In view of the fierce competition in a global environment, we realize in order to excel ourselves among others in the respiratory treatment application, more resource shall be devoted in to achieve that goal. Under the careful planning, the respiratory analytic laboratory was established in the late 2014. The instruments acquired include Anderson Cascade Impactor (ACI), Next Generation Impactor (NGI), SprayTec, Breath Simulator, HPLC, and others. With those state-of-the art equipments, we are able to monitor our device quality, improve the aerosol performance of the new devices and provide respiratory analytic service to our global partners both in medical devices and pharmaceutical industries. To hold ourselves to the highest standard, ISO 17025 certifications is applied, and will be accredited to our respiratory analytic laboratory in second quarter of 2017. We would continue this relentless self-evolving process, and become the world leading respiratory device manufacturer.
- Aerodymanic particle size distribution testing (NGI or ACI)
For your nebulizer products, we measure the particle size distribution according to standard procedures, such as ISO27427 or USP <1601>.
The instruments including Next Generation Impactor (NGI) and Anderson Cascade Impactor (ACI), which is fabricated under the requirement of Pharmacopeia. Coupled with HPLC analysis, the quantities of MMAD, GSD, FPF, and FPD are resulted out base on the mass of active pharmaceutical ingredient (API) of medication. Close
- Drug substance delivery rate and total drug substance delivered testing
The effectiveness of any nebulizer is also dependent on (a) the total active pharmaceutical ingredient (API) delivered to the user, and (b) the rate at which that active is delivered.
With the breath simulator, the standard breath patterns can be employed to determine the exact amount of API delivered to the user.
These tests in our Lab are performed following the requirement of ISO27427 or USP<1601>. Close