| dc.rights.license | All rights reserved | en_US |
| dc.contributor.advisor | Morales, José A. | |
| dc.contributor.author | Adams Monell, Glorynette | |
| dc.date.accessioned | 2020-12-15T13:39:11Z | |
| dc.date.available | 2020-12-15T13:39:11Z | |
| dc.date.issued | 2010 | |
| dc.identifier.citation | Adams Monell, G. (2010). Reliability of operators performing the visual inspection of parenteral drug products [Unpublished manuscript]. Graduate School, Polytechnic University of Puerto Rico. | en_US |
| dc.identifier.uri | http://hdl.handle.net/20.500.12475/988 | |
| dc.description | Design Project Article for the Graduate Programs at Polytecnic University of Puerto Rico | en_US |
| dc.description.abstract | The visual inspection of parenteral
product filled vials is performed to assure that any
damaged or defective unit is detected and removed
prior to packaging. This investigation evaluated
the visual inspection process of parenteral products
with manual handling to enhance actual process
and reduce regulatory exposure. It challenged the
probabilistic inspection results due to variability
within operators and inspection time. A total of
three (3) different standard sets of 100 vials each
were evaluated by three (3) inspectors of high,
medium and low experience level. The study
concluded with a 95% confidence level that there is
no significant difference between the results
obtained at forty (40) and fifty (50) seconds
inspection time neither between the interaction of
inspectors and inspection time but that there is
significant difference between operators.
Consequently, initial and continuous training are
essential elements for the quality assurance of the
visual inspection process.
Key Terms – analysis of variance, operators
reliability, parenteral products, visual inspection | en_US |
| dc.language.iso | en_US | en_US |
| dc.publisher | Polytechnic University of Puerto Rico | en_US |
| dc.relation.ispartof | Manufacturing Engineering; | |
| dc.relation.ispartofseries | Spring-2010; | |
| dc.relation.haspart | San Juan | en_US |
| dc.subject.lcsh | Analysis of variance | en_US |
| dc.subject.lcsh | Pharmaceutical technology--Quality control | |
| dc.subject.lcsh | Polytechnic University of Puerto Rico--Graduate students--Research | |
| dc.title | Reliability of Operators performing the Visual Inspection of Parenteral Drug Products | en_US |
| dc.type | Article | en_US |
| dc.rights.holder | Polytechnic Universy of Puerto Rico, Graduate School | en_US |
