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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.

More About Compounding Standards

Hospital Pharmacutical Room
Hospital Pharmacutical Room

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

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 570nm Amber LED circuit, whereas UV and some short-wavelength visible light can create unwanted chemical reactions, prematurely degrading medications.

Kenall luminaires using Indigo-Clean Technology (ICT) take the lighting for compounding cleanrooms to the next level. They meet the stringent USP-797 & 800 ligthing requirements, while using a combination of 405nm indigo and white LEDs, killing harmful bacteria while providing ambient illumination for the space.