Background and importance Materials used in aseptic manufacturing, such as medical devices (MD), infusion bags (IB), bottles (B), infusion vials (V) and ampoules (A), usually undergo disinfection with alcohol 70%. Alcohol, however, is known not to eradicate all microbes (eg, bacterial spores).
Aim and objectives To explore the effectiveness of a sporicidal aseptic transfer approach using high speed H2O2.
Material and methods For 12 materials and their cardboard packaging (MD, IB, B, V and A), three samplings each at the outer and inner sides of the packaging and at the unpacked material surface were tested with contact plates (108 plates) applied for 5 s. After incubation for ≥72 hours at 20–25°C and 30–35°C, respectively, contact plates were observed for colony forming units (CFU). Unpacked materials were additionally tested, three samplings each (36 contact plates), after sporicidal disinfection using high speed H2O2 (wipes and foam).
Results Without disinfection, CFU appeared on 81% and 33% of contact plates for the outer and inner sides of the cardboard boxes. The surface of the materials showed contamination for 25% of the plates. The microbes found on the plates included bacteria, aerobic endospore formers (Bacillaceae) and Aspergillus. After sporicidal disinfection, microbial growth was seen on none of the plates.
Conclusion and relevance As a risk based approach to contamination control is fundamental for aseptic transfer procedures, our results reflect the strategy for minimising contamination for aseptic manufacturing. Endospore forming bacteria were found as part of the contamination flora on the surface of several material samples. Therefore, a sporicidal agent (eg, high speed H2O2) is required to minimise the contamination risk not only when materials are transferred to clean room classes B and A, but preferably when entering the production area (zone D).
Conflict of interest No conflict of interest
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