2016 Pharma Expo

Disposable technology is one of the existing key emerging trends that must be continuously watched. However, the fill and finish industry does not view disposable equipment as likely to replace stainless steel technology. But what must be taken into consideration are the special fields within the production process where disposable technology is positioned to be a valuable alternative option. And, while both technologies have their respective pros and cons, it is valuable to verify the unique selling positions of each in order to be able to arrive at a well-thought through decision.

Before examining a number of parameters that are crucial and, therefore, must be considered when creating a decision grid, it is important to note that there is one guideline that is essential. That is, disposable equipment is especially suitable in cases when drug substances come in direct contact with the equipment being used.

According to our experience, which is based on numerous customer projects, we consider the following parameters as key:

  • Time
  • Costs and yield
  • Flexibility
  • Drug’s individual characteristics

In order to verify time, one needs to include a comparison of both stainless steel and disposable equipment’s procurement time, the possibility of needed cleaning validation time, and the requalification of cleaning equipment.

The parameters cost and yield encompass investment costs of both technologies as well as the possibility of arising destruction costs at the end of their usage. Similarly, efficient use must be made of the available API, always incorporating the appropriate pharmaceutical quality as it pertains to the product itself and its accompanying processes.

The issue of flexibility underlines the importance of equipment offering the highest possible flexibility due to frequently changing project and process parameters.

Finally, one must consider a drug’s characteristics, which refer to the aspects of individual project and product characteristics, as well as process requirements. This involves parameters such as batch size and compounding volume, the right choice of equipment to meet with the products’ light and oxygen sensitivity, as well as the products cooling needs in compounding stage. Additionally, this parameter encompasses the possible arising risks that pertain to ‘extractables and leachables’.

To summarize, both technologies have their respective advantages and disadvantages. As with other cases in drug manufacturing, there rarely exists a ‘one size fits all’ approach. Based on experience, every sponsor, together with their supplier network has to look for the best solution in their particular situation, always keeping in mind the goal of achieving a safe, flexible, and fast manufacturing process.

By Jorge Rodriguez, PE, Director of Engineering and Qualification,
Vetter Development Services USA, Inc.

Pharma EXPO Conference Program Details:
Learn about disposable technology and additional pharmaceutical education sessions at Pharma Expo, 6 – 9 November in Chicago, Illinois, USA.  Tracks include Manufacturing Operations, Compliance Trends, and Pharmaceutical Packaging.

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