PDA Aseptic Task Force

Process
Simulation
R. M. Johnson
Abbott Laboratories
 PDA Aseptic Task Force
 David Miner (Chair), Eli Lilly  Russ Madsen, PDA
 William Frieben, Pharmacia
 Nigel Hall, GlaxoSmithKline
 Richard Johnson, Abbott
 Carol Lampe, Baxter
 Kenneth Muhvich, Micro-
Reliance
 Richard Prince, Richard
Prince Associates
 Andreas Sachse,
Schering AG
 Martin Van Trieste,
Abbott
 Richard Wood, Pfizer

 Terry Munson, KMI/Parexel  Glenn Wright, Eli Lilly

Process Simulation PDA Aseptic Task Processing Task Force

PDA Draft Technical Report
Points to Consider for Aseptic Processing

“What should be the current

expectation regarding
process simulation
acceptance criteria?”

Process Simulation PDA Aseptic Task Processing Task Force

PDA Draft Technical Report
Points to Consider for Aseptic Processing

“What is the
appropriate duration
of a process
simulation trial?”
Process Simulation PDA Aseptic Task Processing Task Force
PDA Draft Technical Report
Points to Consider for Aseptic Processing

“What are suitable

incubation conditions
for process
simulations?”
Process Simulation PDA Aseptic Task Processing Task Force
PDA Draft Technical Report
Points to Consider for Aseptic Processing

“Should it be required
to incubate
procedurally excluded
units?”
Process Simulation PDA Aseptic Task Processing Task Force
PDA Draft Technical Report
Points to Consider for Aseptic Processing

“Should it be required
to incubate non-
integral (i.e. damaged)
units?”
Process Simulation PDA Aseptic Task Processing Task Force
PDA Draft Technical Report
Points to Consider for Aseptic Processing

“What are the

reconciliation /
accountability
requirements for process
simulation units?”
Process Simulation PDA Aseptic Task Processing Task Force
PDA Draft Technical Report
Points to Consider for Aseptic Processing

“Should process simulation

units be inverted at some
point during the
incubation period?”

Process Simulation PDA Aseptic Task Processing Task Force

PDA Draft Technical Report
Points to Consider for Aseptic Processing

“How and when should

growth promotion of
process simulation units
be performed?”
Process Simulation PDA Aseptic Task Processing Task Force
PDA Draft Technical Report
Points to Consider for Aseptic Processing

“When should
anaerobic process
simulations be
performed?”
Process Simulation PDA Aseptic Task Processing Task Force
PDA Draft Technical Report
Points to Consider for Aseptic Processing

“Can aseptic process

simulations be performed as
separate segments, or must
they include simulation of
all aseptic processes?”

Process Simulation PDA Aseptic Task Processing Task Force

PDA Draft Technical Report
Points to Consider for Aseptic Processing

“What fill volume should

be used for process
simulations to assess
potential
contamination?”
Process Simulation PDA Aseptic Task Processing Task Force
PDA Draft Technical Report
Points to Consider for Aseptic Processing

“What types of
interventions are
required for process
simulations, and with
what frequency?”
Process Simulation PDA Aseptic Task Processing Task Force
PDA Draft Technical Report
Points to Consider for Aseptic Processing

“Is video taping of process

simulations required? If it is an
optional tool for investigation and
training, must it be retained after the
conclusion of the process simulation
and any associated investigation?”

Process Simulation PDA Aseptic Task Processing Task Force

PDA Draft Technical Report
Points to Consider for Aseptic Processing

“Under what
conditions can you
invalidate a process
simulation?”
Process Simulation PDA Aseptic Task Processing Task Force
PDA Draft Technical Report
Points to Consider for Aseptic Processing

Please submit comments to

Russell Madsen,
Sr. VP Science and
Technology, PDA,
by e-mail to
madsen@pda.org

Process Simulation PDA Aseptic Task Processing Task Force