{"id":51539,"date":"2021-11-05T08:58:04","date_gmt":"2021-11-05T07:58:04","guid":{"rendered":"https:\/\/packaging-journal.de\/?p=51539"},"modified":"2024-03-13T15:43:04","modified_gmt":"2024-03-13T14:43:04","slug":"faubel-leads-to-success-with-blinding","status":"publish","type":"post","link":"https:\/\/packaging-journal.de\/en\/faubel-fuehrt-mit-verblindung-zum-erfolg\/","title":{"rendered":"Faubel leads to success with double blinding"},"content":{"rendered":"
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Since the start of the Covid-19 pandemic and the efforts to combat the virus, clinical trials have increasingly become the focus of public attention. However, without blinding, their results are often not meaningful. Labelling specialist Faubel knows the challenges that need to be overcome when it comes to the targeted concealment of information.<\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Research on Covid vaccines is sometimes the subject of controversy due to their accelerated implementation, without the basics of clinical trials even being known. In general, every drug must be approved by the authorities before it enters the market. Authorisation procedure<\/a> in which efficacy, quality and safety must be proven by means of preclinical and clinical tests. In order to prevent unconscious falsification of the test results by the study participants, the study physicians and the nursing staff in charge, a Blinding indispensable<\/strong>.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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The colour of the liquid in the vial is blinded by a self-adhesive coloured film. (Image: Faubel)<\/figcaption>\n\t\t\t\t\t\t\t\t\t\t<\/figure>\n\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Which authority is responsible for the clinical trial depends on the specific product and the countries in which the pharmaceutical company wishes to launch the medicine. In the European Union, authorisation can be granted centrally via the European Medicines Agency or nationally. In Germany, the Federal Institute for Drugs and Medical Devices (BfArM)<\/strong> or the Paul Ehrlich Institute (PEI)<\/strong> responsible for vaccines and blood products.<\/p>

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In Germany, the requirements for Drug authorisation in the German Medicinal Products Act (AMG)<\/strong> are defined. The Medicinal Products Act also authorises the legislator to lay down further regulations. One such regulation is the GCP Regulation<\/strong>, which regulates the requirements for clinical trials with regard to principles, guidelines and the application of good clinical practice.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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The cardboard was elaborately folded and punched for the blinding of the syringe.\n(Image: Faubel)<\/figcaption>\n\t\t\t\t\t\t\t\t\t\t<\/figure>\n\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Multiple phases, double fuse<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Frank J\u00e4ger, who is a member of the management of Faubel Group<\/strong><\/a> who is also responsible for product development and new technologies, describes the Ideal case of a study<\/strong>, \u201eif neither the study participants nor the study physicians or the caring nursing staff know which group the patients have been assigned to\u201c. This approach describes a double-blind study approach<\/strong>.<\/p>

Initially, the tolerability of the drug or active substance is investigated in phase I with healthy participants. In phase II and III trials, efficacy and tolerability are first tested in a small number of patients and then in a large number of patients. The approval of the drug after phase III is usually followed by phase IV trials, in which comparisons are made with other drugs, for example.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Well thought-out concepts of blinding and labelling are a prerequisite for usable results in clinical trials.<\/p><\/blockquote>

Frank J\u00e4ger<\/strong> is Managing Director for Product Development and New Technologies at the Faubel Group, Melsungen.<\/p>

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The patient collective, also known as the intervention group, receives the new active substance. In contrast, a control group, patients with the same disease or the same disease risk, are given no medication, an ineffective dummy medication (placebo) or the current standard medication. In addition to the random and unpredictable allocation to the treatment groups (randomisation)<\/strong> blinding prevents unconscious falsification of the study results. The processes in this context are very complex.<\/p>

Labelling specialist Faubel has been supplying the pharmaceutical industry since it was founded in 1855. \u201eIt was a logical step for us to specialise in the Labelling of clinical studies<\/strong> These labels are subject to high quality standards and are often more complex in terms of the number of pages and the function of the labels. Our pharmaceutical customers value our experience and expertise, which means that the Clinical Trial Labelling around 70 per cent of our sales<\/strong> makes the difference,\u201c as J\u00e4ger emphasises.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Labels as all-round talents<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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One Blinding makes the packaging, the medication and the placebo look the same<\/strong>. According to Frank J\u00e4ger, this poses various challenges: \u201eWe usually produce blinding for vials, blister packs, tubes or syringes. In particular, containers where the application requires the original packaging require a customised blinding and labelling concept.\u201c<\/p>

Many of these customised concepts are labels<\/strong>. Labels blind syringes, blisters, tubes and inhalers and can label them at the same time. The design, format and number of pages are flexible and the The properties of the material and adhesive can be adapted to the filling, storage and transport conditions<\/strong>. \u201eFor example, special films, strong adhesives and resistant colours can withstand high humidity during application, or these labels can be frozen together with the medication,\u201c says J\u00e4ger. The labels cover the primary packaging so that it is opaque and impermeable to light.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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The cardboard box is labelled with a transparent label and has a flap for optimum handling. (Image: Faubel)<\/figcaption>\n\t\t\t\t\t\t\t\t\t\t<\/figure>\n\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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In multinational clinical trials, various national languages often have to be taken into account. The Use of booklet labels<\/strong> is obvious for Frank J\u00e4ger. \u201eA few years ago, a customer commissioned us with the blinding and labelling of a small tube. Our product development team created a large-sided booklet label with a larger base label. The base label blinded the tube and the booklet label offered enough space for different languages in a reader-friendly font size.\u201c<\/p>

This clinical trial was double-blind; the allocation of active substance, placebo and standard medication was unknown to the study participants and the study physicians. The booklet label revealed the study, kit and patient numbers as well as the expiry date. It also contained information on how to use the ointment, how to store the tube and the contact details of the sponsor of the clinical trial. According to the documentation provided to the physicians by the study coordinator, each tube could be clearly assigned<\/strong>. In the event of a medical emergency, the patient number and the randomisation list could be used to trace the allocation.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Alternative blinding and 3D printing\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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A label is not always suitable for blinding. If the height or circumference of the primary packaging differs from one another Boxes made of sturdy and opaque cardboard for full-surface lamination<\/strong>. Supplemented with an insert, the differences are invisibly evened out. \u201eIf the box encloses a vial, the injection needle can be inserted easily thanks to a punched-out hole. An adhesive film protects the injection site from external contamination. This is particularly useful if liquid is injected several times from the same vial,\u201c explains J\u00e4ger. A combination of box and foil is also useful for infusion bags and bottles. An integrated foil flap makes it easier to hang them up.<\/p>

Nowadays, the 3D printing process enables the production of highly customised containers<\/strong>. Instead of cardboard, the box can also be made of plastic: These include versions that have a punched-out inspection window. If the liquid is cloudy, doctors and carers can remove the spoiled medication directly from circulation.<\/p>

The plastic gives the veneer enormous stability and offers a high degree of variance for very small series.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Sophisticated concepts reduce costs<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\u201eAs a rule, a lengthy and cost-intensive process is required before a drug is ready for the market. On average, it takes more than ten years, the development costs amount to around two billion US dollars, and only just under nine per cent of active substances ever reach market maturity.\u201c These figures influence Frank J\u00e4ger and his team when they develop blinding agents. \u201eWell thought-out concepts reduce effort, costs and time<\/strong> of clinical research. It was not only through Covid-19 that we all learnt that the time factor can save lives<\/strong>. As a supplier, our company is aware of this responsibility.\u201c<\/p>

http:\/\/www.faubel.de<\/a><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Magazine articles<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\n\t\t\t\n\t\t\t\tSonja B\u00e4hr | When Science Doesn't Create Knowledge\t\t\t<\/a>\n\t\t<\/h3>\n\t\t\t\t
\n\t\t\tIn her new column, packaging expert Sonja B\u00e4hr questions the scientific basis of planned PPWR labels. She demonstrates why coloured labels could consume enormous resources \u2013 without any demonstrable added benefit for waste separation.\t\t<\/div>\n\t\t\n\t\t\n\t\t\tRead more \"\t\t<\/a>\n\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/article>\n\t\t\t\t
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\n\t\t\t\n\t\t\t\tPackaging Act: More bureaucracy than necessary\t\t\t<\/a>\n\t\t<\/h3>\n\t\t\t\t
\n\t\t\tThe new Packaging Act Implementation Act (VerpackDG) transposes the PPWR into German law \u2013 and brings significantly more bureaucracy to the industry than is legally required at the European level, according to packaging law expert Dr. Markus Pauly.\t\t<\/div>\n\t\t\n\t\t\n\t\t\tRead more \"\t\t<\/a>\n\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/article>\n\t\t\t\t
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\n\t\t\t\n\t\t\t\tTransporting batteries safely and sustainably\t\t\t<\/a>\n\t\t<\/h3>\n\t\t\t\t
\n\t\t\tThe logistics of lithium-ion batteries require tested dangerous goods packaging and efficient circulation systems \u2013 such as Orbis Europe's robust plastic load carriers.\t\t<\/div>\n\t\t\n\t\t\n\t\t\tRead more \"\t\t<\/a>\n\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/article>\n\t\t\t\t
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\n\t\t\t\n\t\t\t\tPackaging in transition\t\t\t<\/a>\n\t\t<\/h3>\n\t\t\t\t
\n\t\t\tThree trends are currently clearly setting the direction in the packaging world. They influence strategic decisions, investments, and product developments in almost every packaging-intensive market. And they show that innovation needs to become not louder, but smarter.\t\t<\/div>\n\t\t\n\t\t\n\t\t\tRead more \"\t\t<\/a>\n\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/article>\n\t\t\t\t
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\n\t\t\t\n\t\t\t\tWhen sustainability becomes a process question\t\t\t<\/a>\n\t\t<\/h3>\n\t\t\t\t
\n\t\t\tTechnologies like ultrasonic sealing are increasingly gaining importance against a current backdrop.\t\t<\/div>\n\t\t\n\t\t\n\t\t\tRead more \"\t\t<\/a>\n\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/article>\n\t\t\t\t
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\n\t\t\t\n\t\t\t\tProcess over material as the decisive factor\t\t\t<\/a>\n\t\t<\/h3>\n\t\t\t\t
\n\t\t\tDiscussion around sustainable packaging traditionally focuses on materials, but a significant portion of emissions arises from processing, such as in gluing, sealing or labelling.\t\t<\/div>\n\t\t\n\t\t\n\t\t\tRead more \"\t\t<\/a>\n\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/article>\n\t\t\t\t<\/div>\n\t\t\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"Even before the Covid-19 pandemic, clinical trials were an important part of research. Faubel supports labelling with blinding.","protected":false},"author":1,"featured_media":51541,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"__cvm_playback_settings":[],"__cvm_video_id":"","rank_math_description":"Auch vor der Covid-19 Pandemie waren klinische Studien ein wichtiger Teil der Forschung. Faubel unterst\u00fctzt bei der Etikettierung mit Verblindung.","rank_math_focus_keyword":"Verblindung","rank_math_title":"Faubel f\u00fchrt mit doppelter Verblindung zum Erfolg","_earpaper_enabled":false,"_earpaper_voice_id":"","_earpaper_audio_url":"","_earpaper_audio_id":"","_earpaper_article_id":"","_earpaper_status":"","_earpaper_error":"","_earpaper_duration":0,"_earpaper_generated_at":"","csco_display_header_overlay":false,"csco_singular_sidebar":"","csco_page_header_type":"","csco_page_load_nextpost":"","csco_post_video_location":[],"csco_post_video_location_hash":"","csco_post_video_url":"","csco_post_video_bg_start_time":0,"csco_post_video_bg_end_time":0,"footnotes":"","_links_to":"","_links_to_target":""},"categories":[28,21],"tags":[60310,42,58744,59371,40],"class_list":["post-51539","post","type-post","status-publish","format-standard","has-post-thumbnail","category-aus-dem-magazin","category-verpackungstechnik","tag-ccl-faubel","tag-etikettieren-kennzeichnen-codieren","tag-forschung","tag-magazin-8-2021","tag-pharma-kosmetik-chemie","cs-entry","cs-video-wrap"],"acf":[],"vimeo_video":null,"_links":{"self":[{"href":"https:\/\/packaging-journal.de\/en\/wp-json\/wp\/v2\/posts\/51539","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/packaging-journal.de\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/packaging-journal.de\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/packaging-journal.de\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/packaging-journal.de\/en\/wp-json\/wp\/v2\/comments?post=51539"}],"version-history":[{"count":0,"href":"https:\/\/packaging-journal.de\/en\/wp-json\/wp\/v2\/posts\/51539\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/packaging-journal.de\/en\/wp-json\/wp\/v2\/media\/51541"}],"wp:attachment":[{"href":"https:\/\/packaging-journal.de\/en\/wp-json\/wp\/v2\/media?parent=51539"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/packaging-journal.de\/en\/wp-json\/wp\/v2\/categories?post=51539"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/packaging-journal.de\/en\/wp-json\/wp\/v2\/tags?post=51539"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}