Knowledge Hub · Saxsons Laminar Flow Hood
A laminar flow hood is the OPPOSITE of a fume hood — positive pressure for sterile prep, not negative pressure for radioactive containment. The Saxsons range puts the sterile-prep work zone inside a lead-lined chassis, so the same hood handles ISO 14644 Class 5 air quality AND radiopharmacy-grade shielding for Lu-177 / Ga-68 labelling chemistry.
Laminar flow vs fume hood
A fume hood pulls air INWARD (negative pressure) — it keeps radioactive aerosols inside the work chamber away from the operator. A laminar flow hood pushes filtered air OUTWARD (positive pressure) — it keeps room bacteria OUT of the sterile compounding zone. The two are NOT interchangeable. Laminar flow is for STERILE prep (Tc-99m kit reconstitution, Ga-68 elution + labelling, Lu-177 PSMA / DOTATATE labelling). Fume hood is for HOT-LAB DISPENSING.
Source: EU GMP Annex 1 (revised 2022); AAPM Report 88; ISO 14644-1.
ISO 14644 Class 5 / EU GMP Grade A
Sterile radiopharmaceutical injectables need a Class A / ISO 5 work-zone air quality — fewer than 3520 particles ≥ 0.5 µm per m³ at-rest. A HEPA H14 filter (99.995 % at 0.3 µm) delivers this on the vertical-flow output side. Class A is the GMP-grade sterile-prep envelope; lower-class environments fail the cleaning-validation cycle for parenteral radiopharmaceuticals.
Source: ISO 14644-1 — Cleanrooms and associated controlled environments; EU GMP Annex 1.
HEPA H14 + UV decontamination
HEPA H14 stops particulate contamination at 99.995 % efficiency at the 0.3 µm MPPS — bacteria (1–5 µm) and large viruses are stopped. UV-C decontamination cycle handles surface-bound bacterial spores and viable particles that escape filtration. Pre-filter handles larger particulates and extends HEPA service life. The three-layer pack covers the bacterial-contamination side of sterile radiopharmaceutical compounding.
Source: EU GMP Annex 1; ISO 14644-3 — Test methods for cleanrooms.
Lead-lined chassis tiers
The labelling chemistry happens inside the hood — Lu-177 PSMA / DOTATATE / FAPI, Ga-68 DOTATOC. The 5 mm Pb tier handles the per-batch labelling activity (≤ 7.4 GBq Lu-177; ≤ 1.85 GBq Ga-68); the 3 mm Pb tier is the cost-optimised choice for lower-activity sterile-prep workflows. Lead tier is on TOP of the sterile filtration — the hood does BOTH jobs simultaneously.
Source: AAPM Report 88; AERB Safety Code; NIST XCOM database.
Clean-room SS 304 + wash-basin
GMP-grade radiopharmacies running cleaning-validation need an operator-hand-wash station inside the cleaning cycle SOP — typically before each compounding session and between batches. The clean-room SS 304 inner + outer variant (BSCLF-47-32-71-3-I-S-C-C-02-0) ships with an integrated water-drainage wash-basin. Same hood, the GMP-side cleaning protocol is now self-contained.
Source: EU GMP Annex 1 (revised 2022); WHO Good Manufacturing Practices for sterile pharmaceutical products.
Sterile-prep + radiopharmacy-grade-shielding framework.
EU GMP framework for sterile manufacturing including clean-room and laminar-flow specifications.
ISO standard defining Class 5 air quality.
WHO framework for sterile-prep manufacturing including laminar-flow work zones.
Indian regulatory framework for radiopharmacy compounding.
AAPM framework for radiopharmacy QC including sterile-prep expectations.