INDUSTRY PRACTICES IN BACTERIAL ENDOTOXIN TESTING FOR INJECTABLE PHARMACEUTICALS: A MULTICENTRE SURVEY OF INDIAN MANUFACTURERS
Authors: Sunil Gavate, Amar Mohite, Girish R Pathade*
Publication Date: 2026/07/07
DOI: 10.59551/DOI: 10.59551/IJHMP/25832069/2026.7.1.154
Abstract
<p>Background: Bacterial endotoxins are a serious safety hazard in the manufacture of injectable pharmaceuticals. Although the Limulus Amebocyte Lysate (LAL) gel-clot method is the reference standard in the pharmacopeia, questions exist about subjectivity, matrix interference, sustainability as well as the arrival of alternative technologies, which require a full assessment of industry practices.</p>
<p>Objective: To describe the existing practices of Bacterial Endotoxin Testing (BET), risk-based approaches and preparedness for technical modernization by injectable pharmaceutical manufacturers.</p>
<p>Methods: A designed cross sectional questionnaire of 21 items was administered to pharmaceutical professionals involved in sterile injectable manufacturing company. The 107 valid replies were evaluated using descriptive statistics, chi-square tests for association, correlation analysis, factor analysis and a novel Modernization Readiness Index (MRI).</p>
<p>Results: The gel-clot approach remains the most common and used by 86.9% (93/107) of the respondents. The respondents were quite technically mature with 61.7% having >10 years of industry experience and 79.4% were from Quality Control departments. Although 71.0% (76/107) found recombinant Factor C (rFC) and Monocyte Activation Test (MAT) to be potential options, 94.4% (101/107) stressed the need for further validation and regulatory harmonization before routine implementation. AI based techniques were perceived positively, with 48.6% feeling that they could greatly enhance endotoxin control, whilst 25.2% assessed their influence as limited or untested. Factor analysis indicated three main aspects accounting for 65.6% variance: Regulatory & Validation Compliance (28.5%), Technology Adoption Readiness (21.3%), and Operational Challenges (15.8%). The Modernization Readiness Index found that only 16.8% of respondents were “high readiness” for technology change.</p>
<p>Conclusion: The injectable pharmaceutical market remains heavily dependent on gel-clot BET, but there is good knowledge and cautious optimism for modernization. Regulatory harmonization, strong validation procedures and focused capacity building are still key drivers for the shift towards alternative methodologies and AI integrated systems.</p>
<p>Keywords: Bacterial Endotoxin Test, Gel-clot method, Recombinant Factor C, Monocyte Activation Test, Artificial Intelligence, Risk-based Quality, Pharmaceutical Production, Validation, Modernization Ready.</p>
References
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