Sterilization Adoption and Validation
Ethylene Oxide | Gamma | E-Beam
Adopt your product to the M4D Sterilization cycle and save time and units
Expedited EtO Sterilization Adoption
Adopt your product to the M4D Sterilization cycle and save time and units. Our Expedited Sterilization cycle has been pre-validated per ANSI/AAMI/ISO11135 2014, Sterilization of Healthcare Products, Ethylene Oxide.
How it works: M4D has a pre-validated cycle that can be used to incorporate your product. As long as your product does not present as a new worst-case challenge, we can perform an adoption. Give us a call or fill out our request for quote today to discuss the details of our cycle. We can perform a preliminary assessment, give you an answer if your product is suitable for adoption, and map out the next steps to achieve full 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
Validate your product to our gamma or e-beam cycle. Our we will ensure that a sterilization assurance level of 10^-6 is achieved. We will follow ANSI/AAMI/ISO11137 2016, Sterilization of Healthcare Products - Radiation and ensure that your product is validated accordingly.
How it works: M4D will guide you through the radiation validation process and ensure that your product will be able to withstand the radiation exposure. We will utilize bioburden units to characterize the natural microbial load on the product/package. Per the guidance, the microbial load will be used to determine a verification dose. This dose will be used to sterilize the products and tested for sterility. When testing shows your targeted sterility assurance level has been achieved, then the validation was successful. Average time to complete this validation is approximately 1 month.
Conclusion: Save time with an alternate to EtO and have a very high degree in sterilization confidence! Contact us today!