By Scott Patterson, VP of Commercial Sales, ILC Dover
Myriad considerations, spanning the full complement of pharmaceutical manufacturing stakeholders, influence the containment solution decision-making process in pharmaceutical manufacturing. Plant managers are tasked with the efficient use of floor space and managing capital and consumable expenses. Process engineers worry about the system’s impact on the integrity of the formulation and cross-contamination mitigation. Project engineers wring their hands over user-friendliness and operational efficiency. Environmental health and safety
professionals concern themselves with occupational exposure levels.
All of these concerns often overlap and roll up into one, simple requirement: that the containment solution works well for every stakeholder. With high potency active pharmaceutical ingredients (HPAPIs) come a heightened awareness of this requirement and the added burden of a higher level of regulatory oversight. Throw the demand for multi-use CMO facilities into the mix — with their increased cost of line change maintenance and inherent cross-contamination risks — and these considerations are further intensified.
Each of these stakeholders evaluates containment solutions through a slightly different lens, but they seek the same objectives: First, can I solve the problem for which I am responsible using the technologies available to me? And second, will the technology that works best for me satisfy the requirements of the other stakeholders in the decision-making process?
Satisfying all parties in the containment solution decision equation usually requires the demonstration of three critical outcomes:
• It works. It limits occupational exposure levels as advertised while facilitating a contained formulary environment.
• It’s affordable. Both the up-front investment and total cost of ownership for the life of the line are budget friendly.
• It’s usable. Line operators and operations managers can efficiently and confidently perform their duties.
Let’s dig into some details around how flexible containment options, manufactured using durable, proprietary, pharmaceutical-grade plastics, fare in the face of these critical requirements.
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