The pharmaceutical vial capping process: container closure systems, capping equipment, regulatory framework, and seal quality tests
R Mathaes, HC Mahler, JP Buettiker, H Roehl… - European Journal of …, 2016 - Elsevier
Parenteral drug products are protected by appropriate primary packaging to protect against
environmental factors, including potential microbial contamination during shelf life duration …
environmental factors, including potential microbial contamination during shelf life duration …
Studies on contamination of intravenous solutions from PVC-bags with dynamic headspace GC-MS and LC-diode array techniques
A Arbin, S Jacobsson, K Hänninen, A Hagman… - International journal of …, 1986 - Elsevier
The contamination of intravenous solutions from PVC-bags was studied by:(1) dynamic
headspace GC-MS of the PVC-material; and (2) screening and identification of the impurities …
headspace GC-MS of the PVC-material; and (2) screening and identification of the impurities …
Parenteral container closure systems
R Mathaes, A Streubel - Challenges in Protein Product Development, 2018 - Springer
Parenteral container closure systems are in direct contact with the drug product formulation
and can significantly impact the product quality. The interaction between the drug product …
and can significantly impact the product quality. The interaction between the drug product …
Production of parenterals in hospital pharmacies: II. Testing of recipients
ETHGJ Oremus, FA Boom, BH Graatsma - Pharmaceutisch weekblad, 1981 - Springer
Glass bottles with rubber closures are in most Dutch hospitals the recipients for large and
small volume parenterals. During 'in-process control', attention can be paid to the various …
small volume parenterals. During 'in-process control', attention can be paid to the various …
[BOOK][B] Development of improved physicochemical test procedures for pharmaceutical elastomeric closures
CJ Milano - 1998 - search.proquest.com
Due to their unique physical and chemical properties, elastomers have been used as
closures for pharmaceuticals since the early 1900's. Over the years, however, extractables …
closures for pharmaceuticals since the early 1900's. Over the years, however, extractables …
A new methodology to evaluate the mechanical properties of elastomeric closures
E Zour, G Okoye, SA Lodhi… - Drug development and …, 1992 - Taylor & Francis
A quantitative method was developed to evaluate the mechanical properties of elastomeric
closures commonly used in liquid parenteral dosage forms. The new methodology was …
closures commonly used in liquid parenteral dosage forms. The new methodology was …
[CITATION][C] Validation of sterile products
MJ Akers, NR Anderson - Drugs and the pharmaceutical …, 1993 - pascal-francis.inist.fr
Validation of sterile products CNRS Inist Pascal-Francis CNRS Pascal and Francis
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