HiSiaddi is an innovative foreign trade service provider driven by dual pillars of technology transformation and foreign trade services, operating under the “1+2+3+4=1” integrated service framework, with direct access to original manufacturer supplies of Clostridium butyricum and Bacillus coagulans.
As a technology-focused foreign trade enterprise, HiSiaddi has repeatedly collaborated with manufacturers on technology conversion and accurately captured market demands, delivering customized formulation optimization solutions and application improvement recommendations for Clostridium butyricum and Bacillus coagulans. Below is a consultation case detailing our formulation optimization work for these two strains.
Contact HiSiaddi customer service for additional formulation optimization consulting support.
The partner client is ProBioCare, a leading high-end functional nutrition enterprise headquartered in the Netherlands specializing in hospital-grade intestinal probiotic formulations and post-operative rehabilitation nutritional powders. Its products are distributed through premium private hospitals, specialist clinics and organic specialty supermarkets across the Netherlands, Belgium and Luxembourg. All manufacturing adheres strictly to EU food standards, cGMP production protocols, European Pharmacopoeia (EP) specifications and strain safety assessment criteria. Positioned as premium medical-grade products, the brand enforces stringent requirements for strain viability, blending stability, production compatibility and end-user therapeutic efficacy.
The client long sourced high-viability Clostridium butyricum and Bacillus coagulans for compound probiotic powders and granules produced at fixed blend ratios. Recently, continuous mass production failures emerged after repeated internal R&D adjustments to formulations and production parameters, resulting in reduced production line efficiency, lower finished product pass rates and delayed new product launches. Original raw material suppliers only provided goods without downstream application technical support, prompting the client to formally commission HiSiaddi’s technical team to conduct full root-cause analysis and deliver actionable optimized solutions for stable mass production and consistent product quality.
Combining the client’s formulation system, full production workflow, finished product test data and stored sample records, HiSiaddi’s technical team completed comprehensive simulation testing and fault diagnosis, pinpointing four prevalent technical challenges:
1.
Rapid Viability Attenuation Post-Strain Blending Clostridium butyricum is an obligate anaerobe, while Bacillus coagulans is an aerobic bacterium. Direct physical mixing creates antagonistic microenvironmental interactions between the two strains. After 24 hours of ambient-temperature storage post-blending, Clostridium butyricum viable counts drop by over 35%, accompanied by mild activity loss in Bacillus coagulans, rendering finished products unable to meet labeled viable counts and violating European labeling regulations.
2.
3.
Severe Viability Loss During High-Temperature Pelletization The client utilized wet granulation + fluidized-bed pelletization maintained at 78–82°C. The two strains exhibit divergent heat tolerance; Clostridium butyricum is heat-sensitive, resulting in over 40% total viable count loss after pelletization and insufficient end-product efficacy.
4.
5.
Poor Powder Flowability Causing Hopper Blockages Uneven raw material particle fineness and high moisture absorption lead to bridging, caking and inconsistent feeding within automated filling equipment. Net weight deviation per sachet exceeds EU permissible tolerances, drastically reducing production throughput.
6.
7.
Strain Imbalance During Finished Product Shelf Storage After 3 months of ambient, light-shielded storage, Bacillus coagulans concentrations rise disproportionately while Clostridium butyricum continuously declines, shifting strain ratios away from designed specifications and compromising shelf-life stability required for a 24-month expiry window.
8.
HiSiaddi assembled a dedicated task force of probiotic fermentation engineers, formulation specialists and pharmaceutical process consultants, following a standardized workflow: lab-scale prototype validation → pilot production rollout → standardized process finalization to resolve each technical failure sequentially.
Separate Pre-Treatment & Gradated Multi-Stage Mixing Traditional single-batch blending was discarded; independent pre-processing workflows were implemented for each strain: Clostridium butyricum stored in nitrogen-sealed oxygen-isolated chambers, while Bacillus coagulans was pre-blended with carrier materials separately. Low-temperature gradated mixing (ambient temperature controlled below 22°C) with three slow incremental blending cycles minimizes microenvironmental conflict during strain contact.
Regulatory-Compliant Viability-Protective Carrier Additives EU-approved compound carriers of corn starch and fructooligosaccharides were selected; porous carrier structures physically isolate individual bacterial cells to block antagonistic reactions. Post-optimization, Clostridium butyricum viability loss over 24-hour blended storage is capped below 6%, maintaining consistent strain ratios.
Shift to Low-Temperature Pelletization by Reducing Process Temperatures Fluidized-bed granulation temperatures were lowered from 78–82°C to 55–60°C, with extended hot air circulation durations to preserve complete granule formation while avoiding heat-induced Clostridium butyricum mortality.
Adjust Production Sequence to Add Strains Post-Thermal Processing Full production line workflow restructuring: complete auxiliary material granulation, drying and cooling first; only after granules cool to ambient temperature are both probiotic strains added via aseptic dry blending, fully isolating strains from high-temperature process stages. Post-revision, total viable count loss during pelletization is reduced to under 8%.
Inert Gas Blanketing Across Open Process Stages Continuous nitrogen purging at mixing, granule sizing and transfer stations minimizes oxygen exposure, further boosting strain heat and storage resistance.
Powder Particle Size Classification via Airflow Screening Secondary airflow classification of raw materials standardizes particle size ranges, eliminating uneven fine/coarse powder mixing that impairs flowability.
Regulated Anti-Caking Agent Formulation Food-grade silicon dioxide (EU-permitted dosage within regulatory limits) is incorporated to mitigate powder moisture absorption and caking tendencies.
Filling Equipment Parameter Calibration Client filling machinery parameters (agitation speed, feed nozzle diameter, vibration frequency) were fine-tuned to achieve consistent powder feeding, with single-sachet net weight deviation controlled within ±0.5%, fully complying with EU metrology standards and restoring full production throughput.
Adjust Formulation Buffer System Tweaked composite carrier ratios to optimize finished product pH to 5.0–5.8, the optimal range for sustained viability of both strains, inhibiting activity divergence during long-term storage.
High-Barrier Packaging Upgrade Conventional composite film packaging replaced with high-barrier aluminum foil pouches, sealed under vacuum with nitrogen flushing to block oxygen and moisture ingress.
Standardized Warehouse Storage Protocols Formalized storage requirements: cool, dry environments with ambient temperature ≤25°C and avoidance of abrupt temperature fluctuations.
Lab Prototype Testing: 5 distinct formulation and parameter sets were trialed, with 72-hour viability monitoring, flowability assessments and simulated pelletization trials to select the optimal solution.
Pilot Production Validation: Remote real-time guidance provided to the client for equipment parameter adjustments and production line sequencing changes; three consecutive stable pilot batches were completed with zero blockages or caking defects.
Long-Term Shelf-Life Stability Monitoring: Finished products underwent ambient long-term storage and accelerated aging testing, with monthly sampling for 6 consecutive months. Viable counts and strain ratios remained consistent with design benchmarks, supporting a stable 24-month shelf life.
Standardized Technical Documentation Handover: Full operational manuals transferred to the client, including Strain Blending SOP, Low-Temperature Pelletization Operating Specifications, Powder Processing Standards and Warehouse Control Protocols for consistent daily implementation by the client’s technical team.
1.
Full Resolution of All Technical Failures Strain antagonism, heat-induced viability loss, hopper blockages and shelf-life strain imbalance were completely eliminated. Finished product viable counts, strain ratios and filling precision all meet design specifications, restoring full production line capacity with finished product pass rates rebounding above 99%.
2.
3.
Enhanced Product Market Competitiveness Optimized formulations deliver higher consistent strain activity and stable quality, generating positive end-user feedback at Dutch hospitals and clinics, further consolidating the brand’s reputation within Europe’s premium medical-grade probiotic sector.
4.
5.
Long-Term Strategic Partnership Established The client designated HiSiaddi as its exclusive raw material supplier and technical service partner, prioritizing HiSiaddi for all new product R&D, process upgrades and production line optimization, with year-over-year expansion of Clostridium butyricum and Bacillus coagulans procurement volumes.
6.
Client Testimonial: “We only sought premium strain raw material supply, yet received a complete production application framework tailored for high-end European formulations. HiSiaddi’s expertise extends far beyond strain characteristics to full probiotic formulation manufacturing processes, delivering targeted solutions to resolve long-standing mass production bottlenecks—an unwaveringly reliable technical backbone.”
For overseas mid-to-high-end brands purchasing compound Clostridium butyricum and Bacillus coagulans raw materials, baseline strain viability is merely a foundational requirement. Strain blending compatibility, manufacturing process adaptability, powder physical property regulation and long-term storage stability ultimately determine mass production success and end-product quality. Most standalone raw material suppliers only focus on product delivery, lacking formulation-stage application technical capabilities that frequently lead to production disruptions and compromised quality for clients.
For this project, HiSiaddi leveraged end-to-end probiotic technical expertise to deploy integrated solutions across formulation, manufacturing processes, powder characteristics, packaging and warehouse management. Beyond resolving immediate production malfunctions, standardized operational workflows were established to prevent recurring identical issues. This fully addresses stringent European high-end product standards for quality, compliance and stability, while enabling HiSiaddi to evolve from a simple raw material trading provider to a comprehensive integrated technical service partner delivering expanded value.
Contact HiSiaddi customer service for additional formulation optimization consulting support.
+86-13120989737 
info@hisiaddi.com 
English
