HI All,
My question is in specific reference to ISO 22716:2007 4.4.5 which states " facilities are of adequate size, construction, and design for their intended use such as receipt, storage, and production."
We have a space now that I am trying to make compliant. Our compounding area for cosmetic material currently shares the same "air space" as our manufacturing area and is not enclosed. Kettles of course are enclosed but the room is not.
Rather than enclosing the space, I am trying to see if I can justify using some excellent SOPs for cleanliness and containment as we open raws to dump into the kettles. Something along the lines of PPE, gloved, spray gloves with IPA and container. I may also implement a portable HEPA filter system at point of opening the containers but I am trying to figure out if this is all in vain if the auditory is going to want to enclose the space.
My question is in specific reference to ISO 22716:2007 4.4.5 which states " facilities are of adequate size, construction, and design for their intended use such as receipt, storage, and production."
We have a space now that I am trying to make compliant. Our compounding area for cosmetic material currently shares the same "air space" as our manufacturing area and is not enclosed. Kettles of course are enclosed but the room is not.
Rather than enclosing the space, I am trying to see if I can justify using some excellent SOPs for cleanliness and containment as we open raws to dump into the kettles. Something along the lines of PPE, gloved, spray gloves with IPA and container. I may also implement a portable HEPA filter system at point of opening the containers but I am trying to figure out if this is all in vain if the auditory is going to want to enclose the space.