Automated Sample Preparation for Inhaled Drug Delivery Device Testing
When the speed of drug development and time to market is of critical importance, comprehensive analytical testing places a significant burden on limited resources. Automated workstations can be a simple first step towards a faster, more consistent and efficient sample preparation system.
It is vital patients receive the correct dose from the first to the last dose when they use their inhaler. Manufacturers have to ensure their formulation and drug delivery device work together to give the patient the correct dose over the stated life of the product, when used as directed. There are many tests that are carried out, for example Delivered Dose Uniformity (DDU) and Particle Size Determination (PSD).
Automated Sample Preparation – Shaking, Firing/Actuating, Collecting, Wasting and Recovery
A Metered Dose Inhaler (MDI) consists of a suspension in a canister fitted with a dose metering valve inserted into an actuator body. Shaking is a necessary part of the test process prior to dose extraction and analysis, to ensure the drug and its suspension medium are well mixed. The dose delivered from the first and last puff, or actuation, needs to be tested. This means the device needs to be used, or fired, and the waste drug safely collected, until it reaches its last dose.
Traditionally testing has been done manually or using equipment that is often not robust due to a non-standardised/harmonised build quality. Differences in the data generated across the different platforms and poor result replication can certainly delay product development and production. So, there is a strong justification for a standardised platform to shake, fire, waste, collect and recover doses when testing inhalers.
Automated Shake and Fire Equipment
Automating sample preparation of any kind can significantly increase throughput whilst minimising variability and reducing operator exposure. The Xelair® 1 Series of Shake & Fire workstations are a simple, scalable way to introduce automation, that:
- Provides a controlled, consistent and repeatable process
- Produces, records, stores and reports more consistent, reliable data
- Provides operationally reliable and safe automated equipment
- Reduces the potential for Repetitive Strain Injuries (RSI), caused by manual procedures
The Xelair® 1 Series Shake & Fire workstations offer a number of options, such as interchangeable nests to accommodate different devices and a wide variety of adjustable parameters as standard.
The Xelair®1 Series Shaker, with its patented friction-less motor, is configurable for parameters such as shake frequency, distance (amplitude), duration, acceleration, velocity and wave profile. Up to 10 devices can be pre-loaded in to each ‘nest’ thus speeding up loading of the work station. Read more about shaking…
If you want to minimise manual intervention for your device testing, we can supply more integrated workstations as your automation needs become more advanced. You can upgrade to the Xelair® 3 Series which includes additional functionality, for example Sample Recovery. Our Xelair® 5 Series, our premium technology offers a fully automated solution including device storage, waste firing, dose collection, dose recovery all the way up to primary and duplicate vials for HPLC analysis. We can even include HPLC integration if necessary.
As data becomes increasingly important to process improvement, we can assist you with the generation and data capture at every step of your process. All key variables can be stored and reported to assist with your validation process. This functionality provides you with the information and insight that matters most to you. Our systems conform to the highest standards and are built to last, providing you with a cost-effective solution, which will meet your future needs. Talk to our team about your automated sample preparation application today.
Applications for device shaking technology
Generally, this technology is used for metered-dose inhalers, but it can be employed for a wide variety of device testing and sample preparation. Our patented linear motor technology gives you a more robust, functional and flexible system, requiring less maintenance than traditional belt driven shakers. We can work with you, helping you to achieve the optimal system of sample preparation for your application.
Providing uniformity testing automation from a single preparation stage to a 24/7 fully robotic process
The Xelair® system can simulate the use of an inhaler, replicating the patient’s actions from start to finish, with no manual intervention needed. Business benefits offered by the X-Products portfolio include:
- Reduced variability in resultant data
- Increased volumes of test data
- Increased productivity
- Significant reduction in Health and Safety issues including WR-ULD
- Reduced analyst time spent on labour intensive processes
- Contained handling of drug product, minimising operator exposure
- Upgrade paths throughout the Xelair, Xelize and Xelox ranges
- Harmonised testing throughout the Xelair, Xelize and Xelox ranges
If you are considering integrating your device shaking equipment into a fully automated system we can help. Our highly skilled team have experience delivering automation solutions for demanding industries.
Our Quality Commitment
Quality is as important for us as it is for our customers and so we support projects that work within GAMP® and PRINCE2 Guidelines. Because we have the capability to customise equipment, we are able to match the specification of your application. Read more about our quality process.
Recognised by the Queen’s Award for Enterprise (Innovation 2009), Xelair is fast becoming the industry standard used by a broad range of pharmaceutical clients. The Xelair range incorporates analyst workstations, semi-automated and fully automated systems for high throughput applications. Xelair eliminates the human variability factor, produces repeatable and reliable data and caters for changing client needs by allowing seamless migration between products in the Xelair range. Core technology at the heart of the Xelair ensures data is harmonised across the entire product range.