| Modeling of parenteral container headspace pressure. | |
| | |
MedLine Citation:
|
PMID: 9691675 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
|
When containers and related closure systems holding fluids are heated, internal pressures are generated. Depending upon conditions, surprisingly high pressures can be developed. These pressures are often sufficient to break system integrity. Numerous factors combine to determine the pressure generated within the container and closure system. Each of these factors can vary during the manufacture and service life of the product. Prudent pharmaceutical design seeks to set and control all the factors in such a manner that container and related closure integrity are maintained from the time of assembly to the time of use. Answers can be obtained by pure experimentation ("cut, try, recut and retry until it comes out right") or by predicting performance with a good mathematical model and testing once to verify the model. Pure experimentation requires extensive prototype parts and testing thereof. The mathematical model approach is more exact and produces a better product quicker and at lower cost. This paper uses a simple tubing vial to demonstrate the two approaches to controlling internal pressures from assembly to use. A mathematical model with experimental verification produces high confidence that the system integrity will be maintained as desired. The model used to predict the headspace pressure of the tubing vial is of significance in estimating performance of similar containers and related closures. It can rapidly produce product with predictable behavior. As such, the model is an excellent tool for designers of pharmaceutical products. |
| | |
Authors:
|
P L Bryant |
Related Documents
:
|
17529855 - Tympanometry and laser doppler interferometry measurements on otitis media with effusio... 4058215 - True vocal cord paralysis following intubation. 7073605 - Eustachian tube dysfunction in submariners and divers. 9300555 - A self-filling micropipette for the isolation of single coccidial oocysts. 862445 - Reproducibility of data on steady-state gas exchange and indices of maldistribution of ... 1804575 - Biomechanical wall properties of the porcine rectum: a study using impedance planimetry. |
Publication Detail:
|
Type: Journal Article |
Journal Detail:
|
Title: PDA journal of pharmaceutical science and technology / PDA Volume: 52 ISSN: 1079-7440 ISO Abbreviation: PDA J Pharm Sci Technol Publication Date: 1998 May-Jun |
Date Detail:
|
Created Date: 1998-08-26 Completed Date: 1998-08-26 Revised Date: 2000-12-18 |
Medline Journal Info:
|
Nlm Unique ID: 9439538 Medline TA: PDA J Pharm Sci Technol Country: UNITED STATES |
Other Details:
|
Languages: eng Pagination: 123-8 Citation Subset: IM |
Affiliation:
|
Abbott Laboratories, Hospital Products Division, Abbott Park, Illinois, USA. |
Export Citation:
|
APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
|
Drug Packaging* Models, Theoretical Pressure |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
Previous Document: Identification and mass spectrometric sequence studies of fragments of l-asparaginase produced durin...
Next Document: Influence of DL methionine and sodium metabisulphite on the photostability of vitamin k1.