Member of SKAN Group Cleanroom services

We leverage our joined innovative expertise in aseptic processes and production of single-use assemblies to offer you custom solutions that meet your needs. Choose custom single-use assemblies and packaging : • Optimized for complex pharmaceutical manufacturing • Reduced product loss • Smoother validation effort Mastering the single use: more than 20 years of experience in custom cleanroom assemblies Production of critical pharmaceutical ready-to-use assemblies, such as sterile single-use fluid path kits and aseptic connectors. • Design and prototyping of the assembly, including its packaging...

Custom manufacturing by Aseptic Technologies minimizes the risk of particle contamination by ensuring ISO5 or ISO7 surrounding in operation while monitoring Grade C microbiological conditions. Custom assemblies are sterilized in double or triple packaging to ensure the cleanliness and sterility chain is maintained in addition to providing peace of mind for our customers. • Optimizing the manufacturing processes • Respecting most aggressive timelines • Reducing validation efforts • Validated to withstand H2O2 decontamination cycles (skanfog®)

Development of customized single-use solutions • Experienced manufacturing, quality, and logistic teams. • Deep understanding of pharma and bioprocessing requirements. • Modern ERP, robust quality system, productions released by internal QPs. • Cleanroom capacity meeting highest pharmaceutical cleanliness standards. • Grade A laminar air flow for critical operations. • 700+ items managed in stock. • Product and packaging validation. • Shipping and transport validation, as per ASTM/ISTA standards. • Daily shipping, leading to over 2000 yearly shipments all over the world. • Endotoxin validation...

Production capacity two dedicated production sites Two production sites: • ISO5 qualified cleanroom, T° controlled, RH monitored. • ISO7 qualified cleanroom, T° and RH controlled and monitored. SKAN Group sites Cleanroom production sites in Belgium Combined with: Three storage sites (T° and RH monitored) for raw materials and finished products. Two sites qualified for gamma irradiation. Our quality certifications ISO 9001:2015 Quality management systems. ISO 15378:2017 Primary packaging materials for medicinal products.

SKAN AG Kreuzstrasse 5 4123 Allschwil, Switzerland +41 61 485 44 44, [email protected] SKAN Stein AG Industriestrasse 3 4332 Stein, Switzerland +41 62 885 03 00, [email protected] SKAN Deutschland GmbH Nickrischer Straße 2 02827 Görlitz/Hagenwerder, Germany +49 358 223 789 0, [email protected] SKAN US, Inc. 7409 ACC Blvd., Suite 200 Raleigh, NC 27617, USA +1 919 354 6380, [email protected] SKAN Japan 5194-61 Katsuren-Haebaru Uruma-shi Okinawa 沖縄県 904-2311, Japan 日本 +81 98 934 9922, [email protected] © 2023 – Aseptic Technologies S.A. – Brochure Custom Single-Use Assemblies – V2.0 Aseptic Technologies...