ISO certification for Rommelag FLEX flexible containment solutions
Waiblingen, Germany: – Advanced aseptic liquid filling and bottling specialist Rommelag Engineering has congratulated fellow Rommelag Group member Rommelag FLEX on gaining ISO certification for its innovative flexible, single-use containment solutions as well as for their continuous liners and cleanroom manufactured bags.
The DIN ISO 15378 certification is a major milestone for Rommelag’s FLEX department in confirming that its ingenious Flecotec single use aseptic packaging and containment systems and Flecofilm pharmaceutical packaging materials meet the legal requirements for primary packaging materials for pharmaceutical and medical products.
ISO 9001 quality
The certification also confirms the Rommelag products and processes meet the quality standards of ISO 9001 as well as the principles of Good Manufacturing Practice (GMP) as required by regulators for the pharmaceutical and medical device industry worldwide.
This will help Rommelag FLEX provide its clients with enhanced efficiencies in production processes, helping them avoid safety hazards for operating personnel and minimize risks of product contamination, all supporting enhanced product efficacy and shelf life.
Flecotec: single-use packaging & containment systems
Rommelag FLEX developed the Flecotec system, including FlecoZip interfaces, as a highly flexible and adaptable containment concept that can be ideally adapted to existing processes, requires no new certification, and reduces subsequent cleaning work to a minimum.
The system of adaptable transparent enclosure bags and covers overcomes the manufacturing challenges of pharmaceuticals involved in handling toxic or highly sensitive solids that can pose a direct threat to people’s safety and where cross-contamination has to be avoided at all times.
Flecofilm pharmaceutical packaging
The certification also applies to Rommelag FLEX Flecofilm that has been specially developed for pharmaceutical, fine chemicals, food, and cosmetics packaging applications. The highly transparent Flecofilm DL (DoubleLayer) offers electrostatic discharge capabilities, is heat sealable and being made from pharmaceutical-grade polyethylene in accordance with European Pharmacopoeia, chapters 3.1.3 and 3.1.5, also meeting USP <88> standards for in vivo non-reactivity and USP <661> for physicochemical properties.
Rommelag Engineering sets standards in the aseptic packing of liquids and semisolids with its proprietary bottelpack® aseptic filling systems and Blow-Fill-Seal (BFS) technology.
Rommelag is the overall brand for the Group of companies that invented and developed BFS technology and has become a global market leader in the aseptic filling of liquids and semisolids with its bottelpack machines as well as film-based packaging and flexible containment solutions.
BFS technology powers a range of fully automatic bottelpack systems that can manufacture canisters, bottles, tubes, ampoules, drop bottles, bellows containers, and portion packaging in a variety of forms and plastic blends. Rommelag Engineering also supplies a range of expansion options and ancillaries including Cap-Welding Machine (SM), Ampoule Inspection System (VIM), Particle Inspection Machine (PIM) and High-Voltage Leak Detector (HVLD).
Rommelag CMO, applies BFS and bottelpack technology on behalf of clients, contract filling more than two million containers a day for customers all over the world. Rommelag CMO operates more than 50 systems in multiple configurations, set up to meet stringent pharmaceutical standards, perform test fillings, and realize production batches or small-scale series for clients.
At Rommelag Flex, is a specialist in applications for sophisticated containment solutions in the pharma industry.
Rommelag Service forms a one-stop shop for everything from consulting to spare parts to upgrades, along with expert advice from the earliest stages of process, when developing a formula or fine-tuning a product design.
More information at: https://www.rommelag.com/en/.
Click on Rommelag FLEX DIN ISO 15378 certification for full details.
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Click on Rommelag FLEX Flecotec in action to watch video.
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