Sterile Does Not Necessarily Mean Clean

[RetCurious]

A good article helping to define conditions that may affect us.

"It is well established and indeed obvious that any medical device that punctures the skin or any medication that enters the bloodstream must be sterile. Sterilization procedures are fairly well established in the pharmaceutical and medical device industries and suitable testing is relatively straight-forward. What may not be as obvious is that these devices and products should also be free of foreign particles (i.e., clean). Control of unwanted particulate matter in products requires knowledge of potential sources of particles and processes that might generate particles to avoid potential problems. Identification of particulate matter is important in determining the root cause and to address safety concerns."

Sterile Does Not Necessarily Mean Clean

Pharmaceutical products and devices entering the blood stream must be sterile and particle free. Sterilization does not ensure products are clean. Forensic analysis for identification of particles when they appear is necessary to determine the source.

www.mccrone.com

 

[Chili777]

More reasons to filter.

 

[RetCurious]

More reasons to filter.

And more reasons to get Pharma grade when possible.

 

[Chili777]

And more reasons to get Pharma grade when possible.

Yeah, well, that ain't happening 😂

 

[RetCurious]

Yeah, well, that ain't happening 😂

Why not?

 

[Chili777]

Why not?

Well, I use depyrogenated, sterile vials, but USP pharma standards aren't something the RUO community strives to match, and it shouldn't.

If vendors are going to sell strictly under RUO, especially in the US, they need to test against RUO specifications, not USP pharma grade specifications. Vendors using anything labeled with USP testing are implying it’s safe for human use. Legally, they're advised to strictly keep all testing against RUO specifications or potentially alert the FDA.

USP specs have been defined by the life sciences community since the 70s, as greater than or equal to 95% purity, endotoxin less than or equal 1.0 EU/ug . Animal-free RUO grade and GMP RUO grade is classified as greater than or equal to 98% purity and Endo less than or equal to 0.1 EU/ug, although we know only some vendors care about endo concentration. So sterility aside, there are valid reasons to not use USP Pharma specs.

 

[HouseCat]

I use depyrogenated, sterile vials

Where are you getting them? I just did a super quick Google search and at ThermoFisher 100 2mL vials are CRAZY expensive…like one empty vial costs more than a full vial of peps! If that;s the price…

Yeah, well, that ain't happening 😂

😂

 

[Calm Logic]

What may not be as obvious is that these devices and products should also be free of foreign particles (i.e., clean).

On the positive side, no known obvious issues apparently from glass particles when breaking glass ampules (more common in other countries).

 

[Chili777]

Where are you getting them? I just did a super quick Google search and at ThermoFisher 100 2mL vials are CRAZY expensive…like one empty vial costs more than a full vial of peps! If that;s the price…

😂

I use two sites for vials. If the Astor is out, I get them at the other one. Med & Lab supplies has 2 mL and 5 mL, The 2 mL actually hold close to 3 mL. Thermo is off the charts for everything.

Pyrogen-Free Vials | Astor Scientific

Astor Scientific’s Pyrogen-Free Vials are manufactured and certified to be free of detectable endotoxins and pyrogens, ensuring reliable sample handling for endotoxin testing, pharmaceutical research, and sterile product preparation. Produced under strict quality control standards, these vials...

www.astorscientific.us

Ultra Spec Sterile 2ML (13mm neck) Clear Sealed Glass Vials

In order to receive vials in sealed shrink wrap boxes, please order in multiples of 25 Ultra Spec Sterile 2ML-13mm Clear Sealed Glass Vial, Qty 1 ULTRA SPEC sterile depyrogenated vials are assembled with Teflon coated non-latex chlorobutyl rubber stoppers (conforming with USP<381>) and vials...

www.medical-and-lab-supplies.com

 

[HouseCat]

I use two sites for vials. If the Astor is out, I get them at the other one. Med & Lab supplies has 2 mL and 5 mL, The 2 mL actually hold close to 3 mL. Thermo is off the charts for everything.

Pyrogen-Free Vials | Astor Scientific

Astor Scientific’s Pyrogen-Free Vials are manufactured and certified to be free of detectable endotoxins and pyrogens, ensuring reliable sample handling for endotoxin testing, pharmaceutical research, and sterile product preparation. Produced under strict quality control standards, these vials...

www.astorscientific.us

Ultra Spec Sterile 2ML (13mm neck) Clear Sealed Glass Vials

In order to receive vials in sealed shrink wrap boxes, please order in multiples of 25 Ultra Spec Sterile 2ML-13mm Clear Sealed Glass Vial, Qty 1 ULTRA SPEC sterile depyrogenated vials are assembled with Teflon coated non-latex chlorobutyl rubber stoppers (conforming with USP<381>) and vials...

www.medical-and-lab-supplies.com

Thanks- whoa, Astor has comparable pricing to Amazon and for a higher quality product! Much appreciated! 😁

 

[RetCurious]

Well, I use depyrogenated, sterile vials, but USP pharma standards aren't something the RUO community strives to match, and it shouldn't.

If vendors are going to sell strictly under RUO, especially in the US, they need to test against RUO specifications, not USP pharma grade specifications. Vendors using anything labeled with USP testing are implying it’s safe for human use. Legally, they're advised to strictly keep all testing against RUO specifications or potentially alert the FDA.

USP specs have been defined by the life sciences community since the 70s, as greater than or equal to 95% purity, endotoxin less than or equal 1.0 EU/ug . Animal-free RUO grade and GMP RUO grade is classified as greater than or equal to 98% purity and Endo less than or equal to 0.1 EU/ug, although we know only some vendors care about endo concentration. So sterility aside, there are valid reasons to not use USP Pharma specs.

I wasn't thinking of vendors or their constraints, I'm advocating for end users to have access to better products. I'm appalled at some of the trash that gets passed off in the grey community as acceptable. Pubes or manufacturing debris in your vials are not acceptable, at least not for me.

 

[Chili777]

I agree completely. We have to hold vendors to RUO standard on M/P and Endos, and also the various crap that effects sterility. And there is more of that happening now than I can remember in the last two years. Even normally solid vendors are now producing or selling peps with fibers (or whatever they are) and are under dosed or even zero peps. The way I do that is with my wallet and calling it out when I find it.

The demand is so high that they now ship product before testing it and seem to be waiting for customers to find out for themselves. It's the vendor fanboys that irk me the most because you can see them making excuses in the vendor forums for crap that is totally unacceptable. We have to vote with our wallets and be vocal when they don't meet standards. They also need to accept more than Jano COAs as proof and some are starting to do that, but not enough.