Sterile Filtration of Pharmaceutical Products - Validation and Regulatory Requirements

• Sterile filtration is amongst the major basic steps in sterile pharmaceutical production. This is as a result of the filtration procedure that provides sterility certainty in the finished drug items.
• Therefore, the plan, approval and continuous supervision of a sterile filtration system are significant for guaranteeing the quality and security of the pharmaceutical product.
• Appropriate comprehension and testing of the sterile filtration system as indicated by the international regulatory standards is critical for both the approval and progressing monitoring of the system.

Why should you attend ?

• It is vital that the sterile filtration process is completely comprehended and appropriately approved for your specific application. The procedure prerequisites and approval needs are different based on the filtration necessity. This webinar will enable you to have a broad comprehension of this essential topic with an emphasis on the diverse kinds of sterilizing filtration accessible and their application to your specific system. For instance, the utilization of sterile filtration to use point compacted air is talked about in detail.
• A study on diverse filtration media is delivered along with the characteristics and features of the structure of every point.  of the diverse filtration media is given the development qualities and properties of each point by point. A comprehensive description of a normal pharmaceutical sterile filtration system with its distinct component is given. engineering representations are incorporated. Microbiology and molecule retention components are examined.
• Integrity testing techniques are examined and in addition media criterion. Techniques for the cleansing of the filter are displayed (SIP, autoclave, and so forth.).
• The appropriate approval of sterile filtration is imperative to guarantee that the filter will reproducibly get rid of unwanted components (bioburden) while permitting entry of desirable components (drug item). The working parameters of time, weight and temperature are completely examined and also the filters possible impact on the products (similarity, endotoxin, leachable, fibers, and so on.). Microbial maintenance trial testing is one of the validation necessities.
• Finally, an assemblage of all FDA/EU GMP administrative directions concerning sterile filtration is introduced. In connection with this; the obligations of the filter producer versus the users of filters is broadly examined.

Areas Covered in the Session :

• Endorsement of Sterile Filter Systems
• Microbial Retention Challenge Testing
• Regulatory Requirements
• Sterile filtration - Significance of Quality
• Sterility Assurance of Sterile Filtration
• Sterile Filtration System Design
• Product Compatibility Testing
• Extractable/Leachable Testing
• Discussion of diverse Filtration Media Properties and Retention Mechanisms
• How to sterilize filters
• Integrity Testing

Who will benefit:

the webinar will give beneficial help to all staff in:

• Validation 
• Microbiology
• Manufacturing
• Engineering
• Maintenance
• Quality Assurance
• Environmental Monitoring