Regulatory Compliance

USP 800 states the following:

Environmental wipe sampling for HD surface residue should be performed routinely (e.g., initially as a benchmark and at least every 6 months, or more often as needed, to verify containment). Surface wipe sampling should 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

If any measurable contamination is found, the designated person must identify, document, and contain the cause of contamination. Such action may include reevaluating work practices, re-training personnel, performing thorough deactivation, decontamination, cleaning, and improving engineering controls. Repeat the wipe sampling to validate that the deactivation/decontamination and cleaning steps have been effective.

Common marker hazardous drugs that can be assayed include: 5-Fluorouracil, ifosfamide, cyclophosphamide, paclitaxel, docetaxel, methotrexate, platinum analogues, busulfan, etoposide, cytarabine, doxorubicin, daunorubicin, and vincristine.

  • Busulfan
  • Cyclophosphamide
  • Cytarabine
  • Daunorubicin
  • Docetaxtel
  • Doxorubicin
  • Etoposide
  • Fluorouracil
  • Ifosfamide
  • Methotrexate
  • Paclitaxel
  • Platinum Analogues
  • Vincristine
  • Gemcitabine
  • Irinotecan
  • Mitomycin C
  • 5-Azacytidine