the healthcare group - sfm

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.


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


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


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.


CLASS 8 CLEANROOM

A S SEMBLY


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.


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.


Sterilization

We offer in-house ETO sterilization and other options through our approved partners.


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


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


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.


BRANDED BY SFM

NE X TARO®

SFM RF-NEEDLE

MANUFAC TURING CAPABILITIE S

ME TAL 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



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


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


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

the healthcare group - sfm

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