Designed for Emergencies. Backed by Science.
Callie Baby is more than innovative—it’s evidence-based. We’re committed to rigorous testing and research to ensure our system is safe, effective, and ready for real-world deployment in high-stakes environments.
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Research
Sterility & Shelf-Life Testing
Tested in Partnership with Los Alamos National Laboratory (LANL)
- LANL is currently conducting shelf-stability and sterility testing of the dual-pouch system.
- Testing evaluates:
- Sterility retention over time and under variable temperature conditions
- Seal integrity and microbial safety
- Product performance after exposure to field-like conditions (heat, freezing, shipping stress)
- Initial results support the product’s ability to maintain sterility and safety in disaster-prone settings.
Key Areas of Testing Include:
List partnership paths with short descriptions:
Sterility Retention:
- Microbial integrity over time
- Pouch integrity during and after shipping
- Contamination resistance during activation (mixing)
Shelf-Life Stability:
- Testing under varied temperature extremes (freezing to high heat)
- Aging studies simulating long-term storage without refrigeration
- Real-time and accelerated aging protocols
Transportation Resilience:
- Package integrity after vibration, pressure, and impact simulations
- Analysis of durability during bulk transport and distribution
FDA-Alignment Studies:
- Testing procedures follow FDA guidelines for sterility, shelf life, and packaging safety
- Data from LANL will inform future submissions to support regulatory clearance
Sterility & Shelf-Life Testing
Tested in Partnership with Los Alamos National Laboratory (LANL)
- LANL is currently conducting shelf-stability and sterility testing of the dual-pouch system.
- Testing evaluates:
- Sterility retention over time and under variable temperature conditions
- Seal integrity and microbial safety
- Product performance after exposure to field-like conditions (heat, freezing, shipping stress)
- Initial results support the product’s ability to maintain sterility and safety in disaster-prone settings.
Key Areas of Testing Include: - 🔬 Sterility Retention:
- Microbial integrity over time
- Pouch integrity during and after shipping
- Contamination resistance during activation (mixing)
- ❄️ Shelf-Life Stability:
- Testing under varied temperature extremes (freezing to high heat)
- Aging studies simulating long-term storage without refrigeration
- Real-time and accelerated aging protocols
- 🚛 Transportation Resilience:
- Package integrity after vibration, pressure, and impact simulations
- Analysis of durability during bulk transport and distribution
- 📋 FDA-Alignment Studies:
- Testing procedures follow FDA guidelines for sterility, shelf life, and packaging safety
- Data from LANL will inform future submissions to support regulatory clearance
These evaluations are essential to confirm that Callie Baby can safely deliver sterile, ready-to-use infant nutrition—even in harsh, unstable environments.
Feasibility & Usability Pilot Study
Before entering clinical trials, Callie Baby is undergoing a pilot study focused on usability and feasibility. This real-world assessment ensures:
- Intuitive use by caregivers and frontline workers
- Clear instructions and safe activation
- Positive infant feeding experience
- Packaging suitability for humanitarian distribution
Results will support product refinement, training design, and IRB preparation for clinical research.
Clinical Pilot Study
Preparing for Real-World Clinical Use
- Pilot clinical study will assess:
- Ease of use in low-resource settings
- Acceptance by caregivers and medical staff
- Nutritional outcomes for infants
- Compatibility with emergency feeding protocols
- Goals: Generate data for regulatory approval, humanitarian procurement, and scaling.
Academic & Research Collaboration
Seeking Institutional Partners
- We're actively seeking:
- IRB-approved collaborators
- Global health researchers
- Pediatric nutrition experts
- Institutions with interest in emergency feeding, WASH (Water, Sanitation, Hygiene), and maternal-infant health
Data Use & Clinical Potential
Callie Baby’s standardized system supports controlled dosing, consistent delivery, and data collection for studies on malnutrition, feeding safety, and infant development—offering valuable clinical and humanitarian research opportunities.
Trust & Transparency
We are committed to transparency, scientific rigor, and partnerships that improve outcomes for vulnerable infants worldwide.