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ASTM
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ASTM F2315-18
Действует
Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels — 8 стр.
ASTM E2329-17
Действует
Standard Practice for Identification of Seized Drugs — 3 стр.
ASTM F2602-18
Действует
Standard Test Method for Determining the Molar Mass of Chitosan and Chitosan Salts by Size Exclusion Chromatography with Multi-angle Light Scattering Detection (SEC-MALS) — 7 стр.
ASTM D8229-19
Действует
Standard Guide for Corrective Action and Preventive Action (CAPA) for the Cannabis Industry — 8 стр.
ASTM D8233-19
Действует
Standard Guide for Packaging and Labeling of Consumer Resin Cannabis Products for Sale to Adult Consumers, Legally Authorized Medical Users, and Caregivers in a Business-to-Consumer Retail Environment (Retailers) — 8 стр.
ASTM D8250-19
Действует
Standard Practice for Applying a Hazard Analysis Critical Control Points (HACCP) System for Cannabis Consumable Products — 7 стр.
ASTM F2475-20
Действует
Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials — 3 стр.
ASTM E2503-13(2020)
Действует
Standard Practice for Qualification of Basket and Paddle Dissolution Apparatus — 4 стр.
ASTM E3219-20
Действует
Standard Guide for Derivation of Health-Based Exposure Limits (HBELs) — 30 стр.
ASTM E3230-20
Действует
Standard Practice for Extraction of Particulate Matter from the Surfaces of Single-Use Components and Assemblies Designed for Use in Biopharmaceutical Manufacturing — 12 стр.
ASTM E2898-20a
Действует
Standard Guide for Risk-Based Validation of Analytical Methods for PAT Applications — 7 стр.
ASTM E2891-20
Действует
Standard Guide for Multivariate Data Analysis in Pharmaceutical Development and Manufacturing Applications — 7 стр.
ASTM E2500-20
Действует
Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment — 6 стр.
ASTM F2559/F2559M-21
Действует
Standard Guide for Writing a Specification for Sterilizable Peel Pouches — 6 стр.
ASTM F3163-22
Действует
Standard Guide for Categories and Terminology of Cellular and/or Tissue-Based Products (CTPs) for Skin Wounds — 6 стр.
ASTM E3336-22
Действует
Standard Test Method for Physical Integrity Testing of Single-Use Systems — 15 стр.
ASTM E3326-22
Действует
Standard Guide for Application of Continuous Manufacturing (BioCM) in the Biopharmaceutical Industry — 16 стр.
ASTM E2476-22
Действует
Standard Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes for Pharmaceutical Manufacture — 11 стр.
ASTM F640-23
Действует
Standard Test Methods for Determining Radiopacity for Medical Use — 6 стр.
ASTM E3263-22e1
Действует
Standard Practice for Qualification of Visual Inspection of Pharmaceutical Manufacturing Equipment and Medical Devices for Residues — 21 стр.
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