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Bridging the Gap: Mitigating a Hidden Cleaning Risk in Large-Scale Freeze-Thaw Unit Commissioning: Poster Presented
1Genetech nicoleb1@gene.com.
PDA Journal of Pharmaceutical Science and Technology
|August 7, 2026
Summary
A new freeze-thaw unit had a hidden cleaning risk due to a Teflon plate gap. Redesigning the pins allowed for easier plate removal, improving GMP cleanability and reducing contamination risks.
Area of Science:
- Pharmaceutical Manufacturing
- Equipment Design
- Good Manufacturing Practices (GMP)
Background:
- A critical cleaning challenge was identified during the commissioning and qualification (C&Q) of a large-scale freeze-thaw unit.
- A non-fixed Teflon plate created an inaccessible gap, leading to fluid accumulation and potential microbial contamination risks.
Purpose of the Study:
- To investigate a hidden cleaning risk associated with the bottom shelf assembly of a freeze-thaw unit.
- To collaborate with the equipment vendor to re-engineer the design for improved cleanability and safety.
Main Methods:
- Investigative approach to identify the cleaning risk in the Teflon plate gap.
- Collaboration with the equipment vendor to re-engineer the pin design for easier component removal.
- Evaluation of the revised design for enhanced GMP cleanability and reduced ergonomic risks.
Main Results:
- The original design featured a narrow, inaccessible gap prone to fluid accumulation and microbial growth.
- The existing removal process for the Teflon plate was labor-intensive and posed ergonomic and mechanical risks.
- A redesigned pin mechanism enabled horizontal plate removal without lifting the shelf assembly, resolving the cleaning issue.
Conclusions:
- The re-engineered pin design successfully addressed the critical cleaning concern in the freeze-thaw unit.
- The modification enhances GMP compliance by ensuring adequate cleanability and reducing cross-contamination risks.
- The collaborative approach with the vendor highlights the importance of design evolution for manufacturing equipment.
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