Principles of Sip

s40 Pharmaceutical Technology FILTRATION 2004 www.pharmtech.com

dequate configuration of steamin-

place (SIP) systems is vital

and must be considered at the

early conception stage of the plant.

The critical requirements associated

with SIP include proper steam distribution,

noncondensable gases removal,

and continuous condensate

elimination. Good engineering

practices, adequate piping design,

steam traps, valves, and monitoring

instrumentation are essential to ensuring

SIP validation.

Gas filter engineering

System design, installation, and standard

operating procedure.Vent filters

are required for the sterile introduction

of air or nitrogen during and

after the process of vessel sterilization.

Gas filters are made of hydrophobic

materials such as PTFE to

prevent blockage by humidity during

use. Therefore, condensate may

accumulate on the membrane during

SIP and produce blind filters. In

such circumstances, the steam no

longer passes through the membrane,

leading to incorrect sterilization.

The filter housing must there-

Principles of Steam-In-

Place

Jean-Marc Cappia

A

MILLIPORE CORPORATION

Steaming-in-place (SIP) is a

widely adopted method for the

in-line sterilization of processing

equipment.The main advantage

of SIP relies on manipulation

reduction and aseptic connections

that might compromise the

integrity of the downstream

equipment.

Jean-Marc Cappia is the

program director for high filtration

performance solutions in the

BioPharmaceutical Division of

Millipore Corporation, 80 Ashby

Road, Bedford, MA 01730, tel.

781.533.2219, jean-marc_cappia

@millipore.com.

Pharmaceutical Technology FILTRATION 2004 s41

fore be designed and installed

for correct drainage

of condensate, with the inlet

sterile side of the cartridge

fitted on the sterile vessel.

This setup is preferred, since

the housing closure as well

as the connections to vent

and drain valves may present

risks of leakage on the

upstream side of the...