Clinically Validated Antiperspirant Spray Valve with Actuator for Prescription-Strength Formulations Featuring Exact Metering & Sterility Assurance

Clinically Validated Antiperspirant Spray Valve with Actuator for Prescription-Strength Formulations Featuring Exact Metering & Sterility Assurance

Product Description:

Meet the stringent demands of prescription and high-potency over-the-counter (OTC) antiperspirants with our pharma-grade antiperspirant spray valve with actuator. This precision dispensing system is engineered and clinically validated to deliver uncompromising reliability and accuracy essential for therapeutic applications. It features an ultra-precise spray valve core enabling exact metering of concentrated active ingredients (like aluminum chloride hexahydrate), ensuring consistent dose delivery critical for efficacy and patient safety. Manufactured under strict GMP-like controls, the system offers sterility assurance options (e.g., gamma irradiation compatible components, cleanroom assembly) to prevent microbial contamination. Constructed from highly inert materials (e.g., 316L stainless steel springs, fluoropolymer seals), it provides exceptional chemical resistance against aggressive actives and solvents. The robust actuator delivers consistent force for reliable actuation, while the optimized atomizing mechanism ensures even coverage. This delivery assembly undergoes rigorous performance testing, including dose uniformity, extractables/leachables profiling, and stability studies, providing the documentation and traceability required for pharmaceutical and high-potency OTC applications. It integrates with specialized aseptic or controlled-environment filling lines.

Bullet Points:

Exact Metering: Precision-engineered spray valve guarantees consistent dose delivery (±5% variance) for potent actives.

Sterility Assurance: Components and assembly processes designed for gamma irradiation compatibility and cleanroom manufacturing.

Clinically Validated: Performance data (dose uniformity, spray pattern) generated to support regulatory submissions.

Pharma-Grade Materials: Inert construction (fluoropolymers, 316L SS) ensures compatibility with high-concentration actives.

Full Traceability & Documentation: Lot-controlled materials, DMF availability, comprehensive testing reports (E&L, stability).

Specific Application Scenario: Seamlessly integrated into the aseptic filling line of a 20% Aluminum Chloride Hexahydrate prescription antiperspirant. The pharma-grade spray valve ensures exact metering of the potent dose. The validated actuator provides reliable delivery. The sterility assurance features maintain product integrity throughout its shelf life, crucial for patient safety.

FAQ:

Q: What level of dose uniformity (metering precision) can be guaranteed for prescription-strength actives?
A: Our exact metering system consistently achieves dose uniformity with RSD (Relative Standard Deviation) typically below 5% for aqueous/alcoholic solutions, meeting pharmacopeial standards (e.g., USP <603>).

Q: What sterility assurance options are available for the valve/actuator?
A: We offer sterility assurance via Gamma Irradiation (25-45 kGy validated) or ETO sterilization. Components are designed and tested for compatibility. Terminal sterilization of the assembled can is also supported.

Q: Do you provide regulatory support documentation like a Drug Master File (DMF)?
A: Yes, a comprehensive Type III DMF for this antiperspirant spray valve with actuator is maintained with the relevant regulatory agencies (e.g., US FDA) to support customer filings.

Q: Are extractables and leachables (E&L) data available for this clinically validated system?
A: Absolutely. Extensive clinically validated E&L studies are conducted per ICH Q3 guidelines, identifying and quantifying potential leachables under various conditions, available for regulatory review.

Q: Is the actuator designed for ease of use by patients with conditions like hyperhidrosis who may have reduced dexterity?
A: Yes, the actuator ergonomics are specifically tested for manageable depression force, and options for larger finger pads or textured surfaces are available to aid users with dexterity challenges.