Production Process Integration and OPV Bulk Manufacturing Efficiency at PT Bio Farma (Persero): An ABC, CBA, and FMEA-Informed Evaluation
DOI:
https://doi.org/10.59261/bustechno.v7i4.750Keywords:
Activity-Based Costing, Failure Mode and Effect Analysis, Oral Poliovirus Vaccine (OPV), Production Efficiency, Production Process IntegrationAbstract
Background: Sustained global demand for oral poliovirus vaccine requires manufacturers to shorten production cycles without weakening pharmaceutical quality controls. At PT Bio Farma (Persero), the Polio Single Harvest (PSH) stage includes an approximately 60-day holding period before clarification and sterile filtration, extending baseline bulk-production lead time to 274 days and increasing storage and utility requirements.
Objective: This study evaluates whether integrating the PSH-to-Polio Monovalent Bulk (POL) process improves production efficiency while preserving regulatory compliance, and examines the operational benefits, risks, and requirements for industrial adoption. Its contribution lies in evaluating stage integration within a vaccine-manufacturing quality system.
Methods: A mixed-method, evaluative single-case study combined direct process observation, focus group discussion, and production records from 2021-2025. Quantitative assessment used Activity-Based Costing (ABC) and a preliminary Cost-Benefit Analysis (CBA), while an FMEA-informed qualitative risk review identified critical failure modes and required controls for the proposed integrated flow.
Results: The proposed integration reduced simulated production lead time from 274 to 213 days (22%). Quantified material and utility savings reached at least Rp345.3 million per batch, excluding labor-cost effects, while direct labor requirements decreased by 6.83%. Key risks concerned aseptic integrity, product comparability, validation, quality hold points, and regulatory change control.
Conclusion: Production process integration can improve OPV bulk-manufacturing efficiency if implementation is governed through process validation, comparability studies, aseptic process simulation, quality-risk management, and regulatory approval. The study extends lean-process improvement into a tightly regulated biological manufacturing context.
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