Filtering integration

Validation Guidefor the Palltronic FFE03-P Filter Integrity Pest Instrument TRFFE03-P, PaU Corp., East HiUs, N.Y., 1992. 

Filters used in the system (commonly at point of use) should be included in a routine filter integrity testing program. Establish the life cycle of the filters to maintain the system. 

To describe the procedure for validation of the sterile filtration to ensure filter integrity before and after the filtration... 

Filter Integrity Test prior to and after Sterilization... 

Filter Integrity Test after Product Filtration... 

HEPA filter integrity testing is performed at 6-month intervals on level I and level II HEPA filters. HEPA filter testing includes Measuring (Machines, Eilters, Diffusers) Inlet and Outlet Air Velocity or Volume and Integrity Test of HEPA Filters Using Aerosol and Photometer. Refer to (provide reference to attachment no.). 

Key words Drug discovery, chem-informatics, molecular design, combinatorial chemistry, combinatorial library, synthesis protocol, PGVL, reactant, product, enumeration, filtering integration, workflow, streamline, desktop tool, software deployment. 

Thomas, A. J., Durrheim, H. H., Alport, M. J. Validation of filter integrity by measurement of the pore-distribution function. Pharm Tech 16 32-43 (1992). 

Filter integrity, including HEPA filter leak test... 

A) turret mounted discrete filters, integrating sphere and moveable mirror referencing. 

In modern freeze-drying systems, the filter integrity test is carried out automatically. All the relevant process parameters are documented by the control system of the unit. The important thing is to make sure that after every integrity test, the filter and the entire piping system are perfectly dry. This is effected by means of the installed liquid ring pump. 

Regarding device reliability, the stability of a-Si H under such conditions as high light intensity, high temperature, or operation in a vacuum should be confirmed. During fabrication, in addition, decreasing the deposition temperatures to 150°C or less would also be useful if a-Si H were deposited directly on a filter-integrating substrate. 

When the filter integrity test fails, the sterile filtration process must be rejected. 

Once the materials have been sterilized, interventions near either the formulation or product contact surfaces/parts should be minimized. Direct handling of these materials should only be done with sterilized tools or implements nonsterile objects, such as operator gloves, should never directly contact a sterilized surface. Sampling, filter integrity testing, process connection, and other activities should all be designed to eliminate the need for personnel exposure to sterile items. 

Meltzer, T., Agalloco, J., et al. (2001), Filter integrity testing in liquid applications Revisited, Part 1, Pharm Technol, 25(10), and Part 2, Pharm Technol, 25(11). 

High thermal shock resistance to ensure filter integrity during soot regeneration... 

ISO 13408-1 First Edition, 1998-08-1, Aseptic Processing of Health Care Products, Part 1 General requirements Section 17.11.1 Investigation, m. pre- and post-filter integrity test data, and/or filter housing assembly ... 

Filter leakage tests (To verify filter integrity) All classes 24 months Filter penetration tests to be carried out by a recognized authority to demonstrate filter media and filter seal integrity. Only required on HEPA filters. In accordance with ISO 14644-3 Annex B6 ... 

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