Sterility Doesn't Guarantee a Particle-Free Product

[RetCurious]

A useful piece that outlines circumstances which could impact us.

"Everyone accepts, and it is plainly evident, that a medical device designed to pierce the skin, or any drug delivered into the bloodstream, has to be sterile. Within the pharmaceutical and medical device sectors, sterilization methods are quite standard, and appropriate testing is comparatively simple. Less apparent, perhaps, is the need for these items to also contain no foreign particles (in other words, they must be clean). Managing undesirable particulates in products demands awareness of where particles may originate and which processes could produce them, so that potential issues are avoided. Pinpointing particulate matter matters for establishing the root cause and for resolving safety questions."

Sterile Does Not Necessarily Mean Clean



Drugs and devices that go into the bloodstream need to be both sterile and free of particles. Being sterile is no assurance that a product is clean. When particles show up, forensic testing to identify them is required in order to trace their origin.

www.mccrone.com

 

[Chili777]

Additional grounds for using a filter.

 

[RetCurious]

Chili777 said:

Additional grounds for using a filter.

That's another argument for choosing Pharma grade whenever you can.

 

[Chili777]

RetCurious said:

Chili777 said:

Additional grounds for using a filter.

That's another argument for choosing Pharma grade whenever you can.

Yeah, that is not something I can see happening

 

[RetCurious]

Chili777 said:

RetCurious said:

Chili777 said:

Additional grounds for using a filter.

That's another argument for choosing Pharma grade whenever you can.

Yeah, that is not something I can see happening

What's the reason for that?

 

[Chili777]

RetCurious said:

Chili777 said:

RetCurious said:

Chili777 said:

Additional grounds for using a filter.

That's another argument for choosing Pharma grade whenever you can.

Yeah, that is not something I can see happening

What's the reason for that?

I do rely on vials that are both sterile and depyrogenated. That said, matching USP pharma standards isn't a goal the RUO community pursues, nor is it one it ought to pursue.

When a vendor sells only under RUO — particularly inside the US — the testing they run has to align with RUO specifications rather than USP pharma grade criteria. If a vendor puts USP testing language on a product, that carries the suggestion that the product is fit for human use. From a legal standpoint, they're better off keeping every test tied to RUO specifications, or they risk drawing FDA attention.

Since the 1970s, the life sciences field has set USP specs at greater than or equal to 95% purity with endotoxin less than or equal 1.0 EU/ug. Animal-free RUO grade and GMP RUO grade fall under greater than or equal to 98% purity with Endo less than or equal to 0.1 EU/ug, though it's clear that endo concentration only matters to certain vendors. So even setting sterility to one side, there are solid grounds for steering clear of USP Pharma specs.

 

[HouseCat]

Chili777 said:

RetCurious said:

Chili777 said:

RetCurious said:

Chili777 said:

Additional grounds for using a filter.

That's another argument for choosing Pharma grade whenever you can.

Yeah, that is not something I can see happening

What's the reason for that?

I do rely on vials that are both sterile and depyrogenated. That said, matching USP pharma standards isn't a goal the RUO community pursues, nor is it one it ought to pursue.

When a vendor sells only under RUO — particularly inside the US — the testing they run has to align with RUO specifications rather than USP pharma grade criteria. If a vendor puts USP testing language on a product, that carries the suggestion that the product is fit for human use. From a legal standpoint, they're better off keeping every test tied to RUO specifications, or they risk drawing FDA attention.

Since the 1970s, the life sciences field has set USP specs at greater than or equal to 95% purity with endotoxin less than or equal 1.0 EU/ug. Animal-free RUO grade and GMP RUO grade fall under greater than or equal to 98% purity with Endo less than or equal to 0.1 EU/ug, though it's clear that endo concentration only matters to certain vendors. So even setting sterility to one side, there are solid grounds for steering clear of USP Pharma specs.

What's your source for those? I ran a really fast Google check, and over at ThermoFisher, 100 2mL vials cost an absurd amount…an empty one ends up pricier than a whole vial of peps! If that's what it runs…

Chili777 said:

RetCurious said:

Chili777 said:

Additional grounds for using a filter.

That's another argument for choosing Pharma grade whenever you can.

Yeah, that is not something I can see happening

 

[Calm Logic]

RetCurious said:

A useful piece that outlines circumstances which could impact us.

"Everyone accepts, and it is plainly evident, that a medical device designed to pierce the skin, or any drug delivered into the bloodstream, has to be sterile. Within the pharmaceutical and medical device sectors, sterilization methods are quite standard, and appropriate testing is comparatively simple. Less apparent, perhaps, is the need for these items to also contain no foreign particles (in other words, they must be clean). Managing undesirable particulates in products demands awareness of where particles may originate and which processes could produce them, so that potential issues are avoided. Pinpointing particulate matter matters for establishing the root cause and for resolving safety questions."



View attachment 11158



Sterile Does Not Necessarily Mean Clean



Drugs and devices that go into the bloodstream need to be both sterile and free of particles. Being sterile is no assurance that a product is clean. When particles show up, forensic testing to identify them is required in order to trace their origin.

View attachment 11159


www.mccrone.com

A reassuring point: when glass ampules are snapped open—something seen more often in other nations—there have been no apparent well-known problems tied to glass fragments.

 

[Chili777]

HouseCat said:

Chili777 said:

RetCurious said:

Chili777 said:

RetCurious said:

Chili777 said:

Additional grounds for using a filter.

That's another argument for choosing Pharma grade whenever you can.

Yeah, that is not something I can see happening

What's the reason for that?

I do rely on vials that are both sterile and depyrogenated. That said, matching USP pharma standards isn't a goal the RUO community pursues, nor is it one it ought to pursue.

When a vendor sells only under RUO — particularly inside the US — the testing they run has to align with RUO specifications rather than USP pharma grade criteria. If a vendor puts USP testing language on a product, that carries the suggestion that the product is fit for human use. From a legal standpoint, they're better off keeping every test tied to RUO specifications, or they risk drawing FDA attention.

Since the 1970s, the life sciences field has set USP specs at greater than or equal to 95% purity with endotoxin less than or equal 1.0 EU/ug. Animal-free RUO grade and GMP RUO grade fall under greater than or equal to 98% purity with Endo less than or equal to 0.1 EU/ug, though it's clear that endo concentration only matters to certain vendors. So even setting sterility to one side, there are solid grounds for steering clear of USP Pharma specs.

What's your source for those? I ran a really fast Google check, and over at ThermoFisher, 100 2mL vials cost an absurd amount…an empty one ends up pricier than a whole vial of peps! If that's what it runs…

Chili777 said:

RetCurious said:

Chili777 said:

Additional grounds for using a filter.

That's another argument for choosing Pharma grade whenever you can.

Yeah, that is not something I can see happening

I have 2 sources for vials. When Astor doesn't have them in stock, I buy from the other supplier. Med & Lab supplies carries 2 mL and 5 mL sizes; the 2 mL version actually holds nearly 3 mL. Thermo's prices are extremely high across the board.

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]

Chili777 said:

HouseCat said:

Chili777 said:

RetCurious said:

Chili777 said:

RetCurious said:

Chili777 said:

Additional grounds for using a filter.

That's another argument for choosing Pharma grade whenever you can.

Yeah, that is not something I can see happening

What's the reason for that?

I do rely on vials that are both sterile and depyrogenated. That said, matching USP pharma standards isn't a goal the RUO community pursues, nor is it one it ought to pursue.

When a vendor sells only under RUO — particularly inside the US — the testing they run has to align with RUO specifications rather than USP pharma grade criteria. If a vendor puts USP testing language on a product, that carries the suggestion that the product is fit for human use. From a legal standpoint, they're better off keeping every test tied to RUO specifications, or they risk drawing FDA attention.

Since the 1970s, the life sciences field has set USP specs at greater than or equal to 95% purity with endotoxin less than or equal 1.0 EU/ug. Animal-free RUO grade and GMP RUO grade fall under greater than or equal to 98% purity with Endo less than or equal to 0.1 EU/ug, though it's clear that endo concentration only matters to certain vendors. So even setting sterility to one side, there are solid grounds for steering clear of USP Pharma specs.

What's your source for those? I ran a really fast Google check, and over at ThermoFisher, 100 2mL vials cost an absurd amount…an empty one ends up pricier than a whole vial of peps! If that's what it runs…

Chili777 said:

RetCurious said:

Chili777 said:

Additional grounds for using a filter.

That's another argument for choosing Pharma grade whenever you can.

Yeah, that is not something I can see happening

I have 2 sources for vials. When Astor doesn't have them in stock, I buy from the other supplier. Med & Lab supplies carries 2 mL and 5 mL sizes; the 2 mL version actually holds nearly 3 mL. Thermo's prices are extremely high across the board.



View attachment 11160



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...

View attachment 11161


www.astorscientific.us



View attachment 11162



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...

View attachment 11163


www.medical-and-lab-supplies.com

Appreciate it—wow, Astor's prices are in the same range as Amazon, and the product is better quality! Thanks a lot!

 

[RetCurious]

Chili777 said:

RetCurious said:

Chili777 said:

RetCurious said:

Chili777 said:

Additional grounds for using a filter.

That's another argument for choosing Pharma grade whenever you can.

Yeah, that is not something I can see happening

What's the reason for that?

I do rely on vials that are both sterile and depyrogenated. That said, matching USP pharma standards isn't a goal the RUO community pursues, nor is it one it ought to pursue.

When a vendor sells only under RUO — particularly inside the US — the testing they run has to align with RUO specifications rather than USP pharma grade criteria. If a vendor puts USP testing language on a product, that carries the suggestion that the product is fit for human use. From a legal standpoint, they're better off keeping every test tied to RUO specifications, or they risk drawing FDA attention.

Since the 1970s, the life sciences field has set USP specs at greater than or equal to 95% purity with endotoxin less than or equal 1.0 EU/ug. Animal-free RUO grade and GMP RUO grade fall under greater than or equal to 98% purity with Endo less than or equal to 0.1 EU/ug, though it's clear that endo concentration only matters to certain vendors. So even setting sterility to one side, there are solid grounds for steering clear of USP Pharma specs.

Vendors and whatever limits they face weren't on my mind. What I want is for the people actually using these products to be able to get higher-quality options. It disgusts me that so much junk circulates in the grey community and gets treated as fine. Finding hair or leftover manufacturing debris inside your vials shouldn't be tolerated—certainly not by me.

 

[Chili777]

I'm in full agreement. Vendors need to be held to RUO standards when it comes to M/P and Endos, plus all the other junk that messes with sterility. And right now there's more of that going around than at any point I can recall over the past 2 years. Even vendors that used to be reliable are putting out or selling peps that contain fibers (or whatever those things are), and those peps are under dosed or sometimes have zero peps at all. My approach is to use my wallet and speak up whenever I spot it.

Because demand is through the roof, they're now shipping product before it's been tested and appear to be letting customers discover the problems on their own. What bothers me most is the vendor fanboys—you can watch them in the vendor forums making excuses for stuff that should never be tolerated. We need to vote with our wallets and be loud when standards aren't met. They also have to start accepting more than Jano COAs as proof; a few are beginning to, but it's not nearly enough.