The Green, Clean and Lean Approach to Cleaning API Equipment

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1 The Green, Clean and Lean Approach to Cleaning API Equipment By: Albin J. Friedrich Project Manager - Mork Process Inc. Traditional Clean-in-Place (CIP) technology has its shortcomings: its labor intensive, results in unproductive downtime, and often wastes resources. For many industries, traditional CIP methods remain unable to respond to their necessary cleaning needs and requirements. MORK Process, Inc. is advancing CIP technology by reducing important measures such as cost, down time, and resources needed. Our case study describes how MORK has developed a leaner, greener approach to CIP and successfully introduced it within the Active Pharmaceutical Ingredient (API) industry. MORK s automated and totally controlled cleaning technology, uses less labor and time and greatly reduces utility usage with environmentally friendly results. Moreover, the MORK CIP Process delivers measurable results. Our innovative process allows for quick turnaround, getting labor and equipment back into service for production, faster and safer coupling competitive advantage with environmental responsibility. Background A common reactor system found at and API producer will consist of several reactors, receiving vessels and associated equipment such as condensers and transfer piping. The reactor components such as the condenser, dip tubes, transfer lines, etc. are all interconnected. Traditional cleaning Traditional cleaning of this system involves an initial wash-down step utilizing an initial cleaning agent such as Micro 90 along with 4,000 gallons of purified water. This mixture fills into the reactor, boils into a vapor and then dumps into a holding area for hazardous disposal. The next step utilizes over 2000 gallons of purified water with HCL for another fill/boil cycle. Finally, 4000 more gallons of purified water, along with over 400 gallons of methanol, are needed for the last segment of the cleaning. Some of the challenges and shortcomings are: Ineffective and inconsistent cleaning often leading to yet more increased downtime and an additional cleaning cycle The presence of hazardous vapors resulting in a potential risky environment for personnel Large utility requirements Excessive disposal costs Environmentally negative operations that may no longer be sustainable New CIP Technology Modern day cleaning equipment offers flexible, efficient technology for cleaning many types of process equipment. These CIP systems are portable units with the ability to run automated, validated recipes for repeatable cleaning of all components. A typical CIP skid will contain a single buffer tank, a high pressure pump, cleaning agent modules with dosing pumps, instruments and an easy-to-use control system for performing specific recipes; each written to minimize cleaning time and required utilities. The control system will monitor all-important parameters and produce a cleaning report at the end for batch recording purposes. Typically, in the API environment, the CIP system will be an explosion proof rated unit, due to the nature of the area.

2 The cleaning of the reactor systems will involve a top down cleaning approach. All the transfer lines from one floor to the next are utilized for CIP flow path, since these must be cleaned anyway. The CIP unit will direct water through a series of valves that will each operate for a specified amount of time. The first zone will typically be the top condenser zone. The second zone will be some associated piping lower down on the system. Other intermediate zones may include the dip tubes or sub-surface addition lines. Finally, two rotary jet head spray devices will be operated independently inside the main vessel for overall cleaning. These two devices are mounted high and low in the reactor for effective coverage. Agitators inside the reactor are run at a slow speed to expose all surfaces to the impinging water streams. Shadow effect areas do receive coverage since the impinging water streams have enough energy to reflect off the vessel walls and thoroughly clean behind blind spots. The cleaning recipe will involve optimal use of the TACCT concept (time, action, and temperature). By utilizing elevated temperatures and cleaning pressures, the overall time and cleaning agent concentration can be significantly reduced. Additionally, environmentally friendly cleaning agents (which can be directed toward the drain) are utilized. The control system utilizes the S88 programming concept, perfect for the batch operated cleaning systems. This control system is in line with the FDA s 21st century initiative of PAT - in line monitoring and continuous process improvement through immediate feedback and adjustment of critical cleaning parameters. Case Study / Empirical Data: The case study below is actual data from a system that has been installed for nearly two years at an API producer on the East Coast of USA. Prior to the CIP system, the API producer was cleaning all the systems manually with the reflux method. Reactor and receiver tank sizes average between 750 gallons and 3,000 gallons. Reactor tanks were constructed from Hastelloy and several were glass lined. Cleaning requirements for both were identical. The API plant operated 24hrs/day 7 days per week. The largest negative cost for cleaning was the downtime of the vessels. Commonly, cleaning was a 5-day process. Analysis of the performance over the course of a year shows the benefit of the CIP system (tables based on monthly cleanings). Additionally, new CIP technology offers many other unrealized cost savings: Safety of personnel operators are no longer moving, transferring, sampling, and dispensing hazardous materials such as HCL and methanol. The commercially available CIP cleaning agents are available in a 5-gallon container that is neatly and safely dispensed from the CIP unit. Environmental impact and public image from a green perspective a largely variable cost with vastly differing monetary and perception values. Although the former cleaning method was handled in an environmentally responsible manner, waste presented and issue. New CIP cleaning residue can be directly sent to the drain. Introduction of in-line monitoring and automated approval QA personnel are no longer required for lengthy sampling. The new CIP systems monitor the quality of the rinse water and produce cleaning reports instantly. Reallocation of personnel Once the CIP system is connected and running, personnel are available for value added tasks since the process is now fully automated. Utility costs no energy necessary to boil 12,000 gallons of water and several thousand gallons of Methanol. Consistent, high quality cleaning results are achieved. There is no need to repeat the cleaning cycle.

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5 Conclusion Substantial cost savings from API producers can be realized by utilizing new CIP technologies. Traditional cleaning using only static spray balls with flow and time of water and chemicals will not result in the savings or quality of clean identified above. In order to realize these benefits, CIP equipment must manage the entire TACCT cycle, particularly pressures, in developing cleaning recipes. By eliminating the manual cleaning and reflux methods, tremendous savings are realized through increased availability, reduced cleaning agent costs and substantial water savings. Moreover, the greener approach to cleaning issues in both the private and public eye offers a largely variable cost savings with vastly differing monetary and perception values.