1. Background

The global anticancer drug market continues to expand in scale, and how to seize the initiative to bring new products to market as early as possible has become a top concern for pharmaceutical companies worldwide. Tofflon OSD Containment Modular Plant solution integrates the overall design of clean-room, engineering with the selection of high-containment equipment into a standardized, modular solution. This helps pharmaceutical companies around the world shorten the time to launch to market, accelerate expansion, and enhance international competitiveness.

2. Modular Solution Features

• 2.1 Standardized Design and Rapid Deployment

The production facility adopts a standardized modular design. The innovative modular approach ensures that only 6 months are required from contract signing to Factory Acceptance Test (FAT).This means customers can quickly move from the design phase to actual installation and commissioning, significantly shortening the pharmaceutical facility construction timeline.

Thanks to the advantages of modular design, after transportation to the site, the on-site assembly workload is extremely low, requiring only a small amount of connection and commissioning work. Compared with traditional construction methods, it saves a great deal of on-site construction time, enabling the production facility to be put into operation rapidly and helping pharmaceutical companies seize market opportunities faster.

- Off site work: reduced 80% 

- Turnkey time: 6 months 

- Cost predictability deviation: 5%

In Tofflon’s factory

In customer’s factory

• 2.2 Enhanced Pre-Qualification

The entire facility can undergo a comprehensive FAT at Tofflon's facility. It allows all equipment and systems to be tested in a controlled environment within Tofflon's factory. This enables potential issues to be identified and resolved prior to delivery, ensuring the modules fully meet quality and performance standards. When the modular facility is transported to the site, it can be restored to the exact condition as tested at Tofflon's factory, significantly reducing a series of complex and time-consuming on-site testing for customers. The Site Acceptance Test (SAT), Installation Qualification (IQ), and Operational Qualification (OQ) can be completed in as fast as three months, allowing the facility to be put into use promptly.

• 2.3 Perfect Combination up to OEB 5

All key process equipment is equipped with isolator systems to strictly prevent high-potency raw materials from contaminating operators and the environment. This design is particularly critical for producing high-potency drugs such as those with OEB 4-5 classification. When manufacturing highly toxic and sensitive drugs, the use of process equipment integrated with isolator not only effectively avoids cross-contamination of materials but also minimizes the risk of leakage, while protecting operators and the environment from harmful substances like pharmaceutical dust.

• 2.4 Design Flexibility and Durability

The modular design provides the facility with great flexibility. According to different production needs, such as product types and production scales, modules can be easily adjusted and combined to meet specific production conditions. This flexibility enables the facility to adapt to various pharmaceutical scenarios, whether it is large - scale production or small - batch customization. Moreover, each module of the modular facility is independent. When it is necessary to upgrade or maintain a certain part, there is no need to stop the production of the entire facility. Operations can be carried out only on a single module, reducing production downtime and improving production efficiency. This ensures that the production facility is still advanced and applicable in the future, continuously creating value for customers.

3. Summary

Tofflon’s OSD Containment Modular Factory Solution is the optimal choice for small-batch production of high-potency drugs.

We will be showcasing the modular factory model at the PMEC India exhibition at booth:Hall No.11, Booth A07, you are warmly invited to visit our booth and there will be professional staff to explain it to you.