With one of the most challenging and stringent regulatory environments of any industry, Life Sciences manufacturing requires meticulous adherence to quality standards and process controls.
On top of operating within the boundaries imposed by this regulatory environment, the life sciences market should also proactively aim to satisfy customer demand. However, maintaining inventories at high levels in an industry where expiration dates are a strong constraint should not be viewed as the right answer. Very often, companies face logistical issues, such as complex distribution networks regulated by different legislative regimes, resulting in very high costs. But extreme fragmentation in the networks of manufacturing facilities, sales offices, distribution warehouses and suppliers, as well as the number of different actors in the supply chain, must not lead to an inability to react.
The extremely restrictive dynamics in production (traceability, batches, deadlines, contamination) and sequencing optimization rules require companies to be extremely flexible in production operations as well: management of API, primary and secondary packaging require continuous and consistent processes and optimization.
A real case…
One customer from the Life Sciences industry successfully implemented a project ranging from long-term planning to finite capacity scheduling.
Due to the high complexity of planning and scheduling activities, the customer was looking for a solution able to support S&OP validation over a horizon of two years and to support production planning over a six-month horizon, capable of drilling down to the lowest level as well as scheduling and optimizing production sequences day by day in the factory.
One of the biggest challenges was organizing the SIP (sterilization in place) and CIP (cleaning in place) to create efficiency in the production process (zero time loss). In addition, another focus of development was the need for the solution to be fully integrated with SAP.
The sedApta project focused on 3 main areas of intervention:
- Supply Planning
The creation of a long-term production plan supports sizing the production resources (production / inspection lines) with load balancing aimed at planning the campaigns for each single line over the long term (two years)
- Production planning and campaigns generation
The creation of production orders for formulation, filling, inspection, and cleaning in the medium term (six months).
The creation of production campaigns through a verticalized algorithm according to parameters specified by the user: maximum number of lots by campaign/period, maximum number of suspensions by campaign/period, etc.
Carrying out detailed scheduling with management of tanks, filtration lines, cleaning and all the constraints related to production per campaign of a single line (preparation and filling) that comes to define an inspection plan in the short term (1–3 months).
The benefits can be summarized as:
- Load balancing and sizing of production resources over the long term
- Efficiency in evaluating long-term workloads: before sedApta, the evaluation took three days, now it is down to just one day
- Automatic campaign creation
- Generation of feasible and optimized work plans: work sequences on individual lines
- Cleaning / reclamation / sterilization management
- Ability to simulate alternative scenarios through performance analysis supported by KPIs
- Reduction of plan scheduling times for the following two months: before sedApta, scheduling took two days, compared to just half a day now
The sedApta solutions consists of:
- Demand Planning, through automatic generation of statistical sales forecasts at different levels of the product/market hierarchy, based on sales history and past promotions, and powered by predictive ML/AI algorithms with demand and customer association. New product introduction, phasing in/out and de-listing are available as well. On top of that, collaborative digitalized approval flows are offered to orchestrate a demand validation process among different roles in central HQ and local subsidiaries (top-down or bottom-up), generating a consensus forecast.
- DRP and Inventory Management, with Multi-Warehouse Stock Ability, which aim to compute the ideal replenishment plan of your distribution network, optimizing the stock deployment based on timing and costing of alternative routes
- Production Planning starting from the Demand Priority Index, at finite capacity with batch and bulk/API production optimization (through implementation of verticalized algorithms), generating production proposals aligned with available batch capacity and the time required to produce the bulk/API itself. Flexibility in Report Generation, Orders Release Evaluation and Continuous Constraints Evaluation are available to support business objectives. A powerful multi-simulation engine enables creating and comparing different “What-if” scenarios, integrating transportation tracking real-time data.
- Material Requirement Planning (MRP): starting from a feasible production plan, a purchasing plan can be generated, allowing better synchronization with suppliers of raw materials and components. The solution provides Production Method Selection with Lots Assignments and Flexibility of Unit of Measure.
- Collaboration with suppliers and subcontractors resulting in increased visibility across the entire supply chain. This approach improves flexibility and avoids the inefficiencies that currently plague you. Increase the quality and timeliness of reminders to suppliers and subcontractors by synchronizing external activities with internal production. Shipping management and ASN exchange are available for suppliers
- Transportation tracking for over-seas shipments: A tool allows you to check the status of your inbound and outbound shipments from the moment they are shipped from the supplier until they are delivered to the warehouse, integrating commercial data (SKUs and order) linked to the logistics data (container), with AI/ML-powered predictive ETAs.
- Scheduling at plant level, generating automatically optimized work plans that take into account order delivery dates, availability of production resources, materials, production sequences and equipment setup times, with the possibility to manage production campaign optimization and quantity, time overlaps and batch size production sequence management. This approach offers better synchronization between bulk and finished goods by managing batch-to-batch connections and allows rapid responses to various change requests by being able to easily run various simulations.
- sedApta scheduling tools are fully connected with the best EBR/MES systems available on the market. This interaction gives you total control of the factory and near-real-time rescheduling capabilities.