Aseptic Bag on Valve Technology for Sterile Pharmaceutical and Medical Spray Products with Contamination-Free Dispensing and Precise Metering
Ensure the highest standards of safety and efficacy with our aseptic Bag on Valve technology, a premier sterile packaging system engineered for the most demanding medical and pharmaceutical applications.
This advanced medical-grade BOV is manufactured in certified cleanroom environments, providing an hermetically sealed, contamination-free dispensing solution for nasal sprays, wound cleansers, ophthalmic mists, and other sterile therapeutics. The system's core is a pre-sterilized, collapsible pouch that maintains product sterility from filling through the entire product lifecycle, completely isolating the formulation from the propellant.
This critical barrier protects sensitive drug compounds and preserves sterility, while the integrated precision metering valve delivers an accurate, consistent dose with every actuation, which is paramount for patient safety and treatment efficacy. Our aseptic BOV system supports 360-degree operation, allowing patients to administer medication in any position without compromising performance.
By choosing this specialized Bag on Valve technology, you invest in a packaging solution that meets rigorous regulatory standards, mitigates contamination risks, and provides healthcare professionals and patients with a reliable, sterile, and user-friendly delivery system for critical medical treatments.
- Aseptic Bag on Valve system manufactured in ISO Class 7 cleanrooms or better.
- Provides a guaranteed sterile packaging system from point of fill to final use.
- Ensures contamination-free dispensing for sensitive pharmaceutical formulations.
- Features a highly accurate precision metering valve for consistent therapeutic dosing.
- This medical-grade BOV is validated for sterilization methods like gamma irradiation.
Specific Application Scenario
A patient requires a sterile saline nasal spray for post-surgical care. Using a product with our aseptic Bag on Valve system, they can administer the spray confidently, knowing the solution remains sterile inside its hermetically sealed pouch. They can use it comfortably lying down or sitting up, receiving the same precise, sterile dose every time.
Factory Production Floor
The production of this medical-grade BOV is a testament to precision and purity. It takes place within an ISO Class 7 cleanroom where personnel wear full sterile gowning. Automated assembly systems, housed within laminar flow hoods, handle the pre-sterilized pouch and valve components. The crimping process is meticulously controlled and validated. Every single aseptic BOV system is 100% integrity tested using sophisticated methods like helium leak detection to ensure the sterility barrier remains uncompromised.
Packing and Transportation
To preserve the sterile integrity, the assembled valves are packed in double-layer, sterile barrier packaging. The inner bag is a sterile pouch, and the outer is a protective pouch, both sealed within the cleanroom. These are then packed in sealed, labeled cartons and shipped under controlled conditions to ensure they arrive at the filler with their validated sterile status intact.
FAQ
1. What sterilization methods are compatible with this aseptic Bag on Valve system?
Our aseptic Bag on Valve system is designed to be compatible with terminal sterilization methods such as Gamma Irradiation and Ethylene Oxide (EtO) gas, with full validation support available.
2. How do you guarantee a sterile packaging system throughout the supply chain?
We guarantee a sterile packaging system through controlled cleanroom manufacturing, validated sterile barrier packaging, and by providing certificates of sterilization and conformity with each batch.
3. What documentation is provided for regulatory submissions for a medical-grade BOV?
For our medical-grade BOV, we provide a comprehensive Device Master File (DMF) or a Technical Dossier, along with certificates of analysis and biocompatibility, to support your regulatory filings with agencies like the FDA and EMA.
4. How does the system ensure contamination-free dispensing until the last dose?
The contamination-free dispensing is ensured by the hermetically sealed pouch that only compresses when actuated, preventing any ingress of contaminants and protecting the product until the pouch is fully emptied.
5. What is the dose accuracy of the precision metering valve?
The precision metering valve is engineered for high accuracy, typically achieving a dose volume tolerance within ±5% or better, which is critical for the efficacy and safety of pharmaceutical products.
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