Surface sampling for equipment used for preparing sterile HDs

By | June 29, 2016

USP Chapter <800> HAZARDOUS DRUGS—HANDLING IN HEALTHCARE SETTINGS is organized into the following main sections:

  1. Introduction and Scope
  2. List of Hazardous Drugs
  3. Types of Exposure
  4. Responsibilities of Personnel Handling Hazardous Drugs
  5. Facilities and Engineering Controls
  6. Environmental Quality and Control
  7. Personal Protective Equipment
  8. Hazard Communication Program
  9. Personnel Training
  10. Receiving
  11. Labeling, Packaging, Transport, and Disposal
  12. Dispensing Final Dosage Forms
  13. Compounding
  14. Administering
  15. Deactivating, Decontaminating, Cleaning, and Disinfecting
  16. Spill Control
  17. Documentation and Standard Operating Procedures
  18. Medical Surveillance

And of course the glossary and appendices.

Section 6 – Environmental Quality and Control covers wipe sampling for HD surfaces. According to Section 6, wipe sampling of HD surfaces should be performed initially to establish a baseline/benchmark and then at least every 6 months, or more often as needed, to verify containment.

Areas that should be sampled include:

  • Interior of the C-PEC and equipment contained in it
  • Pass-through chambers
  • Surfaces in staging or work areas near the C-PEC
  • Areas adjacent to C-PECs (e.g., floors directly under C-PEC, staging, and dispensing area)
  • Areas immediately outside the HD buffer room or the C-SCA
  • Patient administration areas

Emphasis is mine.

For the interior of C-PECs and equipment contained in it, that means that pharmacies using an IV robot or IV workflow management system (IVWMS) for sterile HD compounding must sample inside the robot as well as all the hardware tied to the IVWMS. This includes cameras, scales, barcode scanners, and even touchscreen computers both inside and adjacent to the hood. I don’t think most pharmacies are doing this.

As far as pass-through chambers go, this includes refrigerators and dual-sided carousels attached to HD compounding areas. Again, I don’t think most pharmacies are doing this.

There is currently no standard for acceptable limits for HD surface contamination. However, USP <800> lists the following common marker HDs that can be assayed: cyclophosphamide, ifosfamide, methotrexate, fluorouracil, and platinum-containing drugs. I don’t think I’ve ever been in a hospital pharmacy larger than 100 beds that doesn’t have a patient receiving at least one of thsse drugs.

If any measurable contamination is found, the facility must identify, document, contain the cause of contamination, and come up with a way to fix it, which may include something as simple as re-evaluating work practices, re-training personnel, performing thorough deactivation, decontamination, and cleaning, or something as difficult as improving engineering controls, i.e. hoods and buffer rooms.

So remember folks, make sure you’re performing appropriate surface sampling on your technology in and around your hoods.

Leave a Reply

Your email address will not be published. Required fields are marked *