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12/21/2010

Clean-in-place Automation: Ensuring Efficient and Effective Cleaning Validation
By: Piyush Dewangan

Pharmaceutical manufacturing facilities are moving towards multi-purpose facilities, capable of producing diversified range of products instead of having dedicated product lines. This results in smaller batch sizes and increased changeover requirements. The manual procedure is time consuming and poses a major challenge in reducing the batch cycle time. The cleaning cycle time, which generally ranges between 30-40 percent of the processing time and sometimes more than 50 percent of the total processing time, adds additional challenges besides others, such as maintaining quality and adhering to regulatory compliances. Thorough cleaning is of paramount importance to eliminate cross-contamination and ensure quality of the drug products. Automation of cleaning process helps pharmaceutical companies to overcome such challenges. Clean-in-place (CIP) automation systems are available as either a semi-automatic or a fully automatic system with programmable logic controller (PLC). The system consists of multiple balance tanks, sensors, valves, heat exchangers, chemical feed equipment, spray nozzles, data acquisition systems, and such others. A well designed CIP system helps in minimizing the cleaning cycle time while ensuring significant improvement in the cleanliness and hygiene of equipment. The performance of cleaning activities largely depends on measuring and controlling the critical parameters. It is important for a plant manager to use appropriate amounts and type of chemicals, and ensure that those chemicals are removed completely before the next processing to prevent contamination. Contamination can be with active ingredients, unintended materials or compounds, or it could be microbiological contamination. Inappropriate cleaning or failure to prevent cross-contamination or adulteration may cause serious problems, which can harm the subsequent batches of pharmaceutical products in terms of safety, efficacy, quality, and other parameters. Additionally, ineffective cleaning may result in scraping expensive materials as waste and result in regulatory action. In case of equipments that require microbiological cleaning, a sterilizing-in-place (SIP) cleaning process is required for sanitizing or sterilizing them. The cleaning process automation with clean-in-place (CIP) technology enables tracking of all cleaning procedures, helps in maintaining highly hygienic conditions, and ensures repeatability of processes. The CIP cleaning process involves multiple rinses with water, weak acids, weak bases, various detergents, and other cleaning agents. An automated CIP technology facilitates cleaning interior surfaces of pipes, vessels, process equipment, filters, and such other equipments without disassembling. It helps in reducing the downtime between product run and changeovers, and facilitates improved safety and repeatability with reduced human error. A well-designed automatic CIP system is permanently fitted with several cleaning equipments. This facilitates reduced waste time, efforts, damages, deterioration due to transportation, and handling of equipments prevalent in case of manual cleaning system. Automating the cleaning process enhances the effectiveness of cleaning with automatic and controlled supply of cleaning solutions, detergents, and water. This enables appropriate balance in terms of time, temperature, concentration, pressure, and hydraulics which results in improved cleaning performance. Sometimes increase in temperature can enhance the effectiveness of the cleaning process, which is normally achieved by applying thermal energy of cleaning solutions, and chemical energy of detergent or solvent used. The objective is to maximize safety by eliminating cross-contamination, minimizing cleaning cycle time, reducing changeovers, and such others. It not only increases the plant utilization, but also results in significant savings due to reduced labor-hours, recycling of cleaning agents, and increased environmental protection. The automatic clean-in-place system facilitates easy and successful cleaning validation by satisfying several validation parameters, such as proper cleaning process, equipment, cleaning agent, cleaning techniques, number of cleaning cycles, time frame for validation, and others for ensuring regulatory compliance. ARC welcomes your opinions regarding clean-in-place system deployment, its usefulness, limitations, and such others that could host further discussion on this topic. Please write to pdewangan@arcweb.com.