A closer look at automated in-line dilution

BioPharm International

Volumn 22, Issue 10, 2009, Pages 52-65

  Patterson, Brandon J ^a  

^a Kymanox   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG;

AUTOMATION; BATCH PROCESS; CALIBRATION; CHANGE MANAGEMENT; CHROMATOGRAPHY; CONTROL SYSTEM; DILUTION; DRUG INCOMPATIBILITY; DRUG INDUSTRY; DRUG MANUFACTURE; DRUG PURIFICATION; DRUG QUALITY; ENVIRONMENTAL SANITATION; EQUIPMENT; FINANCIAL MANAGEMENT; FLUID FLOW; INSTRUMENT STERILIZATION; ONLINE SYSTEM; PH; PROCESS DESIGN; PROCESS MONITORING; PROCESS TECHNOLOGY; QUALITY CONTROL; REVIEW; RISK ASSESSMENT; SENSOR; VALIDATION PROCESS;

EID: 77951631883     PISSN: 1542166X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (5)

1. US Food and Drug Administration. Pharmaceutical cGMPs for the 21st Century-A risk-based approach, Final Report. Rockville, MD; 2004 Sept.
2. US FDA. PAT-A framework for innovative pharmaceutical development, manufacturing, and quality assurance. Rockville, MD; 2004 Sept.
3. International Coference on Harmonization. Q10, Pharmaceutical quality systems. Geneva, Switzerland; 2007 May.
4. Walker J. Kick-starting PAT to achieve Quality by Design in cGMP bioprocessing. Available from: http://www.technikrom.com.
5. Patterson BJ. Automated in-line dilution-A QbD manufacturing method." J GXP Compliance. Fall 2008:12(5)20-34.