Background and Importance Fully automated aseptic preparation of cytotoxic ready-to-administer (RTA) and ready-to-use (RTU) parenterals is already well established. More recently, innovative robotic systems for the preparation of non-cytotoxic parenterals were brought to the market.

Aim and Objectives The objective of the study was the microbiological performance qualification of the fully automated robotic systems APOTECAsyringe and APOTECAunit (Loccioni, Italy) by media-fill tests and supplemental environmental monitoring in the critical zones.

Material and Methods During the performance qualification phase of the APOTECAsyringe over a 5-day period 500 syringes (10 mL volume) were automatically filled from a bag reservoir containing single-strength tryptic soy broth, capped and labelled. With the APOTECAunit (designed for individual/in series preparation of bags, syringes) over a 10-day period 250 bags and 250 syringes were prepared. Syringes were prepared by dilution of 25 mL of double strength tryptic soy broth with 25 mL of water for injection in 50 mL syringes. Bags were prepared by injection of 50 mL double strength tryptic soy broth into infusion bags prefilled with 50 mL 0.9% sodium chloride solution. Test solutions were incubated at room temperature and visually inspected after 7 and 14 days. Supplemental environmental controls encompassed particle counting, active air sampling (only APOTECAunit), settle plates, contact plates for critical surfaces, and fingerprints. Plates were incubated and colony forming units (cfu) counted.

Results None of the 500 media-fill products prepared by the APOTECAsyringe and 500 products prepared by the APOTECAunit showed turbidity when inspected after 7 and 14 days of incubation, thereby indicating no growth of microorganisms. Particle numbers were below the maximum limits set for cleanroom Grade A, EU-GMP Guide, Annex 1 and cfu counts of the plates met the acceptance criteria.

Conclusion and Relevance APOTECAsyringe and APOTECAunit passed the microbiological performance qualification and allow safe fully automated aseptic preparation of non-cytotoxic RTA and RTU parenterals.

Conflict of Interest No conflict of interest.