Small Volume Injection Preparation System

The small-volume injection preparation system is a core pharmaceutical equipment used to prepare sterile small-volume injections (such as injections in ampoules and vials, usually with a capacity of ≤100mL). Its design must comply with GMP (Good Manufacturing Practice) and aseptic preparation production requirements to ensure accurate preparation, sterility and stability of the liquid medicine.

System composition

Small volume injection preparation systems usually consist of the following core modules:

· Liquid preparation tank :

 Material : 316L/304 stainless steel (corrosion-resistant, easy to clean).

 Capacity : Designed according to production requirements (such as 50L~1000L).

 Function : Dissolve and mix APIs with solvents (such as water for injection, buffer).

· Filtration system :

Sterilizing grade filter : 0.22μm pore size polyethersulfone (PES) or polytetrafluoroethylene (PTFE) filter element for terminal sterilization.

 Pre-filter : 1~5μm filter element, used to remove particulate impurities.

· Conveying system :

Pumps : peristaltic pumps (to avoid contamination), centrifugal pumps (for large flow rates).

Pipeline : sanitary stainless steel or disposable pipeline (to reduce cross contamination).

· CIP/SIP system :

Online cleaning (CIP) : Clean the tank and pipelines through spray balls and cleaning fluid circulation.

 Sterilization in Place (SIP) : Pure steam (121 °C ) is introduced to sterilize the system.

· Control system :

 Automation control : PLC (Programmable Logic Controller) or SCADA (Supervisory Control and Data Acquisition System).

Sensors : Real-time monitoring of temperature, pH, conductivity, pressure, liquid level and other parameters.

2. Applicable Products

· Dosage form : injection (such as antibiotics, vaccines, nutrient solution, chemotherapy drugs).

· Packaging forms : ampoules, vials, prefilled syringes, etc.

1. Sterility assurance design

· Closed System :

 The whole process is operated in a closed manner to avoid environmental microbial contamination (such as air and human contact).

 The system maintains positive pressure (via sterile air or nitrogen) to prevent the intrusion of external contaminants.

· Sterile filtration and sterilization :

 Final 0.22μm sterile filtration to retain bacteria and spores.

SIP (steam sterilization) procedures to verify sterilization effectiveness (such as biological indicator challenge tests).

· Materials and surface treatment :

The inner wall of 316L stainless steel is electrolytically polished (Ra≤0.4 μm ) to reduce microbial attachment.

 The seal is made of PTFE or EPDM (high temperature resistant, no dissolution).

2. Homogeneity and stability control

· Hybrid Dynamics Optimization :

Computational fluid dynamics (CFD) is used to simulate the flow field in the tank and design the optimal stirring blade shape (such as anchor type and spiral type).

Real-time monitoring of the pH, conductivity and turbidity of the drug solution, and automatic adjustment of mixing parameters.

· Temperature Control :

Sandwich design (heating/cooling medium circulation), precise temperature control (±1 ℃ ).

Low temperature preparation (2~8 ℃ ) is used for heat-sensitive drugs (such as protein preparations).

3. Automation and intelligence

· Recipe Management :

Pre-store a variety of liquid preparation programs, and switch to produce different products with one click.

 Automatic calculation of solvent addition amount (based on API density and concentration).

· Fault warning and protection :

Automatically shut down and alarm when over-temperature, over-pressure or low liquid level occurs.

 Filter integrity testing (bubble point method or diffusion flow method) is performed automatically.

4. Modularity and flexibility

· One-time technology integration :

Optional disposable liquid preparation bags (reduce cleaning validation, suitable for multi-variety production).

Disposable tubing and filters to avoid cross contamination.

· Scale up :

 Supports modular expansion from R&D level (10L) to commercial production level (1000L).

· Biopharmaceuticals : buffer preparation for monoclonal antibodies and vaccines.

· Chemotherapeutic drugs : safe closed preparation of highly toxic drugs.

· Hospital preparation : Rapid preparation of small batches of drugs for clinical trials.