Usp 797 Cleaning Requirements

USP 797 requires the preparation of PSCs to occur in iso pre-buffer zones of Class 5 (Class 100), ISO Class 7 (Class 10,000) and ISO Class 8 (Class 100,000). Achieving and maintaining USP 797 compliance in cleanroom environments with sterile compounding requires the application of specialized cleaning procedures and protocols. Contec Healthcare offers cleaning and disinfection products that meet or exceed the minimum standards set by USP . Our wiping systems, wipes and disinfectants are used to clean, disinfect and decontaminate sterile preparation plants and pharmaceutical clean rooms worldwide. We bring more than 25 years of experience in cleaning critical environments in preparation pharmacies. The gloves are sterilized by gamma irradiation to meet AAMI and ASTM standards. They are approved for use in USP797 and chemotherapy applications. Each case is marked with lot numbers to meet internal quality control requirements and full product traceability. Texwipe sterile windshield wipers quickly and easily clean aseptic cleanrooms without compromising the sterility of these environments. Texwipe sterile windshield wipers are ideal for cleaning pharmaceutical aseptic filling areas, biotechnology production facilities, microbiological laboratories and sterile suites. Texwipe® sterile windshield wipers quickly and easily clean aseptic cleanrooms without compromising the sterility of these environments. 70% sterile isopropanol, when applied with the appropriate wiper substrate, is effective for single-step cleaning of relatively clean surfaces and is ideal for the final rinse and residue removal step of many critical cleaning protocols.

Table [3] on page 15 of the USP chapter requires that floors be cleaned daily. The chapter states: “Floors in the buffer or clean zone, in the pre-treatment area and in the separate preparation area shall be cleaned by wiping once a day with detergent and disinfectant, at a time when no aseptic operation is in progress.” Table [3] on page 15 of the USP chapter recommends daily cleaning of work surfaces. The chapter states: “Work surfaces in iso class 7 buffer zones (see table 1) and iso class 8 prerequisite zones (see table 1) as well as separate composition areas must be cleaned and disinfected at least once a day.” And. “All detergents, such as windshield wipers, sponges and mops, shall not be disposed of, preferably made of synthetic microfibers and intended for use in the buffer or clean zone, in the forecourt and in separate mixing areas and shall not be removed from these areas except for disposal.” Disposable polyester mop head with burrs for cleaning and disinfection Wiping system with disposable microfiber lids for cleaning and disinfecting CLEANROOM FLOORS USP Chapter establishes minimum standards for cleaning and disinfecting the pharmacy`s clean room, including the types of products that should be used. The USP (page 16) also recommends that “all detergents, such as windshield wipers, sponges and mops, do not need to be discarded, preferably made of synthetic microfibers” and “Ideally, after a single use, all cleaning tools are disposed of by collection in appropriate plastic bags and removed with minimal stirring.” Chapter describes the minimum cleaning and disinfection requirements for the typical environment of a sterile preparation pharmacy. Our recommendations apply to pharmacies with a typical ISO 7 buffer zone, however, facilities with ISO Class 5 cleanrooms have stricter standards and may require products other than those listed here. Carefully select cleaning products and tools, taking into account the areas to be cleaned and the load on the floor. Experienced Contec Healthcare representatives can assist you in product selection. Contec Healthcare offers numerous wiping systems, wipes and disinfectants to clean all areas of the preparation pharmacy, including the vestibule. Contecâ ̄Healthcare`s experienced employees can help you with product selection. â ̄ Always consult the facility`s standard operating procedures (SOPs) prior to cleaning and disinfection.

Contec Healthcare recommended best practices for cleaning and disinfecting walls and ceilings: Would a facility comply with USP if aseptic “turbulent airflow” (CAI) insulation is used to propagate or distribute sterile drug preparations (provided that the above ICS placement and staff cleaning meet USP requirements )? Yes. USP states: “The use of technologies, techniques, materials and processes not described in this chapter is not prohibited until proven to be equivalent to or superior to those described in this chapter and to be of statistical significance.” In addition, however, a policy should be developed and enforced that requires conventional hand cleaning when hands or arms are visibly dirty. .