There are many reasons why manufacturers of medical devices or pharmaceutical products often switch to e-beam sterilization, such as the high reliability of the technology, the quick turnaround time, the low cost and the ease of validation. (For more information about the advantages of using e-beam for sterilization, see my blog “Why do companies choose electron beam irradiation to sterilize their products?“.) But just how much will it cost to validate your products?
The sterilization validation requirements are set forth in the international standard ISO 11137. Check back in for my future blog “How do I validate my medical device for e-beam sterilization?” for details on what each step entails. In addition to working with E-BEAM Services, you will need to work with a microbiological lab, such as NAMSA, LexaMed, WuXi Apptec, or Nelson Labs to complete the validation process.
If you are validating multiple related products, often these services can be combined and your costs will be lower per product. Of course, your cost will vary based on your specific needs and timeline. For example, microlab testing will be more expensive if you are using Method 1 validation (as per ISO 11137), but that is rarely required. Also, if you do not have experience writing a protocol for sterilization validation, it is recommended that you take advantage of a protocol preparation service, offered by many microbiological labs. This service usually costs about $3,700, and often comes with the added benefit of support through future FDA audits of this product.
Most manufacturers choose the VDMax validation method (per ISO 11137) for cost efficiency as well as convenience. With the VDMax method, you can expect the following “outside” costs to validate one product:
Microbiology Costs
~$300-$600 bioburden recovery validation
~$3000 initial bioburden determination
~$300-$400 bacteriostasis/fungistasis
~$120 sterility dose set determination
~$180-$250 test of dose verification samples (aka sterility-direct transfer method)
~$3,700 (optional) protocol preparation service
Total: ~$3,900 to ~$8,070
E-BEAM Services Costs
$1200 material test
$1800 dosemap (qualification on 2 accelerators, with 3 cases of product provided)
$1200 dose verification beaming
Total: $4,200
Grand total: about $8,100 to $12,270
There are no extra costs for continuing support from E-BEAM Services personnel during this process!
Overall, this cost is generally much less than validation with EtO and is competitive with gamma. If you have more questions about validating your particular product, contact us or feel free to give us a call!
www.ebeamservices.com • Ohio (513) 933-0031 • New Jersey (609) 655-7460