Sterilization Adoption and Validation
To validate a typical EtO Sterilization Cycle Example*
To adopt a typical product to the M4D EtO Sterilization Cycle Example*
| Cycle | Full units Needed | Time (weeks) |
|---|---|---|
| EtO Sterilization Protocol and Plan | 1 | 1 |
| Bioburden | 10 | 0.5 |
| First Fractional Cycle | 10 | 1 |
| Second Fractional Cycle | 10 | 1 |
| First Half Cycle | 6 | 1 |
| Second Half Cycle | 6 | 1 |
| Third Half Cycle | 6 | 1 |
| Full Cycle | 19 | 1 |
| Total (Too many units and too much time!!!!!) | 68 | 7.5 |
| Cycle | Full Units Needed | Time (weeks) |
|---|---|---|
| Sterile Cycle Adoption Evaluation | 1 | 0.5 |
| Bioburden | 10 | 0.5 |
| Full Cycle Verification | 13 | 1 |
| Total (Save time and product cost!) | 24 | 2 |
*The M4D estimates are best case turnaround times, we could achieve these only under ideal circumstances but nevertheless it is possible. During the quoting process we could identify roadblocks and adjust accordingly.
Conclusion: Save cost on number of units needed for testing and save significant time on the validation work. EtO validations have a habit of not being able to successfully pass the first time. Eliminate that risk with the M4D Expedited sterilization adoption! Contact us today!
Gamma & E-Beam Validation
Conclusion: Save time with an alternate to EtO and have a very high degree in sterilization confidence! Contact us today!
