How to Stop Cross-Contamination in Multi-Product Facilities

The first step is to understand what will be made, how it will be handled and what the consequences of unintended transfer could be. The quality team and process owners should define the products, materials, exposure routes, cleaning approach and operational controls that inform the facility brief. Requirements can differ substantially between products and stages of manufacture.

EU GMP Chapter 5 describes technical and organisational approaches to prevention, including segregation where appropriate, air handling, cleaning and closed processing. It does not prescribe one universal layout for every multi-product facility; the control strategy must be justified for the operation.

Map the movement of people, materials, product, waste and equipment. Consider where activities need separation, where transfers can be controlled and where shared support areas could create unwanted crossings. Airlocks, pass-throughs, dedicated rooms or time-based separation may be relevant in some projects, but their use depends on the assessed risks and operating model.

• Show product and personnel flows in the early planning brief.
• Coordinate room relationships with air handling, equipment and process requirements.
• Allow access for cleaning, changeover and safe waste removal.
• Consider whether shared equipment or storage complicates cleaning status or material identification.

A room that is difficult to clean can undermine an otherwise sensible process plan. Finishes, junctions, furniture, service penetrations and equipment positions should be reviewed against the cleaning methods and agents the client intends to use. Storage and equipment parking also need defined places so surfaces remain accessible.

Changeover is an operational activity, not simply a gap in the schedule. The design should leave space for equipment access, cleaning, inspection and any documented checks required by the client. Quality teams should set acceptance criteria and responsibilities for commissioning or qualification.

Facility planning works best when quality assurance, production, engineering, health and safety and laboratory users contribute before the layout is fixed. Their input helps distinguish controls from preferences, identify existing-building constraints and coordinate the systems that support the process.

A control strategy needs to remain connected to actual production. New products, equipment, cleaning agents or process changes can affect assumptions made during design. The organisation should have a route for reviewing changes with quality, engineering and operations before the facility or shared systems are altered.

• Confirm which rooms, equipment and services are shared.
• Record the cleaning and release steps between different product campaigns.
• Review proposed process changes for effects on flows, extraction and room relationships.

Design can support these controls with accessible layouts and coordinated services, but day-to-day procedures and GMP decisions remain with the operator and its quality system.

The project brief should also define the information needed to approve room changes. This may include updated process maps, equipment lists, cleaning provisions and service changes. Having an agreed review route helps the organisation determine whether a proposed change affects its existing control strategy before that change is made.

ParkLaine’s pharmaceutical design work brings space planning, equipment and building services together around the agreed brief. Explore our laboratory design and consultancy service or contact our team to discuss a multi-product facility.