Final Steps
Final Sterilization
There is a vast misconception that putting closed and finished vials into your autoclave will sterilize them. Because the vial is sealed and cannot be penetrated by steam, there is no veracity to this claim. The heat generated from your autoclave alone is not sufficient to sterilize the inside of the vial. See this page for more info.
Therefore, you do not need to take any final sterilization steps if you followed the previous steps precisely.
Of course, some bacteria is killed at 121°C. An autoclave cycle won’t do nothing, but it is not sufficient to create conditions of sterility in your vial. You may put your vials into the autoclave for 30-60 minutes, as a final just-in-case, but in theory it’s not needed.
Making a Record
It’s important that you have a written record of everything you did with this brew. This is an extremely important quality control technique.
- The ingredients and supplies used, where they were acquired, when they were acquired, and their lot/batch numbers if available
- The items that were sanitized, sterilized, and depyrogenated
- The temperature, time length, and technique that was used for those “cleanings”
- Bubble point test info
- Outcome of fingertip+ and sterility testing+
- As much as you can write about exactly what you did
- Anything else you can think of.
This data should be given a Batch Number. If you encounter any problems with any of your vials down the line, you can look at the batch number and review the process and ingredients.
Labeling
You should label each vial with the following information
- Active ingredient and strength (e.g. 40mg/mL)
- Total volume
- Manufacturer name (that’s you!)
- Manufacture date
- Batch number
Optionally you might add
- Inactive ingredients and concentrations
- Logo/design/cat girls/memes
Here’s an example of something we might use:
If you plan to mail your vials, especially T, you may consider making fake labels for your vials to claim that something else is inside of them. If you’re doing this make sure your recipient knows you’re doing it and knows where to find the correct information that should be on the vials.
Check status of tests
If you preformed fingertip testing and final sterility testing #TODO
All done :)
If you have plans to sell your vials, or if you’re already doing so, we recommend you read through the tips on the next page to help your security culture.