Manufacturing of semi-solid pharmaceuticals

Summary

In this video, Yuan from Qualifier shares the company’s experience with upgrading their production equipment for ointments and creams. The new system from Zoetec offers flexibility in batch sizes, ease of cleaning, and a closed process that ensures both product safety and operator protection. With an intuitive control system, improved efficiency, and faster production times, Qualifier has significantly boosted output. Thanks to the system’s adaptability, compliance with GMP standards, and optimized cleaning process, the company is now able to meet future demands while maintaining high-quality manufacturing standards.

Takeaways

• 😀 Flexible production equipment is crucial for varying batch sizes, from a few hundred kilograms up to 2,000 kilograms.
• 😀 Equipment must be easy to clean, with a closed process ensuring both product safety and operator protection.
• 😀 The system's control system is user-friendly, with intuitive process visualization and recipe guidance for operators.
• 😀 The recipe editor is intuitive, allowing easy creation, management, and version control of recipes.
• 😀 The new equipment meets the increased capacity needs, allowing the company to produce four times more in a single shift.
• 😀 With the upgraded equipment, the company can complete a week's worth of work in just two days, including cleaning time.
• 😀 ZOA Tech conducted trial batches to refine process parameters, ensuring smooth upscaling without drastic changes.
• 😀 The equipment can handle a wide range of batch sizes (400 to 2,000 liters), supporting diverse product transfers.
• 😀 The system complies with stringent pharmaceutical regulations (GMPs), ensuring the manufacturer meets all legal requirements.
• 😀 A strong collaboration between the supplier and client is essential for ensuring the equipment meets all specified production, cleaning, handling, and maintenance needs.
• 😀 The built-in CIP (Cleaning In Place) system enables efficient, automatic cleaning with customizable cleaning programs.

Q & A

What was Qualifier's primary objective when looking for new production equipment?

Qualifier aimed to buy new production equipment for their ointment and cream department. The primary objectives were flexibility in batch sizes, ease of cleaning, and ensuring a closed process to protect both the product and operators.

What specific features were important for Qualifier in choosing the production equipment?

The equipment had to be flexible in handling batch sizes ranging from a few hundred kilograms to 2,000 kilograms, easy to clean, and provide a closed process to ensure product safety and operator protection.

How does the control system contribute to the production process?

The system is convenient and easy to use, allowing operators to adjust production processes. It provides a clear overview of the system, and operators are guided through recipes via prompts, with an intuitive recipe editor for creating and managing recipes.

What improvements were achieved in production capacity with the new equipment?

The new equipment enabled Qualifier to produce four times the amount of ointment and cream in one shift compared to the previous equipment. One week's work can now be completed in just two days, including cleaning time.

How did ZOA Tech assist in optimizing the production process?

ZOA Tech conducted several trial batches in their customer process center to refine process parameters. These parameters served as a good foundation for developing recipes, and during the upscaling process, no drastic changes were needed.

What batch size range can the ZOA Tech system handle?

The system can handle a wide range of batch sizes, from 400 liters to 2,000 liters, allowing for flexible production and the transfer of other products to the new system.

How does the ZOA Tech system comply with pharmaceutical industry regulations?

The ZOA Tech system is designed to comply with stringent laws and directives such as GMP (Good Manufacturing Practice). This ensures that the equipment supports the necessary requirements for production, cleaning, handling, and maintenance.

What role did collaboration between Qualifier and ZOA Tech play in the development of the production system?

Close collaboration between Qualifier and ZOA Tech was vital during the design and development of the production equipment. This partnership ensured that the system met all specified criteria for production, cleaning, handling, and maintenance.

What is the function of the built-in CIP (Cleaning in Place) system?

The built-in CIP system allows for automatic cleaning of the plant in a short amount of time. Individual cleaning programs can be created, saved, and optimized in collaboration with ZOA Tech, ensuring efficient cleaning processes.

How does Qualifier view their future with the ZOA Tech system?

Qualifier is confident that the ZOA Tech system will help them meet future production demands. They are satisfied with its flexibility, ease of use, cleaning efficiency, maintenance-friendliness, and overall performance, which positions them well for future market demands.