Mystaire and USP <800>

Compliance Products

Isola Edge

The USP 800 Hazardous Drugs-Handling in Healthcare Settings document provides a broad yet defined approach for safety to patient and healthcare worker. Mystaire, Inc. products address several key areas within this document as it relates to section 5, Facilities and Engineering Controls, section 13, Compounding and section 15 as it discusses Cleaning and Disinfection.

How Mystaire products can aide in USP 800 compliance

Mystaire products can provide compliance to USP 800 in the following areas:

The enclosures outlined below allow, with additional measures, a facility to become compliant to USP 800 requirements. These products are considered to be either Class I and LAFW's for use in compliance to USP 800 as well as relevant sections of USP 795 and USP 797.


Reference

Below are excerpts of the standard and are intended for reference only. The full standard should be reviewed and used for compliance determination by healthcare facilities.

  • 5.1 Receipt- Antineoplastic HD's and all HD API's must be unpackaged (i.e., removal from external shipping containers) in an area that is neutral/normal or negative pressure relative to the surrounding areas. HD's must not be unpacked from their external shipping containers in sterile compounding areas or in positive pressure areas.

  • 5.3.1 Nonsterile Compounding- In addition to this chapter, nonsterile compounding must follow standards in Pharmaceutical Compounding-Nonsterile Preparations (795). A C-PEC is not required if manipulations are limited to handling of final dosage forms (e.g., counting or repackaging of tablets and capsules) that do not produce particles, aerosols, or gasses. The C-PECs used for manipulation of nonsterile HD's must be either externally vented (preferred) or have redundant-HEPA filters in series. Nonsterile HD compounding must be performed in a C-PEC that provides personnel and environmental protection, such as a Class I Biological Safety Cabinet (BSC) or Containment Ventilated Enclosure (CVE). A Class II BSC or a compounding aseptic containment isolator (CACI) may also be used. For occasional nonsterile HD compounding, a C-PEC used for sterile compounding (e.g., Class II BSC or CACI) may be used but must be decontaminated, cleaned, and disinfected before resuming sterile compounding in that C-PEC. A C-PEC used only for nonsterile compounding does not require unidirectional airflow because the critical environment does not need to be ISO classified. The C-PEC must be placed in a C-SEC that has at least 12 ACPH. Table 2 summarizes the engineering controls required for nonsterile HD compounding.
    • Table 2. Engineering Controls for Nonsterile HD Compounding
      • C-PEC- Externally vented (preferred) or redundant-HEPA filtered in series
      • Examples: CVE, Class I or II BSC, CACI

  • 5.3.2 Sterile Compounding- In addition to this chapter, sterile compounding must follow standards in (797). All C-PECs used for manipulation of sterile HDs must be externally vented. Sterile HD compounding must be performed in a C-PEC that provides an ISO Class 5 or better air quality, such as a Class II or III BSC or CACI. Class II BSC type A2, B1, or B2 are acceptable. For most know HDs, type A2 cabinets offer a simple and reliable integration with the ventilation and pressurization requirements of the C-SEC. Class II type B2 BSCs are typically reserved for use with volatile components. Appendix 3 describes the different types of BSCs. A laminar airflow workbench (LAFW) or compounding aseptic isolator (CAI) must not be used for the compounding of an antineoplastic HD. A BSC or CACI used for the preparation of HDs must not be used for the preparation of a non-HD unless the non-HD preparation is placed into a protective outer wrapper during removal from the C-PEC and is labeled to require PPE handling precautions.

  • 13. Compounding- Entities and personnel involved in compounding HDs must be compliant with the appropriate USP standards in compounding including (795) and (797). Compounding must be done in proper engineering controls as described in Compounding.

  • 15.3 Cleaning- Cleaning is a process that results in the removal of contaminants (e.g.,soil, microbial contamination, HD residue) from objects and surfaces using water, detergents, surfactants, solvents, and/or other chemicals. Cleaning agents used on compounding equipment should not introduce microbial contamination. No cleaning step may be performed when compounding activities are occurring.

  • 15.4 Disinfection- Disinfection is a process of inhibiting or destroying microorganisms. Before disinfection can be adequately performed, surfaces must be cleaned. Disinfection must be done for areas intended to be sterile, including the sterile compounding areas.

As with any standards document the use of acronyms are present and requires a clear understanding of those as you read and interpret USP 800. Acronyms that relate to Mystaire products and performance are:


  • ACPH- Air changes per hour
  • BSC- Biological Safety Cabinet
  • CACI- Compounding aseptic containment isolator
  • CAI- Compounding aseptic isolator
  • C-PEC- Containment primary engineering control
  • C-SEC- Containment secondary engineering control
  • HEPA- High-efficiency particulate air
  • ULPA- Ultra-low particulate air
  • CVE- Containment ventilated enclosure

In addition to acronyms, varying terms are used to describe the proper safety apparatus and environment when dealing with HDs. The use of a BSC (Biological Safety Cabinet) is explained throughout USP 800 but which type is compliant and right for your healthcare facility. As stated in the document, Appendix 3 outlines the definitions of each type of BSC as well as outlines which BSC is right for each situation.


Appendix 3: Types of Biological Safety Cabinets


Class I: A BSC that protects personnel and the environment but does not protect the product/preparation. A minimum velocity of 75 linear feet/minute of unfiltered room air is drawn through the front opening and across the work surface, providing personnel protection. The air is then passed through a HEPA/ULPA filter, either into the room or to the outside in the exhaust plenum, providing environmental protection.


Class II: Class II (Types A1, A2, B1, and B2) BSCs are partial barrier systems that rely on the movement of air to provide personnel, environmental, and product/preparation protection. Personnel and product/preparation protection are provided by the combination of inward and downward airflow captured by the front grille of the cabinet. Side-to-side cross-contamination of products/preparations is minimized by the internal downward flow of HEPA/ULPA filtered air moving toward the work surface and then drawn into the front and rear intake grilles. Environmental protection is provided when the cabinet exhaust air is passed through a HEPA/ULPA filter.


Type A1 (formerly, Type A): These Class II BSCs maintain a minimum inflow velocity of 75 feet/minute; have HEPA-filtered, down-flow air that is a portion of the mixed down-flow and inflow air from a common plenum; may exhaust HEPA-filtered air back into the laboratory or to the environment through an exhaust canopy; and may have positive-pressure contaminated ducts and plenums that are not surrounded by negative-pressure plenums. Type A1 BSCs are not suitable for use with volatile toxic chemicals and volatile radionucleotides.


Type A2 (formerly, Type B3): These Class II BSCs maintain a minimum inflow velocity of 100 feet/minute; have HEPA-filtered, down-flow air that is a portion of the mixed down-flow and inflow air from a common exhaust plenum; may exhaust HEPA-filtered air back into the laboratory or to the environment through an exhaust canopy; and plenums. If these cabinets are used for minute quantities of volatile toxic chemicals and trace amounts of radionucleotides, they must be exhausted through properly functioning exhaust canopies.


Type B1: These Class II BSCs maintain a minimum inflow velocity of 100 feet/minute; have HEPA-filtered, down-flow air composed largely of uncontaminated, recirculated inflow air; exhaust most of the contaminated down-flow air through a dedicated duct exhausted to the atmosphere after passing it through a HEPA filter; and have a contaminated ducts and plenums under negative pressure or surrounded by negative-pressure ducts and plenums. If these cabinets are used for work involving minute quantities of volatile toxic chemicals and trace amounts of radinucleotides, the work must be done in the directly exhausted portion of the cabinet.


Type B2 (total exhaust): These Class II BSCs maintain a minimum inflow velocity of 100 feet/minute; have HEPA-filtered, down-flow air drawn from the laboratory or the outside; exhaust all inflow and down-flow air to the atmosphere after filtration through a HEPA filter without recirculation inside the cabinet or return to the laboratory; and have all contaminated ducts and plenums under negative pressure of surrounded by directly exhausted negative pressure ducts and plenums. These cabinets may be used with volatile toxic chemicals and radionucleotides.


Class III: The Class III BSC is designed for work with highly infectious microbiological agents and other hazardous operations. It provides maximum protection for the environment and the worker. It is a gas-tight enclosure with a viewing window that is secured with locks and/or requires the use of tools to open. Both supply and exhaust air are HEPA/ULPA filtered. Exhaust air must pass through two HEPA/ULPA filters in series before discharge to the outdoors.


  • Cleaning and disinfection of enclosure between HD manipulation and handling
    • Solucide® is an EPA registered hard surface disinfectant. Many EPA registered hard surface disinfectant exist but care should be taken when determining which cleaner and disinfectant to be used in your facility. Material compatibility is critical as many chemicals that are effective in killing microorganisms are not compatibility with equipment materials of construction. This incompatibility will result in expensive equipment being damaged and potentially not working properly. Solucide® has been tested for materials capability to all Mystaire USP 800 solutions that are outlined in this document.

In conclusion, a thorough understanding of individual facility requirements is required before the healthcare workplace can truly become USP 800 compliant or determine the right USP 800 compliance solution. Mystaire products are acceptable methods for handling occupational safety from exposure to potentially potent chemicals and compounds as well as providing a dedicated laminar flow airstream which minimizes airborne contamination. Mystaire welcomes the opportunity to discuss individual healthcare facility demands and capabilities so as to determine which Mystaire products will provide USP 800 compliance and ensure both the healthcare worker and patients' safety.



Disclaimer: The information provided here is the opinion of Mystaire and by no means is an exact interpretation or expert opinion as to each individual healthcare provider facility. The information expressed in this document is for review and consumption by healthcare professionals that are charged with ensuring proper engineering safety controls for workers so as to maintain both patient and employee safety when dealing with HDs.