Incremental Addition of Parenteral Capacity Case Study for a Lyophilizer
Incremental Addition of Parenteral Capacity Case Study for a Lyophilizer
Narlin B. Beaty, Ph.D.
Chesapeake Biological Laboratories, Inc.
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Filling parenterals is capital intensive, with large, fixed ongoing maintenance fees to support continuous operations. There is an additional requirement to remain current with the latest innovations in equipment and best practices leading to regular upgrades and changes within a regulated environment that is generally distrusting of change and requires substantial validation of all improvements. As a case study and model, the addition of new lyophilization business will be considered.
Since removing water from drug and biological molecules significantly reduces hydrolytic reactions and thus enhances stability, lyophilization or freeze-drying is an essential marketing requirement for many biotech drugs. The injectable nature of these products also dictates aseptic processing that is slow, requiring 2 to 4 days on average, and involves substantially more equipment than just a lyophilizer. Aseptic filling and packaging will normally support multiple products that may be campaigned at different times throughout the year, but growth in pharmaceutical manufacturing is typically incremental. Therefore, it is desirable in planning for new increments to estimate the costs, understanding that the different aseptic processes involved consume variable capacity.
The following discussion is about the addition of a lyophilizer. It includes information about maximizing capacity and minimizing costs, not only cost of the new lyophilizer, but also of all support equipment and environments that are needed for a parenteral product. Obtaining the capacity of a single piece of equipment without consideration to its impact within a facility is insufficient to achieve that rated capacity. If new equipment does not smoothly interface into a manufacturing operation, one will discover unexpected bottlenecks that prevent previously planned capacity from being realized. The goal is to increase capacity incrementally, and to know in advance the magnitude and cost of the increase.
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