HEPA filters & safe change boxes 3

[pharma9]

Does anyone know on what occasions is it necessary to use safe change boxes in cleanrooms for the replacement of HEPA filters?

 

[SAK9]

Safechange filters are normally used in the exhaust duct of biosafety/nuclear labs.It is dangerous to touch filters in such contaminated exhaust streams so a safe change filter housing is recommended

 

[lilliput1]

They are also called bag in/bag out HEPA filters.

 

[abcmex]

Usually I have seen HEPA filters mainly in the technical areas, separated from the clean areas. This may be done to avoid the return of the contaminants (that you costly remove by using a Hepa filer) to the clean area.

Still I can imagine that certain equipment require Hepa filters in the clean area but you may avoid contamination by using this safe change systems.

 

[grim900]

They are also used on dust extract systems from powder filling rooms. Basically, anywhere where a potentially harmful product can be drawn into the extract system and would otherwise come into contact with the person carrying out the filter change.

 

[pharma9]

Thanks for all the help! I am in a situation where I am trying to justify the addition of a safechange filter based on referenced standards - does anyone know if it is a requirement to install them in Pharmaceutical cleanrooms or if it is just up to the company? From the standards I've read there's been hardly any mention of safechange filters at all!

 

[quark]

I have been in Pharma field for past 8 years and never heard any rule(you name any regulatory authority in the world and we got their approval). In highly contained areas, generally, HEPA In(no containment of active ingredients) and HEPA Out(you will change these with coveralls) configuration is used. So you need not worry about being exposed.

You have to perform clean down activity after changing the filters and validate the environment. You should maintain HEPA filter change SOP and record.

Regards,


Believe it or not : A cobweb with it's strands a pencil width, can catch hold of a concord. All questions directed to Discovery Channel.

 

[lilliput1]

The MSDS (material safety data sheet) would list the precautions required for the material. For flexibility, safety & to avoid potential law suite, use of bag in/bag out filter is recommended.

 

[twainagain]

Don't forget dust fire protection. If the filter's dust is conductive or combustible, the filter change area might need to be upgraded electrically (see NFPA for regulatory capture criteria).

Don