{"id":15396,"date":"2025-07-11T11:57:55","date_gmt":"2025-07-11T10:57:55","guid":{"rendered":"https:\/\/www.piramide-ambiente.it\/filler-stick-machine-sanitization\/"},"modified":"2026-06-15T17:34:43","modified_gmt":"2026-06-15T16:34:43","slug":"filler-stick-machine-sanitization","status":"publish","type":"post","link":"https:\/\/www.piramide-ambiente.it\/en\/filler-stick-machine-sanitization\/","title":{"rendered":"Filler Stick: Machine Sanitization"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">Stick-fill machines, designed for filling single-dose stick-format pouches, offer a state-of-the-art solution for the safe and hygienic packaging of powders, liquids, and granules in compliance with the most stringent quality standards.<\/p>\n\n<p class=\"wp-block-paragraph\">In the world of pharmaceutical and nutraceutical manufacturing, precision and efficiency are essential requirements.<\/p>\n\n<h2 class=\"wp-block-heading\" id=\"h-cosa-sono-le-macchine-filler-stick\">What are stick filler machines?<\/h2>\n\n<p class=\"wp-block-paragraph\">Stick-pack filling machines are automated systems designed to fill and seal stick packs\u2014thin, elongated pouches that are ideal for single-dose applications.<\/p>\n\n<p class=\"wp-block-paragraph\">These formats (stick packs) are becoming increasingly popular for their convenience, both in the OTC (over-the-counter) sector and in professional settings such as clinics, laboratories, and pharmacies.<\/p>\n\n<p class=\"wp-block-paragraph\">In pharmaceutical packaging, these machines are widely used in the production process for:<\/p>\n\n<ul class=\"wp-block-list\">\n<li>Powdered dietary supplements (e.g., vitamins, minerals, probiotics);<\/li>\n\n\n\n<li>Oral solutions;<\/li>\n\n\n\n<li>Single-dose antibiotic or antipyretic powders;<\/li>\n\n\n\n<li>Oral solutions and suspensions.<\/li>\n<\/ul>\n\n<p class=\"wp-block-paragraph\">In the nutraceutical and pharmaceutical packaging sectors, stick packs are the ideal format for health-conscious consumers looking for convenience.<\/p>\n\n<p class=\"wp-block-paragraph\">They are ideal for products taken on the go or at specific times of the day, such as energy boosters, sports supplements, or products for gut health.<\/p>\n\n<h2 class=\"wp-block-heading\" id=\"h-sanificazione-delle-macchine-filler-stick-un-aspetto-critico-per-la-qualita-del-prodotto\">Sanitization of stick filling machines: a critical factor for product quality<\/h2>\n\n<p class=\"wp-block-paragraph\">In the pharmaceutical and nutraceutical industries, sanitizing stick-filling machines is not merely a routine operational step, but a critical control point (CCP) in ensuring the quality of the finished product.  <\/p>\n\n<p class=\"wp-block-paragraph\">The very nature of the products being processed (which are often highly hygroscopic, heat-sensitive, or microbiologically sensitive) requires strict, validated, and systematically verifiable hygiene protocols.<\/p>\n\n<h3 class=\"wp-block-heading\" id=\"h-filler-stick-tecniche-e-protocolli-di-sanificazione\">Filler sticks: techniques and sterilization protocols<\/h3>\n\n<p class=\"wp-block-paragraph\">Sanitization can be performed in various ways, depending on the type of product and the machine\u2019s configuration:<\/p>\n\n<ul class=\"wp-block-list\">\n<li>CIP (Clean-In-Place): an automated system that allows for the internal cleaning of parts in contact with the product without disassembly, using cleaning and disinfecting solutions followed by a rinse with purified water.<\/li>\n\n\n\n<li>SIP (Sterilize-In-Place): involves the use of saturated steam to sterilize the circuits, which is particularly important for aseptic applications or those involving heat-resistant ingredients.<\/li>\n\n\n\n<li>Manual-assisted sanitization: used in small-scale machines or when the configuration does not allow for full CIP; requires detailed SOPs and ongoing operator training.<\/li>\n<\/ul>\n\n<h3 class=\"wp-block-heading\" id=\"h-sanificazione-confezionamento-prodotti-farmaceutici-perche-e-fondamentale\">Sanitization of pharmaceutical packaging: Why is it essential?<\/h3>\n\n<p class=\"wp-block-paragraph\">Inadequate or ineffective sanitization can lead to:<\/p>\n\n<ul class=\"wp-block-list\">\n<li>Microbial contamination (bacteria, yeast, mold), posing a risk to public health;<\/li>\n\n\n\n<li>Cross-contamination between different batches or products, particularly in multi-product facilities;<\/li>\n\n\n\n<li>Compromised stability of the active ingredient or excipients;<\/li>\n\n\n\n<li>Regulatory non-compliance, potentially leading to batch holds, product recalls, or penalties.<\/li>\n<\/ul>\n\n<p class=\"wp-block-paragraph\">Risks Associated with Inadequate Hygiene Management<\/p>\n\n<ul class=\"wp-block-list\">\n<li>Loss of product integrity and reduced therapeutic or nutritional efficacy;<\/li>\n\n\n\n<li>Product recalls and reputational damage;<\/li>\n\n\n\n<li>Impact on shelf life, including potential chemical reactions or uncontrolled microbial growth;<\/li>\n\n\n\n<li>Non-compliance with regulations issued by the FDA, EMA, or other regulatory authorities, which impose strict controls on cleaning and validation processes for facilities.<\/li>\n<\/ul>\n\n<h2 class=\"wp-block-heading\" id=\"h-rischio-di-contaminazione-da-biofilm-sulle-macchine-filler-stick\">Risk of Biofilm Contamination on Stick Filling Machines<\/h2>\n\n<p class=\"wp-block-paragraph\">One of the most insidious risks in pharmaceutical and nutraceutical manufacturing is the formation of <a href=\"https:\/\/www.piramide-ambiente.it\/en\/enzyme-services-and-products\/biofilm-removal\/\"><strong>biofilms<\/strong> on surfaces<\/a> that come into contact with the product.  <\/p>\n\n<p class=\"wp-block-paragraph\">These microbial aggregates, protected by an extracellular matrix, can persist despite standard cleaning procedures, posing significant risks:<\/p>\n\n<ul class=\"wp-block-list\">\n<li><strong>Resistance to disinfectants:<\/strong> The biofilm acts as a physical and chemical barrier that makes bacterial populations up to 1,000 times more resistant to antibacterial agents than free-floating bacteria.<\/li>\n\n\n\n<li><strong>Constant contamination:<\/strong> Mature biofilms continuously release microbial cells (dispersion), contaminating subsequent batches and causing persistent cross-contamination.<\/li>\n\n\n\n<li><strong>Microorganisms involved:<\/strong> Studies in the food industry have identified frequently processed surfaces as being contaminated with bacteria such as <em>Listeria monocytogenes<\/em>, <em>Staphylococcus aureus<\/em>, <em>Escherichia coli<\/em>, <em>and Pseudomonas spp.<\/em> Similarly, in the pharmaceutical sector, colonization by   <em>Staphylococcus epidermidis <\/em>, <em>Propionibacterium<\/em>, and, at the same time, other treatment-resistant species.<\/li>\n\n\n\n<li><strong>Effects on the finished product:<\/strong> Microbial contamination can cause:\n<ul class=\"wp-block-list\">\n<li>degradation of active ingredients and changes in chemical stability;<\/li>\n\n\n\n<li>the onset of infections or immune reactions in the consumer;<\/li>\n\n\n\n<li>shortened shelf life and non-compliance with GMP requirements.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n<p class=\"wp-block-paragraph\">The presence of biofilm on filler sticks poses a silent but significant danger.<\/p>\n\n<p class=\"wp-block-paragraph\">Without adequate CIP\/SIP systems, hygienic surface design, microbiological monitoring protocols, and validated removal tests, machines become chronic sources of contamination, with repercussions for consumer safety, product quality, and regulatory compliance.<\/p>\n\n<figure class=\"wp-block-image aligncenter size-full\"><img fetchpriority=\"high\" decoding=\"async\" width=\"970\" height=\"630\" src=\"https:\/\/www.piramide-ambiente.it\/wp-content\/uploads\/2025\/07\/grafico-trattamento-biliss-filler-stick.png\" alt=\"\" class=\"wp-image-14948\" srcset=\"https:\/\/www.piramide-ambiente.it\/wp-content\/uploads\/2025\/07\/grafico-trattamento-biliss-filler-stick.png 970w, https:\/\/www.piramide-ambiente.it\/wp-content\/uploads\/2025\/07\/grafico-trattamento-biliss-filler-stick-300x195.png 300w, https:\/\/www.piramide-ambiente.it\/wp-content\/uploads\/2025\/07\/grafico-trattamento-biliss-filler-stick-768x499.png 768w\" sizes=\"(max-width: 970px) 100vw, 970px\" \/><figcaption class=\"wp-element-caption\">Figure 1 &#8211; The graph shows the total bacterial count at 22\u00b0C and 36\u00b0C and the Pseudomonas spp. counts measured in samples collected during treatment with BILISS\u00ae and after sanitization on the Filler Stick used for dietary supplement production (L) and drug production (R). It can be observed that, during the enzymatic phase, it was possible to remove microorganisms that had been resistant to the previous wash because they were adhering to the surfaces of the treated lines and protected by a biofilm. At the end of treatment, however, the values return to an optimal range.<\/figcaption><\/figure>\n\n<h2 class=\"wp-block-heading\" id=\"h-gestione-del-rischio-da-contaminazioni-di-biofilm-tramite-approccio-enzimatico-con-biliss-un-caso-di-studio-del-team-piramide\">Managing Biofilm Contamination Risk Using an Enzymatic Approach with BILISS\u00ae: A Case Study by the Piramide Team<\/h2>\n\n<p class=\"wp-block-paragraph\">Stick-filling machines, especially when used for packaging liquid or gel-based pharmaceuticals, are difficult to clean and sanitize due to their complex design.<\/p>\n\n<p class=\"wp-block-paragraph\">They typically consist mainly of:<\/p>\n\n<ul class=\"wp-block-list\">\n<li>Rollers, installed at the rear of the machine, onto which the rolls of material that will form the packages are wound;<\/li>\n\n\n\n<li>Product loading hopper;<\/li>\n\n\n\n<li>Filler<\/li>\n<\/ul>\n\n<p class=\"wp-block-paragraph\">Fillers, in turn, are composed of:<\/p>\n\n<ul class=\"wp-block-list\">\n<li>Instructors (for the sticks)<\/li>\n\n\n\n<li>Dispensers<\/li>\n\n\n\n<li>Shutters.<\/li>\n<\/ul>\n\n<p class=\"wp-block-paragraph\">During an audit at a pharmaceutical company experiencing issues with localized contamination of its finished stick-form product by Pseudomonads, the Filler study identified several critical issues, specifically:<\/p>\n\n<ul class=\"wp-block-list\">\n<li>Formers (the outer part of the fillers) onto which the material forming the stick is wound, which is then welded at both ends to create the stick itself;<\/li>\n\n\n\n<li>Dispensers;<\/li>\n\n\n\n<li>Filling machines that fill the product into the package.<\/li>\n<\/ul>\n\n<p class=\"wp-block-paragraph\">In general, one of the critical issues observed regarding the cleaning protocols for the Filler Stick is the difficulty of cleaning and sanitizing this equipment via CIP, due both to the lack of a loading vessel on the machine itself and to the lack of a system for collecting the stoppers or \u201cdummy sticks\u201d capable of keeping the dispensers open but confined within special capsules to collect the sanitizing solution.  <\/p>\n\n<p class=\"wp-block-paragraph\">Given these critical issues, and based on data collected by the client through microbiological analyses conducted at various stages of production, the Filler Stick has been identified as a potential source of contamination caused by a possible biofilm.<\/p>\n\n<p class=\"wp-block-paragraph\">The BILISS\u00ae treatment was performed on two different pieces of equipment, both of which were suspected of being contaminated with biofilm. One is used for filling supplements, the other for a medication.<\/p>\n\n<p class=\"wp-block-paragraph\">As is standard practice, while our team of technicians was on-site at the customer\u2019s facility, a series of samples were taken to assess the actual presence of biofilm on the treated equipment, identify any pre-treatment issues, and evaluate the effectiveness of the treatment.<\/p>\n\n<p class=\"wp-block-paragraph\">The analyses conducted demonstrated that both Filler Sticks were contaminated with biofilm, and also confirmed the presence of Pseudomonas spp.<\/p>\n\n<p class=\"wp-block-paragraph\">The analyses conducted also made it possible to identify critical issues in the daily cleaning protocols, and specific, optimized protocols were therefore proposed, recommending both specific enzymatic products that improve cleaning efficiency\u2014thereby addressing the issues described above\u2014and operational procedures that ensure all parts of the machine are thoroughly cleaned.<\/p>\n\n<figure class=\"wp-block-image aligncenter size-full\"><img decoding=\"async\" width=\"900\" height=\"530\" src=\"https:\/\/www.piramide-ambiente.it\/wp-content\/uploads\/2025\/07\/tabelle-valori-assorbanza-torbidita-e-fluorescenza.png\" alt=\"\" class=\"wp-image-14950\" srcset=\"https:\/\/www.piramide-ambiente.it\/wp-content\/uploads\/2025\/07\/tabelle-valori-assorbanza-torbidita-e-fluorescenza.png 900w, https:\/\/www.piramide-ambiente.it\/wp-content\/uploads\/2025\/07\/tabelle-valori-assorbanza-torbidita-e-fluorescenza-300x177.png 300w, https:\/\/www.piramide-ambiente.it\/wp-content\/uploads\/2025\/07\/tabelle-valori-assorbanza-torbidita-e-fluorescenza-768x452.png 768w\" sizes=\"(max-width: 900px) 100vw, 900px\" \/><figcaption class=\"wp-element-caption\">Figure 2 &#8211; The two tables above show the absorbance, turbidity, and fluorescence values measured following the Slym Bart analysis. According to the reference parameters defined by the Piramide diagnostic protocol, the analyses indicate the presence of biofilm on both treated lines, with a higher risk for the Filler Stick supplement production line.<\/figcaption><\/figure>\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Stick-fill machines, designed for filling single-dose stick-format pouches, offer a state-of-the-art solution for the safe and hygienic packaging of powders, liquids, and granules in compliance with the most stringent quality standards. In the world of pharmaceutical and nutraceutical manufacturing, precision and efficiency are essential requirements. What are stick filler machines? Stick-pack filling machines are automated [&hellip;]<\/p>\n","protected":false},"author":5,"featured_media":14944,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center 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center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[49],"tags":[],"class_list":["post-15396","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-articles"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.8 (Yoast SEO v27.8) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Filler Stick: Pharmaceutical and Nutraceutical Packaging<\/title>\n<meta name=\"description\" content=\"Sanitization of stick-filling machines: a critical factor for product quality in pharmaceutical and nutraceutical packaging\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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