Safe Handling of Radiopharmaceuticals October 2018

ROweMed Medical 4 Life RoweMed AG RoweMed AG - Medical 4 Life is a medium sized innovative MedTech company. Our focus is on developing and producing customized medical plastic systems, especially for the handling of sensitive pharmaceuticals. Juri-Gagarin-Ring 4 19370 Parchim Germany E-mail [email protected] Company Profile For our customers we offer turnkey projects: R&D, MASS PRODUCTION, REGULATORY AFFAIRS. Our Quality Management System is certified according to DIN EN ISO 13485 and FDA 21 CFR Part 820. Our clean room production in Parchim (Germany) is certified according to ISO class 7 (particle...

R&D The development of our systems is closely coordinated with the customer, from first sketch up to a marketready product, including CAD construction, prototyping and product testing. We also offer serial production and full technical documentation. We guarantee the higest standard in order to fulfill the most demanding requirements for medtech, pharma and biotech industries. Production We offer injection molding, assembling & packaging under one roof. In the cleanroom production facility (ISO class 7) in Parchim our employees carry out singlepart, small series & automated mass production. In...

Vent Filters Vent Needles ■ Sterile venting of vessels, bioreactors or vials ■ Retention of liquids, particles, germs, aerosols (> 0.1 pm) Luer, Luer-Lock, Barb

Sampling Needles ■ Withdrawal of drugs and samplings from vessels, bioreactors or vials Luer, Luer-Lock, Tube

■ Hydrophilic particle filter (0.2 Mm, 5.0 Mm, ...) ■ Repeated withdrawal and aspiration of solutions, drugs and toxic substances - different safety valves (needle free) - snap-fit hooks ■ Safe vial connections for bottle caps 13 mm, 20 mm or 32 mm

■ For sterile drug preparation ■ Avoiding particle contamination ■ Hydrophilic particle filter (0.2 pm, 5.0 pm, ...) Luer, Luer-Lock, Tube, Barb

■ Customized filtration systems ■ High hygienic standards ■ Handling of hazardous chemicals and aerosols

Tubings / Lines■ Materials: - Polyethylene (PE) ■ Straight, spiral or dual-spiral

Reaction Vials ■ Material: - Cyclic Olefin Copolymer (COC) ■ Resistant to acids and most organic solvents ■ Complete emptying through optimum housing design

Resistant to acids and most organic solvents Round and flat designs Filling volume <10 ml to 150 ml

■ Supply and withdrawal from bags or bottles ■ Available with check valves to prevent leakages

Hollow Fibre Filter ■ Large filter surface with high flow and good operation performance ■ For ultra and micro filtration ■ Available in High Flux

ROweMed Medical 4 Life Individual complex configurations According special customers requirements