The solution for the Biologics industry is highly integrated, automated and intelligent, designed to improve production efficiency, ensure product quality, reduce production costs and meet strict regulatory requirements. The following is a detailed description of the solution:
1. production line overview
The vials filling production line is a production line specially designed for the pharmaceutical industry, especially suitable for the filling of biological preparations. The production line integrates mechanical arm, conveyor belt, filling machine, capping machine, freeze dryer and other equipment, which can efficiently, accurately and quickly complete the steps of grabbing, positioning, filling, sealing and drying of vials.
2. key equipment and technology
vials full automatic filling machine:
Function: Responsible for accurate filling of biological agents into vials.
Features: high precision, high stability, can reduce human error, improve filling accuracy.
Capping machine:
Function: After the filling is completed, the vial is sealed to ensure the sterility and stability of the product.
Features: High degree of automation, can quickly and accurately complete the capping operation.
Freeze Dryer (if required):
Function: Low temperature treatment of biological preparations that need to be freeze-dried to remove moisture and retain active ingredients.
Features: With SIP device, it can be sterilized with high temperature steam to ensure the sterility of the product.
Purification system:
Function: Purify the vials and filling environment to ensure the aseptic environment in the production process.
Technology: such as pulsed light technology (PLT), can completely purify the surface of vials, kill microorganisms.
Isolator:
Function: Keep the continuous separation of the filling area and the external environment, and realize aseptic production.
Features: with high efficiency air filter (HEPA), can filter one-way air, to achieve ISO-5 environment.
Features and benefits of 3. solutions
Highly automated:
The production line adopts automation and intelligent technology, which can greatly improve production efficiency and reduce manual intervention and operation.
High accuracy and stability:
High-precision equipment is used in key steps such as filling and sealing to ensure the stability and consistency of product quality.
Aseptic production:
Through the purification system, isolator and other equipment, to ensure the sterile environment in the production process, to meet the strict requirements of biological agents on sterility.
Flexibility:
The production line can be flexibly adjusted according to production needs, such as handling different specifications of vials and adapting to the filling requirements of different products.
Compliance with regulatory requirements:
The production line is designed and manufactured in accordance with the requirements of the Dynamic Pharmaceutical Manufacturing Practice (cGMP), the Automated Manufacturing Quality Management Practice (GAMP), and 21 Chapter 11 of the Code of Federal Regulations (21 CFR Part 11).
4. Application Case
Taking the biopharmaceutical enterprise as an example, it has successfully realized the efficient filling and aseptic production of biological agents by adopting the vials filling production line. Through this production line, the company not only improves production efficiency, but also significantly reduces production costs and product quality risks. At the same time, the production line also has a high degree of flexibility and scalability, can meet the future production needs of different products.