Drug Delivery Automation

Astech are a world leader in automated testing systems for drug delivery devices. We have a comprehensive portfolio of products (X-Products®) for the major pharmacopoeia tests encountered in respiratory solid dose and injectable dosage forms. We engineer all our systems to the highest quality standards and can be fully validated for EU, US and RoW regulatory requirements. Our systems are modular, scalable and designed to allow incorporation of different drug delivery devices. The solutions we offer have been designed and built for use in both testing laboratories and production environments.

Our dedicated Drug Delivery automation team have developed solutions to satisfy regulatory testing requirements for the following applications:

Andersen Cascade Impaction
Next Generation Impaction (NGI)
Dose Content Uniformity (DCU)
Waste Firing & Containment
Shaking and Dose Collection
Emitted Dose Weight Verification
Sample Recovery
Blister Recovery
Air Flow Resistance
Flow Generation & Control
Dose Counter Verification
MDI Force to Fire & Shot Detection
Physical Device Function Testing

X-Products®

Established and robust automated systems for regulatory testing of DPI, MDI, BAI, Nasal and the latest ‘SMART’ inhaler devices

Xelair® – Automated products for testing Dose Content Uniformity.

Xelize® – Automated products for Particle Size Determination by Andersen Cascade Impactor.

Xelox® – Automated products for Particle Size Determination by NGI

Syringe Pro® – Automated workstation for testing content uniformity of injectable dosage form pharmaceutical products.

Modules can be stand-alone or integrated into a larger automated system depending on specific test requirements such as higher throughputs.

Custom Robotics & Automation

Astech recognise that companies have different throughput requirements and test methods. In addition to our successful X-Products® range for automated drug delivery testing we also offer a bespoke design and build service for unique, client specific applications. This is a turnkey service, from design concept to project completion including validation. We design, manufacture, test, deliver, install and commission complete automation solutions within our quality driven environment. Once the system is validated and operational, our REACTS® planned maintenance and technical support service offers complete peace of mind for the lifetime of the automated system.

Our processes are aligned with GAMP 5 validation guidelines and we produce software solutions that allow our clients to comply with 21CFR Part11. We hold ISO-9001 TickITplus based accreditation and have a mature, well proven quality system in place. We are regularly audited by our assessment body (BSI) and our clients. Our quality procedures incorporate a Prince 2 based approach to Project Management.

Automated Sample Preparation for Inhaled Drug Delivery Device Testing When the speed of drug development and time to market is…