Quality by design
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.
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.
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.
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).
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.