Yes; however, decontamination can be extremely difficult. The decontamination process must include scientifically sound studies demonstrating the efficacy of the decontamination agents, extensive and statistically appropriate sampling throughout the areas before and after decontamination to verify cleanliness, and appropriate testing of such samples with a validated analytical method having an appropriate limit of detection. The CGMP regulations in 21 CFR 211.176 require that if a reasonable possibility exists that a non-penicillin drug product has been exposed to cross-contamination with penicillin, the non-penicillin product must be tested for the presence of penicillin and cannot be marketed if detectable levels are found using the codified method. Such a reasonable possibility may be present if decontamination has not been conducted effectively. Although CGMP regulations do not prohibit decontamination and conversion, the difficulty of cleaning up penicillin residues can make the process daunting (see also FDA Guide to Inspections, referenced below).
