PPE Requirements in Manufacturing Area of Class IIa Medical Device

D

Dr RA

#1
In a recent audit,on raising NC on the manufacturing area of class IIa were operating without gloves : I heard it is not appropriate for the staff to handle machinery with gloves.

Can someone let me know if the compliance and standards say on the requirements of PPE?

Based on Risk analysis, the area has been asked to wear gloves when working in the area.

Thank you all
 
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ScottK

Not out of the crisis
Staff member
Super Moderator
#2
In a recent audit,on raising NC on the manufacturing area of class IIa were operating without gloves : I heard it is not appropriate for the staff to handle machinery with gloves.

Can someone let me know if the compliance and standards say on the requirements of PPE?

Based on Risk analysis, the area has been asked to wear gloves when working in the area.

Thank you all
as far as safety regulation goes, it's really up to the company to do the hazard analysis on use of gloves while operating machinery.
For me, it depends on the type of equipment and type of glove.

I have worked in drug packaging where you must wear gloves while running the packaging line. If they are wearing lightweigh nitrile gloves the glove will usually rip before a hand can be dragged along... if they are wearing heavy work gloves it could be a danger.

What kind of equipment are you using and what kind of gloves are the auditors asking you to wear?
 
D

Dr RA

#3
Thanks Scott,

The machinery is for filling and packaging of powder disinfectant. It has been assessed to wear gloves(nitrile gloves) in the area as the operators will be in direct contact with the packaging material which will be in contact with the powder. The gloves should not interfere with the operation of machinery.

What was your action to the incident you referred to and how did you resolve the issue?

Thanks again

RA
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#4
Thanks Scott,

The machinery is for filling and packaging of powder disinfectant. It has been assessed to wear gloves(nitrile gloves) in the area as the operators will be in direct contact with the packaging material which will be in contact with the powder. The gloves should not interfere with the operation of machinery.

What was your action to the incident you referred to and how did you resolve the issue?

Thanks again

RA
There was no incident - but gloves were mandatory for all equipment since we were packaging drug product. And we were running automatic bottle fillers and cappers, so there was a lot of moving parts. In my time there we never had an injury due to a glove getting caught in the machine.

I would think that for what you are doing based on the limited information you can provide on an internet forum, the safety risk of wearing nitrile is minimal and the need to keep sanitary would trump the safety issue.
I suggest increase safety awareness training and make sure no one uses loose or ripped gloves.
 
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