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Nov 21, 2012

Clean-in-place (CIP) technolog ies improve cleaning processes and increasecritical equipment uptime. An e fficient cleaning cycl e begins with equipmentand auto mation s ystems desig ned to ensu re suc cessful cleaning.

Equipment design Tank and piping design should be reviewed for sanita ry cleanability, asdescribed in section SD-3.1 of the American Society of Mechancial EngineersBioprocessing Equipment standard (1). This design may include: minimizingdeadlegs; verifying pipes are sloped towar d a drain; checking for low-pointdrains, sanitary connections, and valves; a nd verifying that all product-contact surfaces are accessible to cleaning solutions.

The next step in the cleanability review is to create a preliminary design offlow paths for CIP circuits. Segments of equipment and piping should beproperly separated and/or combined into different cleaning circuits as part ofa preliminary design. Important considerations include process and schedulerequirements, potential residues, and piping design.

Process and schedule. Knowledge of the equipment’s use can provideinsight on process hold or transfer times. Transfer lines and tanks may needto be chained together into a single CIP circuit for quick equipmentturnaround to meet these demands. Clean and dirty hold times may alsoaffect equipment scheduling and cleaning requirements.

Residues. Characterizing residues through cleaning studies and identifyingassociated product-contact surfaces aid in parameter development. Certainresidues may require different cleaning solutions, concentrations, andtemperatures for suitable cleaning to occur. This analysis can help organizecircuits by common cleaning parameters.

Piping design. Available transfer panel connections may limit thecombination of certain transfer lines and tanks. The user should account forline sizes and lengths as major pressure drops may decrease flow andturbulence within the pipe. Additional pumps and other spool pieces may berequired within the system. Caution should be exercised in these cases tominimize manual configuration steps and reduce the risk of setup errors.Finally, the user should consider the availability of low-point gravity drainsthroughout the CIP circuit. Gravity drains remain critical for efficient CIPcycles.

Automation-system design The cleaning automation design should also be reviewed for efficient cleaningcharacteristics. Developing cycles and sequences that complement aparticular automation-control system greatly reduces long-term operatingcosts. For instance, a fast response, direct-action, process-logic controller(PLC) may minimize rinse times and water consumption by toggling through

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Designing a Cl ean-in-Plac e SystemAn efficient cleaning cycl e begins with equi pment andaut o mati on-system desig n.

By Cody Shrader , Andrew WongEquipment and Processing Repo rt

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every auxiliary path on a complex bioreactor quickly enough in parallel withthe sprayballs while not extending sprayball coverage test durations. Incontrast, the path-transition time within a distributed-control system (DCS)depends on its programming style and may require several layers ofequipment module (EM) and sub-EM commands before finally reaching thetarget control modules (CMs). Only after waiting for valve and stateconfirmations can the next step begin. Here, creating a cycle that combinesmultiple transitions into a single grouping will result in the shortest and mostcost-efficient cycle possible. Combining cleaning actions (e.g., rinse, drain,and air blow) within phases also reduces the cycle duration. In contrast, astrategy of using more modular, individual phases may elongate the cycle.

Various time and cost-reducing methods must be balanced with skidequipment capability. For example, one may be able to take advantage ofintegrated PLC capabilities of equipment (e.g., vendor-provided PLC-basedcentrifuges). These design considerations must be identified early in theproject to ensure that quality and validation procedures can be developed toaddress the sampling, instrumentation, and verification requirements beingbuilt into the CIP and recipient systems.

For the CIP cycle itself, the automated step sequencing, step-transitioncriteria, and parameter values must be well defined and documented tooptimize utility usage while providing sufficient process control.

Sequence. Typically, a cleaning cycle should start with water rinsesfollowed by detergent cleaning and post-detergent rinses. In between anyrinse or detergent wash, the system should be drained completely to prevent

dilution or chemical reaction with the next cycle step. An air-blow step, placedbefore the drain, can greatly decrease the gravity drain time and thusdecrease the overall cycle time.

Transition criteria. Defining step-transition criteria provides a way tocontrol the critical cleaning-cycle parameters. For example, the chemical-wash duration, minimum temperature set point, and concentration target canall be set as requirements before the wash step transitions to the next step.

Parameter values. Laboratory-scale process residue cleaning studies canprovide an excellent starting point for CIP cycle parameters. Scalableattributes such as cleaning-agent concentration, process temperature,exposure time, and external energy can be explored within the cleaningdesign space to isolate the most critical parameter(s). Combined with anevaluation of the most effective cleaning agent and identification of worst-case residues in the process, these laboratory-scale efforts can dramaticallyreduce the number of cycle i terations that must be performed duringcommissioning and allow for a focus on improving efficiency.

Reference

Andrew Wong and Cody Shrader are senior engineers at Hyde Engineering +Consulting, Boulder, CO, [email protected].

1.The American Society of Mechanical Engineers, ASME BPE- 2009, Bioprocessing Equipment . (New York, NY, 2009).

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designing a clean-in-place system _ pharmaceutical technology

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