How does single-use stack up with stainless steel technology? Claus Feussner, senior vice president, development service at Vetter explains all.
Vetter
In the fill and finish industry, single-use technology is one of the key emerging trends. However, the industry itself does not believe that single-use equipment is likely to replace stainless steel technology on the whole. However, it can be a valuable option within special fields of the production process. Because both technologies have their respective pros and cons, it is useful to examine the unique selling positions of each in order to be able to make a careful and thoughtful decision that best suits the needs of the situation.
Let’s begin by stating the key guideline - single-use equipment is especially suitable in cases when drug substances come in direct contact with the equipment being used. That said, we can now examine a couple of parameters that are crucial and, therefore, must be taken into consideration when preparing a decision.
From our perspective, based on numerous customer projects, the following parameters must be considered as key: time, costs and yield, flexibility, and the drug’s individual characteristics.
In verifying time, one must establish a comparison of both stainless steel and single-use equipment’s procurement time, the possibility of needed cleaning validation time, and the requalification of cleaning equipment.
In regards to cost and yield, investment costs of both technologies as well as the possibility of arising destruction costs at the end of their usage must be taken into account. At the same time, valuable API must be used efficiently, always incorporating the appropriate pharmaceutical quality as it pertains to the product itself and its accompanying processes.
Flexibility is another crucial parameter and underlines the importance of equipment that offers the highest possible flexibility due to frequently changing project and process parameters.
And last, but certainly not least, a drug’s characteristics must be taken into consideration. This refers to the aspects of individual project and product characteristics, as well as process requirements. This step involves key parameters such as batch size and compounding volume, the selection of equipment meeting the products’ light and oxygen sensitivity, as well as the products cooling needs in the compounding stage. Possible arising risks pertaining to ‘extractables and leachables’ must also be taken into consideration during this step.
At the end of the day, both single use and stainless steel technologies have their individual advantages and disadvantages. There rarely exists, however, a ‘one size fits all’ approach. It is our experience that every sponsor, along with their supplier network must carefully look for the best individual approach that fits with their particular situation. What must always be kept in mind in the foreground is the goal of achieving a safe, flexible, and fast manufacturing process.