USP 797 & 800 Lighting Lighting for Compounding Pharmacies
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.
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
- 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.
Compounding Pharmacies require USP 797 and 800 lighting
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.
Light Fixtures for Compounding Cleanrooms
Kenall’s CSEDO and CTD series are excellent examples of lighting that meets USP-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. These fixtures are also available with amber LEDs, Preventing damage to photosensitive ingredients in compounding pharmacies by using a 570 nm or 590 nm Amber LED curcuit, whereas UV and some short-wavelength visible light can create unwanted chemical reactions, prematurely degrading medications.
