3 replies to this topic

[matthewcc]

Hello all,

 

It seems we have a problem with a door getting propped open for work we are doing in one of our laboratories.

 

The floor got water damage, so it is being ripped out, plus we are doing painting of the walls in the same room. I noticed the door was cracked open multiple times and brought it up as a problem after I shut it twice. I was told that we 'need' to have the door open for removal of damaged flooring materials and for ventilation of vapors from the painting and whatever other work there is. Some of the work will be done on the weekend, which will have me even more concerned about almost no one around with the risk of pests getting in or food defense issues. Anyway, what can we do in this situation? I offered to hold the door open while materials are removed and the response was that we would need it open all day. We have communicated a clear policy rule that we cannot prop doors open at any time.

 

What can be done in this situation so we can remain compliant?

 

This room is where we perform stability studies (with samples in a stability chamber) and where we perform our physical laboratory testing; it is adjacent to our chem lab and in the same building as all our manufacturing and storage of products.

 

We manufacture dietary supplements in the United States and are compliant with 21 CFR Part 111, Part 117, and Part 121 and have certifications with NSF for GMP and SQF for food safety.

 

Thank you,
Matthew

[kconf]

What consequences would you be facing if left open? Are there temperature, humidity, pressure controls in place? 

Are you able to measure deviations when door is open vs closed? Are there security cameras in there?

 

I don't see why you can't have it open while work is being done. 

[GMO]

If you have to circumvent controls, there is always a way. So for example, if you need to remove an external door to a food factory in high care, you bring in some bloody good screening and I mean actually putting up panels of whitewall kind of screening which is fully sealed. Not just a flexible bit of plastic. 

Whether you go that far or not depends on risk. If door open is unacceptable but it needs a way to vent, what other ways could there be? Could there be a mesh instead if pests are the issue. If air is, do you need to build an airlock around it and vent another way?

 

There's always a way, there's just a cost associated with whatever way you choose. Right now they've chosen the cheapest option. As a team, you need to decide if that's appropriate risk or not.

[jfrey123]

What they said.  If your only complaint is pests then ask your maintenance department to build you a temp screen that can be affixed to the door frame to prop the door open.  Place signage on the screen that it must be in place any time the door must be left open.  It's a reasonable control for a temporary construction issue.