Devices and drug delivery systems need to be designed for manufacture from the outset. We call this concept Design for Pharmaceutical Manufacture: an approach that prioritises quality, reliability, dependability, usability, and functionality while creating a device that is easy to assemble, low-cost to manufacture and uncompromising on quality.
However, factors such as surface finishes, edge roughness, manufacturability, and assembly can be easily overlooked at the critical points of the design cycle. This cacophony of challenges can manifest in high scrap rates, spiralling manufacturing costs, delays to go-to-market, and, at worst, product recalls and reputation damage.
Springs, deep-drawn components and wire forms are often the cause of many manufacturability issues. Surface roughness is one of the most critical concerns. Rougher surfaces tend to collect bacteria and microorganisms known as particulates attaching to the substrate of components. Additionally, higher roughness and surface irregularities make it difficult for these components to be thoroughly cleaned. Because of this, average surface roughness (Ra) below 0.8μm is considered safe and hygienic for materials such as stainless steel.
Alongside hygiene, surface roughness also has a detrimental effect on device lifespan through the impact of wear and corrosion. Depending on the specific application, surface roughness has an exponential impact on component wear as it increases. In terms of corrosion, high surface roughness leads to concentrated areas that directly result in pitting corrosion. Wear and corrosion are particularly challenging for reusable pharmaceutical devices like inhalers that are expected to function for prolonged periods.
Repeatability is another vital consideration in pharmaceutical environments. Repeatability comes from robust, tried-and-tested manufacturing techniques, using high-quality components that are carefully manufactured using precision machinery.
With higher quality standards, standard scrap rates are higher in the medical industry than many others. Tolerances are often defined tightly in original drawings, which can create difficulties when seeking to maximise yields and manufacturing efficiency and efficacy. With these tolerances, quality products and raw materials are crucial to ensuring the best possible yield.
To minimise the level of surface roughness and rough edges of components, advanced deburring processes can be used such as vibratory and laser solutions. Vibratory deburring consists of placing components in centrifugal, vibratory bowls with dense ceramic or synthetic media. The vibrations and friction between components and the ceramic and media smoothen the rough edges. Additionally, the vibratory bowls can deburr significant batches of components to a reliable level of quality, enhancing manufacturing productivity and volume.
For specialised components that require precise deburring solutions or an extremely low level of surface roughness, laser deburring is often preferred. This is the process of using a high-power laser on the burr of a component to create a dome-shaped end. This produces an exceptionally low surface roughness for specialised pharmaceutical components and designs. For reusable devices, these components greatly extend component lifespan and offer the functionality needed to meet relevant compliance standards.
Assembly complexity and repeatability are key factors in determining manufacturing productivity. Alongside this, identifying and integrating the perfect components that are made from the right forming materials for your design are integral to minimising scrap rates and maximising volume without compromising on quality.
Manufacturers that utilise bespoke forming techniques can directly minimise your scrap rates and enhance repeatability through reliable procedures. These include identifying suitable forming materials for specific components and designs, assigning applicable forming and press solutions and optimising their placement in the assembly process. Automation techniques are also implemented to enhance cost-effectiveness whilst ensuring a high level of quality for your device designs. These manufacturers ultimately provide you with reliable and bespoke component designs that are highly repeatable to enhance volume, minimise scrap rate and ensure compliance/quality at each step.
Developing a pharmaceutical product that ticks all of the boxes, at the first time of asking, can be a real challenge. These devices are complex, and often designed years in advance of their manufacture. Devices and drugs are often subject to dual-approval, which presents further challenges for scaling up production.
Advanex Medical is your on-call partner for everything from springs, deep drawing, wire forming, and more, to help you design, manufacture, and develop market-defining drug delivery devices. With globally located, medical-grade facilities and in-house medical expertise, we’re here to provide you with the support and expertise you need through every stage of your product’s lifecycle.
To see how we can support you in developing a high-quality, easy-to-assemble medical device that goes to market seamlessly, get in touch with one of our experts.