Modular manufacturing is on the rise in the pharmaceutical industry. The last few years have shown an increase of interest in modular solutions for a variety of uses andStevanato集团–a provider of integrated systems for pharma and healthcare–projects that this tendancy will only continue, especially in injectables.
这种受欢迎程度是由于模块化制造提供的灵活性，使制药处理器能够在单个设施中生产一系列产品，并具有更快的转换和提高的整体设备效力（OEE）。模块化制造将系统分解为离散的组件“模块”，该组件可以执行特定的角色，可以随意将其集成或从整体结构中删除。
以下因素正在推动注射量市场中的这一运动：
- Many treatments are moving from hospital to home, reducing costs for healthcare providers and increasing patient comfort, requiring the need for user-friendly injectable devices, which has been further exacerabated by the COVID-19 pandemic
- The demand for auto-injectors and pen injectors is skyrocketing as life-style related diseases, such as diabetes, become more widespread in both developed and developing countries and as the niche of targeted small batch and personalized medicines, including oncological formulations and certain biologics, grows, driving the need for more mobile, less intrusive, and simpler solutions that remain cost-effective, which in turn demands flexibility on the manufacturing side
These self-administered options allow patients to treat themselves more independently and autonomously than ever in a safe manner. As editor Aaron Hand says inBurgeoning Auto-Injector Market Demands Flexible Production Options,“Auto-injectors help avoid common risks associated with self-administration via syringes, such as incorrect dosages and misuse, serious injuries and discontinuation of treatment.”
The benefits for healthcare providers and patients are clear. As injectables continue to become more customized and self-administered, manufacturers will need to modify the design, engineering, and production of their assembly line equipment to meet these and future demands. This will in turn benefit manufacturers–contractors and service providers in particular, who will need to prove adaptable–as the industry will continue to evolve with varying shapes, sizes, and materials of injectables as well as in product volumes, demand, and sub-categorical issues like target audience differentiation. Production processes will need to be time-efficient and customizable.
A Pharmaceutical Networking article,Defining ideal modular design for effective pharma packaging,秒这个角度看,解释说,modular design must be adapted to the existing development process and embedded into ongoing operations during implementation in order to minimize adaptation demands which will surely come.
Automation and Pharma 4.0
Stevanato集团outlines characteristics that modular manufacturing has that assembly machinery needs in order to keep up with the needs of modern combination products: fast format changeover to reduce costly downtime, flexibility to allow reduced CAPEX investments and achieve shorter time to market, and scalability for additional modules to meet increased volumes.
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Another factor Stevanato Group emphasizes is automation. Though lower volumes of product are typically required with auto- and pen-injector production, efficiently switching to wider-scale production efforts can be necessary. Automating processes can also reduce human intervention and further decrease production downtime.
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The company explains that automation becomes valuable through its reliability, precision, repeatability, and process optimization. The greatest benefits come from incorporating automation into the very beginning stages of the development process, offering an alternative to the prototyping phase with a benchtop through a semi-automatic pilot line. This offers inherent scale-up advantages, allows early de-bugging, and mitigates future risks as the technologies used from pilot line to large-scale, fully automated line are the same.
Says Stevanato Group, “Involving equipment partners with modularity experience from the early stages offers a distinct advantage, since they’ve seen for themselves how initial development work is crucial for establishing early proof of principle and validating the assembly process.”
查看遏制系统和自动化量表early on are key, in part due to injectables’ product-specific complexity.
In行业4.0，焦点, Pat Reynolds covered the efforts of the Marchesini Group in the life science space, noting, “…once processes are digitized, it opens the door to other exciting possibilities such as machine learning, condition monitoring, remote-access monitoring, and, ultimately, the smart factory. In the smart factory, operations are carried out with minimal manual intervention, high reliability, and maximum flexibility. The automated workflows, synchronization of assets, and improved tracking and scheduling in the smart factory lead to increased yield and quality along with reduced cost and waste.
“可以预见的是，制药行业对物联网和工业4.0的影响不受任何影响，这些趋势正在以迅速的速度改变制药制造业。”
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This is echoed in the Pharmaceutical Networking article which further builds on the potential for Industry 4.0 concepts in modular manufacturing in pharma, such as shared data, artificial intelligence (AI), and increased connectivity enabled through the Internet of Things (IoT).
Systems incorporating these concepts and created by collaborative efforts fromDividella–a supplier of cartoners and secondary packaging machines for the pharmaceutical and biotech industry–andMedipak系统–a system provider for the pharmaceutical industry–also use the “Plug & Produce concept of vertical integration that imposes a standardized interface between machines in production and the production control system.” This allows modules and production lines to be connected or disconnected through plugging a drive into a computer via a USB interface.
该设置进一步允许Medipak系统创建高级系统，包括智能包装，企业制造智能（EMI），智能设备以及条件监控和预测分析。这些进步改善了最终用户的经验，对运营商的用户友好性，并允许生产者进行卓越的决策。
Benefits of the modular format
除了适应市场需求，快速的转换，改进的OEE以及使用自动化和插件扩展的扩展选项外，还可以带来一系列好处。模块化也可以：
- Deliver standardization–as modules are simplified, produced more economically, and made reusable–and customization by tailoring systems to individual and specialized demands.
- Reduce costs in both implementation and operation
- Ensure faster production and delivery, and when machine utilization rates are high, offer high return on investment within a short timeframe
- Allow manufacturers to meet the need to deploy manufacturing regionally, reduce the cost of goods sold (COGS), increase capacity utilization and speed-to-market, and fulfill multi-product campaigns requiring different production schedules
- 通过以协同性的性质鼓励工程和生产团队通过计划（并行）合作，以近期和更长的扩展需求进行合作
