Electron-Beam Tunnel

Rubrik: Reinraum

(Treffer aus Tech4Pharma, Nr. 02, Seite 84 (2025))

Holzer M | Lehmann F

Electron-Beam Tunnel / An Annex-1-Compliant RTU Transfer System · Holzer M, Lehmann F · Skan
Ebeam Surface sterilization Ionizing radiation Pre-filled/Pre-sterilized RTU packaging material Isolator technology Aseptic transfer The sterilization of surfaces with beta rays (electron-beam, ebeam) has been known for a long time and has been well accepted in the food and medical device industry as well as by the U.S. Food and Drug Administration (FDA) and other regulatory authorities in the pharmaceutical industry [ 1 ]. What is new for the pharmaceutical industry is the speed at which ready-to-use (RTU) packaging material can be aseptically fed into the aseptic filling area of high-speed filling lines using an ebeam tunnel with continuous feeding. With ...

Decontamination processes in pharmaceutical isolators

Rubrik: Technik

(Treffer aus pharmind, Nr. 08, Seite 780 (2024))

Krebsbach T | Lehmann F

Decontamination processes in pharmaceutical isolators / Krebsbach and Lehmann | Decontamination processes · Krebsbach T, Lehmann F · SKAN AG
Isolator Aseptic Processing Decontamination Bioindicator Annex 1 Over the last 2 decades, isolator technology has gained a well-deserved and undisputed place in the pharmaceutical industry, both in the manufacture and quality control of sterile medicinal products. This is also reflected in Annex 1 to the EC GMP Guideline published in Aug 2022, which clearly recommends the use of barrier technology, as it significantly increases the protection of the product against potential contamination in the form of endotoxins/pyrogens, particles and microbial contamination caused, for example, by personnel, materials or the environment [ 1 ]. Consequently, Annex 1 of the EC GMP Guideline requires explicit justification for the use ...

Isolator for the CAR-T-Cell Therapy

Rubrik: Technik

(Treffer aus pharmind, Nr. 08, Seite 784 (2023))

Aldi S | Lehmann F

Isolator for the CAR-T-Cell Therapy / Aldi and Lehmann • Isolator CAR-T-Cell Therapy · Aldi S, Lehmann F · Allschwil (Switzerland)
Advanced therapy medicinal products (ATMPs) are fast-growing fields in the modern medicine and cell & gene therapies become a hot topic for pharmaceuticals and manufacturing industries. Cell & gene therapies were developed by scientists which improved basic research concepts and protocols to be used for clinical purpose, such as gene manipulations via viral transduction, specific phenotypic cell population isolation, and stem cell differentiation. Methodologies, immunology knowledge, and molecular biology approaches have been notably improved during the past 10 years, by the development of magnetic bead-based systems for phenotypic cell isolation, cancer antigen selection as well as clustered regularly interspaced short palindromic repeats -Cas9 nuclease (CRISPR-Cas9) ...