Prefilled Nasal Spray Assembly

Table of contents

1Product Qualifications

2High-quality Controlled Manufacturing Processes

3Product Advantages

4Product Specifications

5Product Components

6RTU Nest Plate/Box

7RTU Pre-sterilized, Ready-to-use Packaging

Product Qualifications

China CDE: B20230001072（Status A, activated)

USA DMF No.40922

Patent: CN116077816B

US12311389B2

EP23861667.6

Single-use prefilled spray devices allow long-term, contamination-free storage of vaccines or drugs, eliminating the need to transfer the liquid into a syringe and avoiding drug loss or waste from device residue. During use, the liquid is converted into uniform fine mist particles and sprayed onto patient mucosa (e.g., nasal or oral), achieving the intended drug delivery.

High-quality Controlled Manufacturing Processes

Product Advantages

The spray nozzle features a
protective cap with an internal
seal to ensure tight sealing and
prevent contamination

Precision turbine design
atomizes the liquid into 10–70
μm droplets

A precise dose-limiting
mechanism ensures uniform
dosing

Auto-disable feature prevents
reuse

Manufactured in GMP-controlled
cleanrooms from injection
molding through final packaging

Product Specifications

Specification	L1	D1	L2	L3	D2	D3	L2
0.5mL	68.00	φ7.50	65.50	16.50	φ5.40	φ6.85	φ4.65

Product Components

Component	Material Description	Regulatory Compliance
Glass Barrel	Borosilicate Glass	YBB00062004、ISO11040-4
Nasal Spray Device	PC	/
Cap	Polyisoprene	YBB00102004
Plunger	PP	/
Limiter	PP	/
Pison	Halobutyl Rubber	YBB00082004、ISO11040-5
Nest Box	PS	ISO11040-7
Nest Plate	PP	ISO11040-7
Silicone Oil	Silicone Oil	USP-NF and EP monographs for dimethyl silicone oi

RTU Nest Plate/Box

RTU Pre-sterilized, Ready-to-use Packaging

Specification	Pcs/pk	Pks/case	Cat.No.
0.5mL	160	15	205101

Name	Pcs/bag	bags/case
Plunger	10000	1
Dose Limiter	5000	2
Pistion	10000	1