FOR PHARMACISTS · SCIENTIFIC COLLECTION 10.0310 monographs · 36 SOPs · 22 forms
Sikaliascompounding.grSikalias Greek Formulary
Home / Quality system / Hazardous materials and volatile solvents · SOP-018

SOP-018 / 2.1

Hazardous materials and volatile solvents

Operations creating exposure, dust, droplets or flammable vapours.

Collection and scientific editing: Stasinos Chr. SikaliasContent edition: 2.1Record editorial review date: 2026-10-14

Download bilingual PDFJSON

Procedure

  1. Review the exact material’s current SDS and hazardous-drug lists. Distinguish drug potency, sensitisation, reproductive toxicity and physical ignition hazard.
  2. Record quantity, frequency, exposure route and open-handling stage. Select engineering containment before PPE.
  3. For flammable solvents select compatible equipment and ventilation, remove ignition sources and do not arbitrarily heat sealed containers. A powder enclosure is not automatically suitable for vapours.
  4. Choose gloves for the actual solvent permeation and task duration. Record glove changes, eye protection and suitable respiratory protection where the assessment requires it.
  5. Provide compatible spill materials, waste collection and an exposure plan. Cleaning addresses active/allergen residue, not only visible powder.
  6. The responsible person authorises work only if available controls cover the actual hazard. If inadequate, refer preparation to a suitable facility.

Additional detail

Record the review date of the static NIOSH list and subsequent notices. The hazardous-drug list alone does not assess solvent ignition risk or an operator’s personal sensitisation.

Stop criterion

Missing suitable containment, ventilation or compatibility information: stop before handling.

Related forms

F-001, F-004, F-007

Sources and references

  1. NIOSH — Managing Hazardous Drug Exposures: Information for Healthcare SettingsDHHS (NIOSH) 2023-130Risk assessment and activity-specific control table, printed pp. 27–33Exposure routes and hierarchy of occupational controls2026-09-12
  2. NIOSH List of Hazardous Drugs in Healthcare Settings, 20242024 list, publication 2025-103Drug lists and inclusion criteriaHazard identification; absence from list is not evidence that a chemical is harmless; consult the live NIOSH notices as well as this static list2026-09-12
  3. PIC/S — Guide to Good Practices for the Preparation of Medicinal Products in Healthcare EstablishmentsPE 010-4, 1 March 2014Chapters 1–9; Annex 2 (nonsterile liquids, creams, ointments)Professional quality-system framework; not automatic national legal adoption or certification2026-10-14
  4. NIOSH — List of Hazardous Drugs in Healthcare Settings, 2024, with subsequent noticesNIOSH Publication 2025-103, December 2024; dynamic notice tableNotice table for updates after the December 2024 listCurrent notice surveillance in addition to the static PDF and exact material SDS; does not certify absence of hazards for an unlisted substance.2026-10-14