Ing. Gustavo Ivan Cano Lugo

Responsible for a team of five mechanics and two supervisors, in charge of supporting the production lines for soft gelatin, tableting, granulation, coating, sachet filling, and liquids. Manages CAPEX budgets, annual equipment expenses, and training programs for operational and maintenance personnel. Handles CAPAs, change controls, deviations, and risk analyses, as well as maintenance KPIs. Oversees relationships with national and international suppliers such as IMA, FETTE, SINOTEK, BICOR, RASCH, and SKY SOFT GEL. Controls and administers computerized systems for production equipment in compliance with CFR 21 Part 11 and GAMP 5. Manages team needs, including work tools, with extensive knowledge in handling compression punches. Versatile, disciplined, and professional, with humility and teamwork as the foundation for success and growth. Participated in the start-up of new solid, liquid, and soft gelatin lines, including the installation of process equipment, performance qualification, installation, operation, and design, as well as validation of processes and computerized systems. Extensive interaction with national and international suppliers and participation in multidisciplinary teams for product transfers.

Specialize in implementing Total Productive Maintenance (TPM) strategies to optimize the performance of production machinery in manufacturing and packaging. My experience covers critical processes such as tablet pressing, blistering, and granulation, working with renowned brands like Uhlmann, Fette, Courtoy, and Glatt. Through comprehensive practices including Cleaning, Inspection, and Lubrication (CIL), ensure operational excellence of the machinery. Additionally, excel at performing precise operational adjustments to improve overall efficiency and maintain the highest productivity standards.

Provided crucial support to production operations by offering expertise in machinery, operational adjustments, and the execution of a comprehensive Preventive Maintenance plan. My role included leading the implementation of Total Productive Maintenance (TPM) and Predictive Maintenance strategies, particularly on production lines using renowned brands such as Marchesini, Universal, Laetus, Domino, and Bergami carton machines. My efforts contributed to optimizing machinery performance, reducing downtime, and ensuring smooth operations in line with the highest industry standards.

Provided comprehensive technical support, including installation, calibration, preventive and corrective maintenance, as well as training, for various models of Fette tablet presses such as 1200i, 1200, 2200, 2200i, 3090i, 3090, 1090, 2090, 2090i, FE75, FE55, FE35, and the related WIP series. Additionally, provided support on Uhlmann lines, specifically the Blu 400 line, ensuring optimal performance and operational excellence.

Involved in the creation and adjustment of Preventive and Corrective Maintenance programs, as well as machinery adjustments for production areas including Granulation, Coating (Film Coating), and Tablet Compression. Developed and successfully executed Preventive and Predictive Maintenance programs, performed equipment failure analyses, and participated in Factory Acceptance Tests (FAT) in Münster, Germany, with the company Lbb (Bohle). Installed Granulation, Coating, and Tablet Compression equipment from various manufacturers such as Fette, Bohle, and Glatt. Responsible for the maintenance of Tablet Compression Lines, including models 2090I, 2090IC, 3090I, and FE 75. Managed the transfer of production recipes for Tablet Compression, Coating, and Granulation processes. Prepared Operation and Maintenance Procedures for various equipment, including Zanasi Encapsulators; Fette 2090, 2090i, and FE 75 tablet presses; Pellegrini Coating Pans; Bohle 400 and 200 Coating Pans; and Glatt WSG 300 and WSG 200 Granulators. Operated equipment such as PMA 800 Vertical Granulator, Glatt 120 Granulator, Pro Glatt WSG 120 Granulator, Container Discharge Stations, Glatt 200, TOTE Container Washer, Fette 3090i, 2090IC, 2090i, and FE 75 Tablet Presses, Pellegrini Coating Pans, Zanasi Encapsulator, Glatt WSG 300 and WSG 200 Granulators, VG 600 Vertical Granulator, Servolift Mixing Columns, Servolift Mixer, Glatt CM 2000 Mixer, Bohle 200 and 400 Perforated Coating Pans, Glatt GSE 200 Sieve, and Glatt LD 200 Mixing Column. Provided support during Internal and External Audits, including EMA, FDA, and Walmart. Successfully closed CAPAs and managed Change Controls. Collaborated with the Validation and Projects departments, participating in the integration of new equipment into Production and Service areas.

Performed daily, weekly, quarterly, semiannual, and annual maintenance routines according to the plant’s scheduled service. Assisted in the operation of sterilization autoclaves, applying Total Productive Maintenance (KAIZEN) principles. Hired for the installation of two GETINGE autoclaves.

Performed Preventive Maintenance on production machinery, including ampoule filling machines, labeling, tablet presses, blister packaging, cartoning, and bottle washers. Conducted Corrective Maintenance and Operational Adjustments of machinery, as well as maintenance of the Service Area: UMA units and effervescent equipment. Managed Work Orders and the Preventive Maintenance schedule. Oversaw supplier management and supervised maintenance personnel. Machines Managed: Marchessini MB 441 Blister Machine, Marchessini BA 400 Cartoner, Aeromatic 100 Drying Ovens, Marchessini PA 300 Cartoner, Divago 6X/8X Packing Machines, Strip Packing Machines, Stokes and Cadmach Tablet Presses, Uhlmann Blister Machines. Direct Supervisors: Ing. Gerardo García López / QFB. Mónica Martínez.

Executed the Preventive Maintenance Program on production machinery, including semi-solid filling machines, coders, bundling machines, sachet machines, and pumps. Performed Corrective Maintenance and Operational Adjustments of machinery, managed work orders, maintained logs, and controlled the Preventive Maintenance schedule. Machines Managed: Mar Liquid Fillers, Arenco Ointment Fillers, Hapa Coders, Serpack Sachet Machines.