Air Filtration System
Hi everyone!
I work for a new company who will be producing PET injection blow mold plastic containers for food packaging. We are going to be going through a cGMP audit in a couple months.
Currently our warehouse has no heating or cooling system. I see in the audit packet/checklist that it has a section on air filtration systems. Are we going to need to put in some kind of air filtration system? And if we don't do we need to have our air tested?
I guess all of this is just very confusing to me, as I'm very new to this industry. I also understand that ceiling lights need to be either covered or contain shatterproof bulbs. Is there any exception to this? We have very high ceilings and these are brand new lights that they just put in right before I was hired. I'm just wondering if I'm going to have to have them all changed out.
Thank you! Please let me know if I have left out any important information.
You'll need to do air testing under cGMP regardless.
Yes, your lighting needs to be shatterproof, inherently or via shields.
Yes, your facility needs an air handling system.
You'll need to do air testing under cGMP regardless.
Yes, your lighting needs to be shatterproof, inherently or via shields.
Thank you I really appreciate you taking the time to respond. I don't have much experience or help and I'm trying to get everything done right. Thank you!
I can't weigh in on the cGMP requirement for air filtration. I've never done cGMP, food grade plastic manufacturing, nor worked in a building where the entire production area had filtered air. For my non-filtered facilities, we did perform routine air testing as part of our environmental monitoring program, nothing concerning was ever recorded. Not sure if that act would get you an exemption in cGMP, might be worth a look.
As for the lights, if they have shields (depending on design), you can get around replacing them with shatterproof bulbs so long as the shields sufficiently contain any broken bits and won't pose a breakage risk themselves. You'll also need to include in maintenance procedures that lights are not to be changed over active production areas, etc. My first facility had fluorescent bulb fixtures with a flat plastic shield on the bottom of the housing. Identified the bulbs (4 per unit) and the plastic shield on my glass and bp register, then got up on a scissor lift and covered the shield with transparent contact film (to prevent any broken shield bits from separating and falling). I was glad that I also put a little colored dot sticker between the shield and the contact film, as my first SQF auditor wanted to be lifted up to verify I was telling the truth. When he couldn't peel the sticker off the shield, he was satisfied that we were truthful about applying the contact film.
I can't weigh in on the cGMP requirement for air filtration. I've never done cGMP, food grade plastic manufacturing, nor worked in a building where the entire production area had filtered air. For my non-filtered facilities, we did perform routine air testing as part of our environmental monitoring program, nothing concerning was ever recorded. Not sure if that act would get you an exemption in cGMP, might be worth a look.
As for the lights, if they have shields (depending on design), you can get around replacing them with shatterproof bulbs so long as the shields sufficiently contain any broken bits and won't pose a breakage risk themselves. You'll also need to include in maintenance procedures that lights are not to be changed over active production areas, etc. My first facility had fluorescent bulb fixtures with a flat plastic shield on the bottom of the housing. Identified the bulbs (4 per unit) and the plastic shield on my glass and bp register, then got up on a scissor lift and covered the shield with transparent contact film (to prevent any broken shield bits from separating and falling). I was glad that I also put a little colored dot sticker between the shield and the contact film, as my first SQF auditor wanted to be lifted up to verify I was telling the truth. When he couldn't peel the sticker off the shield, he was satisfied that we were truthful about applying the contact film.
This is incredibly helpful information regarding the lights. I would have never thought about putting contact film over the shield since it will be made of brittle plastic/breakable material as well. Or making sure to have a lift available during an audit in case they request to go up and look for themselves. I greatly appreciate this thank you!