Developing Your Roadmap to Pharma 4.0

Questions to ask before transitioning into new technologies.

Innovative and helpful technologies are rapidly advancing the state of the pharmaceutical manufacturing industry. When it comes to implementing a Pharma 4.0 operating model, one of the most significant barriers to entry can be where to start. Identifying case studies of various technologies and their design and implementation can help. Certain technologies have become more prominent and are typical in evaluations. These technologies are a great starting point and include:

Yvonne Duckworth

Augmented reality (AR): Augmented reality provides remote troubleshooting, digital work instructions, digital technical data, and critical process data overlays with the use of the digital twin. Operators outfitted with AR technology have real-time data available to them and instrument specifications on-demand. Augmented reality also can be used to train operators on equipment alarms and complex fixes by simulating equipment failures.

Cory Perelman

Biometrics: Biometrics provides capabilities for password-less authentication for multiple systems, an electronic signature for processing steps, and card access into rooms within the facility. Biometrics represents a security measure for enhanced data trails generated by operators while running critical processing equipment. The physical hardware may look like fingerprint scanners or unique bracelets. Users can log in once to a piece of equipment in a suite and stay logged in via a wireless mesh network that can track their proximity to the equipment. Users can be granted access only to specific pieces of equipment as well.

Automated storage and retrieval system (ASRS) and the use of automated guided vehicles (AGVs): ASRSs are automated systems for picking up and putting away items located in various racks within a warehouse. ASRSs become desirable in large warehouses with a high throughput volume. Smaller warehouses tend to limit ROI. An ASRS needs to be coupled with a warehouse management system to work correctly. AGVs reduce labor requirements and costs, reduce potential human errors, and provide a higher level of safety. They assist in the tasks of ASRSs by moving items around a warehouse or designated location.

With your chosen technologies, how can you assess the impact on the project’s budget and timeline?

After identifying technologies, the case-study approach will look at design and cost implications for each technology. The two associated costs would be capital expenditure (CapEx) costs, initial investments, and operating expenditure (OpEx) costs, which are recurring annual costs. For example, let’s consider a use-case for AR. During design, an accurate 3D model would need to be developed. The modeling effort would need to consist of vendor model codes and cutsheets associated with the instrumentation. To develop remote troubleshooting and data overlays, all instruments would need to provide troubleshooting data and diagnostic data. This step is in addition to a traditional output, such as a flow rate over 4-20mA. Diagnostics can be communicated via A fieldbus or, more often, Ethernet. This may require a more robust network infrastructure, including additional Ethernet switches and a higher level of integration complexity.

Biometrics would require the development of a robust mesh wireless network. ASRSs and AGVs may require tracks in floors and specific warehouse layouts and racking. Once design requirements are identified and technologies selected, a timeline and budget for implementation can be developed, as with any traditional design project. When evaluating OpEx costs, the cost of maintaining the technology for the lifecycle of the plant should be evaluated. This may include changes to the 3D model environment or hardware maintenance.

How do you know if your facility is ready for digitalization?

One way to assess your digital maturity level is to utilize the digital plant maturity model (DPMM) written by the BioPhorum Group. This assessment tool identifies five different levels of digitalization ranging from paper-based (Level 1) to fully autonomous facility (Level 5). Below is a summary of the various levels of digitalization included in the DPMM model.

It is important to assess the current level of digitalization at your facility and then identify the target level you wish to achieve. Note that levels can vary for different areas of a pharmaceutical facility, such as manufacturing, packaging, warehouse, and labs. For example, manufacturing can be a Level 4, while labs can be a Level 3. Determining a targeted level of digitalization can significantly impact the digital technologies that ultimately are included in the facility's design.

Incorporating digital technologies can impact the design of a new greenfield facility or existing brownfield facility. As space planning can be a key factor, it is critical to ensure that any new digital technologies have the space required to operate properly. For example, it is important to understand the footprint required for a robotics application. AGVs also require specific space considerations, particularly in hallways for traveling or charging time after hours.

Another critical factor is the network infrastructure. It is essential to build-in the network infrastructure requirements to support the digital technologies being considered. One of the crucial digital technologies of Pharma 4.0 is vertical and horizontal system integration. System connectivity is required to allow data to be collected for historization and transferred to other systems, as required. The network needs to be designed to accommodate that connectivity while keeping data security in mind.

Workforce considerations are an important part of Pharma 4.0 implementation. Some positions might not be needed in some cases, as more automation and robotics become prevalent. However, an additional workforce may be required to fill data analytics, data scientists, and other positions.

Risk analysis is an essential factor in the implementation of digitalization. These are risks to consider.

• Cybersecurity
• IntellectualpProperty (IP)
• Operational
• Implementation
• Solution complexity

One way to help mitigate risks is to consider implementing a specific digital technology at an existing brownfield site in parallel to the design of a greenfield facility. This implementation allows the technology to be tested before implementation in the new facility.

Cost and schedule are important factors to consider when evaluating potential digital technologies. Available funding and resources can be limited for some pharma, biotech, and cell and gene therapy companies. Another factor to consider is speed-to-market. Once a company evaluates these factors, it can decide which implementation approach suits its facility. Some approaches include:

Phased approach – Build in the infrastructure on Day 1 to add future technologies later without having to re-design the facility.

Standardized approach – Leverage the design of a standardized facility, incorporating the same technologies.

Lighthouse approach – Incorporate latest technologies that apply to the facility.

As pharmaceutical companies begin their journey to digitalization, they may encounter numerous roadblocks. But innovative technologies continue to rapidly advance the pharmaceutical manufacturing industry and break down these barriers. By following a sound roadmap and implementing a strategy for Pharma 4.0 adoption, companies can easily integrate digital technologies into the design of their facility.

Yvonne Duckworth is a Senior Automation Engineer and Cory Perelman is a Lead Instrumentation & Controls Engineer, both at CRB.