Rachana Soni
Project Management Expert
Rachana is an expert in project management. She has experience in tracking and reporting KPIs and end to end implementation in global SAP transformation projects.

Temperature Control 4.0: E2E Integration from Sensor to ERP (SAP) – Success Factors for Supply Chain Managers

Temperature control 4.0

Introduction

Temperature-controlled logistics (TCL) has gained attention in recent years due to the increasing regulatory complexity and broader adoption of Good Distribution Practices (GDPs) in the area of temperature control.1 In addition, increasingly complex global supply chains involving multiple supply chain partners as well as the emergence of novel medicine with high-temperature control and supply chain lead time requirements (e.g. radioactive pharmaceuticals) has particularly shifted the focus of Pharmaceutical supply chain managers towards integrated temperature control.

At the same time, enterprises have struggled to maintain transparency over their global operations as there has not been a systematic, integrated approach of tracking temperature exposure across both in-plant manufacturings as well as across global distribution.

Pharmaceutical Value Chain

The temperature-controlled logistics chain comprises various stages from defining drug substance validity, drug substance and drug product manufacturing as well as distribution until the point of dispensing to the end-patient. Each stage of the supply chain possesses different challenges with regards to maintaining TCL norms, such as bulk tracking of temperature data across various drug substance/product containers (bulk containers, shipping boxes, etc.) or tight back-end integration backed up by strong data security.

Last but not least, the main challenge remains in the aggregation of data to create intelligence and automate process steps, thus driving cost savings across the supply chain. One such example is the aggregation of temperature data to understand total exposure, calculate remaining stability budgets to automatically determine batch usage decisions.

While the visibility of temperature data exists, there is currently no systematic method of using this data to generate value. However, as the cost of connected technology decreases and new specialist technology suppliers provide new possibilities in global track and trace, real-time decision making on the basis of IoT becomes possible, with industry-grade security at its core.

This whitepaper provides detailed information on key success factors, shows possibilities with regards to technology, and offers recommendations for the implementation of transformative solutions within the pharmaceutical industry.

Key Success Factors

Based on experience gathered over the implementation of multiple temperature control solutions, the following key success factors need careful consideration:

  1. Device
  2. Connectivity
  3. Back-end integration to S/4HANA
  4. Modular & Secure Architecture
  5. Regulations & Standards
  6. Cost

The current situation and recommendations for each of these success factors are mentioned in the following section.

1. Device

While previously temperature loggers providing only retrospective data were available, next-generation devices are cloud-connected via cellular or gateway-based wireless networks. Critical characteristics of such devices, so-called smart sensors, are battery life, form factor, material, and not to forget, compliance with global regulatory requirements and industry-specific ISO standards (e.g. EN12830 for temperature measurement accuracy).

Tight integration and related dependencies between TCL operators and temperature logger suppliers have caused significant implementation delays, especially in the quick and seamless delivery of changes to the business process. Therefore, it is recommended that the TCL operator either implements a temperature-controlled solution that is completely device-agnostic or develops its own end-to-end solution, consisting of both hard- and software.

Recommendation

In general, Avoras recommends the deployment of connected temperature sensors in order to enable real-time decision making. Such devices can provide additional environmental data, other than temperatures, such as geolocation and movement data, to identify any event the device undergoes. While this may drive up device costs, this can be compensated through shifting from single-use, disposable devices, that currently form the industry standard, towards multi-use rechargeable smart sensors, that we see as the future of TCL. A positive side effect is a lower environmental impact of the end-to-end solution.

2. Connectivity

Over the past few years, data loggers have evolved to incorporate wireless technologies such as WiFi, BLE or Sub1GHz. However, with such technologies, installing gateways becomes necessary in order to retrieve real-time data, driving up solution costs immensely and creating a dependence on infrastructure belonging to supply chain stakeholders.

Recommendation

In general, Avoras’ point of view is to deploy smart sensors that are as independent of gateway infrastructure as possible, ideally leveraging global cellular networks optimized for low power consumption as well as high range and strong in-building penetration. Suitable wireless technologies are for example 4G Cat-NB1 (NB-IoT), or, in some selected emerging markets, even 2G.

To optimize data transmission reliability, fail-over connectivity needs to be considered, such as adding 2G to 4G devices for deployment in low 4G-coverage geographies (e.g. Germany). The selection of such connectivity technologies should be driven by the enabled use cases and geographies involved.

3. Back-end Integration to S/4HANA

Data collected by smart sensors is further processed to generate reports and alerts that are critical for supply chain managers to make real-time decisions. In addition, data can be analysed to automate process steps, for example in quality control. This back-end integration needs to include vertical integration of software and hardware as well as horizontal integration of the various stakeholders (e.g. CMOs, 3PLs) involved at various stages of the TCL chain. Historically, there has been no single approach to generate, retrieve and aggregate TCL data, rendering it difficult to obtain a holistic view of the entire supply chain.

Recommendation

With a vertically and horizontally integrated back-end system, collecting transactional data (S/4 HANA), global track and trace information (SAP GTT) and batch details during warehouse-internal processes (SAP EWM), it is possible to take real-time decisions based on temperature excursions. This information also enables batch releases based on automated stability budget calculations in the case of temperature-sensitive pharmaceutical products (as outlined in the solution approach below). In addition, the use of advanced analytics and business intelligence can ultimately drive cost savings and help optimize the supply chain.

4. Modular & Secure Architecture

Lack of a pre-planned technological architecture impedes the opportunities of making the system scalable to meet the changing business and industry demands. This leads to undue delay and unproductive resource consumption in reengineering or re-developing the systems whenever there is an upgrade or change necessary. The nature of the data collected is business-critical and requires a high level of security embedded at each level of the process.

Recommendation

With a vertically and horizontally integrated back-end system, collecting transactional data (S/4 HANA), global track and A well-planned target architecture, with vertical scalability (i.e. ease of making changes to the solution, such as adding more sensors) and horizontal flexibility (i.e. ease of adding additional supply chain stakeholders to the TCL, e.g. CMOs, 3PLs), can optimize costs and contribute to the competitiveness, efficiency and quality of the TCL system. It is recommended to engage domain professionals to ensure the target architecture is backed by a holistic security concept, based on military-grade data security already at electronics-level, and leveraging industry security standards for data transmissions at each step of the way.

5. Regulations & Standards

In the past few years, regulators have broadened their scope on pharmaceutical products that need to be temperature-controlled1. Particular focus points have been data integrity and solution security. Non-compliance with product safety regulations in different regions has already led to significant costs and wastage.

Recommendation

It is recommended that the pharmaceutical companies engage Good Distribution Practice (GDP) professionals to ensure compliance updates to the end-to-end temperature control solution, including hardware-based solution components such as smart sensors. If the implemented TCL solution features newly engineered devices, particular care needs to be given to device certification, covering electromagnetic compatibility and RoHS- and REACH-compliant enclosure materials. In addition, the solution needs to be compliant with a number of ISO standards, which at the time of printing were still under development.

In addition, the end-to-end solution build and verification needs to follow the formal Computer Systems Validation process.

5. Cost

The costs associated with high supply chain complexity is one of the biggest industry pain points experienced in TCL2. These high costs are mainly a result of the chaotic organisation of logistics and multiple stakeholders and solution providers.

Recommendation

A way to substantially reduce complexity, and therefore costs, is by avoiding the involvement of multiple solution providers in the TCL process. A single end-to-end solution provider can also help reduce the costs related to regulatory compliance and facilitate seamless integrations with stakeholders at various stages of the supply chain.

Example Solution

Avoras is one of the first companies to implement temperature control as a one-stop solution. With our IoT partners, we have recently developed a solution within the Pharmaceutical industry covering the following components:

  1. Hardware: Connected Cryogenic Tanks & Smart Temperature Sensors
  2. Connectivity & Security
  3. Software:
    1. Cryogenic Tank Temperature Dashboard
    2. Back-end Integration to S4/HANA
    3. S4/HANA Enhancement to calculate remaining stability budgets

This solution responds to the specific challenges that the pharmaceutical industry faces with regards to monitoring temperature exposure of drug substances and drug products across the end-to-end supply chain.

In addition, through transmitted location data, highly valuable cryogenic tanks can be tracked across their end-to-end lifecycle (Filling, Storage, Depletion, Cleaning).

Both the cryogenic tank as well as the packaged drug product (e.g. vials, syringes, tablets) are equipped with sensor devices providing edge intelligence, computing power as well as global connectivity in a compact form factor.

Connected Cryogenic Tanks & Smart Temperature Sensors

Hardware

Drug substance containers and individual package shipments are equipped with smart sensors that use cellular connectivity to enable worldwide visibility of shipment location and temperature. As the cryogenic tanks are flown between continents, an airplane mode ensures that radio transmissions are switched off before airplane take-off.

Mechanically, the devices were engineered to withstand particle intrusion and high-temperature water jets (IP69K, operating temperature -50° to +130°C), featuring a hydrogen peroxide-resistant enclosure to endure frequent cleaning cycles with aggressive chemicals (see tank management process overview below).

The engineering process of the Smart Temperature Sensors has been optimized for low battery consumption, global connectivity and low cost.

Connectivity & Security

A combination of multiple wireless technologies is used to connect the sensor devices to the cloud. While 4G (NB-IoT) covers the main connectivity channel, Sub1GHz RF has been incorporated to serve as fail-over connectivity in areas with low cellular coverage (e.g. in specific cold storage rooms of the drug substance production plant).

Based on the IoT partner’s industry-grade security architecture, the solution ensures data security and integrity at all levels.

Software

Cryogenic Tank Temperature Dashboard

The information collected by the smart sensors is presented on a Web App. The solution architecture is built on two separate cloud instances. Temperature data, location data and timestamps are transmitted to the Pharmaceutical company’s SAP Cloud Platform instance for further processing. From there, alerts are transmitted to the relevant stakeholders to enable quick decision making.

Device administration and management of cloud to manage end-to-end device lifecycles, firmware upgrades over-the-air and security updates are handled by our IoT partners.

Back-end Integration to S/4 HANA & calculation of stability budgets

The temperature and location data from the connected devices is transmitted to S/4 HANA, where a system enhancement calculates the remaining stability budgets and automates usage decisions in the system to eliminate manual process steps in the batch release. The enhancement also notifies of exceeded budgets and requests downstream stakeholders to accelerate their process steps.

Establishing a consistent batch and handling unit management as well as batch master data model were key prerequisites for this stability budget calculation logic.

Conclusion

The table below provides a summary of the main factors for future Temperature Monitoring:

We believe that the solution that we have jointly conceptualized and implemented with a large-scale Pharma organisation has the potential to set industry standards with regards to pharmaceutical TCL. While the solution has freed up workforce potential for the company, having a single supplier manage hardware, software, regulatory, security as well as back-end integration, has resulted in a substantial reduction of implementation complexity and costs.


Quality Assurance & Risk Management

Assuring the quality of an initiative is often treated like an afterthought. In truth, it pains us to say that for some organisations QA (verification) only comes into play after the damage is already done and the lack of preventative measures is apparent.


References

  • Pharmaceutical Commerce (2018), Biopharma cold-chain market forecast
  • Pharma Logistics IQ (2019), Benchmarking report: Are you spending too much on Temperature controlled logistics
  • Cold Chain Global Forum (2018), From production to patients, Optimizing the last mile of the life sciences supply chain
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