Application testing as the key to success

Application testing as the key to success

How Hapa contributes to pharma product safety through harmonized ink and technology development

Absolute security and reliability are essential when printing mandatory data on primary pharmaceutical packaging. The principal goal of Hapa is therefore to provide validated print performance for inline printing, particularly for systems integrated into packaging lines in a GMP-compliant setting. “Simply put, we are seeking to print our customers’ artwork on our customers’ material using our inks with a print process that is managed by our technology,” explains a Hapa product manager. “In order to do that, application testing is a foundation of all of our projects.” A key role is played in this context by close collaboration and coordination between Hapa’s Print Tech and ink development departments.

The Print Tech department’s core role is to ensure that the substrate, ink and printing process are compatible and will ensure the expected print quality and operational performance demanded by the application. Samples produced during the rigorous print trials are then subjected to a wide range of tests including rub and scratch resistance, tape resistance, overprint capability, ink flow behavior, and chemical resistance. Special attention is paid to the actual behavior of a printed blister during rotary sealing on the blister line.

The individual tests are carefully documented and entered into a database. “As an ISO 9001-compliant company seeking to provide GMP-compliant print processes, we maintain an audit trail for the database. We keep the physical samples for many years, which enables us to go back and reference the basis for all our projects,” says the in-house expert. Upon conclusion of each test series, the customer receives a detailed report outlining the tests performed and the testing conditions, indicating whether the project can be “Released”.

Hapa is able to call upon its decades of experience to address any issues discovered in the feasibility testing phase. “We will typically recommend a range of solutions that may be considered by the customer and the project teams. This may include recommendations for alternative substrates, pretreatment processes, or specific limitations on the printing process.

Our test reports always give the customer several options for pathways to achieve satisfactory product quality. It is for the customer to decide which of the routes is best, assisted by our consultancy and wide experience we provide.”

In the event that most other options are exhausted, Hapa is able to use its ink development expertise to assist. Hapa develops and produces its own inks specifically for the markets that Hapa serves. “Ink development takes time, which is why it is usually the final option” explains the product manager. “But it is an option that we have, and that’s why we have invested in Hapa inks. They’re an important part of our strategic offering to the market.”

Ink development is focused upon ensuring that non soluble pigments are suspended in a liquid to enable them to be jetted to give a dependable result, reliably. This pigment/dispersion combination needs to be mixed with compounds that will form the ink layer carrying the color, reacting predictably with the trigger for polymerization.

The ink is then adjusted to obtain the desired physical properties such as ink flexibility, toughness and adhesion. Selection of components is critical. Among the big issues addressed by the ink chemists are those relating to optical density, ink flow, adhesion and migration.

The Hapa laboratory has a wide array of analytical and testing facilities at its disposal for formulating inks to a required specification. Migration is an important topic. Hapa works in close collaboration with independent certified laboratories and we are able to consult clients on the steps to validate the safety of the printing process.

Thanks to collaboration between Hapa’s Print Tech and ink development departments, elevated security is assured from application testing and validation onwards. During the actual production, Hapa’s customers can therefore be certain that their print processes will operate reliably from the outset.

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PRIVACY POLICY UNDER ART. 13 OF EU REGULATION 2016/679 (GDPR)

1. General provisions

1.1 Introduction. Coesia S.p.A. (“Company”) is the holding company of an industrial group made up of several entities operating internationally (“Coesia Group’ Companies”), including, in particular, the Coesia companies listed on the website as hereby defined. Company, in accordance with the Coesia Group commitment to international compliance with data protection laws, is accordingly committed to protecting personal data collected through the “Contact us” form of the Coesia Group Companies’ websites (“Website”), according to any national legislation in force on personal data protection (“National Data Protection Laws”) and the EU General Data Protection Regulation 2016/679 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data and repealing the Directive 95/46/EC (“GDPR”). This Privacy Policy explains how information and data identifying individuals (“Personal Data”) received by Coesia Group’ Companies through their Websites are processed.

1.2 Joint-Controller. Coesia S.p.a. and its worldwide affiliates (“Coesia Group”), act as joint-controllers under art. 26 of GDPR of the personal data that you decide to provide us through the website.

1.3 Amendments. Coesia Group reserves the right to amend and update the Privacy Policy because of any further new or revised provisions of any national and EU laws and regulations on personal data protection. Any new release of the Privacy Policy shall be published on the Website as a replacement of the previous version and shall be valid and enforceable from the publication date, unless otherwise specified.

1.4 Applicable rules. Coesia Group processes Personal Data in accordance with: (i) provisions of National Data Protection Laws in force as of the date of the Privacy Policy; (ii) provisions of the GDPR and, in particular, with the principles set forth in the same, such as, inter alia, lawfulness, fairness and transparency, purpose limitation, data adequacy and minimisation, accountability, accuracy, and – prior to any processing activity – the principles of privacy by design and privacy by default; (iii) guidelines and decisions issued by the competent supervisory authority (“Supervisory Authority”).

2. Data subjects and scope of application

2.1 Data subjects. Coesia Group processing activities relate to any individual who decides to fill in the “Contact us” form on the Websites. For the purposes of this Privacy Policy, these persons are to be intended as Data Subjects, as defined in the National Data Protection Laws and in the GDPR.

2.2 Scope of application. The Privacy Policy shall be applicable to Data Subjects, provided that Coesia Group’ Companies, in their capacity as Joint-Controller, are only liable for the processing of Personal Data, which are under its own powers, duties and liabilities.

3. Types and source of processed Personal Data

3.1 Source. Coesia Group processes the Data Subjects’ Personal Data – as hereinafter specified – provided directly by the Data Subjects through the “Contact us” form of the Websites.

3.2 Identification data. Coesia Group processes Data Subjects’ Personal Data, that consist of your identification data (such as, for example, name, surname, company, e-mail address, citizenship, city, phone number ecc.). Furthermore, Coesia Group will process all information – which however shall only include – if any - common personal data - that you will decide to provide us through the “Message” field in the “Contact us” form on the Websites.

4. Legal basis for and purposes of processing the Personal Data. Period of data retention

4.1 Legal basis. The legal basis for the processing of Personal Data is: (i) the execution of a contract or pre-contractual steps to be taken at the request of Data Subjects prior to entering into a contract about purpose under art. 4.2 A); (ii) the consent given by Data Subjects to the processing of their Personal Data; (iii) Legitimate Interest about purpose under art. 4.2 C).

4.2 Purposes. Coesia Group processes Personal Data for the following purposes, as specified in the table here in below, in which is furthermore highlighted (a) if an express consent to processing of Personal Data is needed (or not ) as well as (b) the period of data retention:

Purposes

Consent

Data retention

A) Processing of personal data in order to reply to queries concerning the company activities

Not required

Until the purpose is achieved

B)    Processing of personal data in order to send newsletters, promotional and advertising and/or other materials for marketing communication purposes by Coesia Group’s companies

Required

Until the withdrawal of consent or until a denial has been communicated

C)    
Processing of personal data in order to send to customers email marketing communications, concerning Coesia Group’s services or products similar to those already supplied, by virtue of previous business relationship (“soft spam”), unless a communication to refuse or unsubscribe from marketing (“opt out”) has been made by said customers, according to applicable laws.

Not required

Until the “opt out” has been communicated

4.3 Optional/Mandatory supply of Personal Data. Subject to what specified above, the provision of Personal Data is optional and free. However, failure to provide Personal Data may prevent Data Subjects from receiving communications and/or replies to their queries concerning the company activities.

5. Persons in charge of the processing and processors

5.1 Persons in charge of the processing. As specified above, Coesia Group processes Personal Data collected from the Data Subject through the Websites. Directors, shareholders and independent collaborators (independently from the contractual relationship concerned) of the Coesia Group may process Personal Data in their capacity as persons in charge of the processing, according to National Data Protection Laws and to art. 29 of the GDPR. The persons in charge of the processing are duly trained and empowered to allow access to Personal Data according to the Privacy Policy and subject to their tasks being performed and assignments.

5.2 Processors. The Coesia Group may designate as processors entities/individuals for the purposes described above. The complete list of all processors may be required by Data Subjects to the Coesia Group, by sending an email to the email address cpo@coesia.com.

6. Method of processing, storage of Personal Data and security measures

6.1 Methods of processing. The Personal Data of Data Subjects are processed almost exclusively through automated procedures, by using computerized systems and softwares or, in a limited number of cases, through manual means (e.g. on paper), provided however that in any event such Personal Data are processed adopting methods which are strictly related to the purposes for which such data have been collected and anyway to ensure their security, in accordance with the GDPR and the National Data Protection Laws.

6.2 Place of automated data processing. Processing of Personal Data is made by the Coesia Group as joint-controllers and/or – if appointed – by the processors. Personal Data are stored in the head offices of the Coesia Group’s companies where the physical servers are and in some cases on servers of third parties, which provide cloud services to allow storage of Personal Data.

6.3 Transfer of Personal Data. Personal Data may be transferred in order to achieve the purposes described above to Coesia Group acting as joint-controllers, whether they are located in EU or in third countries outside the EU, provided however that in the latter case, the transfer of Personal Data as above specified shall be made subject to the Coesia Group’s assessment of full compliance with the provisions of chapter V of the GDPR and in particular with article 49.1 B).

6.4 Dissemination of Personal Data. Personal Data will not be disseminated.

7. Data Subjects’ rights

7.1 Rights. Data Subjects, when they are individual/natural persons, may directly address to the Company or the processor/s designated by the same in order to enforce their rights according to provisions of National Data Protection Laws and to the GDPR (articles 15 and subsequent articles), and, in particular, to have access to their own Personal Data, obtain updating and rectification or erasure of the same, restriction of processing, as well as obtain data portability by sending an email to the email address privacy@coesia.com or, with specific regard to the newsletter, by clicking the “unsubscribe” button or following the instructions published on the Website.

7.2 Right to object. With the same procedures described above, Data Subjects may object, in whole or in part, to the processing of Personal Data concerning them, where the relevant legal basis is constituted by the legitimate interests of Coesia Group, pursuant to and with the effects provided for by Article 21 of the GDPR, having regard in particular to direct marketing.

7.3 Complaint. The above notwithstanding, according to article 77 of the GDPR, Data Subjects, when they are individual/natural persons, may lodge a complaint with the competent Supervisory Authority, in order to enforce their rights, as specified above.

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