Quality

Detect specific accuracy issues related to drugs formulations or packaging (drug withdrawal accuracy within ±5% for 99.32% of 3403 total preparations )₍₁₇₎

Validate aseptic process according to the GMP and adapt cleaning standard procedures₍₁₇₎

Assess chemical contamination risk (no contamination on the surface of the end-products) and identify worst cases₍₁₇₎

Simulation of workload and workflow to ensure the use in its best performance configuration₍₁₇₎

Qualification prerequisites: balance and hood (laminar flow speeds, particle counting and filter integrity tests)₍₂₀₎

Pumps qualification (accuracy between 95% and 105% of the target volume)₍₂₀₎

Qualification with placebos (94,5% of 54 bags within the ±10% IE, 100% of 48 syringes within the ±10% IE, and 100% of 24 elastomeric pumps within the ±5% IE)₍₂₀₎

Microbiological qualification in compliance with ISO 7 environment specification (environmental control, glove impressions and Media Fill test with no growth)₍₂₀₎

Preparations can be stored for longer periods than those from hood systems (limited to 24-48 hours)₍₂₂₎

Includes a hydrogen peroxide vapor generator that ensures the biodecontamination of materials in the entry airlock₍₂₂₎

In accordance with Good Preparation Practices, a positive pressure isolator can be installed in a class D clean room (as opposed to a class B or C for a hood)₍₂₂₎

The process has been designed to guarantee the safety of the user and the final product₍₃₀₎

The preparations in advance considerably thins the waiting time for patients₍₃₀₎

The isolator allows the anticipated preparation of standardized doses of chemotherapies quickly₍₃₀₎