M A N U FA C T U R I N G C A PA B I L I T I E S
O E M S E R V I C E S
B R A N D E D B Y S F M
precise understanding
the healthcare group
C O N T E N T
MANUFACTURING CAPABILITIE S
ME TAL PROCE SSING 6
PL A STIC PROCE SSING 8
A SSEMBLY 10
PACK AGING 12
STERILIZ ATION 14
OEM SERVICE S
CONTRACT MANUFACTURING 18
CA SE STUDY VERTEBROPL A ST Y AND K YPHOPL A ST Y SE T 20
BRANDED BY SFM
NE X TARO® 24
SFM RF-NEEDLE 26
Over 300 employees worldwide
Over 65 year of experiens
Privately held
Serving global pharmaceutical
and medical companies
Strong vertical integration
from the design to the finished
product
Redundant manufacturng
facilities reduce risk
SFM AT A GL ANCE
sfm medical devices 3
PAR
TNERSHIP >
< RELIA
BILIT
YREGULATORY
DEVELOPMENT
PRODUCTION
LOGISTICS
precise understanding
Our integrated approach: Everything you need from a single source
HEADQUARTERS
SALES OFFICESSUBSIDIARIES
SFM medical devices GmbH
Germany, Wächtersbach
SAFEMED medical devices s.r.o.
Czech Republic, Prague
SAFETEC medical
engineering s.r.o. Czech Republic,
Prague
SFM medical devices
USA Inc. USA, Virginia
SFM swiss medical AG
Switzerland, Zug
the healthcare
group
Unser Standort in Wächtersbach
oder Übersicht aller Iconsoder Foto Produktion
MANUFACTURING CAPABILITIES
METAL PROCESSING
PLASTIC PROCESSING
ASSEMBLY
PACK AGING
STERILIZATION
OEM SERVICE S
CONTRAC T MANUFAC TURING
CA SE STUDY VERTEBROPL A S T Y AND K YPHOPL A S T Y SE T
BRANDED BY SFM
NE X TARO®
SFM RF-NEEDLE
We offer a wide range of manual,semi-automatic andfully automatic processes.
M A N U FA C T U R I N G C A PA B I L I T I E S
ME TAL PROCE S SING
FORMING
SURFACE TREATMENT
CLEANING
SEPARATING
ELECTRO-CHEMICAL CUTTING
THERMO CUTTING
SHEARINGBEVEL
GRINDING
POLISHING
NOTCH CUTTING
BENDINGBEAD AND
SAND BLASTING
ELECTRO-CHEMICAL POLISHING
FULLY-AUTOMATED CLEANING VALIDATED
SHEETMETAL FORMING
FLARING
SWAGING
MACHINING
C O M P O N E N T F O R D O S I N G A N D D R U G T R A N S F E R S Y S T E M S
REQUIREMENTSome of the largest pharmaceuticals companies require system-specific stainless steel components for their drug dosing and drug transfer systems.
SOLUTION sfm manufactures stainless steel cannulas for various dosing and delivery systems. The product line includes components for low-fragmentation and residue-free penetration of rubber seals on vials, as well as lancing devices for drug capsules.
CA SE STUDY
Stainless steel components: Pencil Point Cannulas and Lancets
sfm medical devices 7
CLASS 8 CLEANROOM
S T I M U L AT I O N N E E D L E F O R G E N T L E N E R V E P U N C T U R E
REQUIREMENTThe development of a needle for effective neurostimulation in the treatment of pain with an improved hub design.
SOLUTION The sfm stimulation needle allows for precise and gentle puncturing of the body tissue and location of the targeted nerve through the use of electrical impulses. Any malfunction and loss of fluids is prevented by the perfect overmolding and conection between needle, tube and connecting cable.
Overmolded Stimulation NeedleWe offer a wide range of manual, semi-automatic and fully automatic processes.
M A N U FA C T U R I N G C A PA B I L I T I E S CA SE STUDY
PL A S TIC PROCE S SING
INJECTION MOLDING
ANNEALING
CRIMPING
FLARINGOVER
MOLDING
MICRO-INJECTION MOLDING
PROCESSED MATERIAL:
PC, ABS, PA, PP, PE, PPO, MABS,
MBS, POM, PS, PBT
sfm medical devices 9
S Y R I N G E F I LT E R S F O R VA R I O U S A P P L I C AT I O N S
REQUIREMENTA particle and sterile filter for extraction of a solution from a vial and filter out any unwanted particles.
SOLUTION sfm installed a fully automatic process for efficient product manufacturing. This unit cuts out the filter material, assembles all needed components and also includes automatic monitoring of the manufacturing process, while being flexible enough to allow numerous versions to be produced within this unit.
SURFACING
JOINING
SEPARATING
INSPECTION
UV-GLUING
MARKING
SILICONIZING
LASER CUTTING
PUNCHING
TUBE CUTTINGLEAK TEST
CAMERA INSPECTION
VISUAL INSPECTION
2-COMPONENT GLUEING
ULTRASOUND WELDING
INDUCTION WELDING
Sterile and Particle Filter
CA SE STUDY
We offer a wide range of manual, semi-automatic and fully automatic processes.
M A N U FA C T U R I N G C A PA B I L I T I E S
CLASS 8 CLEANROOM
A S SEMBLY
sfm medical devices 11
PACK AGING
FORM-FILL-SEAL
LABELING
PRIMARY AND SECONDARY
PACKAGING
SOFT BLISTER
INDIVIDUAL LABELLING
UDI LABELS
BRANDED DISPLAY BOXES
INDIVIDUAL IFUS
READY-TO-SHIP PACKAGING
PEEL POUCH PACKAGING
HARD BLISTER
Packaging
We offer a wide variety of packaging options for your device or kitpacking needs.
M A N U FA C T U R I N G C A PA B I L I T I E S
DOUBLE-BLISTER
I N - H O U S E P R O D U C T I O N O F A L L C O M M O N PA C K A G I N G T Y P E S F O R M E D I C A L P R O D U C T S• Development of individual packaging solutions• Combination of technique,
esthetics, and user aspects• Validated processes• Different printing techniques• Accelerated and real-time aging,
and sterile barrier inspection• Transport simulation• State-of-the-art machines and processes
Please provide the following data to receive a quotation from us:• expected annual volume• Type of product: single device; Set/Kit packaging• Components are provided or to be sourced• Type of packaging: Paper; Tyvek, Film; Pouches;
Hardblister; Labeling etc.
sfm medical devices 13
Sterilization
We offer in-house ETO sterilization and other options through our approved partners.
M A N U FA C T U R I N G C A PA B I L I T I E S
S TERIL IZ AT ION
PREPARATION
RELEASE OF GOODS
AUTOMATIC ETO STERILIZATION
PROCESS
1. VACUUM TESTING
2. CONDITIONING
3. CONTROLLED EXPOSURE TO GAS
4. VENTING CYCLES
TOTAL DURATION APPROX. 9 - 10 HOURS
RECEIPT OF MICRO-BIOLOGICAL TEST RESULTS
(BIOBURDEN AND LAL TEST) AFTER MIN. 72 HOURS
ACCLIMATIZATION:STORAGE OF GOODS
AT ROOM TEMPERATURE >18°C
Please provide the following data to receive a quotation from us:• expected annual volume / Pallets• Type of product• Desired shipping format: Euro pallet;
Shipping box; other
sfm medical devices 15
OEM SERVICES
CONTRACT MANUFACTURING
CASE STUDY VERTEBROPLAST Y AND KYPHOPLAST Y SET
BRANDED BY SFM
NE X TARO®
SFM RF-NEEDLE
MANUFAC TURING CAPABILITIE S
ME TAL PROCE S SING
PL A S TIC PROCE S SING
A S SEMBLY
PACK AGING
S TERILIZ ATION
CA SE STUDYO E M S E R V I C E S
CONTR AC T M ANUFAC TURING SERV ICE
VALIDATION
REQUIREMENTImprove and manufacture an existing vertebroplasty and kyphoplasty set used for the reconstruction of damaged vertebrae. The materials and functional characteristics were to be optimized.
CUSTOMER'S IDEA
R&D @ SFM OR
CUSTOMER SPECIFICATION REALIZATION
SERIAL PRODUCTIONWITH FULL VERTICAL
INTEGRATION
Vertebroplasty and Kyphoplasty Set
SOLUTION As an experienced partner for medical technology and the pharmaceutical industry, we provide instruments with optimized materials that guarantee increased strength and durability. The new sets were created in close collaboration with the customer – from design to contract manufacturing.
sfm medical devices 19
BRANDED BY SFM
NE X TARO®
SFM RF-NEEDLE
MANUFAC TURING CAPABILITIE S
ME TAL PROCE S SING
PL A S TIC PROCE S SING
A S SEMBLY
PACK AGING
S TERILIZ ATION
OEM SERVICE S
CONTRAC T MANUFAC TURING
CA SE STUDY VERTEBROPL A S T Y AND K YPHOPL A S T Y SE T
TURNING MARKE T DEMANDS INTO SOLUTIONSnextaro® is the quality benchmark for reconstitution of lyophilized pharmaceuti-cal components. With its key advantages being the patented screw system and the optimized handling through the use of two component plastic, nextaro provides the market's best stability, and is suitable for people with ailments or those who are in a hurry. The modular design makes nextaro® customizable to meet the indi-vidual requirements of each drug. Contact us today and top off your high quality application set with the device it deserves.The product family is continuously growing and includes current the nextaro for the reconstitution with two vials and nextaro VA for the reconstitution by using a pre-filled syringe. Further product members are in development.
sfm Transfer Device nextaro®
PRODUC T E X AMPLE
PRODUCT IDEA
FEASIBILITY STUDY
TECHNICAL TESTS
VALIDATION
GLOBAL DISTRIBUTION
LONG-TERM OBSERVATION
QUALITY MANAGEMENT
REVIEW
MARKET FEEDBACK
RE-CERTIFICATION
START OF PRODUCTION
CLINICAL EVALUATION
BIOCOMPATIBILITY
VOICE OF CUSTOMERIDEA
1
DEVELOPMENT TO MARKET
AUTHORIZATION
2
MARKET LAUNCH
3
MARKET SURVEILLANCE
4RE-AUDITS
5
W W W.NE X TARO.COM
Further products and current developments under www.sfm.de
B R A N D E D B Y S F M
sfm medical devices 23
W W W.RF-NEEDLE .COM
FACE T JOINT DENERVATION BY THERMOCOAGUL ATION
sfm provides its customers with first-class radiofrequency needles that, without exception, aim directly at the needs of doctors and patients. The cannulas can be used adaptively with all known and existing application systems. Beside HF-generators and appropriate thermoprobes, corresponding high-quality radiofrequency / thermolesion needles that complement these systems are needed to lead the application to optimal results.
• Low penetration force thanks to optimum bevel geometry and a smooth transition to the coated needle region
• Ideal adjustment of the coagulation field thanks to the large number of design variations
• Minimization of pain sensation and posttraumatic stress due to the smooth transition to the coated needle
• Best possible navigation to targeted coagulation area due to the high-quality coating and the optional straight or curved tip geometry
sfm Radiofrequency NeedleFurther products and current developments under www.sfm.de
B R A N D E D B Y S F M
Straight version
Curved version
PRODUC T E X AMPLE
PRODUCT IDEA
FEASIBILITY STUDY
TECHNICAL TESTS
VALIDATION
GLOBAL DISTRIBUTION
LONG-TERM OBSERVATION
QUALITY MANAGEMENT
REVIEW
MARKET FEEDBACK
RE-CERTIFICATION
START OF PRODUCTION
CLINICAL EVALUATION
BIOCOMPATIBILITY
VOICE OF CUSTOMERIDEA
1
DEVELOPMENT TO MARKET
AUTHORIZATION
2
MARKET LAUNCH
3
MARKET SURVEILLANCE
4RE-AUDITS
5
sfm medical devices 25
Notes and Ideas:
SEPARATING
MACHINING
FORMING
SURFACE TREATMENT
CLEANING
INJECTION MOLDING
OVER MOLDING
JOINING
SURFACING
SEPARATING
INSPECTION
FORM-FILL-SEAL
PRIMARY AND SECONDARY PACKAGING
LABELLING
PREPARATION
AUTOMATIC STERILIZATION PROCESS
RELEASE OF GOODS
sfm medical devices GmbHBrückenstrasse 563607 WächtersbachPhone + 49 6053 805–0Telefax + 49 6053 805–[email protected] | www.sfm.deGERMANY
sfm is the leading partner for the development and production of single use medical devices and pharma applications.
11 /2018