Trend Analysis for Sterile Manufacturing - Pharmaceutical Technology

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Trend Analysis for Sterile Manufacturing
A Pharmaceutical Technology survey examines capacity expansions, outsourcing practices, innovation levels, and the role of quality by design in sterile manufacturing and aseptic processing.


Pharmaceutical Technology


Quality by design


Figure 6
The survey examined the importance and application of QbD to sterile manufacturing or aseptic processing. Seventy-one percent of respondents said that their companies are incorporating QbD in their sterile-manufacturing activities, and 29% are not (see Figure 6). A smaller percentage of respondents are implementing process analytical technology (PAT). Forty-five percent of respondents are incorporating PAT, and 55% are not.


Respondents profile
For those companies not integrating QbD into their sterile-manufacturing activities, 43% of respondents said that they do not see process advantages to be gained with QbD. Forty percent said their companies are not incorporating QbD because they lack an understanding of QbD, and 32% said they were not implementing QbD because they lack guidance or direction from regulatory authorities. Almost one-quarter, or 23%, said that they were not using QbD because it was too costly.

The leading benefits gained by companies that have incorporated QbD or PAT into their sterile-manufacturing activities include achieving better process understanding (51% responded thus), improved manufacturing efficiency (48% responded thus), and better regulatory compliance (44% responded thus). And almost one-third of respondents, or 31%, said that their companies lowered costs through QbD.


Figure 7
To implement QbD, 45% of respondents said their companies had to modify or add equipment, and 55% did not (see Figure 7). Similar results were observed for those companies incorporating PAT. Forty-five percent of respondents said that they added or modified equipment when implementing PAT, and 55% did not.

Innovation


Figure 8
The survey evaluated the level of innovation in specific equipment areas relating to sterile manufacturing and aseptic processing. Respondents were generally satisfied with the level of innovation for isolators and barrier systems. Thirty-one percent of respondents characterized the level of innovation as "very good," and 46% said it was "good." Twenty-percent said the level was "satisfactory" (see Figure 8).

Respondents were also generally content about the level of innovation for steam-in-place (SIP) and clean-in-place (CIP) systems for sterile manufacturing. Sixty-nine of respondents characterized innovation in SIP and CIP systems as either "very good" or "good" (see Figure 8).

Respondents were less satisfied with the level of innovation in gowning, automation, and robotics although these areas still received positive ratings. Twenty percent said that the level of innovation in gowning was "very good," 39% said it was "good," and 36% said it was "satisfactory" (see Figure 8). For automation, only 20% of respondents rated innovation as "very good," 43% classified it as "good," and 31% said it was "satisfactory" (see Figure 8). Robotics received slightly lower marks. Fifteen percent classified innovation as "very good," 34% rated it as "good," and 36% ranked it as "satisfactory" (see Figure 8).

Spending

The survey measured spending on equipment and machinery for sterile manufacturing or aseptic processing. Thirty-seven percent of respondents increased spending on equipment and machinery for sterile manufacturing or aseptic processing in 2008 compared with 2007. Twenty-three percent said their spending stayed the same, and 8% decreased spending. For 2009, respondents plan to spend less than they did in 2008. Twenty-four percent plan to increase spending in 2009, and 23% plan to keep it at the same level. Sixteen percent said they plan to decrease spending this year. Companies spent an average of 3.9% of their sales on equipment and machinery for sterile manufacturing or aspetic processing in 2008 and plan to spend on average of 3.4% of their sales this year.


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Source: Pharmaceutical Technology,
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