Operational qualification of the automat DIANA under laminar flow hood in hospital pharmacy

Gwenaelle MATON1, Elodie SIMON1, Hélène BEAUSSART1, Damien LANNOY1,2, Pr Pascal ODOU1,2 1- Préparatoire, Institut de Pharmacie - CHRU LILLE, France
2- Laboratoire de Biopharmacie, Pharmacie Galénique et Hospitalière, EA 4481 GRIIOT, Faculté des Sciences
Pharmaceutiques et Biologiques, LILLE, France.

Objective

Automation solutions for aseptic compounding are still limited. Compared with peristaltic pumps, new volumetric pumps do not need any calibration before their use. We made the operational qualification of the Diana pump (from ICU medical) when used under vertical laminar flow hood (LFH).

Methods

after set up under the LFH,

1) we sampled when operating air near the pump located in class A environment, and around the LFH in class B environment (with an impactor). Two settle plates, designed for microbial monitoring of air in controlled areas, are set up on the left and right of the pump during the 2 hours of production. The finger dabs of the operator under the LFH and the pump (wall and LCD display) are assessed with contact plate.

2) we made a media fill test with the pump. We filled 55 syringes with 1 mL of tryptophane casein soya media, incubated 10 days at 32°C then 4 days at 22°C (with negative tests). When operating, a particular counting was performed near the connection between the pump and the syringe.

3) we estimated the accuracy when measuring the extractable volume of 46 syringes filled with 10.3mL of water.

Results

No colony is found on settled plates under LFH, except in the left wall of the pump; the results in the class B environment are normal. The particle counts are (average) 3.5 p. ≥ 0.5µm and 0.5 p. ≥ 5µm. No turbidity is found in the syringes of the media fill test. The extractable volume is (average ± standard deviation): 10.28 ± 0.02 mL.

Discussion conclusion

The pump complies with the specifications of the national GMP (BPP2007) for an activity in class A. Due to a positive microbiological sample in the pump, operators were educated to correctly decontaminate it. We need to continue to assess the pump in routine manner (speed, ergonomic issues,…).

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