|
FORMAT
EDITION
PUBLISHER
CONTENT TYPE
Act
Admin Code
Announcements
Bill
Book
CADD File
CAN
CEU
Charter
Checklist
City Code
Code
Commentary
Comprehensive Plan
Conference Paper
County Code
Course
DHS Documents
Document
Errata
Executive Regulation
Federal Guideline
Firm Content
Guideline
Handbook
Interpretation
Journal
Land Use and Development
Law
Legislative Rule
Local Amendment
Local Code
Local Document
Local Regulation
Local Standards
Manual
Model Code
Model Standard
Notice
Ordinance
Other
Paperback
PASS
Periodicals
PIN
Plan
Policy
Product
Product - Data Sheet
Program
Provisions
Requirements
Revisions
Rules & Regulations
Standards
State Amendment
State Code
State Manual
State Plan
State Standards
Statute
Study Guide
Supplement
Sustainability
Technical Bulletin
All
|
Description of ASTM-E3425 2024ASTM E3425-24Active Standard: Standard Guide for Development of Automated Membrane Microscopy Test Methods for the Counting and Sizing of Particulate Matter Present in Parenteral Pharmaceutical Manufacturing Processes and Final Drug ProductsASTM E3425Scope 1.1 This guide provides guidance on the development of test methods that apply automated membrane microscopy (AMM) to the measurement of extraneous solid insoluble particulate matter present in parenteral pharmaceutical manufacturing processes and drug products. For the validation requirements for AMM test methods, see Practice E3411. 1.2 In an AMM test method, a test liquid containing suspended particles is filtered through a membrane filter, the particles are retained on the surface of the membrane filter, the membrane filter surface is imaged with an optical microscope and digital camera, and application of image analysis software determines particle count and particle sizes. 1.3 AMM test methods may be applied to the measurement of the commonly defined size categories of subvisible (<100 µm) or visible (≥100 µm) or both particulate matter present during any stage of the manufacturing of parenteral pharmaceuticals. 1.4 The test liquid characterized by an AMM test method may be a process fluid, drug substance or drug product, or liquid extracts from the surfaces of processing equipment, drug containers, delivery devices, and components thereof. 1.5 This guide does not apply to the characterization of particles inherent to parenteral suspensions (for example, cells, protein aggregates, or vaccine adjuvants) or the characterization of liquid droplets (for example, silicone oil). 1.6 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.7 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.8 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee. Keywords development; membrane filter; membrane microscopy; microscopy; particulate matter; pharmaceuticals; ICS Code ICS Number Code n/a DOI: 10.1520/E3425-24 This book also exists in the following packages...Subscription InformationMADCAD.com ASTM Standards subscriptions are annual and access is unlimited concurrency based (number of people that can access the subscription at any given time) from single office location. For pricing on multiple office location ASTM Standards Subscriptions, please contact us at info@madcad.com or +1 800.798.9296.
Some features of MADCAD.com ASTM Standards Subscriptions are: - Immediate Access: As soon as the transaction is completed, your ASTM Standards Subscription will be ready for access.
For any further information on MADCAD.com ASTM Standards Subscriptions, please contact us at info@madcad.com or +1 800.798.9296.
About ASTMASTM International, formerly known as the American Society for Testing and Materials (ASTM), is a globally recognized leader in the development and delivery of international voluntary consensus standards. Today, some 12,000 ASTM standards are used around the world to improve product quality, enhance safety, facilitate market access and trade, and build consumer confidence. ASTM’s leadership in international standards development is driven by the contributions of its members: more than 30,000 of the world’s top technical experts and business professionals representing 150 countries. Working in an open and transparent process and using ASTM’s advanced electronic infrastructure, ASTM members deliver the test methods, specifications, guides, and practices that support industries and governments worldwide. |
GROUPS
|
|
MADCAD.com
by Compu-tecture, Inc.
|
Contact Us
3000 Connecticut Ave, NW
Suite 200
Washington, DC 20008
+1 800.798.9296
+1 202.265.1940
|
|
Partnerships
|