Determination of the moisture content of bromobutyl rubber stoppers as a function of processing: implications for the stability of lyophilized products
AC Templeton, J Placek, H Xu, R Mahajan… - PDA journal of …, 2003 - journal.pda.org
The purpose of the present study is to apply and contrast several analytical techniques to
understand the change in moisture content of 20 mm diameter bromobutyl rubber stoppers …
understand the change in moisture content of 20 mm diameter bromobutyl rubber stoppers …
Determination of moisture in rubber stoppers: effect of Karl Fischer oven temperatures
Z Wang, BA Frankel, WJ Lambert - PDA Journal of Pharmaceutical …, 2001 - journal.pda.org
Moisture released from rubber stoppers of pharmaceutical products may adversely affect
product quality during storage. The objective of the current study was to identify an …
product quality during storage. The objective of the current study was to identify an …
Moisture absorption and desorption of different rubber lyophilisation closures
S Corveleyn, S De Smedt, JP Remon - International journal of …, 1997 - Elsevier
Rubber closures form a critical barrier in the protection of freeze-dried products against the
uptake of moisture. In this study, the moisture absorption of different rubber lyophilisation …
uptake of moisture. In this study, the moisture absorption of different rubber lyophilisation …
Effect of stopper processing conditions on moisture content and ramifications for lyophilized products: comparison of “low” and “high” moisture uptake stoppers
PD Donovan, V Corvari, MD Burton… - PDA journal of …, 2007 - journal.pda.org
The purpose of this study was to evaluate the effect of processing and storage on the
moisture content of two commercially available, 13-mm lyophilization stoppers designated …
moisture content of two commercially available, 13-mm lyophilization stoppers designated …
Lyophilization closures for protein based drugs
F Degrazio, K Flynn - PDA Journal of Pharmaceutical Science and …, 1992 - journal.pda.org
Rubber stopper formulations which are currently used as lyophilization stoppers vary widely
in their capacities to absorb and release moisture. Release of moisture from the stopper over …
in their capacities to absorb and release moisture. Release of moisture from the stopper over …
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 …
Impact of different elastomer formulations on moisture permeation through stoppers used for lyophilized products stored under humid conditions
H Sasaki, J Kikuchi, T Maeda… - PDA journal of …, 2010 - journal.pda.org
The purpose of this study was to evaluate the effect of moisture permeability of different
elastomer formulation stoppers, which had different moisture absorption abilities, on the …
elastomer formulation stoppers, which had different moisture absorption abilities, on the …
Evaluation of container closure system integrity for frozen storage drug products
A Nieto, H Roehl, H Brown, J Nikoloff… - PDA journal of …, 2016 - journal.pda.org
Sometimes, drug product for parenteral administration is stored in a frozen state (eg,–20° C
or–80° C), particularly during early stages of development of some biotech molecules in …
or–80° C), particularly during early stages of development of some biotech molecules in …
Sealing Behaviour of Container Closure Systems under Frozen Storage Conditions: Nonlinear Finite Element Simulation of Serum Rubber Stoppers
A Nieto, H Roehl - PDA journal of pharmaceutical science and …, 2018 - journal.pda.org
There has been a growing interest in recent years in the assessment of suitable vial/stopper
combinations for storage and shipment of frozen drug products. Considering that the glass …
combinations for storage and shipment of frozen drug products. Considering that the glass …
Container/closure integrity testing and the identification of a suitable vial/stopper combination for low-temperature storage at− 80° C
B Zuleger, U Werner, A Kort, R Glowienka… - PDA Journal of …, 2012 - journal.pda.org
It was recently found that after storage of a live viral vaccine at− 80° C in glass vials closed
with rubber stoppers, a phenomenon was revealed which had not been observed before …
with rubber stoppers, a phenomenon was revealed which had not been observed before …
Related searches
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