Hapas BlisterJet installiert bei Almac Pharma Services in Nordirland

Vorsprung durch Serialisieren – Für CMOs kann die Fähigkeit zum Late Stage Customization den entscheidenden Unterschied ausmachen

In mancherlei Hinsicht sind die Zeiten härter geworden für Lohnverpacker (CMOs bzw. CPOs). Starker Wettbewerb, hoher Kostendruck, die allgemeine Konsolidierung der Branche und ein sich aufgrund der Digitalisierung beschleunigender technologischer Wandel stellen erhebliche Herausforderungen dar. Wer sich jedoch gut aufstellt, für denjenigen eröffnen sich gleichzeitig im Moment grosse Chancen. Der Trend zum Outsourcing in der Pharmaindustrie ist ungebrochen. Denn grosse Pharma-Unternehmen konzentrieren sich noch stärker auf wissenschaftliche Forschung und Marketing. Durch den Einsatz von CMOs bzw. CPOs versprechen sie sich weiterhin eine Vielzahl an Vorteilen, zum Beispiel um Produkteinführungszeiten zu verkürzen, um Kosten zu senken, Komplexität in der eigenen Produktion abzubauen und interne Ressourcen profitabler einzusetzen. Chancen ergeben sich aber auch durch die wachsende Zahl an kleineren und mittelgrossen Pharmaunternehmen. Sie haben einen steigenden Anteil an den Zulassungen für neue Arzneimittel, verfügen jedoch oftmals selbst über keine Produktions-, geschweige denn über Verpackungskapazitäten. Doch gerade jetzt gibt es in vielen Märkten immer neue Anforderungen und Vorgaben der Gesetzgeber an Verpackungen und deren Kennzeichnung. Für CMOs und CPOs wird es sich auszahlen, wenn sie noch agiler, flexibler und schneller reagieren können.

Dabei geht es beileibe nicht nur darum, mithilfe modernster Technologien die eigenen Produktionsprozesse noch effizienter zu gestalten und die Menge an Ausschuss zu reduzieren. Wer als CMO ein Pharmaunternehmen gezielt bei dessen Postponement-Strategie unterstützen kann, dürfte ebenfalls gute Karten haben. 

Die technische Voraussetzung für ein Late Stage Customization von Blisterverpackungen kann ein strategisches Schlüsselinstrument sein, weil es CMOs für Pharmaunternehmen attraktiver macht. "Die Fähigkeit eines Auftragnehmers, dies als Dienstleistung anzubieten, kann ein entscheidendes Unterscheidungsmerkmal bei der Auftragsvergabe sein", sagt der Vertriebsleiter von Hapa. Dazu gehören zum Beispiel die Codierung von Einzeldosen und die Serialisierung von Blisterverpackungen. Denn was in diesem Zusammenhang ganz wichtig ist: Feste Darreichungsformen bleiben ein profitables und wachsendes Segment. "Sie sind aufgrund der hohen Patienten-Compliance weiterhin die häufigste Darreichungsform für neu zugelassene Medikamente", so das Beratungsunternehmen PwC in einer Studie über Chancen für CMOs.
 

Hapa’s BlisterJet installed at Almac Pharma Services in Northern Ireland

Hapa’s BlisterJet installed at Almac Pharma Services in Northern Ireland

Bei einer Postponement-Strategie werden auf Blisterverpackungslinien in hoher Geschwindigkeit nur unbedruckte Blister produziert. Doch sobald Bestellungen für kleinere Chargen eintreffen, werden unbedruckte Blister dem Lager entnommen, exakt in der benötigten Stückzahl, also on demand bedruckt und innerhalb kurzer Zeit dorthin geliefert, wo sie benötigt werden. Die technologischen Voraussetzungen, um eine Postponement-Strategie umzusetzen, liefert der Hapa BlisterJet. Dieses Blister-Drucksystem basiert auf der Drop-on-Demand Inkjettechnologie und UV-härtenden Tinten. Es trägen den äusserst unterschiedlichen Produktionsanforderungen Rechnung, indem es sich hochflexibel konfigurieren lässt.

Hapa ist seit mehr als fünf Jahrzehnten spezialisiert auf Drucklösungen für die Pharmaindustrie, sowohl inline als auch offline. Das Schweizer Unternehmen ist weltweit der Technologieführer auf diesem Gebiet. Mehr als 10.000 Flexo- und Digitaldrucksysteme in über 80 verschiedenen Ländern hat Hapa inzwischen installiert. Der Druck mit UV-härtenden Tinten auf Blisterfolie ist extrem widerstandsfähig und abriebfest und liefert ein gestochen scharfen Druckbild selbst kleinster Zeichen und Codes. Es ist heute die effizienteste und sicherste Methode im Pharmaumfeld, um einen validierten Druck zu gewährleisten, insbesondere für Systeme, die in einer GMP-konformen Umgebung integriert sind.

Nahezu alle führenden Pharmaunternehmen setzen heute Hapa Technologien ein. „Wenn ein Auftraggeber eine Hapa Maschine bei einem CMO sieht, weiss er also genau, dass er exzellente Kennzeichnungseffizienz und -qualität erwarten kann“, so der Hapa Vertriebsleiter. Zusammengefasst heisst das: Neue digitale Drucktechnologien ermöglichen ein erweitertes Leistungsspektrum und können einer CMO helfen, sich von Wettbewerbern zu unterscheiden. Die Art der Ausrüstung spielt dabei heute eine entscheidende Rolle.

Form
Country

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.

CAPTCHA
This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.
Image CAPTCHA
Enter the characters shown in the image.
See all news See all news