Ks-Tek Vials?

I too have just begun buying ks-tek vials through aliexpress. Relative to other vials from amazon or China, they appear to be regarded as fairly strong in terms of quality and reliability. Of course, they are not on the same level as what the big global health companies put out. Still, given how difficult it is to source medical supplies here in Sweden/Europe, I plan to keep buying ks-tek vials, while watching for any tests that come back poorly or negative feedback.
 
tcpnomad said:

BlatantlyObviousXL said:

Last month was when I began Reta, and the vials I'm currently using are the 3ml KS-tek ones from Amazon. After filtering into a single vial, there's been no reaction at all and I haven't needed an instapot. Lot codes plus expiry dates are printed on them as well. That said, after going through the other vial threads, the possibility that they aren't sterile is somewhat worrying; endotoxins/gram negative bacteria are being discussed. Since that concerns me, I bought some certified sterile vials, so we'll find out. However, according to the official KS-tek site, they are sterile at 120c for 20 minutes and come in suitable sterilization bags, so I'm unsure what to believe. At times I feel like people push things too far and transform their addictions into hobbies.

As an aside, I have run a lab that performs plate testing for gram negative bacteria, so perhaps I'm jaded.
Is the question about the way the manufacturer sterilizes the vials? Or is it about sterilizing vials so they can be reused?
That's the sterilization method the manufacturer claims for these vials. My assumption (and my hope) is that it involves an autoclave or some validated sterile procedure, rather than something else entirely.
 
I’ve come across claims on multiple sites that KS-Tek vials recently failed a sterility test. I haven’t found any source backing that up, though. Can anyone share what actually happened?
 
On a different forum, I came across a ks-tek pen cartridge that did not pass sterility testing, though I have yet to see the same happen with standard vials.
 
UPDATE:

MedLab sent me the Ultra Spec Sterile 2ML (13mm neck) Clear Sealed Glass Vials. The glass bottles are good quality, however since I bought 50, they arrived as 2 sealed packs of 25. There are Lot #'s etc, and they follow a sterile process. Even with these, I think there's still a risk because after opening the 25 pack I had to transfer them into another container. I did that and will also wipe them with alcohol; ideally I'd keep them submerged in BA until use, if I could be certain the stopper wouldn't break down. MedSupply offers the option below, where they mention Endotoxin testing. So I'll probably stick with them from now on.

Ultra Spec Sterile 2ML-13mm Clear Sealed Glass Vial, Qty 1​#-ultra-spec-sterile-2ml-13mm-clear-sealed-glass-vial-qty-1

ULTRA SPEC sterile depyrogenated vials are put together using Teflon coated non-latex chlorobutyl rubber stoppers (meeting USP<381>) and vials produced from glass tubing (meeting USP<660>). Every vial is assembled under Class 100 regulations. For all lots, testing covers Sterility (USP<71>), Bacterial Endotoxins (USP<85>), and Particulates (USP <788>). Certificates of Analysis and test results can be provided on request.

Because of its low alkali content, this is a high-grade neutral glass tubing of the first hydrolytic class. Its superior hydrolytic resistance greatly lowers the chance of glass delamination, and interaction between the product inside and the container surface is kept to an absolute minimum, making it a better packaging choice for sensitive ingredients. This specific glass offers exceptional chemical resistance, neutrality, impermeability, and strength. Besides being an ideal neutral glass container for injectable solutions, these vials are also an especially safe packaging medium for biotechnological products.

Every ULTRA SPEC® vial has tight geometric tolerances and few cosmetic defects because 100% camera inspection checks dimensional parameters and critical cosmetic defects. All Vials are made and packed in environmentally controlled areas certified by ISO 9001 and ISO 15378. As a Type I glass (neutral glass Type I Class B, per ASTM E438 standard) it satisfies all pharmacopeia requirements in Europe, the USA and Japan. These vials work for laboratory use and sterile storage. These vials are not 510(k) cleared or intended to be used as a medical device or for any pharmaceutical packaging.
 
Back
Top