The Context
A Bengaluru-based generic pharmaceutical manufacturer, specialising in injectables, ophthalmic products, and capsules, faced persistent obstacles on its path to serving regulated export markets such as the United States. Before ZETA’s engagement, the client’s production was managed using legacy systems. Unfortunately, the previous equipment procured from another vendor resulted in non-compliance with critical standards, including cGMP, ASME BPE, and US FDA requirements, which hindered the company’s eligibility for export and regulatory review.
These compliance challenges were further compounded by regular software failures that disrupted manufacturing and formulation activities. As many of the plant’s components were imported, the company frequently found itself without easy access to essential spares, resulting in prolonged downtime. Coupled with outdated automation, these issues made it increasingly difficult to integrate emerging production technologies or scale efficiently.
Faced with these constraints, the client set an ambitious target to achieve a fully compliant and validated capacity expansion within just five months.
The ZETA Solution
Recognising that every manufacturing process is unique and that standard solutions would not suffice, ZETA India developed a fully customised manufacturing and formulation system for the client. All equipment was engineered to meet the ASME Pressure Vessel Code, ASME BPE, and 21 CFR Part 11 standards, with Siemens DCS-based controls providing a consistent and scalable backbone.
Use of Digital Tools and Modern Engineering
Digital tools played a key role throughout, as the project relied extensively on process simulations, digital twin modelling, and three-dimensional layouts devised in AutoCAD Inventor. This approach enabled ZETA and the client’s technical team to virtually model the site, anticipate integration issues, and ensure a smooth installation.
Project Execution and Outcome
The commissioning and qualification phase followed a rigorous process. After mechanical installation and utility connection, ZETA undertook systematic calibration followed by Installation Qualification (IQ) and Operational Qualification (OQ), confirming that the system performed exactly as designed and satisfied all regulatory requirements. Protocols, test plans, and acceptance criteria were built around ZETA’s internally standardised procedures, each reviewed and approved by the client before the project moved forward.
Despite a long lead time in procuring certain components, ZETA’s close coordination and detailed project management meant the facility was still delivered on time. The end result was a facility equipped to meet international compliance and ready for production within the designated schedule.
This transformation delivered tangible benefits, including:
- Full regulatory compliance for export markets
- Enhanced operational reliability, minimising risks of failure and unscheduled downtime
- Improved access to spares and technical support
- Modern automation and integration, creating a robust foundation for future expansion
Key Success Factors
The project’s success can be attributed to several key factors which played a crucial role in ensuring the project met its objectives while exceeding expectations in terms of quality and performance.
1. Timely Design and Engineering Coordination
- Early finalisation and approval of 3D models reduced design cycle time.
- Fabrication and part drawings were released on schedule, ensuring a smooth transition from design to production.
- Continuous coordination between the design and fabrication teams minimised revisions and rework.
2. Efficient Material Management
- Material ordering and procurement clearances were obtained on time.
- Critical items, such as weldable fittings, connectors, and piping valves, arrived as scheduled, thereby avoiding idle time during fabrication.
- Close coordination with suppliers ensured zero material shortage during peak production.
- Long lead items were arranged by the purchase team on time.
3. Parallel Execution Strategy
- Vessel fabrication and piping/skid fabrication were carried out in parallel to optimise overall project duration.
- Teams worked in coordinated shifts to align assembly activities with fabrication progress.
4. Resource Optimisation
- The project’s success was driven by the effective utilisation of the 3M principle. The balanced coordination of man, material, and machinery contributed significantly to the project’s fast-track success.
- Both vessel and piping teams jointly reviewed the available machinery, workforce, and fabrication bays.
- Additional resources were mobilised in advance, where required, to maintain schedule adherence.
- Cross-functional support between departments improved productivity and eliminated bottlenecks.
- Timely decision-making on all technical matters by the design and project teams enabled quick resolutions and eliminated bottlenecks.
Through proactive coordination, effective resource management, and timely decision-making, ZETA India demonstrated its ability to deliver complex manufacturing projects within a compressed schedule while maintaining high-quality standards and customer satisfaction.
Client feedback
The client, reflecting on the project, praised ZETA’s responsiveness, technical capability, and the positive impact of digital engineering and project planning. ZETA’s intervention not only resolved immediate operational difficulties but also established a new standard for compliance and reliability, positioning the company strongly for its next phase of growth.
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