Linked Life Data

10831919

Source:http://linkedlifedata.com/resource/pubmed/id/10831919

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
3
pubmed:dateCreated
2000-7-28
pubmed:abstractText
With the implementation of universal leucodepletion in UK all leucodepletion processes have gone through a standard process qualification and quality improvement. The Haemonetics MCS system is a well established automated platelet collection system for the production of double dose leucoreduced platelet concentrate (WBC approximately 70x10(6)/dose). Recently an automated post collection filtration harness system has been introduced (MCS plus LDP) in which platelets are filtered, using an in-line PALL polyester filter (LRFH6 PALL) to reduce the WBC level to below 5x10(6) WBC/dose. This system passed our Phase I evaluation process based on 20-40 runs. However, some changes in the final volume of the products were needed to conform to national guidelines. Large scale trials using the new volume adjusted protocol revealed occasional failure in the leucocyte content. Therefore, 100% testing had to be implemented on all products. A national evaluation was carried out to determine whether changing the filter to a more efficacious one, the LRFXL (PALL) or slowing the filtration flow rate can influence the overall outcome. To reduce donor variability, known donor population were used with identical apheresis conditions. A more consistent and systematic drop in leucocyte content was observed by reducing the flow rate whereas a similar failure (i.e. 1-3%) rate was found both in controls and LRFXL when using the standard head pressure, which is recommended by the manufacturer. A similar failure rate was found using three different low leucocyte counting technologies (Nageotte, flow cytometry and Imagn 2000). It is recommended that a process qualification/validation program should be implemented when even a small modification in the collection system is introduced.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
T
pubmed:status
MEDLINE
pubmed:month
Jun
pubmed:issn
0955-3886
pubmed:author
pubmed:issnType
Print
pubmed:volume
22
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
165-9
pubmed:dateRevised
2006-11-15
pubmed:meshHeading
pubmed:year
2000
pubmed:articleTitle
The role of in process qualification in quality improvement of the haemonetics MCS plus leucodepleted platelet concentrate.
pubmed:affiliation
National Blood Service, North London, Colindale Avenue, NW9 5BG, London, UK. jerhard.seghatchian@nbs.nhs.uk
pubmed:publicationType
Journal Article, Comparative Study