Skip to main content

Filter Integrity



Bubble point: The measured differential gas pressure which a wetting liquid (e.g., water, alcohol, product) is pushed out of the largest pores of a wetted porous membrane and a steady stream of gas bubbles or bulk gas flow is detected.

Bubble point test: A test to indicate the maximum pore size of a filter. The differential gas pressure at which a liquid (usually water) is pushed out of the largest pores and a steady stream of gas bubbles is detected from a previously wetted filter under specific test conditions. Used to test filter integrity with specific, validated, pressure values, wetting liquids and temperatures for specific pore-size (and type of) filters.

Water intrusion test/ HydroCorr test : The HydroCorr test is based on the fact that water is repelled by the pores Hydrophobic filters by surface tension and capillary forces. The HydroCorr test is a highly sensitive, non-alcohol, water flow integrity test for hydrophobic membrane filters. The minimum pressure required to force liquid into the largest pores is called the water intrusion pressure.

Integrity testing failure analysis-

1. If a sterilizing grade filter fails for integrity test, it could be due to damaged filter, incorrect assembly, incomplete wetting and possible test problems (but not limited to).
2. Damaged filter could possibly result in non-sterile filtrate while other test problems may produce sterile filtrate.
3. Integrity testing failure analysis shall be carried out to distinguish filter damage and possible test problems to take necessary corrective action and preventive action.
Labels:

Comments

Post a Comment

Popular posts from this blog

Change Management System

US Market (Supplement): Post approval drug manufacturing supplement for NDAs/ ANDA submitted to FDA for Major or Moderate manufacturing change. Major change - If a manufacturing change is considered to be major, an applicant must submit and receive FDA approval of a prior-approval supplement (PAS) before the drug product made with the change is distributed. Moderate change- If a manufacturing change is considered to be moderate, an applicant must submit a supplement at least 30 days before the drug product is distributed (a CBE-30 supplement) or, in some cases, submit a supplement at the time of distribution (a CBE-0 supplement).  “CBE” means “changes-being-effected”. Post manufacturing supplement - 1. CBE 0 (Change being effected before 00 days): 2. CBE 30 (Change being effected before 30 days): 3. PAS (Prior approval supplement): EUROPE Market (Variation): A variation to the terms of a marketing authorization is an amendment to the contents of the docume...
Post a Comment
Read more

NVPC

NVPC Online NVPC: Make= Beckman; Model= Met one 6015P; Capacity= 1CFM SOFTWARE= EnVigil Critical alarm: Critical alarms are those alarms when generated indicate excursion which may impact the product quality. Alarm generated in location where the NVPC probe is in close proximity to the product/ sterile container closure/ product contact path. Location for critical alarms includes grade A location - Filling station, Bunging station, Bunging Hopper station, Portable cart, IOS station, AGV station, Near lyophilizer door open, between lyophilizers (near Lyo) and Lyo LAF (rigid barrier transfer conveyor). Critical alarms include the following- 1.     Particle count excursion beyond the acceptance criteria at a particular location. 2.     Sensor Failure, Counter Flow Failure, ERROR or SKIPPED message. Ensure and verify the status of counter flow to meet the below set limit- Target Counter flow – 1.0 CFM. Minimum counter flow: ...
Post a Comment
Read more

Air velocity measurement and correlation to smoke study

Air velocity measurement As part of risk assessment this evaluation should also consider the selection of locations for the critical control points for monitoring air velocity as well as viable and non-viable particles. 1. Problem Statement- Where should airflow velocity measurements be taken with respect to a filling line or other aseptic processing areas? Recommendation Airflow velocity measurements should be taken at locations where meaningful and reproducible results can be obtained. This is typically at a distance of 6 inches from the filter face . Rationale for Recommendation The primary reason for airflow velocity measurements in unidirectional airflow areas (e.g., areas where product, product contact packaging components, and product contact surfaces are exposed) is to assure there is adequate airflow to protect the materials from external airborne contamination . Accurate measurements can be taken and changes over time detected when airflow velocities are e...
Post a Comment
Read more