Containment Strategies in Pharma Facilities

In an interaction with India Pharma Outlook, Deepak Ghagare, Associate Director SBS at Spectrum Pharmatech shares insights on India’s evolving HPAPI manufacturing landscape, emphasizing advanced containment strategies and regulatory alignment. He also outlines how pharma companies are leveraging modern facility design and technology integration in both brownfield and greenfield projects.

With India scaling up HPAPI manufacturing, how are pharma companies enhancing containment strategies to meet stricter OEL compliance and international regulatory expectations?

High Potent Active Pharmaceutical Ingredients (HPAPIs) have become increasingly prominent in the current pharmaceutical industry landscape. As India is often referred to as the "pharmacy of the world," the country is actively adapting to meet the growing demand for HPAPI production. Although India has been manufacturing HPAPIs for nearly two decades, the increasing stringency of international regulatory norms related to safety and Health, Safety, and Environment (HSE) has made it essential for the industry to adopt newer, more advanced technologies.

This adaptation begins with facility design, ensuring proper segregation of core processing areas where HPAPIs are handled. It extends to the careful selection of equipment, where containment and source-control philosophies are prioritized.

Additionally, the design and implementation of HVAC systems play a crucial role, not only in maintaining internal environmental control but also in minimizing the impact of emissions on the external environment, including both liquid and air discharges. In summary, the Indian pharmaceutical industry is actively evolving. With the availability of modern technologies, more high potent products can now be safely and efficiently manufactured within India’s industrial landscape.

What is the most common operational pain point’s Indian pharma firm’s face in implementing multi-level containment systems in brownfield versus greenfield manufacturing setups?

In brownfield projects, one of the major challenges faced is the disruption of ongoing production. Implementing any containment solution typically requires a significant shutdown, which affects operations.

Another major issue is the integration of new containment technologies into existing facilities. Most legacy facilities were not originally designed with containment equipment in mind, making retrofitting a significant challenge. Additionally, facility layout constraints often pose difficulties in achieving proper segregation between protected manufacturing areas and conventional manufacturing areas.

Capital expenditure (CAPEX) is another critical deterrent. Containment equipment generally involves high upfront costs, which can make implementation in older facilities more difficult and economically unfeasible. These combined factors present substantial challenges in brownfield projects.

On the other hand, greenfield projects offer a comparatively simpler pathway. Since the facility is built from scratch, the design and selection of containment solutions can be planned from the beginning. However, even greenfield projects face their own challenges.

The first challenge is CAPEX, as containment devices still demand substantial investment. The second challenge is the availability of skilled manpower, since certain containment systems require trained personnel for effective operation and maintenance.

For new facilities, a systematic approach is adopted for both facility design and equipment selection. Manufacturing units typically engage experienced and knowledgeable consultants who provide support from the initial design phase.

Their role ensures that all aspects—such as facility layout, equipment selection, and HVAC system design, are aligned to ensure effective containment based on the product profile.

Additionally, operator ergonomics is taken into consideration. Before finalizing equipment fabrication, ergonomic trials are conducted. These trials help determine whether operators can reach all necessary parts of the machine and whether effective cleaning is possible.

When containment is incorporated into the facility design from the outset, routine cleaning during production cycles becomes simpler. Only a smaller, designated area of the facility—rather than the entire site, needs to be managed for high-potent compounds, significantly improving operational efficiency and safety.

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What role does real-time monitoring and validation play in improving risk mitigation for cross- contamination in multiproduct containment facilities?

Real-time monitoring, while increasingly discussed in the context of cross-contamination control, is not yet fully validated or proven to be consistently effective. However, there are tools available that can be implemented as part of facility design, particularly in multiproduct containment facilities, to help manage the risk of cross-contamination across different suites.

Cross-contamination can occur through various pathways, such as from one product to another via personnel movement, through airborne transfer, or as a result of ineffective cleaning processes.

One of the key real-time monitoring tools currently used is differential pressure monitoring. This ensures that each core processing area maintains a negative pressure relative to adjacent spaces, thereby helping to prevent airborne contaminants from spreading into other areas.

In terms of personnel-related contamination, effective control is achieved through the selection of appropriate equipment that provides containment at the source.This approach helps protect operators from exposure and minimizes the risk of transferring contaminants to other products or areas.

Another crucial aspect is retention and cleaning. Proper cleaning procedures and validated cleaning methods must be developed to prevent cross-contamination caused by residual product left on surfaces or equipment. While real-time monitoring can effectively support air control through pressure differential tracking, it remains limited in areas such as cleaning validation and monitoring of personnel exposure. These aspects still rely primarily on off-site testing and non-real-time monitoring methods.

As global audits grow more rigorous, how will next-gen containment solutions, including automation and AI, redefine compliance and risk culture in Indian pharma manufacturing?

The option of complete automation, along with the integration of artificial intelligence (AI), is an evolving trend in the pharmaceutical manufacturing sector. As regulatory compliance becomes increasingly stringent and more difficult to achieve, AI is expected to play a significant and positive role, both for auditors and pharmaceutical companies.

Through AI-driven systems, every action performed within the facility can be monitored and analyzed based on data generated and recorded by automated tools.This enhances transparency, ensures accuracy, and significantly improves audit readiness.

For companies, such systems reduce or eliminate the need for human intervention in many cases, thereby minimizing the risk of human error and data manipulation. This evolving technology is now being gradually adopted by Indian pharmaceutical manufacturers to support improved data integrity and compliance. Machine-generated data, which is secure and tamper-proof, provides reliable evidence during audits and strengthens the credibility of operations in the eyes of regulators.

Beyond compliance, automation and AI also contribute to enhanced operator safety, better process optimization, and greater process stability. Over time, as these technologies are fully adopted, they offer additional advantages such as improved cost efficiency and scalability of manufacturing operations. This shift not only supports regulatory expectations but also drives long-term operational excellence for pharmaceutical manufacturing units.