UnoVALTM caters to the needs of complete process filter validation services for sterilizing grade liquid filtration or bio burden reduction filtration irrespective of the filter formats used (Cartridges/ Capsules) and regardless of the filter manufacturer. Filters used in critical application for liquid filtration in BioPharma process shall be validated with product intended for manufacturing primarily for the product and application safety and for fulfilling the regulatory requirements.

 

Current Good Manufacturing Practice guidelines for pharmaceutical products suggests for monitoring of impact factors on the medicinal product's safety and efficacy. Evaluation of possible contaminants such as microbial pathogens, toxic chemical contaminants and particulate matter is essential in drug products. UnoVALTM evaluates liquid filters for drug manufacturing process and validates its intended purpose of providing sterile effluent, low bio-burden effluent and particulate free effluent. We examine the filter for altering the quality attributes of drug product either by adding its chemical components during filtration process or by adsorbing API's and excipients from the product. Our scientists will be available to provide comprehensive technical support and expertise to examine the product characteristics and process conditions for optimizing the filtration train and further supports on correct test methods and conditions to validate your processes.

• Our scientists are experts in liquid filter validation studies
• Neutral third party validation service provider
• Consulting service provider for optimization of filtration train
• Sophisticated and modern laboratories
• Novel validation testing procedures
• Unbeatable time-lines for completion of projects
• Scientific bracketing approach with consent
• Most economical validation service provider

 

By using scale down models of process filters we will work on meeting the regulatory expectations and define applicable test conditions for your product formulation based on the actual process conditions. In addition to the current regulatory requirements outlining validation expectations, we follow Parenteral Drug Association Technical Report No. 26 on "Sterilizing Filtration of Liquids". PDA TR 26 which elaborates a systematic approach for selecting and validating the most appropriate filter. As per the regulatory requirements, it is the responsibility of the filter user to evaluate whether the use of a specific filter element impacts the final drug product with regard to its safety and efficacy. We at UnoVAL help you to select a suitable filter for your product and process conditions by optimizing and validating the filtration process.

UnoVALTM Filter Validation Service Includes:

• Product Definite Integrity Test
• Chemical Compatibility Test
• Adsorption Test
• Extractables Test
• Bacterial Viability Test
• Bacterial Challenge Test

Product Definite Integrity Test : Integrity test should be performed on sterilizing grade filters before and immediately after the filtration of medicinal product to confirm the performance intended. In order to optimize processing, it may be more convenient to test the filter by using product filtered, as wetting fluid.
UnoVALTM Validation Services establishes the filter integrity test values for process filtration assemblies wet with process fluid. The values are correlated to a reference fluid value (typically water for hydrophilic filters and 60:40 IPA: Water for Hydrophobic filters). The reference fluid value is correlated to bacterial retention information published in the filter validation guide. Product definite values are then derived from actual test data, and correspondingly correlated to bacterial retention.

Chemical Compatibility Test : Chemical Compatibility testing is performed by evaluating filter's integrity after exposure to worst-case fluid process conditions. The filter is exposed to the process fluid for a specified worst-case time under pre-determined conditions that include: simulated filter sterilization conditions, exposure time exceeding the maximum process time, temperatures exceeding or equaling to maximum process temperature, and differential pressures that exceed process pressures.
Compatibility is determined by comparing integrity test results before and after exposure to product using the reference fluid as wetting solution. Tests are performed on the filter prior to and after worst-case exposure. A visual inspection of the filter element is also conducted.

Adsorption Test : It is critical that filters are selected to minimize adsorption and loss of product ingredients. Laboratory-scale filter tests can be used to generate adsorption profiles to help with filter selections and process qualification.
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".

Extractables Test : Both quantitative and qualitative information on extracted materials must be generated for filters used in the processing of medicinal products. Extractable should be evaluated by using worst-case processing conditions and solvents. Product simulated by using volatile solvents and products characteristics simulated by using worst case parameters are used as extraction fluid. Extraction conditions are dependent on process conditions; therefore the worst case testing conditions will be used for extractables analysis. Quantification by NVR gravimetric analysis, FT-IR, UV-Visible Spectrometry and Gas Chromatographic analysis can be used to analyze the extracted material.

Bacterial Viability Test : Bacterial viability is the study performing to check the test micro organisms ability of surviving in the given product and processing conditions. Products containing preservatives or antibiotic medicinal properties may kill test organisms. This test verifies the survival rate of the organism selected for microbial challenge testing, either in the actual product formulation or in a suitable product simulant, for the process time. The appropriate methodology is then chosen for the bacterial challenge test.

Bacterial Challenge Test : This study determines the ability of a filter membrane to produce sterile effluent in the given process conditions. Every sterilizing grade filter is design to remove all micro organisms from the fluids passing through it and provide sterile effluents. Sterilizing grade filters will be tested before releasing into market by using a constant temperature and reference fluids (either water or alcohol-water mixture) as per the release criteria of filter manufacturers. In modern science, with better and new formulations, the technology of the drug delivery formulations is being continuously developed and improved. Therefore the ability of retaining microorganisms of a filter in the new and improved formulations and its processing conditions were not known and should be test by the Pharmaceutical manufacturer. A sample of the product or simulant is inoculated with the challenge organism at a concentration > 1 x 107 colony forming units/cm2 of filter membrane area. The challenge is performed on three filter membranes from different production batches.