Temperature Control 4.0

Temperature Control of Cryogenic Tanks enabled by SAP S/4HANA allows the Pharma industry to leverage the technological advantages of SAP and IoT.

E2E Integration from Sensor to ERP (SAP) - Success Factors for Supply Chain Managers

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. 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 manufacturing as well as across global distribution.

Pharmaceutical Value Chain

The temperature controlled logistics chain comprises of 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 possess 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 visibility of temperature data exists, there is currently no systematic method of using this data to generate value. However, as 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