Case Study and its Solutions

Title: Optimizing Drug Development Process through Digital Transformation

Client: - Pharmaceutical Manufacturer

Background:-

A leading pharmaceutical research and development company, faced challenges in streamlining their drug development process. The traditional methods were time-consuming, resource-intensive, and lacked efficiency. The company sought to leverage digital technologies with integration of PLC, HMI and SCADA to enhance collaboration, data management, and overall project efficiency.

The existing process was totally manual and dependent on Operator for manufacturing. We designed the system logic in fully Automatic process where there is least involvement of Operator and gave them report for every activity during process.

Challenges:-

Fragmented Data Management: Data was scattered across various departments and systems, leading to inefficiencies in information retrieval and collaboration.

Processes Prerequisites: To start the process multiple departments need to give approvals or have to be ready within the plant.

For example:-

            PW water supply should be available adequately during the process.

            Steam/Air to be available at the time of process.

Communication Gaps: Communication barriers existed among cross-functional process having multiple interlocks.

Display and Pop-ups: Lack of visual errors and confusion when the system is stopped.

Process and Batch Tracking: No data was stored, so there was no record/tracking of any batch or process.

Redundancy: - In-case of PLC Failure the system went into breakdown till the hardware availability is confirmed and hardware is delivered.

Solution:-

Step 1 :-

Analysis of grey areas and understanding of exact requirements of the customer.

Design system architecture with selection of suitable controller and Hardware.

Initiate with HMI and SCADA designing with reference to P&ID provided by End-user.

Ask End-user to provide final Report format for report generation.

Step 2 :-

List out the process needs to be implemented with suitable interlocks if there are any cross-functional process simultaneously running.

Defining Add-on blocks for the similar process in the logic and testing.

Step 3 :-

Used same Controller (PLC) with redundancy so that if primary PLC is into error of in hardware failure fault, secondary PLC takes charge and continues to process.

Step 4 :-

Integration of Logic with HMI and SCADA for better understanding and suitable color Combination.

Logic testing in simulation mode to rectify the errors and interlocks.

Step 5 :-

On in-house testing, send appropriate Data to SQL for report generation.

Generate Report with clients approved format.

Result:-

Efficiency Gains:

Human error Possibility reduced to 95%.

Accelerated project timelines through workflow automation and reports.

Batch production failure possibility reduced drastically.

Automated Reports helped end-user to analyze the process modification and grey area to be worked on for better quality product manufacturing.

Tracking of Data got in to record by digitalization. Less use of paper trials.

Cost Savings:

Reduced batch failure possibilities resulted in to cost savings.

Automated system helped them to optimize extra man power for operations.

Redundancy helped machine to continue if the primary PLC is in fault, so that process does not stop and product is not wasted.

Process Implementation in Auto-Cycles are as follows:-

·        Clean in Place (CIP)

·        Sterilization in Place (SIP)

·        Pressure Hold Test (PHT)

·        Transfer Line SIP

·        Batch

·        Crystallization

·        Filtration

·        Product Transfer

·        Redundancy

·        21 CFR

·        Report Generation

Conclusion:-

Pharmaceutical Manufacturer successfully transformed its drug development process through digital initiatives, resulting in increased efficiency, enhanced collaboration, and improved regulatory compliance. The implementation of integrated data management, workflow automation, collaboration platforms, and regulatory compliance management led to significant positive outcomes and positioned the company for future success in a dynamic pharmaceutical landscape.