Bacterial contamination of ex vivo processed PBPC products under clean room conditions

Ritter, Markus; Schwedler, Joachim; Beyer, Jörg; Movassaghi, Kamran; Mutters, Reinier; Neubauer, Andreas; Schwella, N.

doi:10.1046/j.1537-2995.2003.00573.x

Cited by 22 publications

(19 citation statements)

References 17 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…A more recent study shows that the contamination rate of syringes is lower when they are prepared in a controlled environment as compared to a non-controlled environment (Stucki et al 2009). Similar results were found when monitoring an assisted reproductive technology facility (Herlong et al 2008) and a peripheral blood progenitor cell (PBPC) products facility (Ritter et al 2003).…”

Section: Discussionsupporting

confidence: 62%

Cleanrooms and tissue banking how happy I could be with either GMP or GTP?

et al. 2013

View full text Add to dashboard Cite

The regulatory framework of tissue banking introduces a number of requirements for monitoring cleanrooms for processing tissue or cell grafts. Although a number of requirements were clearly defined, some requirements are open for interpretation. This study aims to contribute to the interpretation of GMP or GTP guidelines for tissue banking. Based on the experience of the participating centers, the results of the monitoring program were evaluated to determine the feasibility of a cleanroom in tissue banking and the monitoring program. Also the microbial efficacy of a laminar airflow cabinet and an incubator in a cleanroom environment was evaluated. This study indicated that a monitoring program of a cleanroom at rest in combination with (final) product testing is a feasible approach. Although no statistical significance (0.90 \ p \ 0.95) was found there is a strong indication that a Grade D environment is not the ideal background environment for a Grade A obtained through a laminar airflow cabinet. The microbial contamination of an incubator in a cleanroom is limited but requires closed containers for tissue and cell products.

show abstract

Section: Discussionsupporting

confidence: 62%

Cleanrooms and tissue banking how happy I could be with either GMP or GTP?

et al. 2013

View full text Add to dashboard Cite

show abstract

“…Contamination of BM or PBPCs can occur during collection, ex vivo manipulation, storage, or the thawing and infusion process. The reported microbial contamination rates are between 4.4 and 17 percent for BM 26,59‐61 and 0.2‐5.2 percent for PBPC products 59,62‐66 . The most common organisms identified are coagulase‐negative staphylococcus species and other skin flora.…”

Section: Clinical Management Of Contaminated Hpc Productsmentioning

confidence: 99%

Patient care during infusion of hematopoietic progenitor cells

2004

View full text Add to dashboard Cite

“…Microbial contamination of HPC products has been described in frequencies varying from close to 1% up to high contamination rates. [1][2][3][4] Harvesting, ex vivo processing, cryopreservation and the pre-infusion thawing process [5][6][7] can be responsible for contamination, owing to inadequate decontamination of skin at the needle puncture site, indwelling catheter site for peripheral blood progenitor cell (PBPC) collection or owing to contamination by laboratory personnel or equipment. Commonly documented species are part of the normal flora of the skin.…”

Section: Introductionmentioning

confidence: 99%