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Environmental microbial challenges to an aseptic Blow-Fill-Seal process--a practical study
D J Jones1, P Topping, J Sharp
1Waverley Pharmaceutical/Steripak Limited, Runcorn, Cheshire, England.
PDA Journal of Pharmaceutical Science and Technology
|September 1, 1995
Summary
Aseptic filling processes using Blow-Fill-Seal technology maintained product sterility despite environmental microbial challenges. This study demonstrates the robustness of the aseptic filling method for sterile liquid TSB medium.
Area of Science:
- Pharmaceutical Technology
- Microbiology
- Sterile Manufacturing
Background:
- Maintaining product sterility is critical in aseptic filling.
- Environmental factors and personnel actions can impact aseptic processing.
Purpose of the Study:
- To evaluate the impact of environmental microbial challenges on aseptic filling.
- To assess the effectiveness of Blow-Fill-Seal technology under stress conditions.
Main Methods:
- Aseptic filling of sterile TSB medium into 20 ml containers using Blow-Fill-Seal.
- Subjecting the filling process to environmental microbial challenges.
- Incubation and microbial growth assessment of filled containers.
Main Results:
- Approximately 44,000 units were filled under stressed conditions.
- No microbial growth was observed in any of the filled containers post-incubation.
- The aseptic filling system demonstrated resilience to environmental stresses.
Conclusions:
- Blow-Fill-Seal technology effectively maintains product sterility.
- Environmental microbial challenges did not compromise the aseptic filling process.
- The system is robust for sterile liquid filling operations.