Description
Bacillus clausii is a spore-forming aerobic probiotic species widely used in pharmaceutical and dietary supplement applications. The spore form survives gastric transit at near-complete viability and is fully shelf-stable at room temperature without cold-chain requirements.
Supplied as a freeze-dried or spray-dried spore powder with viability between 1 and 50 billion spores per gram (CFU/g) at release. Spore viability is essentially unaffected by typical processing temperatures, oxygen exposure, and acid challenge.
Off-white to pale beige free-flowing powder with a neutral odor. Particle size suitable for capsule, sachet, oral suspension reconstitution, and tablet applications.
We supply food-grade and pharmaceutical-grade Bacillus clausii from manufacturers in China holding ISO 22000, FSSC 22000, GMP, Halal, Kosher, and other certifications relevant to probiotic spore production.
Common market grades include 1, 10, and 50 billion spores per gram powders, multi-strain blends combining the four classical antibiotic-resistant variants (O/C, N/R, SIN, T) used in pharmaceutical products, oral suspension reconstitution premixes, and pediatric sachet blends. Bulk and reduced-MOQ shipments with batch-level COA covering spore count, strain identity, moisture, heavy metals, and pathogen panel.
Introduction
Bacillus clausii has been used in pharmaceutical probiotic products in Italy, France, India, and across Latin America and Southeast Asia for over 50 years. The classical four-strain blend (O/C, N/R, SIN, T) was developed at Sanofi (then Sanofi-Aventis) and commercialized under the Enterogermina brand, with each strain carrying distinct intrinsic antibiotic resistance patterns that allow co-administration with antibiotic therapy.
Industrial production uses aerobic submerged fermentation in defined or semi-defined media, sporulation induction, harvest of mature spores, washing to remove vegetative cell debris and exotoxins, and drying. Final activity is standardized by viable spore plate count after heat-shock treatment to confirm spore-form viability.
Regulatory status includes pharmaceutical authorizations in many countries for the classical four-strain blend, GRAS notifications with FDA for specific dietary supplement strains, and acceptance under traditional medicinal product frameworks in Europe and Asia.
Clinical evidence supports use in acute infectious diarrhea, antibiotic-associated diarrhea, and supportive treatment of bowel dysmicrobism in adults and children. Shelf stability without refrigeration is a key commercial advantage in tropical markets.
Where it is used
- Pharmaceutical probiotic oral suspensions and capsules
- Antibiotic-associated diarrhea adjunct therapy
- Pediatric probiotic sachets and reconstitutable suspensions
- Travelers diarrhea prevention products
- Shelf-stable adult probiotic capsules without cold chain
- Acute gastroenteritis support formulations
- Functional foods for tropical and high-temperature markets
- Multi-strain immune support blends
- Pet and veterinary probiotic supplements
Technical data
| Item | Specification |
|---|---|
| Appearance | Off-white to pale beige free-flowing powder |
| Spore count | ≥ 10 billion spores/g (1B, 10B, 50B grades) |
| Strain identity | Confirmed by 16S rRNA sequencing and antibiotic resistance pattern |
| Moisture (loss on drying) | ≤ 5.0% |
| Particle size | ≥ 95% through 80 mesh |
| Heavy metals (as Pb) | ≤ 1 mg/kg |
| Arsenic | ≤ 0.5 mg/kg |
| Salmonella | Absent in 25 g |
| E. coli | Absent in 10 g |
| Staphylococcus aureus | Absent in 10 g |
| Yeast and mold | ≤ 50 CFU/g |
| Shelf life | 36 months from manufacture under recommended storage |
| Storage | Below 25 °C, dry, sealed |
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