Blow-Fill-Seal (BFS) customization

For the first time, a CMYK digital printing process for BFS products

Because they are lightweight, space-saving, cost-effective and easily portioned, Blow-Fill-Seal containers (BFS) are increasingly replacing glass containers for aseptic liquid pharmaceutical products. This applies to eye drops, inhalation preparations and vaccines in pen injectors.

However, until now it was a challenge to customize the BFS for different market variants. Applying printed labels to BFS products which are very often small-format, is relatively complex and has a major disadvantage with respect to product safety: the labels may peel off accidentally and the stability of glue formulations is difficult to guarantee. The embossing process, which is not color-capable anyway, can cause damage to the BFS, it is time consuming to set up and results in text with poor legibility that cannot be checked by a camera, leading to quality control issues. In order to avoid these challenges, mechanical pad printing using the tampon printing process is commonly used. This requires the use of solvent based inks and print plates, however.

"Since batch sizes become increasingly smaller, the set-up times due to artwork changes have more and more of an impact", says a Hapa expert who has been dealing with the challenges of BFS production for several years. "This sometimes results in a drastic decline in overall equipment effectiveness (OEE)." By contrast, a digital solution means artwork can be changed at the click of a button, color saturation and artwork remain consistent and mechanical adjustments are eliminated leading to a "digital uplift".

Years of research and development work

The solution is the result of a collaboration between Hapa and Graniten and is the world's first system that supports a CMYK digital printing process suitable for this application. Based on Drop on Demand Inkjet technology (DOD), this printing solution was first presented during the Blow-Fill-Seal International Operators Association AGM in 2019, since then many pharmaceutical manufacturers in Europe and Asia have been looking very closely at this new approach. DOD technology offers significant advantages and is the perfect replacement for commonly used technologies: labeling, embossing, solvent based inkjet and pad printing. "The decisive key to success was the use of specially formulated inks which have been developed by Hapa. Furthermore, the development of a repeatable process for product transport, surface treatment, printing and UV curing that assure that the liquid drug products meet the required quality and safety”, reports the Hapa expert. "BFS are generally made of HDLPE (High Density Linear Polyethylene), which has a low barrier function. Our process meets the migration and print quality requirements.”

For Hapa, which specializes in inline printing technology for pharmaceutical packaging, the breakthrough in the BFS project came after years of research and development work. “A great advantage was that Hapa develops and manufactures both the inks and the printing technology. This resulted in a very close interaction between ink development and application technology, which is probably unique in this form in the pharmaceutical sector", the expert emphasizes. As part of the continuous cooperation with a leading pharmaceutical manufacturer, long-term tests with high-precision analytical measuring technology were carried out. From the beginning of the project, the focus was on the practical implementation and quantifiable benefits of late-stage customization, optimized overall equipment effectiveness (OEE), reduced costs and compliance with the EU Packaging Directive.

Maximum data density on the smallest areas

High-precision printing of even the smallest codes and demanding characters, such as those found in Asian fonts, can be handled by Hapa’s redcube or redcube plus. "At the fastest BFS packaging line speeds, these printers can compress more data into small areas reliably and repeatedly and with a higher contrast than probably any other currently available inline technology”, the expert says.

"When compared with traditional analogue customization techniques, market specific artwork and color changes are effortless with this new digital solution", the Hapa expert sums up. “We’ve created a solution that allows for unprecedented flexibility and cost efficiency in the customization of BFS containers and at the same time optimizes product and process safety.”

 

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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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