Normas sobre materiales Marco completo

High-Efficiency Particulate Air (HEPA) and Ultra-Low Particulate Air (ULPA) filters are critical cleanroom components. A HEPA filter must remove at least 99.97% of airborne particles 0.3 micrometers (µm) in diameter. An ULPA filter is even more efficient, removing 99.999% of particles 0.12 µm or larger. They work via a combination of interception, impaction, and diffusion.

FMEA is a systematic, bottom-up, inductive method for identifying potential failure modes in a system, product, or process. For each failure mode, it assesses the potential effects or consequences, their severity, likelihood of occurrence, and the ability to detect them. The goal is to prioritize and mitigate high-risk failure modes before they occur.

The PDCA cycle, also known as the Deming Cycle or Shewhart Cycle, is an iterative four-step management method used for the control and continuous improvement of processes and products. It provides a simple and effective approach for solving problems and managing change, ensuring that ideas are tested on a small scale before being implemented organization-wide.

El recubrimiento en polvo es un proceso de acabado en seco en el que se aplica un polvo de polímero termoplástico o termoestable a una superficie, generalmente mediante electrostática, y luego se cura con calor. Las partículas de polvo se cargan, lo que hace que se adhieran al sustrato conectado a tierra. El calor funde el polvo, lo que le permite fluir y formar un acabado continuo, duradero y de alta calidad, a menudo superior al de la pintura convencional.

A structured methodology for creating new products, typically involving analysis, concept development, and synthesis. It is an iterative cycle where designers research user needs, brainstorm ideas, create prototypes, and test them to refine the final product. This process ensures that the end product is both functional and meets market demands effectively before full-scale production.

Heijunka is the principle of production leveling or smoothing within the Toyota Production System. It involves averaging out the production volume and mix over a fixed period to eliminate peaks and valleys in workload. This creates a predictable and stable manufacturing environment, which is a prerequisite for implementing Just-in-Time (JIT) and standardized work effectively.

Takt time is a theoretical calculation representing the pace of customer demand ([latex]Available Time \div Demand[/latex]). In contrast, cycle time is an empirical measurement of the actual time taken to complete one unit of work at a specific process step. A core principle of lean manufacturing is to ensure that cycle time is consistently less than or equal to Takt time.

Takt time is the maximum time allowed to produce a product to meet customer demand. It is calculated by dividing the net available production time by the customer demand over that period. The formula is [latex]T = \frac{T_a}{D}[/latex], where T is the Takt time, Ta is the net available time, and D is the customer demand.

Just-in-Time (JIT) is a production strategy aimed at increasing efficiency and decreasing waste by receiving goods only as they are needed in the production process, thereby reducing inventory costs. This method requires precise forecasting and highly coordinated supply chains. The goal is to have the right materials, at the right place, at the right time, in the exact amount.

A foundational economic fact is that the total monetary volume of business-to-business (B2B) transactions significantly surpasses that of business-to-consumer (B2C) transactions. This is because a single finished consumer product often involves a long supply chain with multiple B2B transactions—from raw materials to manufacturing components to wholesale distribution—before the final B2C sale occurs.

Kanban, meaning "visual card" or "signboard" in Japanese, is a scheduling system integral to the Toyota Production System. It uses visual cues, typically cards, to trigger action and manage workflow. It is a "pull" system that signals the need to move materials within a manufacturing facility or from an outside supplier into the production facility.

El recubrimiento por centrifugación es un procedimiento para depositar películas delgadas y uniformes sobre sustratos planos. Se aplica un exceso de solución de recubrimiento sobre el sustrato, que se gira a alta velocidad. La fuerza centrífuga distribuye la solución y la evaporación o el curado del disolvente solidifica la película. El espesor final se determina por la viscosidad, la concentración y la velocidad de centrifugado.

The Fill Factor (FF) is a key parameter that determines the quality of a solar cell. It is the ratio of the maximum power a cell can produce ([latex]P_{max}[/latex]) to the theoretical power if it were an ideal voltage and current source ([latex]V_{oc} \times I_{sc}[/latex]). A higher fill factor indicates lower parasitic resistance losses and a more 'square' I-V curve.

The Toyota Production System is founded on the complete elimination of waste, categorized into 7 types, 3 main being described here: Muda (non-value-adding work), Muri (overburden), and Mura (unevenness). While Muda is the most commonly discussed, TPS recognizes that Muri and Mura are often the root causes of Muda and must be addressed first to achieve a truly lean system.

Las Buenas Prácticas de Fabricación (BPF) son un sistema de normas y directrices que garantizan la producción y el control constantes de los productos farmacéuticos, de acuerdo con los estándares de calidad. Abarca todos los aspectos de la producción, desde las materias primas, las instalaciones y los equipos hasta la formación y la higiene personal del personal. Las BPF están diseñadas para minimizar los riesgos inherentes a cualquier producción farmacéutica.