Performance testing within the pharmaceutical and medical sectors

On this interview, Information-Medical talks to Alan Thomas from ZwickRoell UK about supplies testing within the pharmaceutical and medical {industry}.

Why is dependable medical and pharmaceutical system testing essential?

High quality assurance within the medical engineering and pharmaceutical sectors locations the very best calls for on testing know-how when it comes to {hardware}, software program and documentation.

These industries are closely managed by stringent legal guidelines and rules. That’s the reason security necessities are much more essential than in most different industries, since these merchandise, from injector pens and implants to sterile packaging, instantly impression people.

High quality management that satisfies these necessities entails not solely product improvement, manufacturing and packaging of medical and pharmaceutical gadgets in compliance with the authorized framework and relevant requirements, however should additionally reduce threat to sufferers and customers.

ZwickRoell presents the optimum options for mechanical checks required by the medical and pharmaceutical industries, with versatile, modular testing techniques, purpose-designed specimen grips and tooling and intuitive software program to equip laboratories effectively and economically, saving clients money and time.

Our intensive product portfolio caters to nearly each section – from medical and pharmaceutical packaging to surgical devices, orthopedics and biomaterials.

An ever-increasing demand is positioned on software program employed in these sectors to facilitate the documentation and traceability of accomplished actions.

These calls for are glad by the choice of  ‘Expanded Traceability’ as required by FDA 21 CFR Half 11, which is out there for ZwickRoell’s testXpert III testing software program, optimally supporting the operator with take a look at duties.

A big ingredient of course of validation in these sectors is the technical assessment of particular person vegetation and gadgets. This qualification can be required for ZwickRoell supplies testing techniques utilized in these sectors, as a result of take a look at techniques are topic to varied authorized necessities, for instance, Medical Units Directive 93/42/EEC or rules, corresponding to FDA 21 CFR Half 11 and EU GMP Guideline Annex 11.

ZwickRoell offers help for patrons within the DQ/IQ/OQ qualification levels for materials testing techniques within the type of complete, individually tailor-made qualification documentation in accordance with GAMP5 and present tips, and in the course of the on-site qualification process.

ZwickRoell Multi-Station Syringe Testing System. Picture credit score: ZwickRoell UK

Are you able to present an summary of ZwickRoell and its strategy to being a trusted companion for the medical and pharmaceutical industries for over 40 years?

ZwickRoell has been supplying a various vary of testing merchandise to the medical engineering and pharmaceutical industries for the reason that Seventies. By means of the supply of well-engineered, clever testing options, we’ve got gained the arrogance of worldwide product producers, analysis institutes and certification authorities.

What are some particular examples of areas the place ZwickRoell’s clever testing options could be utilized?

ZwickRoell’s wide selection of testing techniques contains a modular design, enabling optimum adaptation to the client’s particular testing necessities.

We offer an in depth portfolio of testing options, from these designed to accommodate standard-based checks through guide operation, to complicated, absolutely automated testing techniques that don’t require a machine operator.

Our clever testing options make sure that we are able to supply the precise product for each software.

Along with testing techniques that cater for the basic challenges related to supplies know-how, we offer complete testing options for all related medical and pharmaceutical segments, together with:

  • Syringes and injectors (that are used for the administration of parenteral medication)
  • Catheters and stents
  • Biomechanics
  • Dentistry
  • Latex and rubber merchandise
  • Medical textiles
  • Packaging
  • Medical implants
  • Surgical devices and take a look at tools that’s employed for medical analysis functions

Remedy injection techniques corresponding to syringes, needles and injector pens are vital for correct medical therapies. What benefits does ZwickRoell’s automated testing supply for injector techniques?

Dependable take a look at outcomes are a primary requirement when testing medical merchandise.

Intensive testing system automation brings many benefits, together with an enchancment in take a look at outcome reproducibility, the elimination of potential machine operator affect, simplification of take a look at validation, and naturally, the flexibility to deal with excessive productiveness throughput.

Auto-injectors are medical gadgets which might be employed to allow sufferers to securely administer parenteral medication and are, due to this fact, topic to stringent high quality management.

Beforehand, parameters such because the firing time and length of drug expulsion might solely be measured manually.

ZwickRoell has engineered an answer for the automated dedication of the actuation power, firing time, drug expulsion pace, along with the active-ingredient profile while the size of the prolonged needle is set through two lasers.

The analysis of all of the take a look at information is carried out time-synchronously through the ZwickRoell testXpert III testing software program. Scales are moreover integrated into the testing system to find out the quantity of energetic ingredient delivered and a microphone could be employed to detect the activation noise of the auto-injector.

The applying of automated testing techniques for injectors ensures the very best stage of take a look at outcome integrity together with a quantity of take a look at throughput that’s merely not achievable when utilizing a operated by hand system.

ZwickRoell Backbone Implant Check Fixture. Picture credit score: ZwickRoell UK

Describe the method of testing merchandise corresponding to catheters and stents?

Catheters are medical gadgets within the highest threat class and are topic to strict high quality necessities. Growth work on catheter and guidewire techniques consists of makes an attempt to scale back the coefficient of friction and the breakaway power.

ZwickRoell has developed a horizontal testing system that allows the dedication of shear forces in a simulated catheter insertion with extraordinarily excessive accuracy.

The frictional conduct of the catheter is measured by pushing it by a man-made artery, referred to as the ‘tortuous path’. The take a look at is carried out in a horizontal orientation to intently replicate the physiological standing of a affected person in the course of the surgical intervention.

Exams could be carried out both in dry circumstances or with the take a look at specimen immersed in a temperature-controlled medium containment chamber. It’s also attainable to hold out checks with or in opposition to a liquid circulate.

Stents are topic to vital masses on insertion and whereas they’re in place in blood vessels or ureters and have to be examined to make sure they’re match for function. Along with acquiring correct materials attribute values, the dedication of radial compression power is a very powerful take a look at to guage stent efficiency.

Stents should exert a radial power which is adequate to make sure that the system stays fastened within the beforehand narrowed location and to forestall renewed constriction of the blood vessels. ASTM F3067 describes the radial compression testing of balloon-expandable and self-expanding stents.

ZwickRoell presents a testing answer that’s geared up with a 37°C chamber to simulate checks at physique temperature.

The radial power is measured utilizing specifically designed radial compression take a look at fixtures – which can be found in varied diameters and lengths. They simulate the strain exerted on the stent by the artery, along with the restoring power, via segmentally organized wedge jaws which generate a uniform floor strain.

The stent is inserted, compressed radially to a minimal goal load, after which unloaded.

What does ZwickRoell supply for testing the efficiency of spinal implants?

Spinal implants, typically consisting of a rod and screw system, are examined beneath static and dynamic loading circumstances in accordance with the procedures described in ASTM F1717.

The implants are mounted in a take a look at fiixture and the usage of simulated vertebral our bodies improves take a look at reproducibility in contrast with utilizing human materials.

Along with conducting purely axial rigidity and compression checks, a pure or mixed torsional load could be utilized to spinal techniques in accordance with  ASTM F1717, ASTM F2706 and ISO 12189 requirements.

These checks could be optionally carried out beneath physiological or ‘in-vivo’ circumstances by immersing the take a look at specimen in a shower containing a temperature-controlled saline answer.

The usual ASTM F2077 describes a collection of various quasi-static and oscillating checks to allow mechanical comparability of intervertebral physique fusion gadgets. These embody shear, compression and torsion checks, which offer a simplified ‘in-vivo’ simulation of the hundreds imposed on spinal implants.

On account of fractures of a vertebral physique, or tumors within the space of the spinal column, it could be mandatory to exchange sections of a vertebral physique with an implant that’s evaluated by finishing up quasi-static or oscillating torsion checks in accordance with ASTM F2077 and ASTM F1717 requirements.

The various vary of textile medical merchandise and devices require a variety of fabric and performance checks. What capabilities are provided to cater to those?

Textiles are used for quite a few medical functions, together with dressing and treating wounds, all kinds of suture supplies, textile-based implant constructions, corresponding to hernia internet implants, and surgical drapes and clothes.

These merchandise use a variety of supplies, together with pure and artificial fibers, along with breathable movies and materials combos. The various completely different merchandise used on this space name for a variety of fabric and performance checks.

To keep away from particular person gauze bandage fibers ‘catching’ on the winding beneath and stopping dependable unrolling, it’s mandatory to find out the power required to unwind the bandage from the roll.

For this take a look at, ZwickRoell presents a low power testing machine incorporating a motor-driven unrolling unit and the take a look at sequence is managed by a specifically tailored program from ZwickRoell’s testXpert III software program suite.

This particular take a look at fixture may also be utilized for pull-off checks on plaster strips, the place the take a look at technique is described in EN 1939. To measure the adhesive power of wound dressings or different self-adhesive medical merchandise, the specimen is pulled off a metallic plate in the course of the take a look at and could be carried out at varied angles.

Nevertheless, forces measured on this approach are considerably larger than these arising when the dressing is used on the pores and skin. Producers of adhesive merchandise steadily take a look at adhesive power on pure pores and skin with a purpose to detect any sensation of ache by the affected person, in addition to any pores and skin irritation which will happen.

ZwickRoell machines are used for the characterization of surgical suture supplies utilizing typical tensile checks. In the course of the take a look at the monofilament, multifilament and braided yarn constructions have to be securely clamped to keep away from slippage, which might lead to inaccurate take a look at information.  

Surgical devices could be divided into holding, greedy and slicing devices, in addition to suture devices, optics and mixed devices.

ZwickRoell, with the good thing about having an in depth take a look at tools portfolio, can use our modular design idea to accommodate the testing of surgical elements and completed items. For instance, we’ve got equipped tools that’s used to find out the slicing traits of ophthalmic scalpels and the damage resistance of bone saws.

ZwickRoell Automated Bottle Screw Cap Testing System

Inform us extra concerning the gadgets created to check medical and pharmaceutical packaging?

Pharmaceutical packaging is very regulated however with some variation within the particulars, relying on the nation of origin. A number of frequent components can embody:

  • Assurance of affected person security
  • Assurance of the efficacy of the drug by the supposed shelf life
  • Uniformity of the drug by completely different manufacturing tons
  • Thorough documentation of all supplies and processes
  • Management of attainable migration of packaging elements into the drug
  • Management of degradation of the drug by oxygen, moisture, warmth, and so forth.
  • Prevention of microbial contamination, sterility, and so forth.

Packaging is usually concerned in meting out, dosing and use of the pharmaceutical product and is an integral a part of the medical or pharmaceutical product.

Packaging testing covers a really vast spectrum however a number of the extra generally used checks embody:

  • Peel checks on blister packs
  • Pill push-out checks on blister packs
  • Compression testing of capsules and tablets
  • Willpower of the residual seal power of drug vials
  • Push and switch checks on screw caps
  • Willpower of the breakaway torque of syringe tip caps
  • Compression checks on cardboard packaging

The intensive expertise of ZwickRoell permits us to accommodate nearly any packaging take a look at by drawing on our earlier information of the sector and the place mandatory, designing a bespoke answer to fulfill the client requirement.

How do biaxial and triaxial testing techniques broaden the capabilities of biomaterial and scientific analysis?

To allow correct modeling, the biomechanical conduct of sentimental organic tissue and its underlying construction should first be exactly decided.

As organic tissues discovered within the physique are repeatedly subjected to multi-axial masses, analysis on this space requires a testing machine that has the potential to use multi-axial masses to the tissue specimen.

The ZwickRoell biaxial testing system incorporates 4 linear drives that are managed independently of one another through place, power or pressure. Power measurement is set through load cells, two of every within the X and Y instructions.

There are additionally 4 digital measurement and management models, in addition to a fluid tub for optimum temperature conditioning of the pattern.

To facilitate the dedication of the shear properties of sentimental organic (orthotropic) tissue, ZwickRoell has developed a triaxial testing system that consists of two primary elements; an higher platform designed to maneuver vertically within the ‘z’ path, and a decrease platform designed to maneuver within the horizontal aircraft in two instructions (‘x’ and ‘y’ instructions) perpendicular to one another.

In the course of the take a look at, the tissue specimen is hooked up to the higher and decrease platforms utilizing a skinny coating of adhesive and immersed in a temperature-controlled physiological answer.

The decrease platform strikes relative to the horizontally fastened higher platform, inflicting the specimen to shear, and the forces occurring within the three orthogonal instructions (x, y and z) could be measured concurrently with a particular load cell mounted on the higher platform.

We’ve additionally developed a triaxial testing system for characterizing cardiovascular tissues which permit an axial power (pressure), an inside strain (inflation) and a rotational motion (torsion) to be utilized to the tissue pattern.

The tissue beneath take a look at is often positioned in a shower containing a physiological fluid. Symmetrically shifting crossheads make sure that the middle of the specimen at all times stays in the identical horizontal place.

As a result of sensitivity of the constructions being examined, it is vital that pressure is measured with out affecting the specimen. We, due to this fact, make use of superior non-contacting measuring devices for this function.

What are some advantages of working with superior testing software program offered by ZwickRoell?

ZwickRoell testXpert III software program is the results of shut collaboration with customers in supplies testing and the expertise gained from an enormous variety of profitable testXpert installations.

With its intuitive, structured operation, testXpert III is straightforward to make use of proper from the get-go, incorporating informative icons and clear visible linking of associated gadgets to help the person, whereas decreasing the mouse motion and required clicks.

The software program guides the operator by the varied levels of a take a look at process, from getting ready and operating the take a look at to the evaluation of the take a look at outcomes.

testXpert III is workflow-based, retaining coaching time to a minimal and enabling environment friendly, dependable testing. Moreover, the software program can talk with any IT system so that each one test-related information is imported shortly and instantly.

Ever-increasing calls for are positioned on the software program used within the medical and pharmaceutical industries to doc the traceability of accomplished actions.

testXpert III’s ‘traceability’ possibility permits the logging of actions and modifications earlier than, throughout and after the take a look at, making take a look at outcomes and documentation traceable, in addition to safeguarding them in opposition to tampering.

In regards to the interviewee

Alan Thomas is employed within the Advertising Division at ZwickRoell Restricted.

Having spent over 40 years within the supplies testing sector, he’s eager to make sure ZwickRoell preserve market chief recognition within the provide of superior testing merchandise and related buyer help.

Alan enjoys utilizing his testing sector information and expertise to tell and educate clients relating to the advantages which could be derived from collaborating with a number one, world model.

His intensive information of supplies and part mechanical testing disciplines permits him to develop sturdy buyer relationships and to advertise premium testing services throughout a variety of {industry} sectors.

About ZwickRoell

With over 160 years of experience in supplies and elements testing, ZwickRoell delivers clever supplies testing options for the medical {industry}, together with drug supply testing techniques for syringes and cartridges, autoinjectors, and pen injectors. Our qualification providers assist guarantee compliance to your {industry}’s stringent testing necessities.

Worldwide presence

ZwickRoell, LP is a member of the ZwickRoell Group, a key participant within the world marketplace for supplies testing techniques. Working in 56 nations worldwide, the ZwickRoell Group has manufacturing amenities in Germany, the UK, Austria, and China, properly as subsidiaries in France, the UK, Spain, the USA, Brazil, Turkey, Singapore, and China.

Prime quality

ZwickRoell produces most elements in-house to make sure more and more top quality. Our specialists perceive the person necessities of the completely different industries to satisfy all testing wants with state-of-the-art options.

Excessive-tech software program and tools

ZwickRoell testing techniques maintain many patents and design awards. We provide state-of-the-art testing machines, industry-leading measurement and management software program, and A2LA-accredited service and help. Our qualification providers assist guarantee compliance to your {industry}’s stringent testing necessities and our cutting-edge extensometry and customised take a look at fixtures accommodate nearly any testing software.


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