It is critical to determine the amount of residue that remains on product contact surfaces after ... more It is critical to determine the amount of residue that remains on product contact surfaces after cleaning to assess whether the equipment is safe for use in subsequent pharmaceutical manufacturing. This is accomplished through the successful execution of cleaning validation protocols, which are mandated by various government regulations. There are two types of sampling techniques commonly used in cleaning validation protocols: direct such as visual, swabbing, or wiping and indirect such as rinsing. This paper focuses on rinse sampling using total organic carbon analysis as the method of detection. The article will describe two different approaches to determine percent recovery values when accounting for volatile components in product formulations.
PDA journal of pharmaceutical science and technology / PDA
Methodology has been evolving for the testing of disinfectants against bacterial single-species b... more Methodology has been evolving for the testing of disinfectants against bacterial single-species biofilms, as the difficulty of biofilm remediation continues to gain much-needed attention. Bacterial single-species biofilm contamination presents a real risk to good manufacturing practice-regulated industries. However, mixed-species biofilms and biofilms containing bacterial spores remain an even greater challenge for cleaning and disinfection. Among spore-forming microorganisms frequently encountered in pharmaceutical manufacturing areas, the spores of Bacillus cereus are often determined to be the hardest to disinfect and eradicate. One of the reasons for the low degree of susceptibility to disinfection is the ability of these spores to be encapsulated within an exopolysachharide biofilm matrix. In this series of experiments, we evaluated the disinfectant susceptibility of B. cereus biofilms relative to disassociated B. cereus spores and biofilm from a non-spore-forming species. Furt...
It is critical to determine the amount of residue that remains on product contact surfaces after ... more It is critical to determine the amount of residue that remains on product contact surfaces after cleaning to assess whether the equipment is safe for use in subsequent pharmaceutical manufacturing. This is accomplished through the successful execution of cleaning validation protocols, which are mandated by various government regulations. There are two types of sampling techniques commonly used in cleaning validation protocols: direct such as visual, swabbing, or wiping and indirect such as rinsing. This paper focuses on rinse sampling using total organic carbon analysis as the method of detection. The article will describe two different approaches to determine percent recovery values when accounting for volatile components in product formulations.
PDA journal of pharmaceutical science and technology / PDA
Methodology has been evolving for the testing of disinfectants against bacterial single-species b... more Methodology has been evolving for the testing of disinfectants against bacterial single-species biofilms, as the difficulty of biofilm remediation continues to gain much-needed attention. Bacterial single-species biofilm contamination presents a real risk to good manufacturing practice-regulated industries. However, mixed-species biofilms and biofilms containing bacterial spores remain an even greater challenge for cleaning and disinfection. Among spore-forming microorganisms frequently encountered in pharmaceutical manufacturing areas, the spores of Bacillus cereus are often determined to be the hardest to disinfect and eradicate. One of the reasons for the low degree of susceptibility to disinfection is the ability of these spores to be encapsulated within an exopolysachharide biofilm matrix. In this series of experiments, we evaluated the disinfectant susceptibility of B. cereus biofilms relative to disassociated B. cereus spores and biofilm from a non-spore-forming species. Furt...
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Papers by paul lopolito