Reduce Machine Stops To Limit Human Intervention In Aseptic Production
(2020) BMEM01 20202Department of Biomedical Engineering
- Abstract
- Production and patient safety requirements are high in pharmaceutical industries where standards are set accordingly and controlled by e.g. the U.S. Food and Drug Administration (FDA). It is crucial that these standards are met without compromising the fact that production must run as effectively as possible, i.e. achieve Overall Equipment Efficiency (OEE), for the pharmaceutical companies to deliver the expected number of batches to retailers around the globe. Stops on the production lines are interruptions to the OEE and human interventions involving opening of protective glass doors following these stops are disturbing the sensitive aseptic production environment. Limiting the root causes of these stops would equal a higher OEE and... (More)
- Production and patient safety requirements are high in pharmaceutical industries where standards are set accordingly and controlled by e.g. the U.S. Food and Drug Administration (FDA). It is crucial that these standards are met without compromising the fact that production must run as effectively as possible, i.e. achieve Overall Equipment Efficiency (OEE), for the pharmaceutical companies to deliver the expected number of batches to retailers around the globe. Stops on the production lines are interruptions to the OEE and human interventions involving opening of protective glass doors following these stops are disturbing the sensitive aseptic production environment. Limiting the root causes of these stops would equal a higher OEE and increased patient safety. Proposals are made based on the two stop causes; Tipped Vials, 46.6\%, and Crushed Glass, 15.6\%, currently causing major interventions and delays. Belt synchronisations and material property changes suggestions are made in order to minimise the door openings with 6\% and 7\% respectively. With only a simple vial material change that helps increase line speed and eliminate crushed glass interventions the probability of door openings can be reduced by over 44\%. Focus is on long-term stability and control, both for line flow and environment, largely following the Lean philosophy. The future of aseptic production is changing and e.g. Artificial Intelligence (AI) has significant potential as enough data is extracted and prepared, correct algorithms developed and taught accordingly. As for now, solutions built on years of studies in the fields of mathematics, physics and chemistry are needed to make aseptic production standards in the pharmaceutical industry even more efficient and, as always, with the interest of the patient as main priority. (Less)
- Popular Abstract
- Reduce Machine Stops for a Safer Aseptic Production
If aseptic production lines had none or very few stops, staff would not have to interfere with the automated process and risk spreading microscopic particles in the high-risk zone where the medicine is fully exposed.
The lines are non-isolated “Filling Lines” where the exposed glass vials move through the line in order to be filled with medicine and sealed with a cap before leaving the area as finished products. When humans intervene, they must open one or more transparent doors around the line protecting the exposed vial and even with full protective gowning align with proper management practice they constitute a contamination risk. Production and patient safety requirements are... (More) - Reduce Machine Stops for a Safer Aseptic Production
If aseptic production lines had none or very few stops, staff would not have to interfere with the automated process and risk spreading microscopic particles in the high-risk zone where the medicine is fully exposed.
The lines are non-isolated “Filling Lines” where the exposed glass vials move through the line in order to be filled with medicine and sealed with a cap before leaving the area as finished products. When humans intervene, they must open one or more transparent doors around the line protecting the exposed vial and even with full protective gowning align with proper management practice they constitute a contamination risk. Production and patient safety requirements are very high in pharmaceutical industries and rules and standards are set accordingly and controlled by e.g. the FDA. It is crucial that these standards are met without compromising the fact that production must run as effectively as possible, i.e. the OEE, for the pharmaceutical companies to deliver the expected number of batches with finished products to their retailers around the globe. (Less)
Please use this url to cite or link to this publication:
http://lup.lub.lu.se/student-papers/record/9029267
- author
- Karlén, Sofia LU
- supervisor
- organization
- course
- BMEM01 20202
- year
- 2020
- type
- H2 - Master's Degree (Two Years)
- subject
- keywords
- Aseptic Production, Filling Lines, Optimisation
- language
- English
- additional info
- 2020-13
- id
- 9029267
- date added to LUP
- 2020-09-17 16:03:33
- date last changed
- 2020-09-17 16:03:33
@misc{9029267,
abstract = {{Production and patient safety requirements are high in pharmaceutical industries where standards are set accordingly and controlled by e.g. the U.S. Food and Drug Administration (FDA). It is crucial that these standards are met without compromising the fact that production must run as effectively as possible, i.e. achieve Overall Equipment Efficiency (OEE), for the pharmaceutical companies to deliver the expected number of batches to retailers around the globe. Stops on the production lines are interruptions to the OEE and human interventions involving opening of protective glass doors following these stops are disturbing the sensitive aseptic production environment. Limiting the root causes of these stops would equal a higher OEE and increased patient safety. Proposals are made based on the two stop causes; Tipped Vials, 46.6\%, and Crushed Glass, 15.6\%, currently causing major interventions and delays. Belt synchronisations and material property changes suggestions are made in order to minimise the door openings with 6\% and 7\% respectively. With only a simple vial material change that helps increase line speed and eliminate crushed glass interventions the probability of door openings can be reduced by over 44\%. Focus is on long-term stability and control, both for line flow and environment, largely following the Lean philosophy. The future of aseptic production is changing and e.g. Artificial Intelligence (AI) has significant potential as enough data is extracted and prepared, correct algorithms developed and taught accordingly. As for now, solutions built on years of studies in the fields of mathematics, physics and chemistry are needed to make aseptic production standards in the pharmaceutical industry even more efficient and, as always, with the interest of the patient as main priority.}},
author = {{Karlén, Sofia}},
language = {{eng}},
note = {{Student Paper}},
title = {{Reduce Machine Stops To Limit Human Intervention In Aseptic Production}},
year = {{2020}},
}