This thesis explores the analysis and fabrication of plastic hypodermic needles. The hypotheses for this work are that replacing metal hypodermic needles with plastic ones will reduce or eliminate the possibility of the second-hand infections from needle sticks and unsterlized reuse and will be more cost and time efficient to recycle. The most critical structural failure mode for plastic needles is buckling due to their shape (thin walled hollow column). The consideration of buckling is critical to avoid structural failure and to ensure reliability for medical applications. The buckling strength of a cannula is analyzed by analytic (Euler buckling theory) and finite element analysis (FEA) methods. A 22 gage needle model (OD 0.7mm, ID 0.4mm, Length 12.7mm) was analyzed. Euler buckling theory was used to calculate the critical buckling load. Numerical approaches using finite element analyses showed very similar results with analytic results. A skin model was introduced to simulate boundary conditions in the numerical approaches. To verify the results of the analyses, cannulas with the same cross-sectional dimensions were fabricated using a micro injection molding technique. To make the parts hollow, a core assembly of straightened wire was used. Using the tip of a 22 gage needle, cannulas with the inverse shape of an actual hypodermic needle were made. The structural (buckling) characteristics of cannulas were measured by a force-displacement testing machine. When buckling occurred, an arch shape was visible and there was an abrupt change in the load plot. Test results showed the relation between the needles length and the buckling load, which was similar to that predicted by Euler buckling theory. However, test values were 60% of the theoretical or analytical results. Several reasons to explain these discrepancies can be found. The first is that an unexpected bending moment resulted from an eccentric loading due to installation off-center to the center of the testing machine or to the oblique insertion. A cannula that was initially bent during ejection from the mold can add an unexpected bending moment. The quality control of cannulas can be another reason. Bent or misaligned core wires produce eccentric cannulas, and the thinner wall section can buckle or initiate fracture more easily. The last reason may be that Euler buckling theory is not fully valid in short cannula, because the axial stress reaches yield stress before buckling occurs. Inelastic deformation occurs (i.e., the modulus is reduced) during compression in short cannula. The Johnson column formula is introduced to explain this situation. Especially for the nylon nanocomposite material tested, a loss in modulus due to moisture absorption may be another explanation for the discrepancies.

No / This study investigates the influence of length scale effects (micro- and macro-injection molded parts) and mold temperature on the epitaxial growth and morphological characteristics in injection-molded bars of isotactic polypropylene (iPP)/high-density polyethylene (HDPE) blends. After preparing the blends with an iPP content of 70 wt% via melt extrusion, the injection-molded bars were formed using both micro and conventional injection molding. Samples were subsequently prepared from the moulded components to allow investigation of the internal morphology using wide-angle X-ray diffraction (WAXD), differential scanning calorimetry (DSC), scanning electron microscopy (SEM) and polarized light microscopy (PLM). The results indicated that the matching of micro scale and appropriate mold temperature was most favorable for epitaxial crystallization. The micro-parts had a large fraction of shear layer compared with macro-parts. The SEM observations showed that the shear layer of the former consisted of a highly oriented shish-kebab structure. Moreover, the effects of different methods of injection molding on the morphological characteristics of the micro-parts and macro-parts in different layers were elucidated in detail using PLM and SEM.

Yes / Micro-injection moulding (μIM) stands out as preferable technology to enable the mass production of polymeric components with micro- and nano-structured surfaces. One of the major challenges of these processes is related to the quality assurance of the manufactured surfaces: the time needed to perform accurate 3D surface acquisitions is typically much longer than a single moulding cycle, thus making impossible to integrate in-line measurements in the process chain. In this work, the authors proposed a novel solution to this problem by defining a process monitoring strategy aiming at linking sensitive in-line monitored process variables with the replication quality. A nano-structured surface for antibacterial applications was manufactured on a metal insert by laser structuring and replicated using two different polymers, polyoxymethylene (POM) and polycarbonate (PC). The replication accuracy was determined using a laser scanning confocal microscope and its dependence on the variation of the main μIM parameters was studied using a Design of Experiments (DoE) experimental approach. During each process cycle, the temperature distribution of the polymer inside the cavity was measured using a high-speed infrared camera by means of a sapphire window mounted in the movable plate of the mould. The temperature measurements showed a high level of correlation with the replication performance of the μIM process, thus providing a fast and effective way to control the quality of the moulded surfaces in-line. / MICROMAN project (“Process Fingerprint for Zero-defect Net-shape MICRO MANufacturing”, http://www.microman.mek.dtu.dk/) - H2020 (Project ID: 674801), H2020 agreement No. 766871 (HIMALAIA), H2020 ITN Laser4Fun (agreement No. 675063)

Yes / Inspired from the low wetting properties of Lotus leaves, the fabrication of dual micro/nano-scale topographies is of interest to many applications. In this research, superhydrophobic surfaces are fabricated by a process chain combining ultrashort pulsed laser texturing of steel inserts and injection moulding to produce textured polypropylene parts. This manufacturing route is very promising and could be economically viable for mass production of polymeric parts with superhydrophobic properties. However, surface damages, such as wear and abrasion phenomena, can be detrimental to the attractive wetting properties of replicated textured surfaces. Therefore, the final product lifespan is investigated by employing mechanical cleaning of textured polypropylene surfaces with multipurpose cloths following the ASTM D3450 standard. Secondly, the surface damage of replication masters after 350 injection moulding cycles with glass-fiber reinforced polypropylene, especially to intensify mould wear, was investigated. In both cases, the degradation of the dual-scale surface textures had a clear impact on surface topography of the replicas and thus on their wetting properties, too. / Europe Union H2020 research and innovation programme.

Yes / The structural formation and development of isotactic polypropylene (iPP) upon the micro-injection molding process was investigated at different mold temperatures and molecular weights utilizing a real-time synchrotron radiation small angle X-ray scattering (SAXS) technique combined with a customized micro-injection molding apparatus. Shish-kebab structure and parent-daughter lamellae were found to be formed during micro-injection molding for all iPP samples. In the case of kebab lamellae, a considerable growth in the long period and in the average thickness of lamellar crystallites and amorphous domains is observed at initial stages of crystallization for samples molded at varying temperatures. This effect is caused by the successive formation of thin lamellae in the outer layer and thick lamellae in the inner layer during the manufacturing process as evidenced by the spatial distribution of the crystalline lamellae across the thickness. In addition, the length of the shish formation increases remarkably at the onset of crystallization, the extent of which is dependent on the mold temperature. Despite the large changes of the lamellar stacks and the shish misorientation, the final length of the shish remains essentially unchanged when varying mold temperature. Since there is a critical orientation molecular weight above which the chains are stretched and oriented to form stable shish, the iPP sample with a low molar mass exhibits an overall decrease in the scattering intensity of SAXS patterns compared to the high molecular weight polypropylene. / This work is financially sponsored by the National Key R&D Program of China (2018YFB0704200), National Natural Science Foundation of China (21674119, 21790342 and 51525305), and Royal Society Newton Advanced Fellowship, United Kingdom (NA150222).

Nowadays, the filling and solidification of macro-scale injection mouldings can be predicted using commercial CAE software. For micro-injection moulding, the conventional tools do not work for all process conditions. The reasons might be the lack of high quality database used in the simulation and the improperly specified boundary conditions which do not reflect the real state in the cavity. Special aspects like surface tension or "size dependent" viscosity might also be responsible for the inaccuracy of the simulations. In this paper, those aspects related to the boundary conditions were taken into consideration, especially the thermal contact behaviour and the melt compression in the barrel which affects not only the temperature of the melt due to the compression heating, but also reduces the actual volume rate in the cavity. It can be shown that the heat transfer coefficient between the melt and the mould wall has a significant influence on the simulation results. In combination with precise material data and considering the reduction of the volume rate due to the melt compression in the barrel, the heat transfer coefficient may be quantified by means of reverse engineering. In general, it decreases when either the cavity thickness or the injection speed increases. It is believed that a pressure dependent model for the heat transfer coefficient would be more suitable to describe the thermal contact behaviour in micro injection moulding. The melt compression in the barrel affects definitely the filling behaviour and subsequently the heat transfer in the cavity as well, which is especially true for micro parts of high aspect ratio.

This thesis investigates the use of micro-injection moulding (μIM), as a high-volume process, for producing three-dimensional, integrated microfluidic devices. It started with literature reviews that covered three topics: μIM of thermoplastic microfluidics, designing for three-dimensional (3-D) microfluidics and functional integration in μIM. Research gaps were identified: Designing 3-D microfluidics within the limitations of μIM, process optimisation and the integration of functional elements. A process chain was presented to fabricate a three-dimensional microfluidic device for medical application by μIM. The thesis also investigated the effect of processing conditions on the quality of the replicated component. The design-of-experiments (DOE) approach is used to highlight the significant processing conditions that affect the part mass taking into consideration the change in part geometry. The approach was also used to evaluate the variability within the process and its effect on the replicability of the process. Part flatness was also evaluated with respect to post-filling process parameters. The thesis investigated the possibility of integrating functional elements within μIM to produce microfluidic devices with hybrid structures. The literature reviews highlighted the importance of quality control in high-volume micromoulding and in-line functional integration in microfluidics. A taxonomy of process integration was also developed based on transformation functions. The experimental results showed that μIM can be used to fabricate microfluidic devices that have true three-dimensional structures by subsequent lamination. The DOE results showed a significant effect of individual process variables on the filling quality of the produced components and their flatness. The geometry of the replicated component was shown to have effect on influential parameters. Other variables, on the other hand, were shown to have a possible effect on process variability. Optimization statistical tools were used to improve multiple quality criteria. Thermoplastic elastomers (TPE) were processed with μIM to produce hybrid structures with functional elements.

Nowadays, the filling and solidification of macro-scale injection mouldings can be predicted using commercial CAE software. For micro-injection moulding, the conventional tools do not work for all process conditions. The reasons might be the lack of high quality database used in the simulation and the improperly specified boundary conditions which do not reflect the real state in the cavity. Special aspects like surface tension or "size dependent" viscosity might also be responsible for the inaccuracy of the simulations. In this paper, those aspects related to the boundary conditions were taken into consideration, especially the thermal contact behaviour and the melt compression in the barrel which affects not only the temperature of the melt due to the compression heating, but also reduces the actual volume rate in the cavity. It can be shown that the heat transfer coefficient between the melt and the mould wall has a significant influence on the simulation results. In combination with precise material data and considering the reduction of the volume rate due to the melt compression in the barrel, the heat transfer coefficient may be quantified by means of reverse engineering. In general, it decreases when either the cavity thickness or the injection speed increases. It is believed that a pressure dependent model for the heat transfer coefficient would be more suitable to describe the thermal contact behaviour in micro injection moulding. The melt compression in the barrel affects definitely the filling behaviour and subsequently the heat transfer in the cavity as well, which is especially true for micro parts of high aspect ratio.

The emergence of microneedle (MN) technologies offers a route for a pain free, straightforward and efficient way of transdermal drug delivery, but technological barriers still exist which pose significant challenges for manufacture of MN systems with high volume outputs at low cost. The main aim of this research was to develop new ways for MN manufacture primarily using micro-injection moulding processes with high performance engineering thermoplastics. During the moulding process these polymeric melts will be subjected to extreme stress and temperature gradients and detailed material characterisation combined with in-line monitoring is desirable to optimise the moulding parameters and will help in achieving sharp microneedles with acceptable quality. Hence high shear rheology of these selected materials was performed at wall shear rates carried out in excess of 107 s-1 over a range of temperatures to predict the flow behaviour of polymer melts at such high shear strain rates. This information was fed into injection moulding simulation software tools (Moldflow) to assist the MN production process design. The optimal design was then used to produce a full 3D solid model of the injection mould and mould insert. Furthermore various design of experiments were conducted considering input parameters such as injection pressure, injection speed, melt temperature, filling time and mould cavity temperature. Response variables including product quality and data acquired from the cavity pressure and temperature transducers were used to optimise the manufacturing process. The moulded MNs were geometrically assessed using a range of characterisation techniques such as atomic force microscopy, confocal microscopy and scanning electron microscopy. An attempt to make hollow MNs was performed and encountered many challenges like partial cavity filling and part ejection during processing. Studies were carried out to understand the problem and identified the major problem was in tool design and improvements to the moulding tool design were recommended. Plasma treatment and mechanical abrasion were employed to increase the surface energy of the moulded polymer surfaces with the aim of enhancing protein adsorption. Sample surface structures before and after treatment were studied using AFM and surface energies have been obtained using contact angle measurement and calculated using Owens-Wendt theory. Adsorption performance of bovine serum albumin and release kinetics for each sample set was assessed using a Franz diffusion cell. Results indicate that plasma treatment significantly increases the surface energy and roughness resulting in better adsorption and release of BSA. To assist design-optimisation and to assess performance, a greater understanding of MN penetration behaviour is required. Contact stiffness, failure strength and creep behaviour were measured during compression tests of MN against a steel surface, and in-vitro penetration of MNs into porcine skin. The MN penetration process into porcine skin was imaged using optical coherence tomography. Finally, a finite element model of skin was established to understand the effect of tip geometry on penetration. The output of findings from this research will provide proof of concept level development and understanding of mechanisms of MN penetration and failure, facilitating design improvements for micro-injection moulded polymeric MNs.

Yes / Plasma technology has been widely used to increase the surface energy of the polymer surfaces for many industrial applications; in particular to increase in wettability. The present work was carried out to investigate how surface modification using plasma treatment modifies the surface energy of micro-injection moulded microneedles and its influence on drug delivery. Microneedles of polyether ether ketone and polycarbonate and have been manufactured using micro-injection moulding and samples from each production batch have been subsequently subjected to a range of plasma treatment. These samples were coated with bovine serum albumin to study the protein adsorption on these treated polymer surfaces. Sample surfaces structures, before and after treatment, were studied using atomic force microscope and surface energies have been obtained using contact angle measurement and calculated using the Owens-Wendt theory. Adsorption performance of bovine serum albumin and release kinetics for each sample set was assessed using a Franz diffusion cell. Results indicate that plasma treatment significantly increases the surface energy and roughness of the microneedles resulting in better adsorption and release of BSA.