chicken Newcastle Disease, Avian Influenza (H9 Subtype) Dual Inactivated Vaccine (La Sota Strain + WD Strain)
1774药典化学药和生物制品卷-2010 Chapter 29 Pediatric Drugs Section 1 Drug Application in Neonates 3. Precautions for Antibiotics Use in Neonates
5药典三部-2020 List of General Chapters/Overview/General Chapters and Guiding Principles of Biological Products newly added in this edition of Pharmacopoeia (Three Volumes)
883兽药质量标准2017年版 Biological Products Volume 1 Veterinary Drug Quality Standard Newcastle Disease Virus Antiserum
804兽药质量标准2017年版 Biological Products Volume 1 Veterinary Drug Quality Standard Newcastle Disease Low Virulence Live Vaccine (ZM10 Strain)
1037兽药质量标准2017年版 Biological Products Volume II Veterinary Drug Quality Standard Instructions for Newcastle Disease Live Vaccine (CS2 Strain)
NY/T 1883-2010 Testing method for densified biofuel molding equipment
796兽药质量标准2017年版 Biological Products Volume 1 Veterinary Drug Quality Standard Chicken Newcastle Disease, Avian Influenza (H9 Subtype) Dual Inactivated Vaccine (La Sota Strain + JY Strain)
1772药典化学药和生物制品卷-2010 Chapter 29 Pediatric Drugs Section 1 Drug Application in Newborns 1. Pharmacokinetic characteristics of newborns
1773药典化学药和生物制品卷-2010 Chapter 29 Pediatric Drugs Section 1 Drug Application in Neonates 2. Calculation of Drug Dose in Neonates
1775药典化学药和生物制品卷-2010 Chapter 29 Pediatric Drugs Section 1 Drug Application for Newborns 4. Common Drugs for Neonatal Resuscitation and Reference Doses of Commonly Used Antibiotics
808兽药质量标准2017年版 Biological Products Volume 1 Veterinary Drug Quality Standard Newcastle Disease Live Vaccine (CS2 Strain)
807兽药质量标准2017年版 Biological Products Volume 1 Veterinary Drug Quality Standard Newcastle Disease Frozen Live Vaccine (VG/GA Strain)
NY/T 1882-2010 Technical conditions for densified biofuel molding equipment
811兽药质量标准2017年版 Biological Products Volume 1 Veterinary Drug Quality Standard Chicken Newcastle Disease Hemagglutination Inhibition Test Antigen and Positive Serum
1113兽药质量标准2017年版 Biological Products Volume II Veterinary Drug Quality Standard Inactivated Newcastle Disease Vaccine (La Sota Strain) Instructions
1112兽药质量标准2017年版 Biological Products Volume II Veterinary Drug Quality Standard Newcastle Disease Virus Antiserum Instructions
797兽药质量标准2017年版 Biological Products Volume 1 Veterinary Drug Quality Standard Chicken Newcastle Disease, Avian Influenza (H9 Subtype) Dual Inactivated Vaccine (La Sota Strain + LG1 Strain)
795兽药质量标准2017年版 Biological Products Volume 1 Veterinary Drug Quality Standard Chicken Newcastle Disease, Avian Influenza (H9 Subtype) Dual Inactivated Vaccine (La Sota Strain + HP Strain)

Group Standards of the People's Republic of China

T/CMA YX059-2024 Quality Control Test Method of Phototherapy Equipment for Neonatal Jaundice
T/SA 50-2022 Technical specification for new resin type artificial stone production equipment
T/IMAS 070-2024 Organic fertilizers produced by biopharmaceutical intermediate by-products
T/CAB 2009-2017 Production of antibiotic-free mutton sheep and mutton quality requirements
T/QGCML 2970-2024 Preparation technology of fermented Chinese herbal biological feed for livestock and poultry
T/YNRZ 010-2024 Leafy Vegetable New Bio-fertilizer Preparation Method and Application Technical Regulations
T/NAHIEM 87-2023 Neonatal ward construction and equipment configuration standards
T/SASE 021-2025 Technical conditions for installation of biopharmaceutical fermentation equipment

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

GB/T 35150.3-2024 Technical requirements of dry process cement production complete equipment— Part 3: Cement preparation system
GB/T 15692.8-1995 Terms of pharmaceutical machinery-Medicine detecting instrument
GB 28670-2012 General rule of pharmaceutical machinery conforming to good manufacturing practice
GB/T 15692.6-1995 Terms of pharmaceutical machinery-Water treatment equipment for pharmaceutical use
GB/T 35945-2018 Terminology in biological fermentation industry
GB/T 35150.1-2017 Technical requirements of dry process cement production complete equipment―Part 1:Raw meal preparation system
GB/Z 39502-2020 Laboratory animal—Guideline of COVID-19 animal models preparation

Hebei Provincial Standard of the People's Republic of China

DB13/T 1538-2012 Biomass compression molding equipment

Anhui Provincial Standard of the People's Republic of China

DB34/T 4969-2025 Requirements for the management of instruments and equipment in biopharmaceutical companies
DB34/T 2067-2014 Biomass Mode Compression Molding Equipment

未注明发布机构

AMPP Paper 17608-2022 Preparation of new combination production chemicals for deepwater oil and gas fields
AMPP Paper 18178-2022 Novel antimicrobial heat-conducting “metallic” coatings against biofouling and biocorrosion

Inner Mongolia Provincial Standard of the People's Republic of China

DB15/T 917-2015 Pharmaceutical logistics drug warehouse facilities and equipment configuration

Shanghai Provincial Standard of the People's Republic of China

DB31/ 373-2010 Pollutant Discharge Standards for the Biopharmaceutical Industry

Zhejiang Provincial Standard of the People's Republic of China

DB33/ 923-2014 Pollutant Discharge Standards for Biopharmaceutical Industry

US-CFR-file

CFR 21-526.1590-2014 Food and drugs. Part526:Intramammary dosage form new animal drugs. Section526.1590:Novobiocin infusion.
CFR 21-520.622b-2013 Food and drugs. Part520:Oral dosage form new animal drugs. Section520.622b:Diethylcarbamazine citrate syrup.
CFR 21-558.415-2014 Food and drugs. Part558:New animal drugs for use in animal feeds. Section558.415:Novobiocin.
CFR 21-526.1696d-2014 Food and drugs. Part526:Intramammary dosage form new animal drugs. Section526.1696d:Penicillin G procaine novobiocin for intramammary infusion.
CFR 21-522.1468-2014 Food and drugs. Part522:Implantation or injectable dosage form new animal drugs. Section522.1468:Naproxen for injection.
CFR 21-522.2100-2014 Food and drugs. Part522:Implantation or injectable dosage form new animal drugs. Section522.2100:Selenium and vitamin E.
CFR 21-522.1698-2014 Food and drugs. Part522:Implantation or injectable dosage form new animal drugs. Section522.1698:Pentazocine.
CFR 21-522.1484-2014 Food and drugs. Part522:Implantation or injectable dosage form new animal drugs. Section522.1484:Neomycin.
CFR 21-520.1604-2013 Food and drugs. Part520:Oral dosage form new animal drugs. Section520.1604:Oclacitinib.
CFR 21-522.1503-2014 Food and drugs. Part522:Implantation or injectable dosage form new animal drugs. Section522.1503:Neostigmine.
CFR 21-520.600-2013 Food and drugs. Part520:Oral dosage form new animal drugs. Section520.600:Dichlorvos.
CFR 21-524.1600b-2014 Food and drugs. Part524:Ophthalmic and topical dosage form new animal drugs. Section524.1600b:Nystatin, neomycin, thiostrepton, and triamcinolone ophthalmic ointment.
CFR 21-522.1820-2014 Food and drugs. Part522:Implantation or injectable dosage form new animal drugs. Section522.1820:Pituitary luteinizing hormone powder for injection.
CFR 21-524.981c-2014 Food and drugs. Part524:Ophthalmic and topical dosage form new animal drugs. Section524.981c:Fluocinolone and neomycin cream.
CFR 21-524.1484j-2014 Food and drugs. Part524:Ophthalmic and topical dosage form new animal drugs. Section524.1484j:Neomycin and prednisolone ophthalmic ointment.
CFR 21-520.309-2013 Food and drugs. Part520:Oral dosage form new animal drugs. Section520.309:Carprofen.
CFR 21-520.2345d-2013 Food and drugs. Part520:Oral dosage form new animal drugs. Section520.2345d:Tetracycline powder.
CFR 21-520.1900-2013 Food and drugs. Part520:Oral dosage form new animal drugs. Section520.1900:Primidone tablets.
CFR 21-524.1484k-2014 Food and drugs. Part524:Ophthalmic and topical dosage form new animal drugs. Section524.1484k:Prednisolone and neomycin suspension.
CFR 21-520.812-2013 Food and drugs. Part520:Oral dosage form new animal drugs. Section520.812:Enrofloxacin.
CFR 21-524.1600a-2014 Food and drugs. Part524:Ophthalmic and topical dosage form new animal drugs. Section524.1600a:Nystatin, neomycin, thiostrepton, and triamcinolone ointment.
CFR 21-520.1780-2014 Food and drugs. Part520:Oral dosage form new animal drugs. Section520.1780:Pimobendan.
CFR 21-520.1408-2013 Food and drugs. Part520:Oral dosage form new animal drugs. Section520.1408:Methylprednisolone tablets.
CFR 21-520.1367-2013 Food and drugs. Part520:Oral dosage form new animal drugs. Section520.1367:Meloxicam.
CFR 21-520.763a-2013 Food and drugs. Part520:Oral dosage form new animal drugs. Section520.763a:Dithiazanine iodide tablets.
CFR 21-526.1810-2014 Food and drugs. Part526:Intramammary dosage form new animal drugs. Section526.1810:Pirlimycin.
CFR 21-520.763b-2013 Food and drugs. Part520:Oral dosage form new animal drugs. Section520.763b:Dithiazanine iodide powder.
CFR 21-526.313-2014 Food and drugs. Part526:Intramammary dosage form new animal drugs. Section526.313:Ceftiofur.
CFR 21-524.1484i-2014 Food and drugs. Part524:Ophthalmic and topical dosage form new animal drugs. Section524.1484i:Neomycin and hydrocortisone ointment.
CFR 21-520.2075-2014 Food and drugs. Part520:Oral dosage form new animal drugs. Section520.2075:Robenacoxib.
CFR 21-524.2098-2014 Food and drugs. Part524:Ophthalmic and topical dosage form new animal drugs. Section524.2098:Selamectin.
CFR 21-520.38b-2013 Food and drugs. Part520:Oral dosage form new animal drugs. Section520.38b:Albendazole paste.
CFR 21-520.2471-2014 Food and drugs. Part520:Oral dosage form new animal drugs. Section520.2471:Tilmicosin.
CFR 21-520.390a-2013 Food and drugs. Part520:Oral dosage form new animal drugs. Section520.390a:Chloramphenicol tablets.
CFR 21-524.154-2014 Food and drugs. Part524:Ophthalmic and topical dosage form new animal drugs. Section524.154:Bacitracin, neomycin, and polymyxin B ophthalmic ointment.
CFR 21-524.1240-2014 Food and drugs. Part524:Ophthalmic and topical dosage form new animal drugs. Section524.1240:Levamisole.
CFR 21-520.955-2013 Food and drugs. Part520:Oral dosage form new animal drugs. Section520.955:Florfenicol.
CFR 21-524.402-2014 Food and drugs. Part524:Ophthalmic and topical dosage form new animal drugs. Section524.402:Chlorhexidine.
CFR 21-524.900-2014 Food and drugs. Part524:Ophthalmic and topical dosage form new animal drugs. Section524.900:Famphur.
CFR 21-520.38a-2013 Food and drugs. Part520:Oral dosage form new animal drugs. Section520.38a:Albendazole suspension.
CFR 21-524.450-2014 Food and drugs. Part524:Ophthalmic and topical dosage form new animal drugs. Section524.450:Clotrimazole.
CFR 21-558.430-2014 Food and drugs. Part558:New animal drugs for use in animal feeds. Section558.430:Nystatin.
CFR 21-529.1030-2014 Food and drugs. Part529:Certain other dosage form new animal drugs. Section529.1030:Formalin.
CFR 21-524.920-2014 Food and drugs. Part524:Ophthalmic and topical dosage form new animal drugs. Section524.920:Fenthion.
CFR 21-524.916-2013 Food and drugs. Part524:Ophthalmic and topical dosage form new animal drugs. Section524.916:Fentanyl.
CFR 21-529.40-2014 Food and drugs. Part529:Certain other dosage form new animal drugs. Section529.40:Albuterol.
CFR 21-524.1484g-2014 Food and drugs. Part524:Ophthalmic and topical dosage form new animal drugs. Section524.1484g:Neomycin, thiabendazole, and dexamethasone solution.
CFR 21-524.1484e-2014 Food and drugs. Part524:Ophthalmic and topical dosage form new animal drugs. Section524.1484e:Neomycin and polymyxin B ophthalmic solution.
CFR 21-524.1484c-2014 Food and drugs. Part524:Ophthalmic and topical dosage form new animal drugs. Section524.1484c:Neomycin, isoflupredone, and tetracaine ointment.
CFR 21-522.1020-2014 Food and drugs. Part522:Implantation or injectable dosage form new animal drugs. Section522.1020:Gelatin.
CFR 21-522.1010-2014 Food and drugs. Part522:Implantation or injectable dosage form new animal drugs. Section522.1010:Furosemide.
CFR 21-529.1660-2014 Food and drugs. Part529:Certain other dosage form new animal drugs. Section529.1660:Oxytetracycline.
CFR 21-520.443-2013 Food and drugs. Part520:Oral dosage form new animal drugs. Section520.443:Chlortetracycline tablets and boluses.
CFR 21-524.1465-2013 Food and drugs. Part524:Ophthalmic and topical dosage form new animal drugs. Section524.1465:Mupirocin.
CFR 21-524.463-2014 Food and drugs. Part524:Ophthalmic and topical dosage form new animal drugs. Section524.463:Copper naphthenate.
CFR 21-520.1195-2014 Food and drugs. Part520:Oral dosage form new animal drugs. Section520.1195:Ivermectin liquid.
CFR 21-522.1962-2014 Food and drugs. Part522:Implantation or injectable dosage form new animal drugs. Section522.1962:Promazine.
CFR 21-524.770-2014 Food and drugs. Part524:Ophthalmic and topical dosage form new animal drugs. Section524.770:Doramectin.
CFR 21-529.1115-2014 Food and drugs. Part529:Certain other dosage form new animal drugs. Section529.1115:Halothane.
CFR 21-520.622a-2013 Food and drugs. Part520:Oral dosage form new animal drugs. Section520.622a:Diethylcarbamazine citrate tablets.
CFR 21-524.1465-2014 Food and drugs. Part524:Ophthalmic and topical dosage form new animal drugs. Section524.1465:Mupirocin.
CFR 21-529.1150-2013 Food and drugs. Part529:Certain other dosage form new animal drugs. Section529.1150:Hydrogen peroxide.
CFR 21-529.778-2014 Food and drugs. Part529:Certain other dosage form new animal drugs. Section529.778:Doxycycline.
CFR 21-522.820-2014 Food and drugs. Part522:Implantation or injectable dosage form new animal drugs. Section522.820:Erythromycin.
CFR 21-522.390-2014 Food and drugs. Part522:Implantation or injectable dosage form new animal drugs. Section522.390:Chloramphenicol.
CFR 21-524.2350-2014 Food and drugs. Part524:Ophthalmic and topical dosage form new animal drugs. Section524.2350:Tolnaftate cream.
CFR 21-524.1005-2014 Food and drugs. Part524:Ophthalmic and topical dosage form new animal drugs. Section524.1005:Furazolidone powder.
CFR 21-522.1242-2014 Food and drugs. Part522:Implantation or injectable dosage form new animal drugs. Section522.1242:Levamisole.
CFR 21-522.2150-2014 Food and drugs. Part522:Implantation or injectable dosage form new animal drugs. Section522.2150:Stanozolol.
CFR 21-522.1289-2014 Food and drugs. Part522:Implantation or injectable dosage form new animal drugs. Section522.1289:Lufenuron.
CFR 21-522.82-2014 Food and drugs. Part522:Implantation or injectable dosage form new animal drugs. Section522.82:Aminopropazine.
CFR 21-524.86-2014 Food and drugs. Part524:Ophthalmic and topical dosage form new animal drugs. Section524.86:Amitraz.
CFR 21-522.1410-2014 Food and drugs. Part522:Implantation or injectable dosage form new animal drugs. Section522.1410:Methylprednisolone.
CFR 21-522.1204-2014 Food and drugs. Part522:Implantation or injectable dosage form new animal drugs. Section522.1204:Kanamycin.
CFR 21-522.1465-2014 Food and drugs. Part522:Implantation or injectable dosage form new animal drugs. Section522.1465:Naltrexone.
CFR 21-522.1610-2014 Food and drugs. Part522:Implantation or injectable dosage form new animal drugs. Section522.1610:Oleate sodium.
CFR 21-522.1066-2014 Food and drugs. Part522:Implantation or injectable dosage form new animal drugs. Section522.1066:Glycopyrrolate.
CFR 21-522.2615-2014 Food and drugs. Part522:Implantation or injectable dosage form new animal drugs. Section522.2615:Tripelennamine.
CFR 21-522.2670-2014 Food and drugs. Part522:Implantation or injectable dosage form new animal drugs. Section522.2670:Yohimbine.
CFR 21-522.90-2014 Food and drugs. Part522:Implantation or injectable dosage form new animal drugs. Section522.90:Ampicillin injectable dosage forms.
CFR 21-524.1484f-2014 Food and drugs. Part524:Ophthalmic and topical dosage form new animal drugs. Section524.1484f:Neomycin, prednisolone, and tetracaine otic suspension.
CFR 21-524.1484d-2014 Food and drugs. Part524:Ophthalmic and topical dosage form new animal drugs. Section524.1484d:Neomycin, hydrocortisone, and tetracaine otic ointment.
CFR 21-522.1452-2014 Food and drugs. Part522:Implantation or injectable dosage form new animal drugs. Section522.1452:Nalorphine.
CFR 21-522.234-2014 Food and drugs. Part522:Implantation or injectable dosage form new animal drugs. Section522.234:Butamisole.
CFR 21-522.304-2014 Food and drugs. Part522:Implantation or injectable dosage form new animal drugs. Section522.304:Carprofen.
CFR 21-524.390-2014 Food and drugs. Part524:Ophthalmic and topical dosage form new animal drugs. Section524.390:Chloramphenicol ophthalmic ointment.
CFR 21-524.660-2014 Food and drugs. Part524:Ophthalmic and topical dosage form new animal drugs. Section524.660:Dimethyl sulfoxide.
CFR 21-524.981b-2014 Food and drugs. Part524:Ophthalmic and topical dosage form new animal drugs. Section524.981b:Fluocinolone solution.
CFR 21-522.883-2014 Food and drugs. Part522:Implantation or injectable dosage form new animal drugs. Section522.883:Etorphine.
CFR 21-522.2005-2014 Food and drugs. Part522:Implantation or injectable dosage form new animal drugs. Section522.2005:Propofol.
CFR 21-522.204-2014 Food and drugs. Part522:Implantation or injectable dosage form new animal drugs. Section522.204:Boldenone.
CFR 21-522.1182-2014 Food and drugs. Part522:Implantation or injectable dosage form new animal drugs. Section522.1182:Iron injection.

American Society for Testing and Materials (ASTM)

ASTM E2500-13 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
ASTM E1567-93(2001) Standard Guide for Biopharmaceutical Facilities Architectural Design Considerations
ASTM E2500-20 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
ASTM E2500-07 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
ASTM E2363-23 Standard Terminology Relating to Manufacturing of Pharmaceutical and Biopharmaceutical Products in the Pharmaceutical and Biopharmaceutical Industry
ASTM E2500-07(2012) Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
ASTM E2500-25 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment Science and Risk Based Approach
ASTM STP 155-1954 Drug formulation and delivery systems: Innovating new uses for old products
ASTM STP 1558-2013 Drug formulation and delivery systems: Innovating new uses for old products
ASTM E1567-93 Standard Guide for Biopharmaceutical Facilities Architectural Design Considerations
ASTM E3051-25 Guide for Specification, Design, Verification, and Application of Single-Use Systems in Pharmaceutical and Biopharmaceutical Manufacturing

GCC Standardization Organization

GSO ASTM E2500:2021 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment

Korean Agency for Technology and Standards (KATS)

KS J 0016-2021 Facility and equipment system policy in biopharmaceutical production based on Good Manufacturing Practice
KS J 0016-2010(2021) Facility and equipment system policy in biopharmaceutical production based on Good Manufacturing Practice
KS C 1806-1991 Neonatal Monitors
KS J 0016-2010 Facility and equipment system policy in biopharmaceutical production based on Good Manufacturing Practice
KS P ISO 8871-4:2010 Elastomeric parts for parenterals and for devices for pharmaceutical use － Part 4: Biological requirements and test methods

US-FCR

FCR 21 CFR PART 526-2014 INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS
FCR 21 CFR PART 526-2015 INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS
FCR 21 CFR PART 526-2013 INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS
FCR 21 CFR PART 522-2014 IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
FCR 21 CFR PART 522-2015 IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
FCR 21 CFR PART 522-2013 IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
FCR 21 CFR PART 99-2015 DISSEMINATION OF INFORMATION ON UNAPPROVED/ NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES
FCR 21 CFR PART 99-2013 DISSEMINATION OF INFORMATION ON UNAPPROVED/ NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES
FCR 40 CFR PART 1054-2013 CONTROL OF EMISSIONS FROM NEW, SMALL NONROAD SPARK-IGNITION ENGINES AND EQUIPMENT
FCR 40 CFR PART 1054-2014 CONTROL OF EMISSIONS FROM NEW, SMALL NONROAD SPARK-IGNITION ENGINES AND EQUIPMENT
FCR 40 CFR PART 1054-2015 CONTROL OF EMISSIONS FROM NEW, SMALL NONROAD SPARK-IGNITION ENGINES AND EQUIPMENT

US-HHS

HHS 21 CFR PART 526-2011 INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS

National Association of Corrosion Engineers (NACE)

NACE Paper 13168-2019 Field trials of new sulfide generation inhibitors found

ET-QSAE

ES 544-2000 Microbiological testing of antibiotics for medicinal, medicinal and crude pharmaceutical products

Magyar Szabványügyi Testület

MSZ 5638-1957 Refresh the device. Steel production purpose

Gosstandart of Russia

GOST R 52896-2007 Manufacturing of medicinal products. Processing equipment for manufacturing of solid dosage forms. General requirements
GOST R 52896-2017 Manufacturing of medicinal product. Manufacturing systems and equipment for the production of medicines. General requirements

US-CLSI

CLSI I/LA34-P-2010 Design and Validation of Immunoassays for Assessment of Human allergenicity of New Biotherapeutic Drugs

German Institute for Standardization

DIN EN ISO 8871-4:2006 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 4: Biological requirements and test methods (ISO 8871-4:2006); English version of DIN EN ISO 8871-4:2006-09

International Organization for Standardization (ISO)

ISO 8871-4:2006 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 4: Biological requirements and test methods

GB-REG

REG 40 CFR PART 1054-2011 CONTROL OF EMISSIONS FROM NEW, SMALL NONROAD SPARK-IGNITION ENGINES AND EQUIPMENT
REG 40 CFR PART 1054-2012 CONTROL OF EMISSIONS FROM NEW, SMALL NONROAD SPARK-IGNITION ENGINES AND EQUIPMENT

IT-UNI

UNI 5304-1973 Technology, pharmaceuticals and sanitary glass products. Determination of surface hydrolysis resistance of new glass containers at 121°C

Canadian Standards Association (CSA)

CSA B125.2 UPD 2-2007 Sanitary faucet drains (Update No. 2)

Association Francaise de Normalisation

NF S93-102-4*NF EN ISO 8871-4:2006 Elastomeric parts for parenteral and for devices for pharmaceutical use - Part 4 : biological requirements and test methods

ISA - International Society of Automation

ISA AUTOMTN APPL BIO-PHARM-2008 Automation Applications in Bio-Pharmaceuticals

ZA-SANS

PIESA 1102-2004 Corrosion protection of new mild steel fabricated equipment

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