Principles of CIP
The underlying principle of CIP is to remove undesirable actives and chemicals from product contact surfaces by mobilizing the soils away from the surface and into a suspension or solution. The mobilization occurs by flowing or spraying rinse and/or detergent solutions over the surfaces to be cleaned, achieving a combination of impingement and cascading surface action and solubility. CIP generally refers to automated systems consisting of spray devices and cleaning agent delivery controlled via HMI/SCADA.
CIP Defined
CIP is the removal of undesirable actives and chemicals from product contact surfaces in their process position, without the need for disassembly to obtain access to the surface being cleaned. Those components that cannot be cleaned in their process position by CIP are removed from the equipment for COP according to procedure. In most cases CIP uses aqueous-type rinse and detergent solutions. In some API processes, volatile solvents are required as a CIP solvent.
CIP-Cleanable Processes
Process equipment needs to meet specific criteria for design, fabrication, MOC, installation, inspection, and maintenance to be suitable for CIP cleaning.
Processing equipment and piping systems that are cleaned in place show less wear and tear (and damage) than comparable items cleaned manually. With automated CIP, the labor required for cleaning and maintenance is reduced and the processing system productivity is increased through a reduction of downtime. At the same time, reproducibility increases as automation replaces manual cleaning procedures.
While CIP-cleanable process equipment is important, substantial experience has shown that successful CIP implementation involves far more than the selection and application of CIP-cleanable components such as pumps, tanks, instruments, valves, etc. The design of a cleanable process requires the consideration of unit operation processing, equipment design conducive to CIP cleaning, process equipment layout, and the interconnecting piping design for the process to provide for proper cleaning via the configuration into CIP circuits. Specialized CIP systems may be required.
CIP is applied to various pharmaceutical processes both for liquid (biotechnology, parenteral solutions, IV solutions, blood fractionation) manufacturing equipment and solid (Drug Substance (DS), DP) manufacturing equipment. Liquid CIP equipment includes tanks, filters, and centrifuges; whereas solid CIP equipment comprises, for example, fluid bed driers, and apparatus for crystallizing, filtering, drying, milling, blending, and bulk container filling.
CIP Systems
The CIP system is a packaged system of properly integrated components typically including tank(s), pump(s), heat exchanger(s), chemical feed equipment, valves, instruments, and system controls. This system is designed to provide automatically controlled spray cleaning operations of storage tanks and processing vessels and pumped recirculation washing of product transfer piping systems. The integrated system makes it possible to achieve complete and uniform control of the TACT key factors.
Practical field experience reveals that it is most commonly easier to pump water into process tanks than to get it back to the CIP system through CIP return. For a two-pump system, rinse and detergent wash solutions must be continuously removed from a vessel being spray cleaned at a rate equal to the solution supply to ensure the return pump does not cavitate. Inconsistent CIP return conditions create commissioning and validation challenges as TACT factors such as surface cleaning action, chemical solution concentration, and cycle time become unreproducible.
Based on process design, facility layout, project budget, and other considerations, the engineer decides on the optimum configuration for CIP return conditions.
Read also: Four Key Factors to be Fonsidered for Cleaning Validation