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Extreme Hygiene Protocol: 20 Years of Refinement at Eserplex Zero tolerance for contaminationIn pharmaceutical packaging, hygiene is non-negotiable. That’s why at Eserplex we have developed an extreme hygiene protocol that goes beyond the ordinary.Key components of the protocol Hand washing with specialized soaps Application of…
Es temporada de auditorías, y como CEO de una empresa de empaques farmacéuticos, he visto cómo una respuesta mal preparada puede costar semanas de trabajo adicional. Aquí están las 5 preguntas más frecuentes de auditores FDA sobre empaques, y cómo prepararse: ¿Pueden demostrar la trazabilidad completa del material? ❌ Respuesta problemática:“Tenemos los lotes en un…
Multiple Certifications: Eserplex’s Path to Excellence Credentials speak for themselvesIn a regulated environment like the pharmaceutical industry, certifications don’t just open doors—they guarantee trust. At Eserplex, we have built a compliance ecosystem that reflects our philosophy of continuous improvement.Our main certifications ISO 9001: Established quality management since…
Maintenance Under ISO 9001: Eserplex’s Comprehensive ProgramDiscover Eserplex’s maintenance program under ISO 9001, which ensures optimal equipment performance and zero failures in pharmaceutical packaging.Introduction: More than fixing—it’s preventing Maintenance in pharmaceutical packaging is not an expense—it’s a strategy. At Eserplex, we treat it as a critical program…
Removable Contamination Prevention: The PVC Cone InnovationEliminate removable contamination in pharmaceutical packaging with Eserplex’s PVC cone solution. Quality guaranteed from the source.Introduction: The invisible also matters Removable particles are silent enemies of pharmaceutical quality. At Eserplex, we take this challenge seriously. That’s why…
On World Humanitarian Day, I reflect on something few consider: the critical role of packaging in relief missions.In emergency situations, medicines and medical devices face extreme conditions: Temperatures of up to 50°C in conflict zones Extreme humidity in natural disasters Rough handling during evacuations…
Total Traceability in Pharmaceutical Packaging: The Eserplex MethodologyEnsure full traceability in pharmaceutical packaging. Discover the Eserplex system that documents every stage and passes audits without failures.Introduction: To see is to trust In the pharmaceutical world, knowing what happened, when, and where is not a luxury—it’s the law. Traceability not only protects the end patient; it protects…
In-Line Quality Control: The Methodology Eserplex Has Perfected Over 20 YearsIntroduction: Beyond Final Inspection In the pharmaceutical industry, it is not enough to inspect the finished product. True excellence is built at every stage of the process. At Eserplex, we understood this more than two decades ago, and since then we have refined a…
The recent update to U.S. Food and Drug Administration (FDA) regulations on pharmaceutical packaging comes into effect on June 15.Key points every quality director should know: Expanded traceability requirements New migration standards for polyethylenes Additional documentation for validation More frequent supplier auditsAt Eserplex, we have already adapted.…
single microscopic particle. That’s all it takes to contaminate an entire batch.The pharmaceutical industry lost more than $450 million in 2024 due to contamination related to inadequate packaging.Our bags with anti-migration technology create an effective barrier against particles as small as 0.2 microns, protecting the integrity of every component.…