ZEISS Insights: Technical Paper

Technical paper
Identify critical particles on medical products
Importance of technical cleanliness in the manufacturing process

ZEISS Medical Industry Solutions
Quality Assurance for the Highest Medical Standards

Identify critical particles on medical products

Medical products have a direct impact on peoples’ lives, themanufacturing. Various influences such as personnel, process

fitting of a contaminated implant would ultimately pose a highequipment and process media can introduce contaminants

health risk to the patient. To avoid this, medical technology

into the manufacturing environment. Cleanroom personnel

companies need to fulfill stringent regulatory requirements

contribute a large percentage of all contamination foundstipulated by various authorities regarding quality. Technicalwithin the cleanroom. In this way medical products can also

Cleanliness is a key factor for quality in all steps of thebe contaminated in the production process. It is important tomanufacturing area, with production processes, the production

identify particle contamination as soon as possible, if not it

environment, and the final packaging all having an influence on

is possible that the contamination leads to a stopping of thecomponent cleanliness. ZEISS Technical Cleanliness Solutions are

manufacturing process. Therefore, medical companies needready for deployment at every step of the production process

to observe their in-process steps for part cleanliness. For theand help to detect and analyse particulates that should not be

whole process it is crucial to combine particle detection andpresent, a mandatory requirement when looking to comply withclassification in a highly efficient workflow that not only finds

regulations, whilst improving productivity through reduced scrap

particles, but also helps classify them by contamination or wear

or rework.

origin.

Importance of Technical Cleanliness in the manufacturing
process
Particle contamination can cause critical medical influences
if not found and dealt with. Particulate cleanliness has beena fundamental requirement in the medical technology sector
for many decades, but problems linked to insufficient levels ofcleanliness still tend to arise.
Total cleanliness cannot be fully reached despite the applicationof established cleanroom technologies. The residual risk of aclean room can always lead to critical contamination during

The quality gates in the production process from raw material to finished medical parts2

Increase your productivity with ZEISS Technical Cleanliness Solutions
In the Technical Cleanliness process, particles are removed from the medical component in the cleaning cabinet by water, air orultrasound. During the process, the fluid flows through a filter whereby the particles are captured ready for analysis under themicroscope.
This filter, once dried, is placed under a ZEISS light microscope (e.g., ZEISS Axio Imager 2, ZEISS Axio Zoom V16) to detect all thenon-metallic and metallic particles on the filter. The intuitive ZEISS ZEN core software then provides a guided workflow to analyze
the particles that are on the filter. It lists all particles in a table and categorize them accordingly. There is no need to be an expert
in microscopes or software operation due to the intuitive user interface as well as the guidance provided to the user when going
through the application and workflow. The support by defined microscope hardware and software settings makes complex analysis
processes much easier to perform and more reliable. The data is stored by the system and exported if required. In addition, thesoftware is also capable of generating a report in accordance with the relevant standards. The software feature ZEISS ZEN Connect
also connects this data to electron microscopy solutions, generating a seamless workflow for switching between these technologies.
The new directive VDI 2083 sheet 21 gives manufacturers and users options to control the risk for patients due to contamination onmedical devices.
A consistent implementation of regular quality controls for medical products, especially in the critical area of particulate cleanliness,
which has not been consistently observed up to now, is therefore recommended. The additional work required for these tests isstraightforward, but the safety benefit for users and patients is considerable. The ZEISS software for Technical Cleanliness Analysis
already contains the VDI 2083 standard, sheet 21.

The intuitive ZEISS ZEN core software lists all particles in a table and categorize them accordingly

3

ZEISS Correlative Particle Analysis Workﬂow

Identify the root cause, make the right decision faster

The functionality of the direct retrieval of highlighted particles
from a light microscope to an electron microscope boosts
productivity and effi ciency by providing immediate access tothe dedicated analysis view in the high-resolution electronmicroscope.
To fi nd out more about the particles, the fi lter is placed in anelectron microscope such as ZEISS EVO or ZEISS Sigma. Its
connected system makes it easy to fi nd the individual particles
with the support of ZEISS SmartPI SEM Software. The useof a uniform portfolio uniquely enables the user to save thecoordinates of critical particles on the fi lter and therefore
identify the particle type with the ZEISS SmartPI software.
The system then analyses the material, how it is built up, andcan assist the user to determine where the contamination has
potentially come from. After all, the chemical composition of
the particles is determined by EDS measurement to determine
their origin.
ZEISS SmartPI provides much more than size, shape, distribution,and corresponding particle morphology. It also provides
chemical composition and material characterization. Thereby
enabling the user to locate the root cause of contamination.
4

Medical Quality Managementon premise) and each result is signed,Regulation

which protects against subsequentGlobal companies need to fulfill themanipulation. Every change is precisely

regulations of various authorities.

recorded. Any incorrect result or

In Europe for example, these rules

deviation from the specified steps isare defined in different EC directives

detected by the system. Checking the(regulations and guidelines of thevalidity of all files and signatures is

European Communities) and summarized

possible at any time.

in the MDR (Medical Device Regulation).
In the USA, the Food and Drug
Administration (FDA) is the relevant
regulative body. Additionally, China,Canada, South America etc. have theirown guidelines.
21 CFR Part 11 in the FDA´s Code ofFederal Regulations defines the criteria
under which electronic records andelectronic signatures are considered
trustworthy, reliable, and equivalent topaper records. Companies in the medical
industry are required to implement
procedures for software and systems
that are used to process electronic data

Services from ZEISS Industrial Quality Solutions

regulated by the FDA.

Technical Cleanliness is rapidly growing in importance within the medical industry.

With the new GxP function, it is possible

At ZEISS, we help professionals understand our systems and bring them closer to theto trace every work step without gaps.

handling of our machines.

The laboratory manager defines theWe provide assistance for everything from construction, service, and repair toworkflows, where he can use ZEISS ZEN

employee training on correct use of the equipment. We are always available and atcore modules specified by the software.

your side every step of the way. Our Demo Center is fully equipped to prepare you for

Data is stored in the database (cloud orevery aspect of our machines.

5Carl Zeiss Industrial Quality Solutions, LLC
6250 Sycamore Lane North
Maple Grove, MN 55369, USAVertrieb
Telefon: +49 7364 20 6337
E-Mail: sales.metrology.de@zeiss.com

Phone: +1 800 327-9735
Fax:+1 763 533-0219

ServiceTelefon: +49 7364 20 6337
E-Mail: info.metrology.de@zeiss.com
www.zeiss.de/imt

Email: info.metrology.us@zeiss.com
www.zeiss.com/metrology

EN_60_012_0035I Printed in Germany CZ-I/2023
Subject to change in design and scope of delivery and as a result of ongoing technical development.

Carl Zeiss IQS Deutschland GmbHCarl-Zeiss-Straße 2273447 Oberkochen