Customized Analytical Services
Customized Analytical Services are specialized services dedicated to partnering with your regular R&D and process developmental activities that will help you meet your business objective faster with the right and quality data.
Customized Analytical Services list includes.
- Surface tension measurement of fluids
- Viscosity measurement of fluids
- Integrity testing of the filter elements
- Particulate contamination analysis
- Filtration process optimization studies
- Extractable analysis for the polymeric process components
Surface Tension – "The intermolecular forces of attraction at the surface of a liquid which in contact with any gas, solid or another immiscible liquid tends to pull the molecules of the liquid inward from the surface". The phenomenon of surface tension arises due to two kinds of intermolecular forces, Cohesion, which is the force of attraction between the molecules of a same liquid enabling the liquid to resist tensile stress and Adhesion, which is force of attraction between the molecules of different liquids or between the molecules of a liquid and those of a solid body when they are in contact with each other. Adhesion enables two different liquids to adhere to each other or a liquid to adhere to a solid body or surface.
Bioture offers the Surface tension measurement of fluid as a service for Process Liquids.
Viscosity – "It is the resistance to flow offered by any fluid as a result of molecular cohesion". The unit of viscosity is generally expressed in Centipoises (cPs).
In general, most of the BioPharma product solutions are viscous in nature as the viscosity enhancers are added for having a better drug delivery at target sites. For example, viscosity enhancers are used in ophthalmic solutions to enable the formulation to remain in the eye for longer duration giving more time for the drug to exert its therapeutic activity or undergo absorption.
Bioture offers the Viscosity measurement of fluid as a service for Process Liquids.
PDA TR 26 states – "Integrity testing is a non destructive physical test that can be correlated to the bacterial retention capability of a filter / filter assembly". Regulatory agencies directs to perform the integrity test of a sterilizing grade filter post-use, but recommends an integrity test pre-use. However, EU Annexure 1 (7), paragraph 113 states: "The integrity of the sterilized filter should be verified before use and should be confirmed immediately after use by an appropriate method such as bubble point, diffusive flow or pressure hold test".
Bioture team has a very good experience in performing the integrity testing of filters and a very successful record on troubleshooting the issues related to filter integrity testing making the entire process simpler, faster and user friendly. The integrity test reports of the individual filters provided can be directly attached to the in-process documentation.
Particulate contamination is one of the critical areas that need to take care of in the manufacture of Bio Pharmaceutical drugs. Particulate matter not only brings down the efficiency of the filter by plugging and reducing its throughput but also becomes a critical quality issue if found in the final drug vials. We at Bioture Labs identify and determine the particulate contamination in Pharmaceutical products and provide manufacturers, a very important data by describing the potential contamination origin. As a service, it includes the detection and identification of particulate contaminants, analysis for impurities and visible particulate leachable. Rapid trouble shooting capabilities and expertise are available for the most demanding and time-sensitive environments.
Analysis for impurities and particulate contaminants, precipitants, visible residues and visible particulate leachable can be identifying by this service.
Filter selection and sizing is one of the critical areas in drug manufacturing process. A proper optimization of filtration train can significantly bring down the overall drug manufacturing cost. Filter selection shall document the choice of the most suitable type(s) of filter, taking into account the chemical and physical characteristics of the filters as established by the filter manufacturers (I.S. EN ISO 13408-2:2011). The filter user shall evaluate filter characteristics following a documented filter evaluation program that takes into account the fluid to be filtered and the process used for filtration. Filter characteristics shall not be adversely affected by the fluid to be filtered; conversely, the product shall not be adversely affected by the filter. Compatibility and process criteria, as applicable, should also be applied to pre filters in view of their intended use.
We have excellent experience in selection and sizing of filters based on compatibility of filter on product and process conditions. A report detailing on filter selection, throughput and sizing depending on filtration area required with available formats starting from small volume batches in R&D to large plant scale batches can be directly attached to the respective in-process documentation.
Extractables – "A chemical component that is removed from a material by the application of an artificial or exaggerated force (e.g. Solvent, temperature or time)" as per the definition of PDA TR 26. The Code of Federal Regulations (CFR), Title 21, Part 211.65 states: "Equipment shall be constructed so that surfaces that contact components, in-process materials, or drug products shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product". Extractable study can be performed on polymeric process equipments by using controlled extraction process. Identification and quantification of the extractable is done using NVR gravimetric analysis, UV-Visible spectrometry, FT-IR and gas chromatography analysis. The detailed report is generated and provided for the necessary documentation.