Sterilization In Place (SIP)

Proper sterilization of bioporcess equipment is very important. Most common technique for sterilization of large scale process equipment is Heat sterilisation using steam. Steam heating kills both live organism as well as their spores which were difficult to be killed by dry heat.

SIP is a process which is necessary for every component like; vessels, air filters, medium filters , valves and piping.

The medical research council proposed the values for saturated steam as: Temp. Time(min) 121 15 126 10 134 3

PERKINS proposed the following values for saturated steam : Temp. Time(min) 116 30 118 18 121 12 125 8 132 2

Usually 121C temp for 15 min is chosen. Time period can be increased depending upon the material. Larger the component greater is the time required for sterilization. Similarly there have been given different pressure and temperature combinations. Usually 1.5 bar is taken.

Some rules to be followed during designing for steam sterilization equipment

Ability to withstand sterilization temperature. Avoid joints. Avoid dead space ,crevices Use more than one valve between sterile and no sterile area. Use easy to be cleaned valves. Design the equipment so that it can be sterilized in parts. Design line for complete drainage without pockets.

Equipment sterilization

Vessel and jacket must be designed to an appropriate pressure vessel code. No glass vessel should be used If it is necessary to use glass then vessel should be protected by plastic films or shielded.

Steam sterilization process

Test any leakage Open all condensate outlet valves Open steam inlet valves Sterilization time starts when temp reaches to 121C and pressure reaches upto 1.1 bar Condensate is eliminated through steam traps Condensing steam is replaced by sterile air slowly.

There are many connection to vessels which need careful sterilization

Sparger: when vessel is steamed sparger leg is steamed first until pressure of vessel reaches .5 barg .then direct horizontal line is steamed. Dip pipes: Dip pipes are steamed downward; steam should be supplied in both inside and out side the valve. Side inlets: In up configuration when vessel is steamed valve A & B are open and C is closed . The transfer line is steamed with valves A & C opened ,B closed. in down configuration valve F & D are open ,E is closed during vessel sterilization .then valve F act as steam supply for sterilization of transfer line.

VALVE CONFIGURATION FOR STEAMING SIDE INLETS

TRANSFER LINE TO VESSEL

C
A

B
E

F D

STEAM

UP CONFIGURTION

DOWN CONFIGURATION

Vessel outlet valve configuration

During sterilization of vessel ,valve C ,A & F are open and B ,D & E are closed. during cleaning of vessel A ,C & E are open and B ,D & F are closed

Steam in
Sterile steam to other equipment A B C E D F

Drain/CIP return

Spray balls must be sterilized with the vessel . Vessel outlet should be at the very lowest point for proper drainage.

Other equipment for sterilizing

Air filters-most modern air filters are of the membrane type. the membrane are hydrophobic they repel and shed water. there should be a steam trap on both side of the filter. Medium filters-their sterilization is of less of problem than above. Valve and piping-diaphragm valve is commonly used.

Validation of sterilization

1. 2. 3.

Directly using media Indirectly using temp and pressure requirements: Internal temperature probe External thermocouples fixed to surface Hand held surface contact thermometer

AUTOMATION

Automation is expensive and time consuming but it reduces labor required and improves process reliability. The control of system is performed by computer. Computer must check that when it ask the valve to open or close the valve actually do so. it can also be used for ph ,temperature etc.

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