IT Isolator for EPA, OSHA, and FDA Regulations
The IT Isolator can help you meet EPA, OSHA, and FDA regulations affecting your industry. Below are examples of regulations the System One glovebox can help you meet:
Toxic Substances Control Act
Congress enacted the Toxic Substances Control Act to give EPA the ability to track industrial chemicals produced or imported into the United States. The IT Isolator gives you the safe, sealed environment EPA requires for chemicals that pose an environmental or human-health hazard.
Filling Operations
The FDA requires systems to be in place to protect products during filling operations.
Vacuum drying ovens are welded and polished without seams and are easily cleaned
The filling area has positive air pressure to prevent contaminants from entering in
The capping and vial washing areas have negative air pressure to prevent powders from escaping into the air
USP <797>
USP <797> addresses standards and requirements for reducing CSP contamination caused by an unclean environment. The System One glovebox can serve as a barrier isolator, providing an excellent alternative to a cleanroom. It provides the same level of air quality a cleanroom does, while taking up less space and being more cost-effective to operate.
NIOSH's alert for Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings
NIOSH's alert is aimed at reducing the risk health care workers face when they deal with hazardous drugs. Health care workers can be exposed to hazardous drugs through inhalation, skin contact, skin absorption, ingestion, or injection.
The IT Isolator can reduce the risk to health care workers by completely isolating hazardous material they are working with.
OSHA Guidelines for Hazardous Drugs
OSHA guidelines for hazardous drugs include preventing employee exposure and developing an appropriate work area. The System One glovebox can reduce the risk to employees by isolating hazardous material they are working with.
Waste Disposal
EPA regulations require that hazardous waste be managed and disposed of properly. Such hazardous waste can include pharmaceuticals. The System One glovebox provides a safe and sealed environment to properly package such waste before it is disposed of.
Call your Innovative Technology sales representative at 978-462-4415 to discuss how the IT Isolator can help ensure that you meet all governmental regulations in your industry.
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Sales and Service
Contact your Innovative Technology sales representative at 978-462-4415 or online to discuss how our glovebox systems and accessories can help you meet your application needs.
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