nitramnaed
Sawhorse
I have a question if you are familiar with ADA exceptions on clean rooms.
According to the City, clean room would need to be reconstructed to meet ADA standards (e.g. to fit a wheelchair). We have used the California Unreasonable Hardship Exemption found in Accessibility for Existing Buildings 2016 CBC, Section 1134 B.2.1, Exception 1, 2017 Valuation Threshold; and it was rejected.
“Clean rooms” are where staff disinfects, gowns up from head to toe and enters the room to collect the finalized raw material that was crystalized during the lyophilzation process. The product is removed from the trays and placed in small bottles using a safety bench. The product is then removed and additional weighing and paperwork is performed.
The rooms are usually small and have very specific engineering controls. The purpose of gowning and the engineering controls is to ensure that API powders/solids released are minimized and/or eliminated. Further the gowning is meant to protect the worker from receiving small doses of these releases.
Are our arguments against ADA compliance are as follows:
Can’t ensure that the wheelchair is sanitized prior to entering the clean rooms.
Can’t ensure that the wheelchair would not be exposed to APIs, which means that the material could be brought into a person’s car or household.
Can’t gown up a wheel chair.
Expanding the room would change the engineering controls, which would be costly.
Expanding the room would increase the chance that the product would be spilled due to increasing travel distance.
Are there any applicable ADA exemptions that we may use?
According to the City, clean room would need to be reconstructed to meet ADA standards (e.g. to fit a wheelchair). We have used the California Unreasonable Hardship Exemption found in Accessibility for Existing Buildings 2016 CBC, Section 1134 B.2.1, Exception 1, 2017 Valuation Threshold; and it was rejected.
“Clean rooms” are where staff disinfects, gowns up from head to toe and enters the room to collect the finalized raw material that was crystalized during the lyophilzation process. The product is removed from the trays and placed in small bottles using a safety bench. The product is then removed and additional weighing and paperwork is performed.
The rooms are usually small and have very specific engineering controls. The purpose of gowning and the engineering controls is to ensure that API powders/solids released are minimized and/or eliminated. Further the gowning is meant to protect the worker from receiving small doses of these releases.
Are our arguments against ADA compliance are as follows:
Can’t ensure that the wheelchair is sanitized prior to entering the clean rooms.
Can’t ensure that the wheelchair would not be exposed to APIs, which means that the material could be brought into a person’s car or household.
Can’t gown up a wheel chair.
Expanding the room would change the engineering controls, which would be costly.
Expanding the room would increase the chance that the product would be spilled due to increasing travel distance.
Are there any applicable ADA exemptions that we may use?
