Page 62 - Assurance of Sterility for Sensitive Combination Products and Materials

Aseptic processing 49

• In what jurisdictions and markets will the product be distributed?
• What are the cost limitations?
• Are there unusual stability limitations (e.g., temperature, humidity)?
• Will product be produced in an existing facility, and if so, then—what
are the limitations of that facility?
• Will redundant manufacturing systems be required?
The product requirements, along with contamination control and effi-
ciency strategies will influence technology decisions. As such, the answers to
these questions will in part determine the technologies and methods used
to manufacture the products, including the use of:
• aseptic or terminal sterilization processes,
• batch or continuous process manufacturing,
• manual fill systems,
• conventional semiautomated filling systems,
• barrier systems such as Isolators, RABS (restricted access barrier sys-
tems), or Blow Fill Seal and Form Fill Seal,
• robotics and automated filling systems,
• steam/sterilize in Place product filtration and transfer systems, and
• continuous total particulate and/or viable environmental monitoring
systems.
The outcome of this evaluation will help provide the information con-
tained in column 2 of Table 4.1.

4.9 User requirement specification (URS)

The URS is important for process design because it sets the criteria for
process performance based on product quality requirements. The URS is
developed once the basic technology strategy is set. The URS presents more
specific user needs that can be translated into a manufacturing process de-
sign. The URS should be prepared prior to the design of the process and the
selection of systems. The URS can then be used to develop the strategy to
select and define critical aspects of the process, process parameters, and qual-
ification/validation acceptance criteria. Information and design require-
ments from the URS can then be used during a design qualification and
process qualification to ensure that the critical aspects of the process have
been incorporated. The URS should address anticipated process variables
that might adversely affect the sterility of the product and control strategy
to ensure reliable process performance and output meeting production/
product requirements. The URS can be used to obtain information needed
to complete columns 2 and 3 of the LOS Evaluation table (Table 4.1) [12].