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Client Profile: Cipla, incorporated in 1935 and headquartered in Mumbai, is a leading global pharmaceutical company, dedicated to high-quality, branded and generic medicines. The company manufactures 1500+ products across various therapeutic categories with 50+ dosage forms. Cipla’s state-of-the-art manufacturing facilities are cGMP compliant in conformity with national and international standards. With a presence in over 80 countries, the company has over 25,000 employees.
Background and Requirement: The pharmaceutical industry is in transition, faced with increasing competition, reducing prices, and patents that are fast reaching their expiry dates. The industry must adhere to stringent regulations that define quality and processes, while advances in healthcare services are pushing pharmaceutical companies to produce diverse products and develop new therapies. The key to success for the industry is therefore in automation of the manufacturing processes allowing production of different batches for specific patient requirements.
In its state-of-the-art facility in Kurkumbh, Maharashtra, the company produces bulk drug active pharmaceutical ingredients (APIs) for a wide range of therapeutic applications that include oncology, anti-diabetic, anti-ulcer, anti-infective, and anti-retroviral (HIV/AIDS) treatments. The design of processes for manufacturing APIs is cost-intensive and time-consuming. Cipla’s objectives were to achieve efficient facility design; streamlined project runtimes; shortened development cycle; and optimized processes; all of which will minimize time-to-market while keeping productivity high. Taking a step further in innovation, Cipla launched an initiative to drive automation solutions across all API manufacturing facilities for various critical operations like reactor automation, solvent dispensing, crystallizer reactor automation; and acquisition of various data, critical to process parameters. To enable this transition and meet their objectives, Cipla selected Process Automation Solutions from Siemens India’s Process Industries and Drives Division.
Solutions Deployed: The solution included supply of engineering and commissioning of automation panels and HMIs suitable for hazardous areas, as well as supply, management, and on-site installation services; laying of cable trays and signal and communication cables; installation and calibration of field instruments; integrated engineering, simulation, and cloud-based solutions. This complex system of cyber-physical machines is controlled through Siemens’ DCS-SIMATIC PCS 7; this helped Cipla to migrate from batch manufacturing to continuous manufacturing by establishing one of the first flow chemistry-based API production systems in India.
Tangible Benefits: Siemens is continually developing its portfolio of products and solutions so that their pharmaceutical customers can benefit from digitalization and strengthen their competitive positions – whether through integrated engineering, simulation, or cloud-based solutions. Siemens’ innovative solutions deployed by Cipla helped them in multiple ways ranging from quality control and regulatory compliances (21 CFR Part 11 for US Food and Drug Administration and other regulatory approvals) to flexible plant manufacturing. Cipla was able to significantly reduce wastage, lower energy and utility costs, and shorten time-to-market, while increasing operational safety and ensuring better quality.
Keywords: Siemens India, Cipla, Active Pharmaceutical Ingredients (APIs), Regulatory Compliances, ARC Advisory Group