From the merger of Ritrama and Arconvert came the Fedrigoni Self-Adhesives. 10 production plants, 18 product lines, 1,535 million square metres of material. They develop and produce self-adhesive solutions for nearly every market, included pharmaceuticals: from wine & liquors to automotive, home & personal care and visual communication. As a global partner, their priority is to provide their clients with performing, high-level safe and tailor-made solutions, guaranteeing the best service, reactive and accountable in satisfying any technical requests. They rely on a dedicated team of R&D and compliance experts to engineer cutting-edge products, where different kinds of adhesives -solvent, emulsion adhesives, hot-melt and UV– are complemented with various technologies, from water to extreme temperature resistance ones.
Patient safety is their priority
They know how important it is to ensure patient safety and, depending on the end use of the product, they follow different regulations. They comply with EU regulations and with the directive on counterfeit and falsified medicines (2011/62/EU) to ensure pharma label safety. Each product has a serial number and must be sealed at all times. They also use low migration materials to make sure their clients are never exposed to any danger.
Changes in the packaging of pharmaceutical products can pose a risk to patient health and safety. This is why they work to protect consumers, ensure supply-chain security and support compliance for the packaging of prescription drugs and high-risk over the counter medicines. Pharma product security consists in ensuring:
- Label security
- Tamper evident labels
- Anti-counterfeit labels
- Supply chain security
- Support compliance for packaging
- Smart security
More than ever, in a market of big players, challenges and methods, it is fundamental to respect good regulation practices to ensure patient safety and product change security, offering smart-quality solutions and high-level safety, technical expertise, global pre-tested materials and long-term availability.
Product security & label change management
This market requires certifications, rigid operating procedures and specialized materials that can withstand demanding conditions and assure security of supply, quality consistency and change management procedures. Besides, introducing or replacing an existing product is a process that can take years and has to go through product approval.
Label Change Management
To let the validation process, begin according to the rules they give their clients a minimum of 6 months advance notice. Every label should contain patient information, secure printability, product maintenance, security of information, a description of the process and temperature storage information.
The industry has to be functional, serving the needs of the patient in the security, labeling and externalization process. Our premium offer focuses on regular coated papers and special materials for hangers, tamper-evident and luminescent adhesives, which resist in extremely harsh conditions, avoiding migration of additives to the product.
A matter of size
Quality must be built into each stage of the manufacturing process, covering all aspects of production, from raw materials, facility and equipment to training and staff hygiene. Long-lasting adhesion, high cohesion, content consistent with the information on the label, optical tracer to ensure no tampering has occurred: this is what their products offer, regardless of their size and shape.
About Pharma and Device Packaging & Labelling
Packaging & Labelling processes play significant roles in preserving medicinal products’ quality, promoting safe use, patient adherence and responsible distribution. With various risks threatening drug supply chain integrity (drug traceability, counterfeiting, medication errors, supply shortage), regulatory guidance and compliance technologies governing the P&L procedures across jurisdictions are transforming and becoming increasingly sophisticated.
World BI offers global insights into and practical guidelines for ensuring Packaging & Labelling compliance throughout manufacturing, artwork, drug registration and distribution processes. Attendees will revise important global & regional regulations relating to Packaging & Labelling, how GMP-compliant artwork processes & technologies maximize drug supply chain integrity as well as disputes related to drug Packaging & Labelling quality. Case studies including OTC, Biosimilars, Combination products, APIs will also be examined in detail to offer attendees practical case studies in real-world setting.