Laboratorios Biogalenic Sterile Water for Inhalation, USP

Laboratorios Biogalenic Sterile Water for Inhalation, USP is a single-use sterile water product supplied in flexible polyolefin bags with a twist-off port. It is designed to fill respiratory humidifier chambers via gravity-fed tubular feed sets and is intended for use in institutional and non-institutional care settings across adult, pediatric, infant, and neonatal populations.

The proposed device uses flexible polyolefin bags (versus predicate's polyvinyl chloride), features the same twist-off port design, integrated hanger, and available sizes (1000 mL and 2000 mL). Both use the same mechanism—transferring sterile water to humidifier chambers where it is heated to produce water vapor for respiratory humidification.

ISO 10993 series (cytotoxicity, sensitization, irritation, pyrogenicity, extractable/leachable testing, and toxicological risk assessment); ASTM D3078-02, ASTM F1929-23, ASTM F1140/F1140M, ASTM D642; ISO 15747:2018; PDA Technical Report No. 1 (Revised 2007); ISO 17665 for moist heat sterilization validation.

Both devices have identical indications for use, the same Class II classification, BTT product code, and substantially equivalent design and technological characteristics. Testing demonstrates equivalent physicochemical and biological performance, and differences in primary packaging material (polyolefin versus PVC) do not pose significant safety or efficacy concerns. The sterilization method, compounding process, and mechanism of action are substantially equivalent.