The lma-1 Bag is a single-use, needle-free container designed for intravenous solution administration using an intravascular administration set. Médication transfer in and out of the bag is conducted with aseptic techniques. The Needle-Free Valve facilitâtes filling the bag with IV solutions, allows for disinfection, and enables access for adding médications. By eliminating needles, our system significantly reduces the risk of needlestick injuries, a leading cause of occupational infections among healthcare workers.
CHARACTERISTICS
• - Clean room facility and documentation is designed to meet ISO 15747 compliance
• - Clear polypropylene container allows for optimal visual inspection
• - Bag is designed to help minimize medicine waste
• - Empty & ready to be filled with custom médications
• - Tube port compatible with needleless syringes
• - Offered with twist-off or spike ports
• - SteamS terilizable at 121°C
• - PVC&DEHPfree
• - Closed system for administration and delivery
• - Elemental impurity Déclaration as per ICH Q3D guideline
• - IR graph report along with ail the supplied batches
• - Validation pack available upon request
• - Custom printing available upon request
KEY FEATURES
FILM TYPE
3 Loyer PP Film
MANUFACTURING ENVIRONMENT
cGMP Compilant Clean room of class 10000
EXTRACTABLE STUDY REQUIREMENTS
Tested according to PQRI guidelines from USFDA approved laboratory
MISC. DECLARATIONS
Following déclarations available
• - TSE/ BSE & Latex free requirements
• - Food grade requirements
TOTM (TRI OCTYL TRIMELLITATE) déclarations
• - Nitrosamine impurities free déclaration
| APPLICATIONS
• - Primary packaging for IV solutions (IV bags)
• - Packaging of antibiotics,