Xelair® 1 Series Waste Firer
Inhaler waste firing is often necessary for inhaled drug development and testing. For Delivered Dose Uniformity (DDU) testing doses are collected at the beginning, middle and end of the inhaler device’s life to ensure consistent, reproducible delivery. To enable the collection of test doses, the device must be waste fired. Ideally, this firing should be done under the same conditions as for the tested doses and the waste doses collected so the drug can be disposed of safely without operator exposure.
Automating Testing of Inhaled Devices
Delivered Dose Uniformity (DDU) testing is a critical requirement for Metered Dose Inhalers (MDIs), Dry Powder Inhalers (DPIs), Aqueous Droplet Inhalers (ADIs), Nebulisers and other aerosolised products.
Testing orally inhaled and nasal drug products (OINDPs) is labour intensive. When done manually, because of the steps involved, results can vary analyst to analyst. Automating testing not only eliminates variations in device handling, firing force, shake technique and actuation, but increases throughput.
Automation also minimizes risk to the operator, by eliminating exposure to the tested product during waste and collection firing as well as preventing strain injuries cause by repetitive manual shaking.
Xelair® 1 Series Waste Shot Firer Overview
The Xelair® waste shot firing unit is equipped with a vacuum channel, providing precise flow control (to a method set point) and instrumentation for flow monitoring. Once the inhaler is automatically actuated it will be advanced into position sealing with the waste collection mouthpiece before the vacuum channel valve is switched to initiate the firing of the waste dose. A balance can be included to weigh devices before and after firing.
All inhaler types and styles can be accommodated including batch storage.
For Dry Powder Inhalers, the waste dose is automatically collected by a ‘reverse jet pulse filter’ unit. The unique design of the filter ensures there is no degradation of flow and no operator exposure through the use of safe change valve technology.
The inhaler waste shot firing unit can be installed as a standalone unit or integrated into Astech’s Xelair® or Xelox® fully automated systems. With these systems, multiple inhalers can be processed in parallel, thereby increasing throughput.
Typical sequence example:
1. Performs flow check, adjustment and monitoring
2. Performs the shake (if necessary) e.g. inversion, rotary or linear
3. Opens and closes the inhaler mouthpiece caps
4. Actuates the inhaler device
5. Safely collects waste doses
Get More Data
Astech’s inhaler waste shot firing system allows you to automatically control the same variables such as flow, force, speed and distance for waste firing as with test dose collection to ensure consistent dosing across the life of the multi dose device.
Recorded data includes; dosing airflow rate, pressure drop, flow duration and dose firing detection.
DCU or UoDD – Select your method in our Relovex® Software
Relovex® allows simple method set up and selection.
For MDIs the Xelair® Waste Shot Firer uses Astech’s patented linear shaking technology. Astech understands the unique shaking requirements of different devices and can offer several options. For more about shaking options read about our Xelair® Shaker.
Xelair® Range for Inhaler Device Testing including:
- Delivered Dose Uniformity (DDU)
- Waste Firing
- Linear or Rotary Shaking
- Flow Generation & Measurement
- Actuation Through Life & Dose Counter Verification
- Emitted Dose/Weight
Eliminates variability, producing repeatable and reliable data
Our ground breaking series of products for testing Delivered Dose Uniformity as well as standalone workstations for waste firing, shaking & firing, dose collection and physical device testing including actuation through life.
Click here for an overview of the range: Xelair Series Overview
Build your automated inhaler testing facility by selecting from our range of systems:
21CFRPart11, ERES, database, records, audit trail, user levels, data integrity, remote monitoring, HMI, Relovex®, balance, emitted weight, dose counter verification, device actuation, storage, safety, temperature & humidity monitoring, device storage
If you want to know more about waste fire options for your application get in contact with us: