The pharmaceutical industry is, for obvious reasons, one of the most heavily regulated. As such, pharmaceutical cleanrooms must meet some of the highest standards in order to remain in compliance with such agencies as the FDA. One such standard, which is FDA enforceable, is USP 797.
This is a set of minimum practice and quality standards for compounded sterile preparation of drugs and nutrients and applies to health care institutions, pharmacies, physicians’ practices and any other facilities where pharmaceuticals are prepared, stored and/or dispensed. The purpose of the regulation (and pharmacy clean rooms) is to prevent infections in patients using pharmaceutical products, as well as to protect pharmacy staff members that are routinely exposed to pharmaceutical products.
Isoltech’s seamless finish, manufactured from heat welded rigid PVC panels, creates walls, floors and ceilings that are durable and impervious to water and chemicals used for cleaning and disinfection. Other characteristics include:
- Superior impact strength allows Isoltech finishes to withstand up to four times more force of impact than the leading competitor.
- Smooth, monolithic surfaces do not harbor dirt, bacteria or other contaminates, which account for at least 10,000 nososcomial infections per year.
The cleanliness of any clean room in the pharmaceutical industry is achieved and maintained by controlling the environment, workforce, products and processes in the room. Environmental controls include maintaining consistent room temperature and humidity; filtering the air entering the room; easily cleaned fixtures and fittings in the room; solid walls, ceilings and floors; flat surfaces; strict room cleaning schedules; and routine testing for microbial contamination. At Isoltech, we can help you install a complete solution that addresses all of your pharmaceutical clean room needs, including gowning rooms, filling rooms, blending rooms, air locks, pass thru’s and corridors.
To learn more about how your pharmaceutical business can benefit from a cleanroom with Isoltech surface finishes or to request a product sample, contact Jon Smith, Technologies Specialist, at 866-331-5910.