Devin Chandler is sales engineer in the Custom Products Group at AeroGo.

Devin Chandler

Maneuvering heavy equipment through cleanrooms or test lab environments is always a challenge for pharmaceutical and biotech firms, especially when the equipment is a chromatography column requiring cleaning and repacking. Most operations default to a simple-wheeled solution, such as a tugger or another material handling system already available in-house. Certainly, a tugger will enable operators to pull the equipment through the facility, but is that really the best solution?

Too many operations are all too willing to rely on a particular material handling system because it is either familiar or already on hand, instead of considering potentially better options. Choosing the optimal material handling system depends on several factors, such as facility characteristics, production process, and the equipment to be moved. To make the right choice, pharmaceutical and biotech companies should conduct a systematic assessment to determine the ideal system to resolve each of the following challenges.

Cleanroom facilities for pharmaceutical operations must protect against contamination that can jeopardize product quality and pose safety hazards to staff or end-users. The material handling system must also preserve the environment’s cleanliness and purity, a concern that immediately eliminates the use of forklifts or other motorized or mechanized systems that require lubricants or fuel. One or both will likely introduce unclean and potentially dangerous fumes, vapors, or other volatile organic compounds into the environment.

Fuel-powered load movers are not the only potential sources of contamination. Non-motorized wheeled solutions can also contaminate the environment if they grind wheel bearings or floor surfaces, which can cause paint to flake or produce other particulates. An ideal solution for avoiding contamination is one that consumes no fuel and requires neither grease nor other lubricants to operate (e.g., human-powered vehicles such as tuggers or air casters).

Special floor surface treatments, such as epoxy coatings, are common in pharma to protect the floor surface from basic wear-and-tear, facilitate cleanup, and maintain the cleanroom environment. Unfortunately, a wheeled cart carrying a multi-ton load can exert more than 3000 psi at each point of contact with the floor, which is more than enough pressure to ruin coatings, tear up paint, and cause gouges and divots. Any load-handling solution that damages the floors will also risk contamination, destroying the benefits of special floor treatments while increasing maintenance and facility costs.

The material handling methods that best resolve these challenges are those that prevent the load from touching the floor as the load moves. Cranes are one solution; air casters are another. Functioning like hovercraft and floating the load above the surface, air casters exert only 30 to 60 psi of floor loading. Other material handling systems that involve floor contact, including wheeled casters, will exert hundreds to thousands of psi of floor loading, which increases risks to the integrity of the floor surface.

Chromatography columns are often packed with specialized media at a precise specification to control flow velocity and ensure optimal performance. Vibration from rolling across the floor coupled with shock loads from hitting bumps or gaps can upset the carefully packed media. The material handling system must protect the column against both damage and de-calibration.

The most effective way to isolate the column from vibration or shock loads is, again, separation from the floor surface. Air casters can overcome this challenge because they float the load on a thin film of air that effectively functions as a shock absorber, shielding the equipment against vibration. At its destination, the air casters slowly and gently deflate until the column is once again resting on the floor.

Operations must consider whether the material handling system is capable of successfully navigating the facility. Although cranes are highly effective at lifting the load off the floor, their operation is obviously limited; they can only move within the envelope of the crane's operational area. If the chromatography column must be relocated to a separate area, perhaps outside of the cleanroom, a crane may not be able to complete the entire move from start to finish. Other material handling systems that require permanent installation, such as rails or conveyor systems, come with the same limitation.

These limitations explain why many operations rely on tuggers. Tuggers are highly portable options that operators can easily maneuver through nearly every facility. However, tuggers, too, have their limitations: they require a considerable amount of space, and they add to the footprint of the column being moved because the steering mechanism extends out from the platform on which the column rests. These characteristics present several major obstacles for moving equipment using tuggers. First, there is increased risk of collision with other equipment or personnel when transporting loads, which in turn forces operators to move more slowly. The machinery then spends more time out of production, decreasing overall productivity. Second, potential efficiencies are reduced. Cleanrooms are expensive, so it is common and sensible to pack as much productive equipment into the space as reasonably possible. More room required for material handling, however, lessens the space available for production. Such inefficiencies mean more money must be spent to build and maintain an environment that is larger and more expansive—and expensive—than necessary.

The alternative is a system that fits entirely within the footprint of the chromatography column, typically an overhead crane (if feasible) or an air caster or skid system placed completely beneath the column. Notably, a system that fits within the equipment footprint can be stored under the columns when not in use. This is not the case with tuggers and similar equipment, however, whose storage requirements further reduce the facility’s productive space.

The relationship between productivity and material handling should never be underestimated or undervalued. The true costs can go well beyond the expense of the material handling system, such as the extra time needed to methodically move through the facility while avoiding equipment and personnel, or the extra space required for handling and storing the system.

Further, costs associated with production efficiency that fall short of potential should not be overlooked. Slow-moving, traditional-wheeled material handling systems tend to impede continuous manufacturing processes, a popular approach in pharmaceutical production for reducing error rates and production times. One dramatic example is Janssen Therapeutics, a pharmaceutical company of Johnson & Johnson, which implemented continuous manufacturing for its HIV medication Prezista (darunavir) and saw its production time decrease from two weeks to just three days. (1)

Facility executives, designers, and planners must ask themselves what the implications may be for every material handling system and the impact of each on operations and production. Which ones can best facilitate continuous manufacturing and its consequent time savings?

Pharmaceutical and biotech organizations are understandably reluctant to risk production on unfamiliar material handling systems, but, as has been shown, defaulting to familiar options can result in unacceptable inefficiencies and additional costs. Traditional solutions may serve well in some scenarios, but not all. Systems that offer controlled operation, reduced footprint space, safe moves, and cost-saving efficiency accomplish more than successful movement of chromatography columns and other equipment; they also strengthen a facility’s overall operation.

Pagliarulo, N. Pharma’s slow embrace of continuous manufacturing. 

Articles

It’s crucial to consider the optimal handling systems for cleanroom and other lab environments.