Plastics in the pharmaceutical isolator

Rubrik: Technik

(Treffer aus pharmind, Nr. 03, Seite 268 (2024))

Kemmerling S | Ladwig T | Mittelviefhaus M

Plastics in the pharmaceutical isolator / Kemmerling et. al. • Plastics in isolator · Kemmerling S, Ladwig T, Mittelviefhaus M · SKAN AG, Allschwil
Pharmaceutical isolators are a common tool for the safe manufacturing and testing of pharmaceutical products by providing an aseptic environment for critical processes. Hydrogen peroxide (H 2 O 2 ) is used as the decontamination agent to achieve aseptic processing conditions. Any material present or introduced in the isolator chamber should be easy to be decontaminated, show good persistence to H 2 O 2 as well as various chemicals and not facilitate the growth of microorganisms.

Risk minimization by collecting and processing analytical data for process control in isolators

Rubrik: Technik

(Treffer aus pharmind, Nr. 03, Seite 308 (2023))

Ladwig T | Kemmerling S | Mittelviefhaus M

Risk minimization by collecting and processing analytical data for process control in isolators / Ladwig et al. • Risk minimization · Ladwig T, Kemmerling S, Mittelviefhaus M · SKAN AG, Allschwil (Switzerland)
To effectively minimize risks and increase the overall safety of processes performed inside an isolator system several requirements need to be fulfilled. This article outlines some of the key considerations and proposes appropriate tests that can be performed to ensure product and operator safety. Described testing includes assessment of material persistence, their absorptive properties, as well as ease of decontamination with hydrogen peroxide (H 2 O 2 ). Such tests will enable the selection of the most appropriate materials and documenting the fulfillment of requirements for aseptic processing. Further tests target the characterization of cleaning and decontamination processes. Understanding the ...

Material selection as a control strategy to limit hydrogen peroxide residuals in drug products

Rubrik: Reinraum

(Treffer aus TechnoPharm, Nr. 02, Seite 100 (2021))

Widmann C | Ravasio D | Ladwig T

Material selection as a control strategy to limit hydrogen peroxide residuals in drug products / Widmann et al. • Material selection · Widmann C, Ravasio D, Ladwig T · SKAN AG, Allschwil (Switzerland)
Aseptically processed pharmaceutical products and packages may be exposed to hydrogen peroxide (H 2 O 2 ) throughout the filling and packaging process. While the advantage of the decontamination with H 2 O 2 lies in its harmless end-products water and oxygen, residual hydrogen peroxide may show detrimental effects on sensitive pharmaceutical products, even at trace concentrations. Therefore, the transmission rate of H 2 O 2 through the packaging material (e.g. polymer packaging foils) during a decontamination process needs to be determined to prevent H 2 O 2 ingress into the product. Thus, in this study, a methodology capable of ...