USP–NF General Chapter <797>

Pharmaceutical Compounding - Sterile Preparations

The objective of the USP <797> Guidelines is to describe conditions and practices to prevent harm, including death, to patients resulting from a contaminated or improperly made compounded sterile preparations (CSPs). USP <797> provides minimum practice and quality standards for CSPs of drugs and nutrients, based on current scientific information and sterile compounding standards detailing requirements for compliance.

USP <797> Standards for

Cleaning & Disinfecting Pharmacy Controlled Environments

USP Chapter <797> establishes minimum standards for cleaning and disinfecting the pharmacy cleanroom, including the types of products that must be used.

Contec Healthcare offers cleaning and disinfecting products that meet or exceed the minimum standards established by USP <797>. Our mopping systems, wipes, and disinfectants are used to clean, disinfect and decontaminate sterile compounding facilities and pharmaceutical cleanrooms around the globe. We bring more than 25 years of experience in cleaning critical environments to compounding pharmacies.

Chapter <797> outlines minimal cleaning and disinfecting requirements for the typical Sterile Compounding Pharmacy environment. Our recommendations are for pharmacies with a typical ISO Class 7 Buffer Zone, however, facilities with ISO Class 5 cleanrooms have more rigorous standards and may require different products than those listed here. Select cleaning products and tools carefully, considering the area(s) being cleaned and the soil load. Experienced Contec Healthcare representatives can assist you in product selection.

USP <797> Standards for Primary Engineering Controls (PEC)

Daily Cleaning of ISO 5 Laminar Airflow Work Bench, Biological Safety Cabinets and other PEC (Primary Engineering Controls)

Minimum Cleaning Frequency:

Beginning of each shift, before each batch, every 30 minutes while compounding, as spills occur, when surface contamination is suspected.

What does USP <797> say?

From page 15 of the chapter, “Cleaning and disinfecting surfaces in the LAFWs, BSCs, CAIs, and CACIs are the most critical practices before the preparation of CSPs. Consequently, such surfaces shall be cleaned and disinfected frequently, including at the beginning of each work shift, before each batch preparation is started, every 30 minutes during continuous compounding periods of individual CSPs, when there are spills, and when surface contamination is known or suspected from procedural breaches.”

The chapter also requires that this be done with a “residue-free disinfecting agent such as Sterile 70% IPA which is allowed to dry before compounding begins.” And…. “When sterile supplies are received in sealed pouches designed to keep them sterile until opening, the sterile supplies may be removed from the covering pouches as the supplies are introduced into the ISO Class 5 (see Table 1) PEC (LAFW, BSC, CAI, CACI) without the need to disinfect the individual sterile supply items.”

Page 15 of the USP Chapter states that the disinfecting step “shall be followed by wiping with a residue-free disinfecting agent such as Sterile 70% IPA, which is allowed to dry before compounding begins.” Always follow site protocols and SOPs

CONTEC HEALTHCARE RECOMMENDED BEST PRACTICES FOR CLEANING AND DISINFECTING IN THE PRIMARY ENGINEERING CONTROLS (PECS):

  • While not required by USP <797>, it is considered best practice to use sterile wipes in the PEC
  • Always use unidirectional overlapping strokes; side-to-side
  • Clean hard to reach areas and IV Bar with a hand wipe prior to cleaning large surfaces of the PEC
  • Wipe gloved hands and cleaning supplies with Contec Sterile 70% IPA. Ensure that all items have been wiped before placing into PEC

Experienced Contec Healthcare representatives can train your staff on the best practices for cleaning and disinfecting per USP requirements.  

USP <797> Standards

For the Anteroom and the Buffer Room

Minimum Cleaning Frequency: Monthly

Contec Healthcare offers many mopping systems, wipes, and disinfectants for cleaning all areas of the compounding pharmacy, including the anteroom. Experienced Contec Healthcare representatives can assist you in product selection.  Always consult the facility’s Standard Operating Procedures (SOPs) before cleaning and disinfecting.

Facilities that compound hazardous drugs should have one dedicated set of hardware for the non-hazardous IV room and a second set for the hazardous compounding area.

What does USP <797> say?

Table [3] of the USP chapter requires that cleanroom walls, cleanroom ceilings, and storage shelving be cleaned monthly. The text on page 16 of the chapter states, “In the buffer or clean area, ante-area, and segregated compounding area, walls, ceilings, and shelving shall be cleaned and disinfected monthly.”

Contec Healthcare recommended best practices for cleaning and disinfecting walls and ceilings:

  • Always clean from top to bottom.
  • Start with the ceilings.
  • Before cleaning walls, clean all irregular surfaces (air returns, outlets, shelving, ports, etc.) by hand with a dry wipe (Amplitude EcoCloth: AMEC0003) and PeridoxRTU.
  • Clean the walls, using slightly overlapping strokes to ensure complete coverage with the disinfectant.  
  • Always follow site protocols and SOPs.

Experienced Contec Healthcare representatives can train your staff on the best practices for cleaning and disinfecting per USP requirements.

What does USP <797> say?

Table [3] on page 15 of the USP chapter requires that floors be cleaned daily. The chapter states that “Floors in the buffer or clean area, ante-area, and segregated compounding area are cleaned by mopping with a cleaning and disinfecting agent once daily at a time when no aseptic operations are in progress.” 

USP (page 16) also recommends that “All cleaning materials, such as wipers, sponges, and mops, shall be nonshedding, preferably composed of synthetic micro fibers” and “Ideally, all cleaning tools are discarded after one use by collection in suitable plastic bags and removed with minimal agitation.” 

In selecting a disinfectant to use for floor cleaning, USP (page 15) states, “When the surface to be disinfected has heavy soiling, a cleaning step is recommended prior to the application of the disinfectant.” And… “Many disinfectants registered by the EPA are one-step disinfectants. This means that the disinfectant has been formulated to be effective in the presence of light to moderate soiling.” 

USP (page 16) states that all “…wipers, sponges and mops…should be dedicated to use only in the buffer or clean area, ante area and segregated compounding areas and shall not be removed from these areas except for disposal.” In other words, your mops and cleanroom floor cleaning supplies must be stored and remain in the clean area. 

Contec Healthcare recommended best practices for cleaning and disinfecting floors: 

  • For best results, begin at the farthest corner of the room and mop backward toward the door.  
  • Use slightly overlapping strokes, in an S-curve pattern, ensuring complete coverage.  
  • Disinfectant dwell time is critical. 
  • Remember that mops and cleaning supplies should be dedicated to the cleanroom floors and stored in the ante area.  
  • Always follow site protocols and SOPs. 
USP <797> Standards for

Monthly Cleaning of Pharmacy Cleanroom Ceilings & Walls

Minimum Cleaning Frequency: Monthly

Contec Healthcare offers many mopping systems, wipes and disinfectants for cleaning all areas of the compounding pharmacy, including the anteroom. Experienced Contec Healthcare representatives can assist you in product selection. Always consult the facility’s Standard Operating Procedures (SOPs) before cleaning and disinfecting.

Facilities that compound hazardous drugs should have one dedicated set of hardware for the non-hazardous IV room and a second set for the hazardous compounding area.

What does USP <797> say?


Table [3] on page 15 of the USP chapter requires that cleanroom walls, cleanroom ceilings, and storage shelving be cleaned monthly. The text on page 16 of the chapter states, “In the buffer or clean area, ante-area, and segregated compounding area, walls, ceilings, and shelving shall be cleaned and disinfected monthly.”

Contec Healthcare recommended best practices for cleaning and disinfecting walls and ceilings:

  • Always clean from top to bottom.
  • Start with the ceilings.
  • Clean hard to reach areas and IV Bar with a hand wipe prior to cleaning large surfaces of the PEC.
  • Before cleaning walls, clean all irregular surfaces (air returns, outlets, shelving, ports, etc.) by hand with a dry wipe (AMEC0003) and PeridoxRTU.
  • Clean the walls, using slightly overlapping strokes to ensure complete coverage with the disinfectant.
  • Always follow site protocols and SOPs​.

Experienced Contec Healthcare representatives can train your staff on the best practices for cleaning and disinfecting per USP requirements.

USP <797> Standards for Primary Engineering Controls (PEC)

Daily Pharmacy Cleanroom Floor Cleaning

Minimum Cleaning Frequency:

Daily, when no aseptic operations are in progress

What does USP <797> say?

Table [3] on page 15 of the USP chapter requires that floors be cleaned daily. The chapter states that “Floors in the buffer or clean area, ante-area, and segregated compounding area are cleaned by mopping with a cleaning and disinfecting agent once daily at a time when no aseptic operations are in progress.” 

USP (page 16) also recommends that “All cleaning materials, such as wipers, sponges, and mops, shall be nonshedding, preferably composed of synthetic micro fibers” and “Ideally, all cleaning tools are discarded after one use by collection in suitable plastic bags and removed with minimal agitation.” 

In selecting a disinfectant to use for floor cleaning, USP (page 15) states, “When the surface to be disinfected has heavy soiling, a cleaning step is recommended prior to the application of the disinfectant.” And… “Many disinfectants registered by the EPA are one-step disinfectants. This means that the disinfectant has been formulated to be effective in the presence of light to moderate soiling.” 

USP (page 16) states that all “…wipers, sponges and mops…should be dedicated to use only in the buffer or clean area, ante area and segregated compounding areas and shall not be removed from these areas except for disposal.” In other words, your mops and cleanroom floor cleaning supplies must be stored and remain in the clean area. 

Contec Healthcare recommended best practices for cleaning and disinfecting floors: 

  • For best results, begin at the farthest corner of the room and mop backward toward the door.  
  • Start with the ceilings.
  • Use slightly overlapping strokes, in an S-curve pattern, ensuring complete coverage.
  • Disinfectant dwell time is critical. 
  • Remember that mops and cleaning supplies should be dedicated to the cleanroom floors and stored in the ante area.
  • Always follow site protocols and SOPs. 
USP <797> Standards for

Daily Cleaning of Cleanroom Pharmacy Counters and Easily Cleanable Work Surfaces

Minimum Cleaning Frequency: Daily

What does USP <797> say?

Table [3] on page 15 of the USP chapter recommends that work surfaces be cleaned daily. The chapter states, “Work surfaces in the ISO Class 7 (see Table 1) buffer areas and ISO Class 8 (see Table 1) ante-areas as well as segregated compounding areas shall be cleaned and disinfected at least daily.” And… “All cleaning materials, such as wipers, sponges, and mops, shall be nonshedding, preferably composed of synthetic micro fibers, and dedicated to use in the buffer or clean area, ante-area, and segregated compounding areas and shall not be removed from these areas except for disposal.” 

Contec Healthcare recommended best practices for cleaning and disinfecting countertops and easily cleanable work surfaces: 

  • Always clean from top to bottom, and back to front.  
  • Use slightly overlapping strokes, not circular motions.  
  • Replace used wipes often. 
  • When disinfecting counters or other hard, non-porous surfaces, dwell time is critical. Follow directions on the label to ensure efficacy is achieved.  
  • Always follow site protocols and SOPs. 
USP <797> Standards for

Monthly Cleaning of Pharmacy Cleanroom Shelving

Minimum Cleaning Frequency: Monthly