The use of different time/temperature combinations in the optimization of sterilization of Ringers/glucose infusion solution
JP Mannermaa, E Muttonen, J Yliruusi… - PDA Journal of …, 1992 - journal.pda.org
The effect of sterilization temperature and sterilization efficacy (F0) on the amount of 5-
hydroxymethyl-2-furaldehyde (5-HMF) and glucose, number of particles generated and color …
hydroxymethyl-2-furaldehyde (5-HMF) and glucose, number of particles generated and color …
Degradation of dextrose during heating under simulated sterilization
ROYJ Sturgeon, NK Athanikar… - PDA Journal of …, 1980 - journal.pda.org
A practical approach for studying the breakdown of dextrose under simulated sterilization
conditions has been developed using a special laboratory instrument. The instrument allows …
conditions has been developed using a special laboratory instrument. The instrument allows …
Determination of conditions for the production scale sterilization of prefilled syringes
N Nishimoto, T Maekawa - PDA Journal of Pharmaceutical Science …, 2003 - journal.pda.org
External and internal differences in pressure of prefilled syringes can cause plunger
movement during sterilization, which might cause drug product contamination …
movement during sterilization, which might cause drug product contamination …
Optimization of moist heat sterilization
J Mannermaa, J Yliruusi - PDA Journal of Pharmaceutical Science …, 1993 - journal.pda.org
The use of different combinations of sterilization time and temperature in a pilot scale
autoclave, GEV 612 AR-2 (Getinge Ab, Sweden), in optimizing the sterilization process was …
autoclave, GEV 612 AR-2 (Getinge Ab, Sweden), in optimizing the sterilization process was …
[HTML][HTML] Factors generating glucose degradation products in sterile glucose solutions for infusion: statistical relevance determination of their impacts
J Haybrard, N Simon, C Danel, C Pinçon… - Scientific reports, 2017 - nature.com
Sterilising glucose solutions by heat promotes the generation of a large number of glucose
degradation products (GDPs). It has been shown that high levels of GDPs may result in …
degradation products (GDPs). It has been shown that high levels of GDPs may result in …
Comparison of different rubber stoppers; the effect of sterilization on the number of particles released
JP Mannermaa, E Muttonen, J Yliruusi… - PDA Journal of …, 1992 - journal.pda.org
The effect of sterilization on the number of particles released from five different types of
rubber stoppers, as well as on their surface roughness and elemental composition before …
rubber stoppers, as well as on their surface roughness and elemental composition before …
[HTML][HTML] Assessing filling technologies for contamination risk
B Verjans - BioPharm International, 2012 - biopharminternational.com
The authors compare four well-established aseptic filling technologies, open vial, ampul,
blow-fill-seal (BFS) and prefilled syringes, to the recently developed closed-vial technology …
blow-fill-seal (BFS) and prefilled syringes, to the recently developed closed-vial technology …
[PDF][PDF] Steam sterilisation: a new option for Ompi EZ-Fill vials & cartridges
A Zambon, V Molinella - ONdrugDelivery, 2015 - ondrugdelivery.com
Ompi Pharmaceutical Systems sterilisation cycle (eg temperature, pressure, humidity, gas
concentration, exposure time, degassing, aeration time and determination of residuals) …
concentration, exposure time, degassing, aeration time and determination of residuals) …
[HTML][HTML] Sterilization of micronized indomethacin
K Krupianskaya, B Croonenborghs, A Gillet… - Frontiers in Analytical …, 2023 - frontiersin.org
Sterilization is a pivotal topic in the pharmaceutical industry, whereby the nomenclature of
“sterile” refers to the absence of viable microorganisms. Since microorganisms can …
“sterile” refers to the absence of viable microorganisms. Since microorganisms can …
Sterilization validation
MJ Akers, NR Anderson - Pharmaceutical Process Validation, 2003 - taylorfrancis.com
Sterile products have several unique dosage form properties, such as freedom from micro-
organisms, freedom from pyrogens, freedom from particulates, and extremely high standards …
organisms, freedom from pyrogens, freedom from particulates, and extremely high standards …
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