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View Barry Bardo’s profile on LinkedIn, a professional community of 1 billion members. C.E.O. at Bardo Communications · Technology Business Development and Marketing.
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- Bardo Communications
- Yale University
- Performance qualification.Filters
- Performance qualification requirements
- Validation
- Validation parameters
- Factors affecting microbial retention
- Bracketing
- Extractables.Another
- Adsorption analysis
- Filter manufacturer
- Membrane disk Device
- Summary and conclusion
must be qualified by the user to demonstrate that their performance in processing will meet or exceed minimum process requirements.
flow rates throughput pressure and temperature resistance hydrophilic or hydrophobic membrane composition compatibility membrane support layers,core,or cage o-rings housings The filter must be tested to verify that it provides the flow rates re-quired by the pharmaceutical process. The filter system must be sized to provide flow rates and vol-umes ...
There are four major elements of the filtration validation process: physical/chemical compatibility, usually established during the qualification phase before valida-tion,is confirmed during the val-idation process binding and adsorption filter characteristics are measured in the qualification phase bacteria retention capability of the filter,which...
product contact time differential pressure flow rates per unit area temperature bioburden integrity test correlation sound rationale to support the deci-sion and use it in challenge testing. Temperature.If the liquid tempera-ture is outside the viable range of the challenge bacteria, it may be necessary to recirculate the product at process tempera...
filter type:polymer,structure fluid properties:pH,viscosity,osmolarity, and ionic strength process conditions:temperature,differential pressure,and flow rate bioburden:quantity,composition preconditioned with pharmaceutical product liquid, and one of several options can be followed, prior to conducting the bacterial challenge. Options are to: modif...
challenge extreme products carefully choose family groupings API concentration levels pH,other validates intermediate products Factors affecting bacterial retention. The bacterial challenge procedure addresses the possible influences upon retention of the membrane polymer, liquid, process conditions, and bioburden level. Adverse effects from any ...
product. It involves soaking the fil-ter, boiling off the solvent, drying important as- the residue, and weighing it. The pect of sterile filter validation is ex- weight of residue per filter is calcu-tractables testing. It is important lated. Pharmaceutical products sel-that the filters are not themselves a domly are used for NVR assay, be-source ...
binding of formulation components to filter potential for OOS ingredients identify any problem address problem if necessary The nonvolatile residue (NVR) test from USP ^661& Containers is used to quantify the amount of ex-tractables released by a filter in a particular process stream. NVR typ-ically is tested by using a model sol- filter extractabl...
Integrity test water/solvent V Q, R, L Q, R, L product V — — Bacterial retention water, SLB, etc. product — V, membrane disk Q, L — Q, L — Effects of chemical compat- ibility on filter integrity Toxicity testing Extractables V — V Q Q Q, R, L Q, R, L Q denotes qualification testing process specific;V denotes validation testing; R denotes recommenda...
— Bacteria retention/integrity test relationship data — and selection R V Q Q test methodology Integrity test methodology Bacterial retention/integrity Effects of sterilization methods on filter integrity set by pharmaceutical manufactur-ers. However, if an adsorption prob-lem is experienced with a certain formulation, it should be addressed. Redun...
The validation report summarizes the protocols, results, and interpre-tations of all testing performed. It also provides parameters and proto-cols for performing steam or auto-clave sterilization and integrity test-ing. The report is an important documentation of the validation process. It should be read and un-derstood by all end users involved in...
Leesa D.McBurnie and Barry Bardo* Liquid nitrogen (LN 2) is a widely used freezing and lyophilization agent,but it is also a potential source of contami-nation.LN. 2.
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