This page will provide information regarding management of the web site www.phyllon.at (hereafter referred to as “site”) with reference to the handling of personal data of users that consult it.
This will be a general document that outlines the criteria for the correct handling of personal data processed on or via the site, criteria that the user will also be able to find clearly illustrated on individual pieces of information published on the various sections of the site that are aimed at outlining the process and purpose of providing various types of information.
This notice is provided in accordance with Article 13 of the Legislative Decree 196/2003 “Code regarding the protection of personal data” (hereinafter “Privacy Code”) to those who interact with the site’s web services and does not include information processing on other sites that the user might access using links presented on the site.
Users will need to carefully read the current Privacy Code before uploading any type of personal information.

Data Handler

Following the consultation of this site, data relating to identified or identifiable people can be processed.
The personal data handler is Phyllon GmbH, with offices in Inffeldgasse 13/4. OG – 8010 Graz, Austria.

Location of Data Handling
The handling of this site’s web services takes place in the Open Marketing S.r.l offices (via Pastrengo 9 in Seriate) They are processed solely by technical personnel entrusted with the handling of data or by possible individuals who carry out occasional maintenance operations.

The Objective of Data Handling

Personal data provided by users that access the site by sending an email directly to the Data Handler, or using the “Information Request” form / “Contacts” section, will be used solely for the requested service and will not be communicated or disclosed to third parties unless required by law, to comply with the specific request or upon the user’s written consent.
The optional, explicit and voluntary forwarding of emails to addresses indicated on the site, by its very nature, involves the subsequent acquisition of sender’s email addresses, necessary to respond to requests, and any other personal information included in the message.
Phyllon GmbH performs the processing of personal data to the implementation of functions requested by the service, but whenever possible anonymous data whenever possible. We ask our users to not send names or other personal data relevant to third parties that are not strictly necessary, particularly sensitive data or judicial proceedings under Section of 4 of Legislative Decree 196/2003 (“sensitive data”), the data suitable to disclose racial and ethnic origin, religious, philosophical, political other convictions, subscription to political parties, trade unions, religious, political, philosophical or union associations or organisations, as well as suitable personal data to reveal provisions of Article 3, comma 1, letters a) to o) and r) to u), of the D.P.R 14 November 2002, n. 313 relating to criminal records, the register of offense-related administrative sanctions and the relevant current charges, or as an accused or suspected person under Articles 60 and 61 of the Code of Criminal Procedure). The user shall guarantee full indemnity and release the owner from any claim, demand , request of refund arising from a third party due to the processing of the data indicated by the user in violation of the provisions of personal data safeguard.
In that sense the users guarantee to the data controller that any type of third party subjects indicated by the user (and that will consequently be treated as if the third party subject had provided itself the informed consent to its handling) has been acquired by the user itself in full conformity to the Privacy Code. Should the user send personal and contact data of any third party different from the person concerned within the request of information has to be aware that the procedure represents a processing of personal data towards which he acts as independent owner undertaking all obligations and responsibilities provided by the Privacy code
Personal data that reveals racial and ethnic origin, religious, philosophical or other types of convictions, subscription to political parties, trade unions, religious, union, political or philosophical associations or organisations will not be collected or divulged, as well as personal data revealing the state of health or sex life.

Types of data handled

During their standard operation, the computer systems and software procedures used to operate this website acquire some personal data, the transmission of which is implied in the use of Internet communication protocols (navigation data).
This information is not collected in order to identify individuals, but identify users because of their nature through processing and associations with information held by third parties.
In this category of data you can find return IP addresses or computer domain names used by users that connect to the site, URI addresses (Uniform Resource Identifier) of requested resources, the time of request, the method used in submitting the request to the server, the size of the file received in reply, the numerical code indicating the status of the reply provided by the server (successful, error, etc.) and other guidelines related to the operative system and to the user’s system environment.
This information is used with the sole purpose of obtaining anonymous statistical information pertaining to site usage and to check its correct function.

The information in question may be used to ascertain responsibility, in the case of any computer crimes against the site in question.
The site uses Google Analytics, a web analytics service provided by Google. Information regarding site usage is acquired through Google Analytics will be transmitted to and stored by Google on servers in the United States. This data will be used by Google for the purpose of examining site usage, to compile site activity reports for operators and to provide other services related to site and internet activity. The data is collected using an aggregate and anonymous method. Google may also transfer this information to third parties when necessary by law or where such third parties process the information on Google’s behalf. Google will not link your IP address to any other information possessed my Google. Google Inc. is the relevant data controller.

Cookie

Specific information outlining the use of cookies is available and consultable in the document Information on cookies.

Optional supplying of data

Apart from what is specified for data navigation and technical cookies, the user is always free to provide personal data for the purpose of connecting to the site.
The lack of personal data impede on the possibility of fulfilling the request.

Processing methods

Personal data is handled with automated instruments for the time strictly necessary to complete the purposes for which they have been collected.
Specific security measures are followed to prevent the loss, illicit or incorrect use, and non-authorized access to data.

Rights of those concerned

The person to whom the data refers to has the right, at any moment, to obtain confirmation of any recordings of their personal information, and to know the content and origin, verify its accuracy, or request its updating or correction. (Article 7 of Legislative Decree 196/2003).
As specified in the Article, you have the right to request cancellation, the anonymization or the stoppage of data that has been processed in breach of the law, and to oppose in any case, for legitimate reasons, their processing. The rights relating to Article 7 of Legislative Decree 196/2003 may be exercised upon informal request (hand delivery, email, fax) to the data handler or security manager and protection of personal data delivered to Phyllon GmbH headquarters in Inffeldgasse 13/4. OG – 8010 Graz, Austria or to the following email address info@phyllon.at.

Legislative Decree 196/2003 Privacy Code: Article 7 – Right to access personal data and other rights
At any time, the user may exercise the rights outlined in Article 7 of Legislative Decree 196/2003:
The person concerned has the right to access personal data.
The person concerned has the right to obtain confirmation of the existence of their personal data, even if not yet recorded, and their communication in a comprehensible manner.
The person concerned has the right to obtain information on:

The person concerned has the right to obtain:

The person concerned has the right to object, in whole or in part:

OSeeT Software

A simple and User Friendly OSeeT software, monitors the growth of the coating thickness and other characteristics throughout the whole process or at-line measurement. Each black spot on the chart corresponds to one thickness evaluation. Individual evaluations can be reviewed clicking on the black spots.

Screenshot of the Results tab in our OSeeT Pharma 1D software at the end of a coating process

Direct vs indirect measurements

 Direct measurements with standard OseeT softwareIndirect measurements with new development software
Typical use casemonitoring of transparent or semi-transparent coatings without scattering pigmentsmonitoring of scattering coatings (containing e.g. TiO₂, Fe₂O₃ etc.), uncoated products investigation, correlation of compression force to dissolution
Coating layersvisible in OseeT imagesnot visible in OseeT images
Calibration and correlationnot necessary – initial results are available right after the first measurementsA model needs to be created to correlate light penetration depth with the desired parameters (coating thickness, compression force, dissolution time)
Evaluationbased on visible interfaces between coating and corebased on penetration depth of light into the sample
Example OCT images

Images fromWolfgang et al., Ascertain a minimum coating thickness for acid protection of enteric coatings by means of optical coherence tomography (2022)Elisabeth Fink, Elen Gartshein, Johannes G. Khinast. Extending the Use of Optical Coherence Tomography to Scattering Coatings Containing Pigments

Comment regarding direct measurement imgs: Imgs are from following time points: 65, 130, 240 min. Include the time points on the images on the HP as on the images of the indirect measurements

Samples measured at 3 different time points of a coating process.
Evaluated area shown in color.

Types of OSeeT systems and probe heads

Depending on the intended application, there are different systems or combinations of OseeT systems and probe heads available.

Base Unit

Use Case

Specification

Image

HW 1.5

Mainly tablets

  • Axial resolution: 4 µm

  • Minimum coating thickness for automatic evaluation: 12 µm

HW 2.0

Samples with layer thicknesses between 12 µm and 150 µm (in certain cases up to 400 µm or more possible)

Suitable dosage forms: tablets, pellets, polymer films, co-extrudates, transdermal patches

  • Axial resolution: 3.7 µm

  • Minimum coating thickness for automatic evaluation: 12 µm

Compared to HW 1.5:

  • Improved image quality

  • Faster acquisition rate

  • Stronger PC components

UHR OCT

Pellets with very thin coating layers starting from about 4.5 µm

(UHR OCT is not recommended for tablets and coatings thicker than about 50 µm)

  • Axial Resolution: 1.5 µm

  • Minimum coating thickness for automatic evaluation: 4.5 µm

Sampling Device

Use Case

Characteristics

Image

SDP

At-line measurements mainly with pellets or tablets

  • Samples stay static and are not mechanically stressed during measurement

  • Samples can be measured in desired and specified positions

  • Only one tablet necessary to perform a measurement (but not limited to one – there can also be many samples)

  • Exchangeable discs available for different products/sizes

SDT

At-line measurement of tablets in a little perforated drum, mimicking an in-line coating process movement of the samples

  • Movement of samples as in a drum coater

  • Larger sample set can be evaluated at once compared to SDP

  • Measurements from different positions of the tablet are evaluated at the same time and give information about the whole batch’s variation with only one measurement

  • Min. 100 ml (ca. 100 tablets) of samples required

  • Depending on characteristics of coating, samples might be damaged during longer measurement periods

Probe

Use Case

In-line installation

Image

Pan Probe

Monitoring of drum coating processes, co-extrudates, films, patches

  • e.g. mounted below the drum of a pan coater with perforated drum

Fluid Bed Monitoring Probe

In-line monitoring for coating processes of pellets and other multi-particulates

  • Directly attached to a fluid bed coater window/port

  • Probe interface includes a funnel to guide pellets in front of the sensor (pellets need to be measured at a certain distance and a suitable velocity)

Application range of OSeeT

OSeeT was originally developed for direct measurement of transparent and semi-transparent materials. High concentrations of pigments in the coating formulation (i.e., titanium dioxide or iron oxide) are scattering the light beam and therefore limiting the direct insight into the material. By establishing advanced image analysis metrics, a second stream of OSeeT software has been developed to evaluate coatings with highly scattering pigments as well as uncoated dosage forms (beta version).

Application range of OSeeT (in the pharmaceutical field)

Transparent or semi-transparent coated products

OSeDirect measurement of coating thickness, roughness, homogeneity for:
Tablets and capsules at-line and in-line
Pellets at-line and in-line
Co-extruded dosage forms
Thin drug layer of transdermal patches and oral films

Uncoated products

Indirect measurement of uncoated samples and correlation with critical quality attributes (e.g. dissolution or tablet hardness) – beta version of the software

Non-transparent coated products

Indirect measurement of the thickness of scattering coatings (beta version) and correlation with critical quality attributes (e.g. dissolution) – beta version of the software