Changing to amber lighting in your packaging production room when running pharmaceuticals that require protection from ultraviolet (UV) light takes valuable time that could be better spent producing good product. Is there an easy alternative? Perhaps so.
During a tour on Sept. 19 of a newly built—and now just completed—pharmaceutical packaging suite at PCI Pharma Services in Rockford, IL (see photo above), an interesting conversation about this subject came up with PCI’s Brian Keesee, vp/general manager, Global Clinical Operations & Supply, and Russell Stevens, director, facilities engineering and maintenance.
As part of its sustainability efforts in building this facility expansion (see photo above), contract manufacturer/packager PCI opted to install LED lights, which don’t emit UV rays. So, there is a possibility that LED lights can save PCI time—hours, in fact—between product/customer changeovers by not having to reset the packaging room with amber lighting for UV-sensitive drugs if allowed by the regulations and by its customers.
I was curious to see if it would be allowed by the Food and Drug Administration and reached out to the regulatory agency with two questions:
1. What are the current regulations regarding amber lighting in a packaging operations room/facility for UV-sensitive drugs?
2. Has the FDA considered updating the current regulations to allow for packaging UV-sensitive drugs in rooms with LED lighting? Why or why not?
Charlie Kohler in FDA’s Trade Press Office replied: “The CGMP [current Good Manufacturing Practices] regulations only require that ‘adequate lighting shall be provided in all areas’ (see 21 CFR 211.44) and do not prohibit or prescribe the use of any type of lighting. Manufacturers may use any lighting that satisfies the CGMP regulations, which means the lighting used must be adequate to enable operators to perform their manufacturing responsibilities, and special lighting conditions or controls be used when needed to preserve product quality.”
Basically: Yes, LED lighting is suitable for packaging areas handling pharmaceuticals that need to be protected from UV light, according to the FDA.
Earlier today, Dec. 4, 2019, PCI announced completion of this latest plant expansion—which includes four high-potent compound capable suites, three new secondary packaging areas, three new coolers and a freezer—to handle specialty drug products for cancer and hormonal therapies, as well as other treatments.