Radiopharmacist's Notes · CRP™ Dispensing System
A CRP + FLEX cyclotron dispensing workflow is three stacked layers: the host hot cell that owns the shielding and the GMP environment, the CRP automation that owns the dispensing mechanics, and the radiopharmacy programme that owns the recipes, the QC release and the AERB licence. Each layer is necessary; none of them is sufficient on its own. This page draws the line.
Three layers, three different sources. The middle layer (CRP) is what we sell; the outer two are needed to make a working radiopharmacy around it.
Source: FLEX product page; AERB cyclotron-facility 2017.
Source: CRP product page.
Source: EU GMP Annex 1 (rev. 2022); Annex 11; AERB 2017 Regulatory Requirements.
A buyer evaluating CRP without the host-cell context will under-spec — assume CRP comes with shielding, or with an AERB licence, or with a calibration chain. It doesn\'t. CRP is the precision dispensing layer; everything around it has to be specified separately.
The Saxsons-supplied Indian package is CRP plus the FLEX host cell plus the AERB import documentation. That\'s what makes the three-layer model add up to a working dispensing bench.
Sources: CRP + FLEX product pages; AERB 2017 Regulatory Requirements; EU GMP Annex 1 (rev. 2022).
Scope of this page
The three-layer split is a buyer-procurement model, not a regulatory taxonomy. The FLEX page provides the full GMP stack mapping (Annex 3 + Annex 1 + Annex 11 + AERB). This page just sets the procurement boundary so the CRP buy is correctly scoped.
Sources cited on this page