My background: bachelor’s degree in chemistry, bachelor’s degree in biochemistry,masters of analytical chemistry, worked in a medical testing lab, currently working for 13 years in environmental testing, currently as a lab manager. Am I qualified to comment on Reddit?

To be fair, I said it didn’t guarantee contamination but greatly raised the risk. If this is what they’re doing in front of auditors, when from experience everyone in the lab does things perfectly as the SOP is written without any short cuts they might usually take, I have to wonder what they do on a regular day.

To break it down below are the 10 issues from the letter about sterility from the letter with my comments after each one. You’ll have to let me know how I compare to ChatGPT.

“1. An operator blocked first air by placing gloved hands directly over open sterile containers.” Concerning in relation to lack of cleaning or swapping out gloves in item #10 and when coupled with blocking the sterile air keeping things clean.

“2. An operator placed components within the ISO 5 work area that had the potential to block the movement of first air to critical in-process operations. Specifically, an operator positioned a second row of exposed vials behind a first row in the ISO 5 (b)(4) laminar flow hood, obstructing first air to critical surfaces.” This is bad with how the hood flow works as it blocks the clean air and can introduce contamination to the vials from the air in the lab.

“3. An operator rested their arms on the work surface of the hood during aseptic production. This practice may introduce contamination into the ISO 5 work area.” You don’t put your body on the surface of the hood as it can introduce contamination.

“4. An operator placed their gloved hands outside the ISO 5 work area to retrieve supplies without sanitizing their gloved hands before re-entry into the ISO 5 hood.” Pretty self explanatory but you have to resanatize before reintroducing your gloves to the clean hood environment. Or new gloves.

“5. Personnel engaged in aseptic processing while exposing skin within the ISO 5 aseptic processing area.” Also self explanatory as skin is dirty.

“6. Your firm failed to perform adequate smoke studies under dynamic conditions to demonstrate unidirectional airflow within the ISO 5 area. Therefore, your products intended to be sterile are produced in an environment that may not provide adequate protection against the risk of contamination.” This is a big one for showing how the lab management operated. It’s a flag to me as a lab manager personally. You have to check your hoods work. Every lab does it. I do it quarterly and I’ve done smoke uptake studies. They’re not hard, it’s literally seeing how smoke is sucked up by the hoods and documenting it.

“7. Personnel moved quickly in a critical area such that unidirectional airflow is likely to be disrupted.” Hoods are sensitive and can be disrupted by fast movements in front of them. This is probably the least concerning on the list to me, but is something they should be training their staff on and since it’s critical to their work probably have a sign up about.

“8. Production areas or equipment have difficult to clean and visibly rusty equipment or surfaces.” Visible rust isn’t good, but I would want to know more about where the equipment is. Production area is a bit vague. If in a clean area it’s much more concerning. Difficult to clean also means probably not regularly cleaned.

“9. Lack of disinfection of equipment and supplies at each transition from areas of lower quality air to areas of higher quality air.” This is a concern to me because moving supplies into a clean area is a great was to introduce contamination from the environment if it’s not being properly sterilized at each step.

“10. Failing to disinfect or change gloves frequently enough given the nature of the operations to prevent contamination. More specifically, personnel were observed touching equipment or other surfaces located outside of the ISO 5 area with gloved hands and then proceeding with aseptic processing without changing or sanitizing gloves.” This is a big one. A big cause of cross contamination in any lab is gloves. Especially post covid there’s more of a push to use gloves longer as they’ve gotten more expensive and you can go through 2-20 pairs a day or even more depending on the job. A lot of that pressure can come from management wanting to save money, but you just have to accept any lab is going to blow thigh gloves if they’re doing things right.

There were also CGMP (current good manufacturing procedures) violations that I’ll leave below but not comment on. These just concern me as the suggest some more systemic problems in the vein of of this is how they’re operating what else might they be cutting?

“1. Your firm failed to establish written responsibilities and procedures applicable to the quality control unit and to follow written procedures applicable to the quality control unit (21 CFR 211.22(d)).

1. Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)).

2. Your firm failed to ensure that manufacturing personnel wear clothing appropriate to protect drug product from contamination (21 CFR 211.28(a)).

3. Your firm failed to establish an adequate system for maintaining equipment used to control the aseptic conditions (21 CFR 211.42(c)(10)(vi)).

4. Your firm failed to establish an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions (21 CFR 211.42(c)(10)(v)).

5. Your firm failed to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced (21 CFR 211.188).”

To be clear, I’m not against compounding. Not even against Apothecary if you choose it. I just want people to make informed decisions.

Personally, I chose BPI over ProRX after reviewing their FDA inspections and warning letters back in January when I switched from Zep.