Spinal Implant Testing Requirements - Bioburden, TGA & Ion Chromatography

M

MeredithMay

#1
We design spinal implants that are provided to the customer non-sterile, and they are steam sterilized in the hospital. There is a product that was released prior to my coming on board here, and the following testing was completed:
1. Biomechanical
2. Sterilization Validation
3. Bioburden
4. Thermogravimetric Analysis (TGA)
5. Ion Chromatography
6. Cytotoxicity

I can understand the need for tests 1, 2, and 6 without question.

Bioburden? In my experience, Bioburden has been used to establish the amount of "stuff" that is the baseline for the gamma sterilization validation. Since these products are provided non-sterile and the steam sterilization validation applies its own "stuff" as part of the process, what is bioburden telling me and why should I do it?

TGA & Ion Chromatography? I have used these tests while executing device cleaning validations but, again, these parts are provided non-sterile. We do not make them here, and the vendors provide us with the results of their cleaning validations.

I am reading through Safety Evaluation in the Development of Medical Devices and Combination Products by Shayne Gad and Marian McCord and have found no justification for using Bioburden, TGA, or Ion Chromatography for titanium.

I believe that for a titanium implant that is provided non-sterile, biomechanical testing, sterilization validation, and cytocoxicity testing would be sufficient for both product release and contract manufacturer change.

Would someone please help me to confirm or deny my assessment? I am generally on the mechanical side of the world and am slightly out of my element in this decision.

Thanks!
Meredith

P.S. We sell in the US only and our products are 510k, not PMA products.
 
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Jim Wynne

Staff member
Admin
#2
Re: Implant Testing Requirements

We design spinal implants that are provided to the customer non-sterile, and they are steam sterilized in the hospital. There is a product that was released prior to my coming on board here, and the following testing was completed:
1. Biomechanical
2. Sterilization Validation
3. Bioburden
4. Thermogravimetric Analysis (TGA)
5. Ion Chromatography
6. Cytotoxicity

I can understand the need for tests 1, 2, and 6 without question.

Bioburden? In my experience, Bioburden has been used to establish the amount of "stuff" that is the baseline for the gamma sterilization validation. Since these products are provided non-sterile and the steam sterilization validation applies its own "stuff" as part of the process, what is bioburden telling me and why should I do it?

TGA & Ion Chromatography? I have used these tests while executing device cleaning validations but, again, these parts are provided non-sterile. We do not make them here, and the vendors provide us with the results of their cleaning validations.

I am reading through Safety Evaluation in the Development of Medical Devices and Combination Products by Shayne Gad and Marian McCord and have found no justification for using Bioburden, TGA, or Ion Chromatography for titanium.

I believe that for a titanium implant that is provided non-sterile, biomechanical testing, sterilization validation, and cytocoxicity testing would be sufficient for both product release and contract manufacturer change.

Would someone please help me to confirm or deny my assessment? I am generally on the mechanical side of the world and am slightly out of my element in this decision.

Thanks!
Meredith

P.S. We sell in the US only and our products are 510k, not PMA products.
Welcome to the Cove. :D It's usually pretty slow here on the weekend, so be patient. I'm sure someone here will be able to help. You might want to stop by on Monday and give the thread a bump (if necessary) so it doesn't get lost.
 

bio_subbu

Super Moderator
#3
Dear Meredith

I think you are getting more confuse about the term “Bioburden” since you are in mechanical background.

See, the term “bioburden” is used to describe the population of viable microorganisms (such as bacteria, fungus, algae, viruses) present on or in product, and sum of the microbial contributions from a number of sources like raw materials, manufacturing components, assembly processes, manufacturing environment, assembly/ manufacturing aids (e.g., compressed gases, water, lubricants), cleaning processes and packaging of finished product. To control bioburden level, you have to follow any of the sterilization processes such as Gamma radiation, Moist Heat (Autoclave), filtration or ETO sterilization and select appropriate method suitable for your product. Since your product being sterilized by steam (Moist Heat), determine the bioburden and fix the limit for acceptable level. Keep in mind if you supply the finished product in sterile condition is nothing but your bioburden level is ZERO.

Also, Bioburden can be used in a number of situations as part of:

1. Validation and revalidation of sterilization processes
2. Routine monitoring for control of manufacturing processes
3. Monitoring of raw materials, components or packaging
4. Assessment of the efficiency of cleaning processes
5. An overall environmental monitoring program


Thanks and Regards
S. Subramaniam, INDIA
 
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