USP 797 & 800 Lighting
Lighting for Compounding Pharmacies in Healthcare & Cleanroom Applications
USP-800 requirements demand changes in hospital construction and operation. Many hospitals are now renovating their compounding pharmacies in order to meet the requirements of USP-800 and the older but still essential, USP-797. These areas handle dangerous or hazardous drugs that can cause health problems for the people delivering the treatment as well as others. Every time a clinician dispenses potent chemicals, they may be taking some of that medicine themselves. The hazards of inhalation or absorption of these drugs can be reduced by following the guidelines and standards described in The United States Pharmacopeia Convention’s (USP) general chapter 797 and 800.
Compounding Pharmacies require USP 797 and 800 lighting.
Many pharmaceuticals are considered hazardous even in microscopic amounts. The National Institute for Occupational Safety and Health (NIOSH) considers a drug to be hazardous if it damages DNA, causes cancer, contributes to infertility, harms a developing fetus, causes developmental abnormalities or causes organ damage. This is why compounding cleanroom regulations are so important. The weakened state of a patient's health, and the frequent exposure to the hospital staff, necessitates controlling the way these medicines are handled in the healthcare setting.
Changes to Cleanroom Requirements
The healthcare facility must now provide protections for the people involved by creating a controlled environment or cleanroom for handling these drugs, including airlocks, sealed rooms and microenvironments or BSCs with controlled airflow using positive and negative pressure to keep the hazardous chemicals separate from the staff and patients. These cleanrooms have separate air handling systems and use hard ceilings fitted with HEPA filters and ISO14644-1 rated cleanroom fixtures as the only penetrations in the room. All other penetrations must be permanently sealed during the construction process.
Kenall Light Fixtures Meet USP797 and USP800 Requirements
Light Fixtures for Compounding Cleanrooms
Lighting for compounding cleanrooms should meet the highest standards for cleanability, like those found in NSF-P442. These fixtures have an IP rating of at least IP65 and have progressive surfaces for ease of cleaning. They have hole-free housing that allow servicing in place without compromising the cleanroom to possible contamination. The fixture housings are permanently sealed into the ceiling using a sealant like caulk. Due to the high air pressures, the conduit system must be sealed to prevent air passage through the wire path. There should be no crevices between the fixture door and ceiling that might hide airborne particles, since each particle may contain enough dosage to permanently damage the health of the pharmacist, technician, or even the cleaning crew or electrician.
Kenall’s CSEDO series is an excellent example of lighting that meets USP 797 & 800. They are part of the SimpleSeal™ family of cleanroom fixtures, providing the highest level of certification and the reliable seal that compounding pharmacies require.