Business

Línea de compresión

A 90-minute, 4-round basic Express simulation for Spanish vocational training (Formacion Profesional), module 1394 Tecnicas de produccion farmaceutica y afines of the Tecnico Superior en Fabricacion de Productos Farmaceuticos, Biotecnologicos y Afines (Real Decreto 832/2014).

4 rounds Undergraduate English, Español

Preview

About this simulation

A 90-minute, 4-round basic Express simulation for Spanish vocational training (Formacion Profesional), module 1394 Tecnicas de produccion farmaceutica y afines of the Tecnico Superior en Fabricacion de Productos Farmaceuticos, Biotecnologicos y Afines (Real Decreto 832/2014).

The learner is Irene Lacasta, a newly qualified compression technician of a fictional generics contract manufacturer, through 2027, at a rotary tablet press that compresses an uncoated tablet from a wet granulate, with a feeder, pre-compression and main compression, punches and dies, an automatic weight control with a reject gate, a granulation room and an in-process laboratory.

Four situations set the year's course: a granulate still in quarantine at the restart, and how the granulate is checked (its release and loss on drying read, never a quarantined granulate compressed) and how the press is set up (on the in-process checks of weight, hardness and thickness, the speed inside the validated range); capping and a drifting weight in the spring campaign, and what is done with the capping (the cause first: moisture, fines, pre-compression, dwell time, punch tips; the automatic weight reject never switched off) and how the weight is controlled (the control loop on the trend); the restart after a humid summer and the August stop, and what is changed in the granulation (the end points set with the granulation room) and how the tooling is run (cleaned, measured and replaced on a plan); and a night when a batch fails its friability, answered by holding the batch, telling quality assurance and holding the next one, and how the year's events are recorded.

Three critical errors cap the round: a quarantined granulate compressed, the automatic weight reject switched off, rejected tablets blended back into the bulk. KPIs: batches released conforming, compression suite operating cost, tablets rejected a week and deviations and out-of-specification results. Lesson: the defect in the tablet is usually born in the granulate. Spanish primary, English parity.

Fictional plant, companies and people; real curriculum cited.

What participants learn

After the session, participants will be able to:

  • Verify a granulate's quality-control release, loss on drying, particle size and flow against the batch record before compressing, and never compress a granulate in quarantine
  • Set up and release a rotary tablet press on the in-process checks of weight, hardness and thickness, with the speed inside the validated range
  • Diagnose capping by its cause, examining moisture, fines, pre-compression, dwell time and punch tips before raising the force, and keep the automatic weight reject switched on
  • Control tablet weight on the trend with the weight-control loop on, agree the granulation end points with the granulation room and maintain the tooling on a plan
  • Decide how to handle an out-of-specification batch: stop the press, hold the batch, inform quality assurance, never blend the rejects back, and write a deviation report with its root cause

Prerequisites

  • Has run or watched a tablet press

Who it is for

An introductory simulation that assumes no prior knowledge of the subject, designed for undergraduate courses. It also works in vocational and high-school programmes and in onboarding sessions.

How a session runs

  1. The instructor creates a session from the Eureka dashboard and invites the participants.
  2. Participants play 4 rounds. In each one they submit their decisions and the simulation calculates the results. The first round opens with: lunes 11 de enero, 6:00: el granulado en cuarentena y el arranque.
  3. The simulation can be run in English, Español.
  4. The instructor follows each participant's progress and results from the dashboard, and uses the class results for the debrief.

Decisions participants make

The decisions participants make during the simulation:

  • Cómo se comprueba el granulado antes de comprimir
  • Cómo se ajusta y se libera la máquina
  • Qué se hace cuando aparece el decapado
  • Cómo se controla el peso
  • Qué se cambia en la granulación
  • Cómo se lleva el utillaje
  • Cómo se responde a un lote fuera de especificación
  • Cómo se registran los sucesos del año

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