Cart (0)
  • No items in cart.
Total
$0
There is a technical issue about last added item. You can click "Report to us" button to let us know and we resolve the issue and return back to you or you can continue without last item via click to continue button.
Filters:
FORMAT
EDITION
to
PUBLISHER
(1)
(338)
(589)
(599)
(55)
(234)
(1006)
(690)
(2183)
(117)
(95207)
(63)
(575)
(124)
(33)
(21)
(20)
(95391)
(3)
(17)
(1)
(374)
(322)
(6938)
(241)
(21)
(6)
(1667)
(17)
(19)
(28)
(4)
 
(6)
(7)
(115)
(3)
(57)
(5)
(5)
(1)
(1)
(2)
(25)
(27)
(27)
(13)
(61)
(24)
(22)
(7)
(8)
(20)
(1)
(3)
(50)
(6)
(33)
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
  • ASTM
    E2968-23 Standard Guide for Application of Continuous Manufacturing (CM) in the Pharmaceutical Industry
    Edition: 2023
    $94.85
    Unlimited Users per year

Description of ASTM-E2968 2023

ASTM E2968-23

Active Standard: Standard Guide for Application of Continuous Manufacturing (CM) in the Pharmaceutical Industry




ASTM E2968

Scope

1.1 This guide introduces key concepts and principles to assist in the appropriate selection, development and operation of CM technologies for the manufacture of pharmaceutical products. Athough selected concepts covered here can be applied to biopharmaceutical CM (BioCM), the focus of this guide is on non-biopharmaceutical applications.

1.2 Particular consideration is given to the development and application of the appropriate scientific understanding and engineering principles that differentiate CM from traditional batch manufacturing.

1.3 Most of the underlying concepts and principles (for example, process dynamics and process control) outlined in this guide can be applied to both Drug Substance (DS) and Drug Product (DP) processes. However, it should be recognized that in Drug Substance production the emphasis may be more on chemical behavior and dynamics in a fluid phase whereas for solid drug product manufacture there may be a greater emphasis on the physical behavior and dynamics in a solid/powder format.

1.4 This guide is also intended to apply in both the development of new processes, or the redesign of existing ones.

1.5 All values are stated in SI units. No other units of measurement are included in this standard.

1.6 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.

1.7 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

application; continuous manufacturing; pharmaceutical industry; process control;


ICS Code

ICS Number Code 11.120.01 (Pharmaceutics in general)


DOI: 10.1520/E2968-23

GROUPS