A pharmaceutical manufacturing company recently had several autoclave sterilization cycles that were very long in duration, resulting in premature failure of stopper and seal RTP bags. The cycles had been developed and validated years ago and the company did not have much in-house autoclave/sterilization expertise. Additionally, they only had one autoclave to support manufacturing and therefore, minimal downtime available for development/testing of the autoclave.
Performance Validation (PV) was selected for the project because of their extensive temperature mapping and cycle development experience specifically with steam sterilizers. PV was integral to the project from understanding the customer needs in the evaluation phase, to devising potential solutions based on extensive previous experience. PV was able to provide and efficiently use wireless temperature probes to evaluate varied cycle parameters quickly and confirm load sterilization requirements were met.
The customer was very pleased with the recommended autoclave cycle changes and the final results as confirmed with testing by PV. PV was able to demonstrate, through development testing and then revalidation of each cycle, that the steam sterilizer continued to provide adequate sterilization of stopper/seal loads with the implementation of significantly reduced pre-vacuum and post-vacuum pulses and durations. The maximum load sizes were reduced by 50% such that proper heat-up and cooling/drying would occur in the shortened cycle times. PV communicated very well with the customer and fostered a collaborative effort, getting review and agreement from key stakeholders, throughout the entire project.
The project accomplished the following for the pharma company:
- The primary goal of reduced fatigue of the RTP stopper/seal bags, extending the life and use of the bags, and reducing the chance of tears and compromised sterility of the stoppers/seals before or during manufacturing operations.
- Despite reducing load sizes by 50%, overall process times (including preparation, load, cycle, and unload times) were reduced by >50%, providing overall time savings for the sterilization of the same number of materials.
- With smaller and shorter cycles, operations were able to facilitate sterilization activities within single shifts and more quickly respond to manufacturing needs.
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Principal Validation Engineer