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Instrumentation Wet Chemical & Vacuum Deposition

for Medical Technology GMP & FDA Compliance 02

Wet Chemical & Vacuum Deposition GMP & FDA Compliance

SINGULUS TECHNOLOGIES focusing quality and to meet the binding market requirements on the Medical Technology Market of health agencies, in particular the rules of the FDA (U.S. Food and Drug Administration) (FDA / 21 CFR), SINGULUS TECHNOLOGIES built machinery for the Semiconductor, Solar and Optical Disc areas SINGULUS TECHNOLOGIES is a globally active for 20 years, and has satisfied the high-quality company certified to DIN EN ISO 9001, DIN EN ISO requirements of the industry. 50001:2011 – certification for medical technology to DIN EN ISO13485 has been prepared. The medical industry, now often referred to by the umbrella term life science, is one of the most Wet Processing Systems important growth markets of the future. The company Batch & Inline Systems as well as gears its processes to the sophisticated characteristics Customized Solutions and functionality expected in medical technology GMP & FDA Compliance and therefore to the quality of the products and the production and processing methods required. This SINGULUS TECHNOLOGIES delivers wet chemical involves adopting the GMP (Good Manufacturing equipment for different applications and industry Practice) principles as well as the GAMP (Good segments. The spectrum ranges from manually Automated Manufacturing Practice) guidelines that loaded wet chemical tools for cleaning applications to apply in regulated industries for the validation of fully automated platforms for cleaning, conditioning, computer-based systems. The corresponding quality or etching for high volume mass production management system has been installed at SINGULUS in demanding technologies. TECHNOLOGIES. This serves to guarantee product 03

Typical Examples for Wet Chemical Applications: >> Washing and pre-cleaning >> Cleaning >> Ultra- or megasonic cleaning >> Surface conditioning >> Etching >> Surface modification >> Coating >> Electrochemical etching

The approved SINGULUS TECHNOLOGIES wet bench equipment is available for applications for a wide range of different materials. Flat substrates in large dimensions can be processed but also small three- dimensional and thin parts are typical for high volume production equipment as well as customized tools for Inline System special applications. with Horizontal Substrate Transport for Flat Substrates

Vacuum Deposition Technology PVD: Sputtering PECVD: Plasma Enhanced Chemical Vapor Deposition GMP & FDA Compliance

SINGULUS TECHNOLOGIES has delivered far more than 8,000 vacuum coating machines since its foundation in 1995. The spectrum of vacuum deposition methods includes physical vapor deposition (PVD, sputtering) as well as plasma enhanced chemical vapor deposition (PECVD). In addition, non-vacuum deposition methods like CVD or aerosol assisted CVD (AACVD) are used. Applications like plasma cleaning and plasma surface conditioning complete the portfolio.

Application Examples for Medical Devices >> Antibacterial POLYCOATER >> Dense barrier layers Inline Sputtering System for 3D Parts >> Gradient layers >> Antireflection coatings, hard coatings and clean coatings >> Adhesion promoting layers >> Plasma functionalization >> Plasma cleaning, plasma sterilization >> Decorative coatings

A variety of deposition materials, e.g. the wide range of metals, metal alloys and ceramics, is available for the respective application. Flat substrates can be processed but also 3-dimensional parts by either simultaneous deposition from different directions or part rotation during deposition. Our production systems typically feature single substrate/parts tracking, in-line quality control, closed loop process stabilization and are fully automated to reduce logistical efforts and personnel intensity. Dedicated All-Electric Injection Molding Machine for Thin-Wall Medical Parts Subsidiaries Offices

← [email protected] Fax +4981413600-100 Tel. +498141 3600-0 82256 Fuerstenfeldbruck, Germany Fraunhoferstr. 9 Branch Office Fuerstenfeldbruck SINGULUS TECHNOLOGIESAG for Wet Processing Systems Production Site www.singulus.de [email protected] Fax +496188440-130 Tel. +496188 440-0 D -63796Kahl,Germany Hanauer Landstrasse 103 SINGULUS TECHNOLOGIESAG Headquarters draws uponits know-how intheareasdraws of automation andprocess technology. For allmachines, processes andapplications SINGULUS TECHNOLOGIES related chemical andphysical processing steps. technology, surfaceprocessing, wet-chemical applications asthe aswell of its existing core competencies. Theapplication areas includecoating SINGULUS TECHNOLOGIES’ strategy isbasedontheuseandexpansion efficient production processes. SINGULUS TECHNOLOGIES builds machinesfor economical andresource- SINGULUS TECHNOLOGIES–InnovationsforNewTechnologies Dep osition [email protected] Tel. +186068380-00 SINGULUS TECHNOLOGIESINC. United StatesandCanada [email protected] Tel. +88622748-3366 TAIWAN LTD. SINGULUS TECHNOLOGIES Taiwan [email protected] Tel. +65674119-12 ASIA PACIFIC PTELTD. SINGULUS TECHNOLOGIES Singapore [email protected] Tel. +551121 6524-10 LATIN AMERICALTDA. SINGULUS TECHNOLOGIES Latin America [email protected] Tel. +333893111-29 FRANCE S.A.R.L. SINGULUS TECHNOLOGIES France [email protected] Tel. +8613822138376 Guangzhou Office SINGULUS TECHNOLOGIES [email protected] Tel.: +8613917382315 SHANGHAI Office SINGULUS TECHNOLOGIES China Subsidiaries Engineering Surface Processing Thermal Chemical

Wet

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