Originally Published EMDM November/December 2001
PRODUCT UPDATE
Melab GmbH
A
company’s test equipment for the quality control of catheters is capable
of performing penetration load tests of the introducer needle, separation force
measurements of each tubing portion with the hubs and connectors, torque tests
of luer connectors, bending tests, leakage tests, and flow rate tests. The Pentrometer
DEKA 8, which incorporates the technology of the company’s older products
with a more up-to-date computer and software system, is the newest test system
offered by Melab GmbH (Leonberg, Germany).
“We are always
working on new methods that make tests easier to perform. This lowers the number
of failures and ultimately reduces costs for the manufacturer,” says Monika
Löffler, product manager at Melab. The company also offers in-house laboratory
testing and product development services.
Interface Associates Inc.
A
marker-band swager was designed to simplify the process of permanently attaching
thin, tubular marker bands to elastomer tubing or catheter shafts. The small
tabletop unit is suitable for a cleanroom environment and is easy to use. Interface
Associates Inc. (Laguna Niguel, CA, USA) also supplies other catheter assembly
products, including a balloon-wrapping fixture, multistation burst tester, multistation
leak tester, and tubing cutter and splitter.
“The main
benefits to OEMs that use our equipment are a drastic reduction in production
times; substantially improved quality, performance, and appearance of the finished
product; high production yields; and a low number of rejects,” says Josef
Stupecky, president and CEO of Interface Associates. The company also supplies
balloon molds in various shapes and sizes.
“We provide
catheter manufacturers worldwide a cost-effective means to increase productivity
and simplify the most intricate steps of catheter manufacturing. Our equipment
has allowed many start-ups to gain a competitive advantage,” says Stupecky.
EFD International
Up to eight different
settings can be programmed into the 2000XL adhesive dispenser from EFD International
(Dunstable, Beds, UK). Digital displays of all of the dispensing parameters
provide high process control.
“The whole
idea behind the technology is to get the dispensing amount exactly right every
time,” says Gary Cordier, technical manager at EFD International. The 2000XL
operates on compressed air and electricity. “It eliminates the inconsistencies
encountered with hand syringes and other manual applicators,” says Cordier.
Tips and barrels
are available in many different styles and sizes. To apply a preset amount of
adhesive, the operator places a tip in position and presses an electric foot
pedal. The dispenser is well suited for balloon attachment in catheter processing.
Degania Silicone
Silicone catheters
and surgical drains are manufactured according to customer specifications. Models
of varying designs are produced, including intricate perforation configurations,
catheter profiles with x-ray lines, fully radiopaque catheters, tips of varying
geometry, balloons, phasing, printing, funnels, special surfaces, and long-
and short-term implantation materials.
“All of our
products are made from 100% silicone, which does not react to body tissues and
fluids, resists clotting and sticking, retains physical properties throughout
a wide range of temperatures, and does not support bacterial growth,” says
Jan Rotem-Bar, international marketing and sales representative at Degania Silicone
(Emek Hayarden, Israel). The company complies with ISO 9001 and EN 46001 and
has CE marking on its own medical disposables.
The final products
can be supplied either in bulk, nonsterile, or in sterile packaging with the
customer’s private label. The silicone materials are suited for sterilization
by any validated method.
Søbygaard Machine Design
A tip-forming device
for both closed and bent tips operates by means of heating by hot air at temperatures
ranging from 120° to 400°C with a tolerance of ±2°C, and
cooling down using air at room temperature. The manually operated tip-forming
machine has the capacity to store up to 99 combinations of heating temperature,
heating time, waiting time, and cooling time.
Production capacity
for the equipment from Søbygaard Machine Design (Naestved, Denmark) is
between 500 and 800 pieces per hour. “This machine has been produced and
sold to several overseas customers, and offers an inexpensive and easy way for
even small producers to be self-reliant,” says Henrik Søbygaard,
managing director of the company.
The company also
supplies eyelet-punching tools that are pneumatically operated and have a production
capacity of 800 to 1200 pieces per hour.
Machine Solutions Inc.
A
machine that incorporates forming, folding, and thermal setting provides high
yields; a uniform, repeatable process; short cycle times; and optimized folded
balloon profiles; and eliminates operator variances. The FFS700 from Machine
Solutions Inc. (Flagstaff, AZ, USA) enables catheter manufacturers to pleat
and compactly fold angioplasty and stent deployment balloon catheters.
“The product
aids manufacturers in achieving precise, consistent, and repeatable balloon
profiles quickly, and without the need for operator hand-folding of the balloon,”
says James Kasprzyk, director of global marketing at the company. Rather than
imitating the hand-folding process, the FFS700 comprises three modules—the
machine base, the pleat head, and the fold head—that fold the catheter
in an entirely different process. The angioplasty or stent delivery balloons
are first processed in the pleat head, which divides the balloon into equal
sized pleats. The fold head then radially compresses the catheter balloon to
compact and fold the pleats against the catheter shaft.
“To preserve
margins and profitability, companies are being forced to look at their manufacturing
processes to achieve whatever cost savings they can,” says Kasprzyk. “This
equipment can help them achieve that goal by reducing cycle times, improving
yields, and, in some cases, reducing the number of operators needed on a line.”
SEBRA
A
system is designed to efficiently heat and reform catheter thermoplastics using
process control. The PIRF system from SEBRA (Tucson, AZ, USA) uses closed-loop
temperature control to provide repeatable control of temperature to 1°C.
Heat time, cool time, and insertion pressure are also controlled for fast, precise,
and consistent results.
The company also
manufactures compact industrial RF welding systems that can be used to weld
single- or multilumen dielectric tubing to lures, fittings, and hubs at the
proximal ends of catheters. “Most customers are using adhesives and injection
moulding processes, which can be labour intensive and produce fumes that require
ventilation equipment and require a large amount of floor space,” says
Judi Laurel, marketing representative at SEBRA. “In response to this need,
we have developed an industrial RF welding system that is compact, fast, and
reliable.” The systems are CE marked.
Technical Innovations
An
automated hole-drilling system with a touch screen graphic interface offers
fast setup capability and easy programming. The Smart Driller TS from Technical
Innovations (Brazoria, TX, USA) features event-driven software and offers an
almost limitless number of hole patterns.
“Special configurations
of the system include hole pattern and data printing, live video capabilities,
and vacuum plug collection and detection systems,” says Gail Brinson, CEO
and president of Technical Innovations. “We are continuing to improve our
existing automated products and have recently perfected methods for accessing
a single lumen in a multilumen catheter over the entire length of the catheter.”
The company specializes
in drills, punches, and hole-making machines. The machines range from simple
hole-drilling and -punching operations to automated electric hole drilling and
pneumatic punching.
Crescent Design
A
hydraulic burst and leak tester (HBLT) is used for hydraulic pressure testing
of such products as tubing, valves, fittings, and angioplasty catheters. Using
distilled water as the working fluid, the HBLT from Crescent Design (San Diego,
CA, USA) has a touch screen that allows an operator to program and save a wide
range of test profiles. “Because the HBLT uses water and its programming
is so versatile, it can be used to simulate in the catheter laboratory the actual
pressure profiles that angioplasty catheters experience. This allows for the
collection of realistic product quality data,” says Steven Royce, president
of Crescent Design.
Along with data
acquisition, remote control operation is a standard feature of the HBLT. The
machine also incorporates a backlit LCD user interface. The HBLT is available
in five models ranging from 100 to 2000 psi.
S-Y-M Products Co.
A tubing set–
and catheter-coiling machine is designed to improve production and eliminate
the strain on the operator’s hands and wrists. “The core or mandrel
on which the catheter is coiled disappears, enabling the operator to slide it
directly into a package,” says Daniel Fowler, general manager of S-Y-M
Products Co. (Stamford, CT, USA).
The operator of the Mini-Winder can change coil sizes without tools, and the speed, number of rotations, direction of motor, height of mandrel, and other features are adjustable. “Our newest models have additional features such as computer preprogramming, pause and resume functions to assist the operator, and foot-switch and push-button operations,” says Fowler. The equipment is manufactured for use in a clean environment. All product contact surfaces are stainless steel or high-density plastic.
Copyright ©2001 European Medical Device Manufacturer
