Production Process, ETC.
Injectables:
Sterilization:
-Vials and stoppers are rinsed in water, and then bathed in methanol, before being baked (Vials are heated to 250*, Stoppers 180*) to dry and sterilize.
-Beakers, stir rods are washed and dried with the same method
-Tubing for sterile oil dispensing is washed with methanol and dried at 170*, then vacuum sealed until next use.
Hygiene:
Medical scrubs are worn, along with a facial mask and disposable gloves (which are frequently changed due to the nature of handling different items throughout the brewing process).
Process:
After a cleaning of the entire production area with methanol cleaner, vials/media bottles are sterilized and placed to heat dry. While they bake, the injectables are prepared with care to ensure sterility. Once the hormone is dissolved throughly, it is run through a .22um filter into a sterile glass media bottle. Sterile tubing is fed into the filtered solution, and connected to a peristaltic pump that very accurately fills vials. This process is very efficient, so there is minimal exposure to air. After filling, stoppers/tops are applied and then crimped, labeled, and sent to storage.
Tablets:
Sterilization/ Hygiene:
While the requirements for oral products require less stringent environments in regards to sterility, all tablets are mixed and produced with machinery that complies with GMP standards. Face masks are worn, as are gloves.
Process:
-Tablet binders, excipients, dyes, and API's are measured, sifted, and then placed into a pharmaceutical mixer to ensure consistent product dosing.
-Once mixed, tablet mix is fed into a tablet press, producing tablets.
-Tablets are counted automatically, then dispensed into HDPE pill bottles, sealed with a shrink band, labeled and sent to storage.
Testing:
As mass spec is hard to have done in Canada, all raw hormones are tested using a melt test on a precise hot plate. I do not have great confidence in labmax test kits, and as such they are not used. All compounds have passed the melt test within the acceptable bounds. We are looking into mass spec, and will have this done when it is available.
References: I am currently not sourcing on any other boards at this given moment.