Reimagining pharmaceutical storage: Multi-Temperature AutoStore as a DSCSA compliance catalyst

In the evolving landscape of pharmaceutical manufacturing and distribution, regulatory compliance is no longer just a box to check—it’s a strategic imperative. The FDA’s sample retention requirements have placed increasing demands on manufacturers, requiring them to store and retrieve product samples for up to three years. This mandate, while essential for safety and traceability, introduces a host of operational challenges: audit-readiness, traceability, immediate accessibility, temperature control, and space constraints.

Enter the Multi-Temperature AutoStore solution—a modular, automated storage system that’s quietly transforming how pharmaceutical companies meet these demands.

The compliance challenge

While the Drug Supply Chain Security Act (DSCSA) focuses on package-level traceability and has undergone phased enforcement since its enactment in 2013, it’s the FDA that requires sample retention for audit purposes. These samples often span multiple temperature zones—from ambient to chilled to frozen—making traditional storage solutions cumbersome and inefficient. Add to that the reality of aging facilities, limited expansion space, and the need for ergonomic working conditions, and the challenge becomes clear: manufacturers need a smarter way to store.

AutoStore’s Multi-Temperature advantage

The Multi-Temperature AutoStore system, integrated by Swisslog, offers a compelling answer. It enables frozen (-25°C) and chilled (+6°C) zones within a single cube, allowing operators to pick frozen items from a chilled environment—dramatically improving ergonomics and reducing exposure to extreme cold. This innovation not only enhances worker safety but also streamlines operations and reduces energy consumption.

What sets AutoStore apart is its ability to fit into existing footprints. Unlike traditional cold storage, which often requires extensive infrastructure, AutoStore can be installed in tight, unconventional spaces—even on mezzanines above conveyor lines. This flexibility allows manufacturers to maximize vertical space and integrate automation without disrupting existing workflows.

Case in point: La Réserve des Saveurs

An award-winning installation in France, La Réserve des Saveurs, offers a powerful reference point. While not a pharmaceutical site, the facility implemented a multi-temperature AutoStore grid that seamlessly handles frozen and chilled goods in one system. The result? Improved order accuracy, reduced labor strain, and faster audit response times. It’s a model of what’s possible when automation meets ingenuity.

Creative configurations for complex needs

Beyond standard installations, AutoStore has proven its adaptability in highly customized environments. In one case, a pharmaceutical manufacturer deployed the system above active production lines, leveraging unused overhead space to meet DSCSA sample retention requirements without expanding their footprint. These creative configurations demonstrate that AutoStore isn’t just a storage solution—it’s a strategic enabler of compliance and efficiency.

Learn more

This article builds on the insights shared in Swisslog’s original blog post, “Why Multi-Temperature AutoStore is Ideal for Pharmaceutical Manufacturing”.

If you're exploring ways to modernize your pharmaceutical storage strategy or want to understand how AutoStore can be tailored to your facility, contact us today. Our team is ready to help you design a solution that meets your compliance needs while maximizing space and efficiency.