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Micro product and process fingerprints for zero-defect net-shape

micromanufacturing of microneedles
Mert 1
Gülçür , Ben 1
Whiteside , Tim 1
Gough , Elaine 1
Brown , Enric Sirera2
1 Centre for Polymer Micro and Nano Technology, Faculty of Engineering and Informatics, University of Bradford, BD71DP, United Kingdom
2 Ultrasion S.L., Parc Tecnològic del Vallès, Av. Universitat Autònoma 23, E-08290, Cerdanyola del Vallès Barcelona, Spain

Abstract
The aim of this research is to provide a fast and robust quality assurance procedure that could be implemented to lower the quality
inspection efforts made for parts with micro and nano features using brand new ultrasonic micromoulding (USM) technology. For this
purpose, process fingerprint concept is introduced where process sensitive variables from the ultrasonic micromoulding process were
taken and related to the final part quality. Fingerprints chosen include process related measurements such as thermal imaging and
machine data alongside with geometric measurements taken from the microneedle arrays using a telecentric optical quality assessment
apparatus. Final quality of the micromoulded thermoplastic microneedle arrays are evaluated in terms of microneedle height and
correlated to the process fingerprints.

Introduction Case study Process monitoring


• Microinjection moulding has been a cost-effective and Units in mm
• USM process was monitored using state-of-the-art
feasible method for manufacturing micro-nano thermal imaging equipment and machine data (Figure 3).
featured parts [1].

• Ultrasonic micromoulding (Figure 1) emerged as a new


alternative for manufacturing of medical components. Units in mm

• USM uses sonication for melting the polymer.

Fig. 2. Important geometric features of microneedle part in mm (left),


ultrasonically micromoulded ABS (Acrylonitrile butadiene styrene) microneedle
array (mid) and telecentric image of a microneedle (right).

• 100 ABS microneedle parts (Figure 2) were


manufactured using following parameters for quality
assessment.
Process parameter Value
Injection force 1500 N
Mould temperature (Tm) 80 - 90 °C
Sonication time 3.5 s
Sonication amplitude 90 μm

• First and second 50 samples were moulded using 80


Fig. 1. Ultrasonic moulding process overview and 90 °C respectively. Fig. 3. Thermal imaging data (up) and machine data (bottom) for USM.

Results
• For every cycle, following process fingerprints were
• ∫Tarray showed a strong linear correlation with the part
recorded and analysed:
quality criterion which is the height of the
Process fingerprint Definition microneedles.
∫Tarray Integral & area under the curve for
thermal image data within the • Tpeak (array) also showed good correlation with part
region of interest of microneedles. quality.
Esonication Energy consumed by the ultrasonic
generator.
Tpeak (array) Temperature peak within the region
• Esonication which is read from the machine data yielded
of interest of microneedles. an R - squared value of 0.722 which represents a
reasonable correlation.
• Microneedle heights were assessed automatically
• Correlations from machine data (such as Esonication) are
using a telecentric optical measurement system.
particularly important as they are measured using
built-in sensors provided on the machine as a factory
• Product fingerprint was defined as the average
feature.
height of the microneedles within one array out of
36 needles.

Conclusion Acknowledgements
• Process monitoring solutions for USM of micro-featured parts were This research work was undertaken in the context of MICROMAN project
successfully implemented for this case study. (“Process Fingerprint for Zero-defect Net-shape MICROMANufacturing”,
http://www.microman.mek.dtu.dk/). MICROMAN is a Marie Skłodowska-
• Strong correlations of process and product fingerprints will pave ways for in- Curie European Training Network supported by Horizon 2020, the EU
line product quality assessment for ultrasonic micromoulding. Framework Programme for Research and Innovation (Project ID: 674801).

• Future work will include USM of functional microneedles and set-up of a low-
cost quality assurance setup using diffraction methods.

References
[1] Nair, K., Whiteside, B., Grant, C., Patel, R., Tuinea-Bobe, C., Norris, K., &
Paradkar, A. (2015). Investigation of plasma treatment on micro-injection
moulded microneedle for drug delivery. Pharmaceutics, 7(4), 471–485.

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