12/08/10 PAAN Pharmatech Engineers Pvt.Ltd. 1

Clean In Place (C.I.P.) Technology

PAANPharmatech

engineers pvt ltd

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What exactly is CIP ?

• CIP is the process used to ensure that process reactors,vessels and lines are free of organic and inorganic contaminants

Critical cleaning applications in the bio-pharmaceutical industry which demand CIP are :• Vaccines• Human insulin• Serums• Plasma fractions• Bacteria and cell cultures

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Applications of CIP

Cleaning of • Fermentors• Media Vessels• Harvest Vessels• Storage Vessels• Transfer Lines• Process

Equipment

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Distinct Advantages of CIP :

• Validatable process for cleaning of process equipment

• Lower Facility Operating Costs• Minimal dismantling of equipment and

piping• Reduced turnaround time for cleaning• WFI requirements for cleaning reduced

significantly• Exposure to hazardous activities or

entry into tanks,is eliminated

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CIP v/s Manual Cleaning• Clean in Place Technology

involves the use of chemicals, high pressure pumps, spray balls and aseptic design principles to ensure that large scale processes are appropriately free of dirt, organic contaminants and micro organisms.

• Automation is another essential element of the modern CIP process.

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• The need for properly automated procedures is necessary to reduce human errors, which can have disastrous consequences on process. However, some companies still have a manual cleaning component in their CIP procedures.

• The terms CBM (clean by mop) or CBB (clean by brush) are often half jokingly used to describe these processes.

• Manual cleaning can be unsafe and the level of cleaning is typically much less effective, consistent and Validatable as compared to a fully automated CIP procedure.

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Effective Cleaning Criteria Factors include :

• Cleaning Cycle Time• Cleaning Agent and Temperature• Concentration and Chemistry of the

Cleaning Agent within the circuit• Degree of Turbulence of the Cleaning

Solution• Characteristics of the surface being

Cleaned• Spray Device Selection ( Static or

Dynamic )

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Benefits of using NaoH for cleaning and sanitising process media :

• Efficacy• Low Cost• Ease of Detection,Removal,Disposal• Effective in removal of Proteins,Nucleic

Acids• Effective for inactivating most

Viruses,Bacteria,Yeasts,Endotoxins

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The CIP Procedure

There are a number of steps involved in a full cleaning and sterilizing CIP process. These are as follows :

• Soft water wash at 60° to 80°C.

• Alkali wash at 60° to 80° C.

• Neutralising wash at Room Temp.

• WFI wash at Room Temp.

• WFI final rinse at Room Temp.

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Process Control The CIP Module is activated by a

Touch Screen based PLC with the following unique features

• Completely Automated Process Cycle

• On line display of process parameters

• Fault messages displayed• Restarting of cycle from the same

stage where stopped, due to power failure or fault

• Printing of process parameters• Once the user configurable cycles

are set and validated, a supervisory access code allows prevention of unauthorized changes

• Supply pump, return pump provided with auto draining system

• On Line pH,Conductivity Sensing

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• P & I Diagram of System

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Validation Documentation  CIP Module

• Manufactured by : Adam Fabriwerk• Client : • Date : 28 / 01 / 02• Time : 13:13• Vessel No : 6• Recipe No : 01 • Operator Name : ERIC • Operator Password : ******• Manager Password : #####• Parameters Set Value Actual Value• Wash Cycle Temperature 80 C 81 C• Wash Cycle Time 180 S 181 S• Alkali Cycle Temperature 80 C 82 C • Alkali Cycle Time 180 S 180 S • Alkali Cut Off pH 11.0 11.1• Acid Cycle Temperature RT 33 C• Acid Cycle Time 180 S 182 S • Acid Cut Off pH 07.0 07.2• WFI Cycle Time 180 S 180 S• Conductivity After Final WFI Rinse 0.4-0.6 0.6• Process Status COMPLETED

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