Tests for impermeability against microorganisms on plastics for intravenous injections (ISO 15747: 2018).
Test with the Good Laboratory Practices (GLPs) certificate.
ISO 15747 describes the biological requirements for plastic containers for intravenous injections. One of the requirements is that the infusion container must be impermeable to microorganisms. To demonstrate this, the impermeability test described in section C.2 of the standard and described below is carried out.
To perform the impermeability test, empty containers are filled to their nominal capacity with culture medium under sterile conditions and sealed. Subsequently, the containers, or appropriate parts thereof, are immersed in a suspension of challenge microorganism (Bacillus atrophaeus ATCC 9372, formerly Bacillus subtilis) for at least 30 minutes. The containers are removed from the inoculation suspension and incubated for at least 7 days at 30ºC (appropriate temperature for the growth of the inoculated microorganism). The test must be carried out with 5 replicates and in parallel with a negative control (containers not submerged in the bacterial suspension) and a positive control (container prepared in the same way but inoculated with 1 mL of a culture of the microorganism). After 7 days of incubation, the contents of the test container are examined to detect any microbial growth. The positive control should exhibit turbidity, and the negative control and samples from the test container should not exhibit any turbidity.
The ISO 15747 standard only indicates the performance of the test directly after inoculation of the test sample, but if the client wants to validate different times, the samples can be preserved after inoculation at room temperature for the time indicated by the client and thereafter, proceed to incubation for a week and subsequent observation of turbidity as an indication of growth. In this case, a negative control, a positive control and 5 replicates of the test product should be analyzed for each requested test period.