Can the multi-packaging be a vector of chemical contamination in isolator?
2. EA 4481, Laboratoire de Biopharmacie, Pharmacie Galénique et Hospitalière, Faculté de Pharmacie, Lille, France
3 Laboratoire de Toxicologie, CHRU, Lille, France
Introduction – objective
The recent marketing of sterile medical devices of preparation in multiconditioning presents numerous advantages (saving of time, reduction of waste and cost). In view of the persistence of the chemical contamination in isolators, the objective of this work is to determine the possible contamination on multipackaged syringes exposed to the environment of isolator.
The study was made on 2 batches of 10 syringes (Plastipack, BD) presented in a multipackaging opened and placed on a shelf. The surface of each syringe was sampled with a wipe before its use with a new pair of gloves. Twelve molecules were measured by LCMSMS on samples made from the 2nd hour of exposure and every 30 minutes over an 8h-period. Results are presented in total detected amount/number of sample.
All the drugs were compounded without any incident through the study day. A contamination was detected on 12 samples (52.2 %): 5-FU (374 ng/1), ifosfamide (6.9 ng/1), cyclophosphamide (24.1 ng/4) and gemcitabine (30.3 ng/8), among which 3 are multi-contaminated. Positive samples have been detected at 2h, 5h, 7h and 8h.
Discussion – conclusion
This study shows that a chemical contamination is found on syringes multi-conditioned before their manipulation when stored in a contaminated environment. No relationship between contamination and time of exposure is highlighted. These results have to be weighted with the advantages of this packaging and questioned on its relevance during the simultaneous manipulation of different active drugs in the same preparation area.