RT Journal Article
SR Electronic
T1 Particulate Matter Determination in LVPs Produced in Dutch Hospital Pharmacies
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 343
OP 358
VO 54
IS 4
A1 F. A. Boom
A1 J. Van der Veen
A1 Ph. Verbrugge
A1 F. J. Van de Vaart
A1 A. C. A. Paalman
A1 Th. Vos
YR 2000
UL http://journal.pda.org/content/54/4/343.abstract
AB The Laboratory of Dutch Pharmacists determines LVP particulate matter contamination of LVPs produced in Dutch hospital pharmacies. The investigated LVPs must conform to the NVZA/LNA criteria, which prescribes eight samples and sets limits for particles ≥ 2 μm, ≥ 5 μm, ≥ 10 μm, and ≥ 25 μm for both mean and mean + 2x standard deviation. LVPs produced in 500 mL glass containers or plastic containers mostly met the NVZA/LNA criteria, but LVPs produced in 100 mL glass containers showed higher levels of particulate matter contamination. The composition of the LVP significantly affected the extent of particulate matter contamination, but the effect was relatively small when compared to the influence of the type of container. LVPs produced in Dutch hospital pharmacies and LVPs obtained from pharmaceutical industries showed comparable amounts of particulate matter contamination.