Hello everyone.
I believe I have reached a conclusion on the source of contaminant(s) and formed a plan for remedy of any chance of foreign matter entering vials.
Contaminant source:
A: I feel almost 100% certain that any fibers found inside the vials would be cellulose or polypropylene fibers from the sterilization wraps I used for my vial trays. In all honesty, I was somewhat surprised at how commonplace it is for sterilization wraps and sterile gowns to shed fibers. I will try to code a link and add a pdf with informative information about the subject at the end of this post. I have never coded a link here; so I am unsure how but I will try. I the links work, there is an image of the type of 'lint' I saw on my gloves that prompted me to discard the sheets and 28 vial trays a while back. It may be in the PDF; I can't remember. I have read and looked at an enormous amount of information. What I encountered was nothing as severe as the picture; but it was the same color and texture.
B: Hematite or iron oxide (rust) is one of the most frequent contaminants found in sterile liquid pharmaceutical products. Some articles claim that it is the most frequent contaminant. Any black specks seen within the vials will most likely be rust particles from vial manufacturing or, again, from the sterilization wraps manufacturing equipment.
C: It is possible that things floating in the air can get in the vial during the time my smaller trays are exposed before the wrap is applied. I am very careful and practice very good hygiene when this is done; but I do not have a certified clean-room and I am not sterile during the vial transfer to my autoclave trays.
Please keep in mind that this is common enough for billion-dollar pharmaceutical companies and hospital surgical suites to have encountered the same issues-----prompting articles to be written and resolution strategies to be designed. While I do my very best to do a good job at this; I am not nearly as equipped as many entities who have had similar issues. In short----I have done the absolute best I could do with what I had to work with.
Going forward:
From my deduction, there is a singular root cause to any potential contamination of a vial; and that is the process of sterilization of the vials. I have looked for hours at different sterile vial suppliers and I have found one with vials that are of nearly the same dimensions as mine but do not have the blowback ridge for the stopper since they are not North American made. This is not a problem and I intend to use these pre-sterilized vials for any future injectable preparations.
I am not using pre-sterilized vials because they will be 'more sterile' than my process; but because they are sterilized by gamma radiation and have no contact with synthetic or natural fiber wraps. It will cost me more money; but will take a step out of my process that will benefit everyone.
Existing stock:
I'm not going to empty out all of those vials and re-filter them. I'm just not. The contents of those vials are sterile and I have not found one single fiber/floater/pube/or otherwise in them. I'm not finished with them yet; but I haven't found anything so far
EXCEPT some inclusions that look like black spots within the walls of a few of the vials. This is a common problem that is discussed in one of the links I have as well if anyone would like to read about it. These black spots are rust also and they are contained within the glass; so there is no way that they could ever enter the body through injecting the contents of the vial. The injectable vials will still be available for purchase after each one is examined and then examined again under blacklight.
Refunds and reshipments:
Nothing has changed about the way I stand behind my products.
Anyone who has any product that has:
- a bad analytical test (with a legitimate report),
- a vial with visible contaminants (with a photo of the contaminant), or
- an omission/mistake in their order
will receive his/her choice of an immediate refund for the affected container(s) or a reshipment of the same value.
I was very caught off guard by this whole thing and I was/am embarrassed about it.
However, in the last couple of days there have been many people who emailed me to demand their entire order be replaced, including oral suspensions and armodafinil.
One even threatened to ruin my "bitch ass in the anabolic world" if I didn't refund AND reship his order. I do not respond to threats well.
I am not going to reship or refund full orders as some sort of expectation; and those representatives of the community have completely removed any excess generosity I had going into this problem resolution.
I do not mind helping and I require myself to make amends; but I will certainly not be taken advantage of in that way.
I am open to any questions or comments and I am always willing to work for an amicable solution. This is a sound theory of contamination possibility and a sound proposal for remedy of any future contamination potential.
I am very very tired and I need to sleep tonight. I realize that there will be some emails that pass the 24 hour mark before I can reply in the morning; but I have gone as long as I can without sleep now.
No person will be left with an issue that is not addressed. Just please remember that there are 10x as many worried-well emails as there are potential issues and each person gets the same level of attention. Emails are answered in the order they are received; except for new order emails which are left to the autoreply only.
I want to briefly inquire about the widespread inability to take photographs of these contaminants:
My phone is fairly old; but it has a 8mp camera that takes very good photos.
In the photos below there is a speck I saw in a NPP vial. It is tiny and is circled in blue. It was actually on the label and circled in blue in the 2nd picture although I mangled the label when trying to remove it. Yes, this is in my bathroom and this is from my personal supplies that are the same as what I send out in packages. And yes, that is a floss pick beside it for reference of size. The point of these pictures is to show that my ordinary phone can take pictures of very tiny specks at very close distances. Also, of note is that I did not see that until I looked into the vial for about 2 minutes.
The link for the article is here. I hope it is done right.
Code:
https://www.mccrone.com/mm/contaminant-identification-pharmaceutical-products/
And no none of that shit is kept in house after purchase. Too many sorry fuckers have gotten busted during otherwise mundane random police calls, ie the wife calls the police after a a break in and what's that is that illegal steroids on that dresser, here comes the search warrant and here comes your life getting tossed upside down. And then theres the disgruntled ex etc etc etc.
