Safe Handling of Radiopharmaceuticals

Product catalog summary

Company Overview
RoweMed AG is a medium-sized innovative MedTech company focused on developing and producing customized medical plastic systems for handling sensitive pharmaceuticals. They offer turnkey projects including R&D, mass production, and regulatory affairs, with a quality management system certified to DIN EN ISO 13485 and FDA 21 CFR Part 820 standards. Their clean room production facility in Parchim, Germany, is certified to ISO class 7.

Research and Development
RoweMed coordinates closely with customers from initial sketches to market-ready products, including CAD construction, prototyping, and product testing. They offer serial production and full technical documentation, ensuring high standards for the medtech, pharma, and biotech industries.

Production Capabilities
The company provides injection molding, assembling, and packaging under one roof in their ISO class 7 cleanroom. They handle single-part, small series, and automated mass production, utilizing common welding and gluing technologies. Their production concept emphasizes flexibility and cost efficiency.

Regulatory Affairs
RoweMed complies with all regulatory requirements and has over 15 years of experience in medical device and disposable product approval. They provide complete technical documentation according to Council Directive 93/42/EEC and US market 21 CFR part 820.

Product Offerings

Drug Production and Preparation: Includes mixing drug solutions, filling patient vials, and administration sets for critical pharmaceuticals.
Vent Filters: For sterile venting and retention of liquids, particles, and aerosols, with hydrophobic filters available in various sizes.
Sampling Needles: For drug withdrawal and sampling, available in different materials and lengths with various connections.
Injection Filters: For sterile drug preparation, avoiding particle contamination, with hydrophilic particle filters in different diameters.
Tubings/Lines: Made from materials like COC and glass, resistant to acids and solvents, with heat stability and optimal design for complete emptying.
Reaction Vials, Bottles, Vials, Vessels: Available in polyethylene and glass, resistant to acids and solvents, with various designs and filling volumes.
Bag Spikes: For supply and withdrawal from bags or bottles, available with check valves and Luer-Lock connections.
Hollow Fibre Filter: Offers large filter surface for ultra and micro filtration, available in high flux, endotoxin, or plasma configurations.
Customized Sets: Tailored complex configurations according to specific customer requirements.

Catalog excerpts

Safe Handling of Radiopharmaceuticals October 2018

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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...

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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...

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

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

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■ 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

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

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

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Safe Handling of Radiopharmaceuticals-10

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

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

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