Untitled

16
Seiberling
products in asingle facility, active pharmaceutical ingredient (API) processes, and
even liquid creams and ointments. The physical arrangements have varied from
single floor to five floors with CIP in abasement, maximizing the use of gravity CIPR.
The degree of process automation has varied but all CIP functions have been
fully automated, and the CIP programs successfully validated. There is virtue in
considering the avoidance of all line CIP circuits by designing to clean every vessel in
combination with its downstream transfer line and SIPing every vessel with its
upstream transfer line, to achieve uniformity of design and operation, minimize the
circuits required, and reduce water, time, and chemicals required for cleaning the
total process.
CIP Cleanable Equipment and Process Design Criteria
Process equipment and piping that have been designed to be totally disassembled
for manual cleaning, as used in the pharmaceutical industry until the recent past, is
not suitable for application of automated CIP cleaning. The general design criteria
for processes that handle fluid or semi-fluid products that must be maintained in a
very clean or sterile condition include:
1. All equipment that will be contacted by cleaning solutions must be made of
stainless steel, glass-lined, or equally corrosion resistant construction, and CIPcleanable
materials, sealed and closed with elastomers which are validated for
the intended application.
2. The equipment must be designed to confine the solutions used for flushing,
washing, and rinsing.
3. The entire process, consisting of the equipment and interconnecting piping,
must be drainable.
4. A minimum radius of 1in. (25.4 mm) is desirable at all corners, whether
vertical or horizontal.
5. Mechanical seals must be used for agitators.
6. Projectile-type thermometer sensors are acceptable for use with filled tube or
resistance temperature detector (RTD)-based temperature indicating and
recording systems. Thermocouple(s) or RTD(s) installed so as to sense only
the temperature of the tank surface provide an even more satisfactory
installation from the standpoint of cleanability.
7. Automatic orbital welded joints are the most suitable for all permanent
connections in transfer systems constructed of stainless steel.
8. Clamp-type joints of CIP design are acceptable for semi-permanent connections.
An acceptable CIP design infers ( i )ajoint and gasket assembly which will
maintain the alignment of the interconnecting fittings, ( ii) agasket positioned
so as to maintain aflush interior surface, and ( iii)assurance of pressure on each
side of the gasket at the interior surface to avoid product build-up in crevices
that might exist in joints which are otherwise “water-tight.”
9. Dead ends and branches are prohibited, and all mandatory branches or tees
should be located in ahorizontal position and limited to a L / D (length/diameter)
ratio of 2, or the branches shall be cleaned-through during CIP. Vertical
dead ends are undesirable in fluid processes because entrapped air prevents
cleaning solution from reaching the upper portion of the fitting.
10. All parts of the piping or ductwork should be continually sloped at 1/16 in.
(5 mm/m) to 1/8 in. (10 mm/m) per feet to drain points.