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14 Cleanable Solids Processing Equipment
and Systems
INTRODUCTION
Simon E. J. Forder
JM Hyde Consulting, Inc., San Francisco, California, U.S.A.
Dry powder processing equipment can be cleaned through the use of clean-in-place
(CIP) systems. As described in this book, thereare anumber of advantages to using
CIP systems for cleaning many types of biopharmaceutical equipment including:
controls of cleaning parameters, control of variability in the cleaning process
(consistency), and the ability to more easily validate the cleaning process. The
ability to establish controlled conditions of time, concentration, and temperature via
application of aCIP system has been demonstrated to be superior to manual
cleaning under any conditions.
Dry powder equipment and piping that have been designed to be totally
disassembled for manual cleaning, as in the pharmaceutical industry until the
recent past, are not suitable for application of automated CIP cleaning. Similar to
tank and vessel design, there are anumber of design criteria that need to be met
to successfully use CIP with dry powder processing equipment. The general design
criteria for processes that handle dry or powdered products, which must be
maintained in avery clean or sterile condition will include:
1. All equipment that will be in contact with cleaning solutions must be of
stainless steel, glass-lined construction or equally corrosion-resistant and
CIP-cleanable materials, sealed and closed with elastomers that are Food and
Drug Administration (FDA) approved for the intended application.
2. Traditionally, 316-L stainless steel has been specified for bioprocess equipment
and should be used in the construction of dry powder equipment.
Additionally, attention to surface finish on product contact surface should
be considered.
3. All welds need to be fully penetrated and sanitary. Edges should be rounded
and sanitary as well to minimize powder collection and holdup. Asurface
finish of less than 25 rouchness average (Ra) is sufficient to ensure residue
removal. The use of electroplating will also facilitate residue removal.
4. The equipment must be designed to confine the solutions used for flushing,
washing, and rinsing. Recirculation is essential for economical and effective
CIP operations.
5. The design or modification of the process equipment should allow cleaning
solutions to freely drain from all equipment surfaces to one or more return
collection points.
6. All parts of the piping or ductwork should be pitched at 1 ⁄ 6 in. (5 mm/m) to 1 ⁄ 8 in.
(10 mm/m) per ft to drain points. Pitch must be continuous.
7. Aminimum radius of 1in. (25.4 mm) is desirable at all corners, whether vertical
or horizontal.
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