Bacterial Endotoxin Testing: A Report on the Methods, Background, Data, and Regulatory History of Extraction Recovery Efficiency

Biomedical Instrumentation and Technology

Volumn 38, Issue 1, 2004, Pages 73-78

  Bryans, Trabue D ^a   Braithwaite, Carolyn ^b   Broad, John ^c   Cooper, James F ^d   Darnell, Kimbrell R ^e   Hitchins, Victoria M ^f   Karren, Amy Jo ^g   Lee, Peter S ^h  

^a AppTec Laboratory Services   (United States)

^b Gambro BCT   (United States)

^c NAMSA's California Laboratory   (United States)

^d Endotoxin Consulting Services   (United States)

^e C R BARD INC   (United States)

^f CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^g Nelson Laboratories   (United States)

^h BAXTER HEALTHCARE CORPORATION   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BACTERIA; BIOASSAY; BIOMEDICAL ENGINEERING; BIOMEDICAL EQUIPMENT;

BACTERIAL ENDOTOXINS TEST (BET); EXTRACTION EFFICIENCY;

BACTERIOLOGY;

ENDOTOXIN;

ANALYTIC METHOD; BACTERIUM CULTURE; BACTERIUM IDENTIFICATION; DATA ANALYSIS; DEVICE; DIAGNOSTIC ACCURACY; DIAGNOSTIC VALUE; ENDOTOXEMIA; HISTORY OF MEDICINE; HUMAN; INTERMETHOD COMPARISON; KINETIC CHROMOGENIC METHOD; KINETIC TURBIDIMETRIC AND GEL CLOT METHOD; LIMULUS LYSATE TEST; MEDICAL SOCIETY; METHODOLOGY; MICROBIOLOGICAL EXAMINATION; MODIFIED BIOWHITTAKER CHROMOGENIC TEST; NONHUMAN; REVIEW; ROUND ROBIN GEL TUBE METHOD; STANDARD; TOXICITY TESTING; VALIDATION PROCESS;

ADVISORY COMMITTEES; BACTERIAL TOXINS; CONSUMER PRODUCT SAFETY; ENDOTOXINS; EQUIPMENT CONTAMINATION; LIMULUS TEST; UNITED STATES;

EID: 1242352631     PISSN: 08998205     EISSN: None     Source Type: Journal    
DOI: 10.2345/0899-8205(2004)38[73:BETARO]2.0.CO;2     Document Type: Review

References (8)

1. Cooper JF. Bacterial endotoxins test. In: Prince R, ed. Microbiology in Pharmaceutical Manufacturing. Bethesda, Md: Parenteral Drug Assoc; 2001:537-567.
2. Williams KL. Endotoxins: Pyrogens, LAL Testing, and Depyrogenation. 2nd ed. New York, NY, and Basel, Switzerland: Marcel Dekker Inc; 2001:136-164.
3. Food & Drug Administration. Guideline on Validation of the Limulus Amebocyte Lysate Test as End-Product Test for Human and Animal Parenteral Drugs, Biological Products and Medical Devices. Rockville, Md, December 1987.
4. Ross VC, Twohy CW. Endotoxin and medical devices. Progress in Clinical and Biological Research (US). 1985;189:267-81.
5. Twohy CW, et al. Extraction of bacterial endotoxin from medical devices. J Parenter Sci Technol. 1986;40:287-91.
6. Roslansky PF, et al. Plastics, endotoxins and the Limulus Amebocyte Lysate Test. J Parenter Sci Technol. 1991;45:83-87.
7. Berzofsky R, et al. Validation of endotoxin removal from parenteral vial closures. BioPharm. June 1994:58-66.
8. Ragab, AA, et al. Measurement and removal of adherent endotoxin from titanium particles and implant surfaces. J Orthoped Res. 1999;17:803-809.