{"id":17403,"date":"2022-01-11T12:29:47","date_gmt":"2022-01-11T11:29:47","guid":{"rendered":"https:\/\/gfh-gmbh.de\/leak-testing-of-medical-pharmaceutical-vials-through-laser-drilling-ensures-the-tightness-of-entire-product-groups\/"},"modified":"2026-06-12T09:01:43","modified_gmt":"2026-06-12T07:01:43","slug":"leak-testing-of-medical-pharmaceutical-vials-through-laser-drilling-ensures-the-tightness-of-entire-product-groups","status":"publish","type":"post","link":"https:\/\/gfh-gmbh.de\/en\/leak-testing-of-medical-pharmaceutical-vials-through-laser-drilling-ensures-the-tightness-of-entire-product-groups\/","title":{"rendered":"Leak testing of medical-pharmaceutical vials through laser drilling ensures the tightness of entire product groups."},"content":{"rendered":"
\"Microdrilling<\/span><\/div>
Labeling and processing in one step<\/div><\/div>
\n

Um den Zugang zu hochwertigem und sicherem medizinischem und pharmazeutischem Equipment auch zuk\u00fcnftig gew\u00e4hrleisten zu k\u00f6nnen, bedarf es innovativer L\u00f6sungen zur schnellen und kosteng\u00fcnstigen Leckagepr\u00fcfung der geforderten Hygiene- und Qualit\u00e4tsstandards. Bereits w\u00e4hrend des Herstellungs- und Bearbeitungsprozesses von Produkten wie beispielsweise Spritzenzylindern, Vakzin\u2013Durchstechfl\u00e4schchen oder Infusions- und Transfusionsbeuteln werden diese verschiedenen Qualit\u00e4ts- und Stabilit\u00e4tstests unterzogen. Dabei m\u00fcssen die eingesetzten Kontrollmechanismen beispielsweise kleinste Ver\u00e4nderungen und Besch\u00e4digungen im Material zuverl\u00e4ssig erkennen k\u00f6nnen, um Kontaminationen im Rahmen der Anwendung auszuschlie\u00dfen. Daf\u00fcr bietet die GFH GmbH den Herstellerfirmen medizinisch-pharmazeutischer Erzeugnisse eine laserbasierte L\u00f6sung an. Mit dem Bohren hochpr\u00e4ziser Leckagel\u00f6cher von gerade einmal 5 \u00b5m bis 50 \u00b5m Durchmesser in einzelne Exemplare einer Fertigungslinie wird eine kosten- und zeitsparende M\u00f6glichkeit zur Validierung dieser Qualit\u00e4tspr\u00fcfung geboten, die besonders flexibel und materialschonend arbeitet. W\u00e4hrend die Lochma\u00dfe sehr genau eingehalten werden k\u00f6nnen, entstehen keine Risse oder Belastungen des Materials um die Bohrstelle herum.<\/p>\n<\/blockquote>\n

Als Folge der anhaltenden Pandemie steigt die Nachfrage insbesondere f\u00fcr sogenannte \u201eLeckagebohrungen\u201c in Spritzenzylindern rapide an. Mit diesen bewusst gesetzten Stichproben sollen Fehlstellen im Material der Phiolen und Zylinder bereits w\u00e4hrend der Herstellung ausgeschlossen werden, um etwa eine sp\u00e4tere Kontamination der Transfusion oder ein Auslaufen w\u00e4hrend der Anwendung zu verhindern. Der zunehmende Bedarf an solchen Kontrollverfahren ist nicht zuletzt auf die weltweiten Impfkampagnen und die damit einhergehende gestiegene Nachfrage an einwandfreien medizinischen und pharmazeutischen Produkten zur\u00fcckzuf\u00fchren. Die Hersteller ben\u00f6tigen daher zuverl\u00e4ssige Verfahren, die die stichprobenartige Qualit\u00e4tspr\u00fcfung zeitund kostensparend in hoher Pr\u00e4zision ausf\u00fchren k\u00f6nnen. Eine daf\u00fcr pr\u00e4destinierte Methode stellt die Lasertechnologie aufgrund ihres sehr genauen und ber\u00fchrungslosen Bearbeitungsstrahls dar, weshalb sich bereits einige namhafte Hersteller bez\u00fcglich der Erzeugung von Leckagebohrungen an die GFH GmbH gewandt haben.<\/p>\n<\/div><\/div><\/div>

\"Drilling<\/span><\/div>

Drilling highly precise leak holes in individual items on a production line provides a cost- and time-saving method for validating the control mechanisms used in manufacturing.<\/p>\n<\/div><\/div><\/div>

The laser experts have developed a process that allows for the drilling of highly precise leak holes to validate the control mechanisms used in production without significant effort. The resulting (flawed) products with micro-drilled holes are then deliberately integrated into the manufacturing process of medical product manufacturers. These \"prepared\" products then form the control group for quality and leak testing. \"The ultra-short pulse laser serves as an excellent tool to provide the glass vials with leakage holes that are very small and precise, yet do not damage the material around the borehole,\" explains Andreas Reitberger, Sales Director at GFH GmbH. \"There are several reasons for this: Firstly, the ultra-short laser pulses that impact the material prevent stresses and cracks in the material through so-called 'cold ablation'. Secondly, there are no limits to the variety of materials that can be processed with laser technology. Thus, even difficult-to-machine materials such as glass or special medical plastics can be processed with high precision.\"<\/p>\n<\/div><\/div><\/div>

Labeling and processing in one step<\/div><\/div>

F\u00fcr die zuvor beschriebene Prozessanwendung der Leckagebohrungen wird der Laserstrahl \u00fcber zwei Spiegel mit einem Scanner auf dem Werkst\u00fcck positioniert. Da durch diese optischen Achsen nur geringe Massen bewegt werden m\u00fcssen, sind h\u00f6chst dynamische und flexible Bearbeitungen m\u00f6glich. Der Laserstrahl wird hierf\u00fcr auf eine extrem kleine Fl\u00e4che fokussiert und somit k\u00f6nnen Bohrungen mit einem minimalen Durchmesser (untere Grenze 5 \u00b5m) hergestellt werden. Die Laserbearbeitung hat dar\u00fcber hinaus keinen Werkzeugverschlei\u00df zur Folge, weshalb die Bearbeitungen jederzeit wiederholbar sind. Zudem entf\u00e4llt bei der Lasermikrobearbeitung die Nachbearbeitung. \u201eBei dieser Technologie profitiert der Hersteller durch die mikrometergenaue Einstellung der Laserbohrung und die nahezu uneingeschr\u00e4nkte Flexibilit\u00e4t des Lasers\u201c, erg\u00e4nzt Reitberger.<\/p>\n<\/div><\/div><\/div>

\"GFH<\/span><\/div>

\"Andreas Reitberger, Head of Sales at GFH GmbH, explains, 'The ultra-short pulse laser serves as an excellent tool for providing glass vials with leakage holes that are very small and precise, yet do not damage the material around the borehole.'\"<\/p>\n<\/div><\/div><\/div>

The medical-pharmaceutical glass containers typically have a wall thickness of only one millimeter. Depending on customer requirements, the highly precise percussion bores have a diameter ranging from 5 \u00b5m to 50 \u00b5m. With a tolerance of just +\/- 2.5 \u00b5m, the bores demonstrate extreme accuracy, which would be hardly achievable with conventional mechanical drilling methods. Based on the highly accurate measurement methods used at GFH using optical microscopes, a test protocol is created for each individual borehole following the laser processing, ensuring that each hole is precisely certified and validated.<\/p>\n<\/div><\/div><\/div>

Laser processing saves multiple setups<\/div><\/div>

In addition to machining, products, especially in the medical and pharmaceutical fields, need to be precisely labeled or marked for subsequent certification and traceability. Conventional machining methods often require multiple machines for this task, as the workpiece needs to be clamped onto different machining machines several times. However, with laser processing, multiple clamping operations are eliminated. In this modern processing method, both drilling and marking can be performed in a single operation. Combining these two processing steps saves significant time and setup costs.<\/p>\n<\/div><\/div><\/div>

\"Laser<\/span><\/div><\/div><\/div>
\"Micro<\/span><\/div><\/div><\/div>
\"Laser<\/span><\/div><\/div><\/div>

Scanning electron microscope image of the leakage bore created by the ultra-short pulse laser in a glass vial (side view of a 20 \u00b5m bore).<\/p>\n<\/div><\/div><\/div>

GFH's extensive expertise in laser microprocessing and in the construction of production machines allows the company to manufacture or process these particularly demanding products for manufacturers in the pharmaceutical-medical technology sector in-house. Furthermore, the company even develops its own laser systems according to specific requirements if requested. \"If a customer expresses a specific need for such a machine, we work together to select the appropriate GFH production model and equip it with modular hardware and software solutions for the specific application,\" explains Reitberger. All GFH production machines are equipped with ultra-short pulse lasers from renowned manufacturers. During this consultation, technicians also provide information on possible custom solutions and other processing methods that can be implemented in the systems \u2013 from laser cutting to laser ablation and laser turning. \"We are pleased to have been able to support many renowned manufacturers in securing their supply chains with our established drilling process for leakage holes in syringe cylinders in response to short-term special requests. Drilling leakage holes with ultra-short pulse lasers in syringe cylinders has become a mainstay in our precision manufacturing,\" concludes Reitberger.<\/p>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":8346,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[94,31],"tags":[],"class_list":["post-17403","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-2022-en","category-press-articles"],"_links":{"self":[{"href":"https:\/\/gfh-gmbh.de\/en\/wp-json\/wp\/v2\/posts\/17403","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/gfh-gmbh.de\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/gfh-gmbh.de\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/gfh-gmbh.de\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/gfh-gmbh.de\/en\/wp-json\/wp\/v2\/comments?post=17403"}],"version-history":[{"count":18,"href":"https:\/\/gfh-gmbh.de\/en\/wp-json\/wp\/v2\/posts\/17403\/revisions"}],"predecessor-version":[{"id":21866,"href":"https:\/\/gfh-gmbh.de\/en\/wp-json\/wp\/v2\/posts\/17403\/revisions\/21866"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/gfh-gmbh.de\/en\/wp-json\/wp\/v2\/media\/8346"}],"wp:attachment":[{"href":"https:\/\/gfh-gmbh.de\/en\/wp-json\/wp\/v2\/media?parent=17403"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/gfh-gmbh.de\/en\/wp-json\/wp\/v2\/categories?post=17403"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/gfh-gmbh.de\/en\/wp-json\/wp\/v2\/tags?post=17403"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}