Summary
Protak Scientific were instructed by The Royal Liverpool University Hospital (RLUH) NHS Trust to validate the Isolator vaporised hydrogen peroxide (H2O2) decontamination cycles and loading patterns of their new Pharmacy Aseptic Production Unit (PAPU).
This activity included the assessment of H2O2 exposure levels for both load item interaction and personnel safety.
To achieve this objective, Protak Scientific employed the use of the Picarro PI2114 Gas Concentration Analyser (Ref.1/Fig.1 ).
Figure 1a: Picarro P12114 Gas Concentration Analyser: performance specifications
Figure 1b: The Picarro Analyser connected to the PAPU Isolator
Introduction
The new Pharmacy Aseptic Production Unit (PAPU) at The Royal Liverpool University Hospital (RLUH) will house aseptic dispensing services including preparation of Central Intravenous Additives (CIVAs), Total Parenteral Nutrition (TPN), Intravenous Cytotoxic medication (Cytotoxic) and clinical trial (Gene Therapy) medication.
The new PAPU facility houses a number of bespoke, production Isolators with dedicated H2O2 generators supplied by Envair Technologies (Ref.2).
The importance of establishing that the aeration phase is of suitable duration to return to safe operation levels before an isolator can be used and, additionally, the potential risk of residual levels with load items was factored into the validation strategy created by Protak Scientific.
The validation strategy assessed the following considerations:
- The aeration process was required to be effective in achieving <1ppm of H202 at the end of the cycle as a minimum but due to potential medicinal product interactions, the measurement of this needed to be accurately recorded and determined.
- Materials of construction for H2O2 compatibility, permeability and also safety for personnel and product exposure required a robust risk assessment of all items to be used within the isolator (Ref.3,4).
Once the strategy was complete, a method was needed to conduct the testing. The solution was determined by using the Picarro PI2114 Gas Concentration Analyser. An extremely sensitive, continuous, real-time H2O2 monitoring system with a low detection limit of <3 ppb (parts per billion)
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