2024 ISPE FOYA Category Winner – Honorable Mention | ISPE | International Society for Pharmaceutical Engineering

Zydus Pharmaceuticals

Location: Ahmedabad, Gujarat, India
Project: Oral Solid Dosage (OSD) Manufacturing Facility

Zydus Pharmaceuticals Ltd. is a subsidiary of Zydus Lifesciences Ltd. (Formerly Cadila Healthcare Ltd.), a leading Indian Pharmaceutical company with origins dating to 1952.

The new greenfield cutting-edge OSD manufacturing facility is 100 percent dedicated to United States exports of OSD products and built on the concepts of agility and economies of scale. It comprises two production blocks: Small Volume (Cheetah – Agility) and Large Volume (Elephant – Economies of Scale). The Small Volume Block has a conventional horizontal design with wide variety of manufacturing capabilities including wet/dry granulation, top spray, bottom spray, capsule and sachet filling, imprinting, blister, and bottle packing with flexibility to accommodate products with different manufacturing processes and catering to wide range therapeutic categories. The Large Volume Block has an unconventional and innovative design catering to high volume products, with larger batch sizes with an installed capacity of 6 billion units per year.

Large Volume Manufacturing Block plant strives to be the lowest cost producer globally for patient affordability, using latest technologies and high volume as a lever to achieve economies of scale. The facility has a four-floor unidirectional vertical material flow design, equipped with two fully automated integrated closed system trains from material charging to final packaging, to avoid human intervention. Each is designed to handle high material volume with an integrated 1.8 kiloliter integrated granulation line followed by an 18 kiloliter Glatt bin blender (one of the largest blenders available), two Fette compression machines with segmented turret technology (allowing for 110 stations – largest commercially available), an O’Hara continuous coater (1,200 kilograms per hour throughput), and a fully automated 360-degree Sensum tablet inspection machine. The central packaging area consists of three 200 bottles-per-minute high speed CVC Technologies bottle packaging lines.

To ensure smooth and fast material transfer at this scale, “Dense Phase Transfer System” was installed for the first time in the pharmaceutical industry. This system can transfer 600 kilograms of material in 15 minutes, able to handle batch size of ~6 million tons (~ 6 million to 50 million tablets). Blenders are equipped with process analytical technology (PAT)for online blend homogeneity. To reduce material loss, a seamless material handling system uses Matcon cone valves and gentle transfer chute (GTC) Technology. Automated wash-in-place (WIP) systems in all equipment ensure no cross contamination for improved cleaning and water conservation.

The facility is equipped with AI-enabled robots for material transfer and floor cleaning. The warehouse has a storage capacity of 12,870 pallets with an integrated warehouse management system and fully automated storage retrieval system (ASRS), which delivers materials up to fourth floor at a height of 32 meters. It will deliver one of the fastest manufacturing turn-around time of five days from dispensing to packaging, with a significant reduction in number of batches.

The Zydus OSD project focused on process innovation and automation to scale up, reducing costs and turn-around times. It is for those reasons it has been recognized with an Honorable Mention for the 2024 ISPE FOYA Program.